81 FR 30451 - Significant New Use Rules on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 94 (May 16, 2016)
Federal Register Volume 81, Issue 94 (May 16, 2016)
| Page Range | 30451-30481 | |
| FR Document | 2016-11121 |
[Federal Register Volume 81, Number 94 (Monday, May 16, 2016)] [Rules and Regulations] [Pages 30451-30481] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11121] [[Page 30451]] Vol. 81 Monday, No. 94 May 16, 2016 Part III Environmental Protection Agency ----------------------------------------------------------------------- 40 CFR Parts 9 and 721 Significant New Use Rules on Certain Chemical Substances; Final Rule Federal Register / Vol. 81 , No. 94 / Monday, May 16, 2016 / Rules and Regulations [[Page 30452]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2015-0810; FRL-9944-77] RIN 2070-AB27 Significant New Use Rules on Certain Chemical Substances AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. ----------------------------------------------------------------------- SUMMARY: EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 55 chemical substances which were the subject of premanufacture notices (PMNs). Ten of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture (defined by statute to include import) or process any of these 55 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 will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. DATES: This rule is effective on July 15, 2016. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on May 31, 2016. 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 June 15, 2016 (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 June 15, 2016, 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-2015-0810, by one of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: [email protected]. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture (defined by statute to include import), process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: Manufacturers, or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of a proposed or final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec. 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D. B. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html. II. Background A. What action is the Agency taking? 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) (FRL-3658-5). 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 [[Page 30453]] that a use of a chemical substance is a ``significant new use.'' EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use. Persons who must report are described in Sec. 721.5. C. Applicability of General Provisions General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to Sec. 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action. 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 55 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 55 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 (assigned for non-confidential chemical identities). Basis for the TSCA section 5(e) consent order or the basis for the TSCA non-section 5(e) SNURs (i.e., SNURs without TSCA section 5(e) consent orders). 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 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 10 PMN substances (P-11-150, P-11-484, P-11-543, P-14-67, P-15-59, P-15-60, P-15-104, P-15-154, P-15-328, and P-15-502) that are subject to ``risk-based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called ``TSCA section 5(e) SNURs'' on these PMN substances are promulgated pursuant to Sec. 721.160, and are based on and consistent with the provisions in the underlying consent orders. The TSCA section 5(e) 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 Sec. 721.30 requests 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. This rule also includes SNURs on 45 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a ``significant new use.'' These so-called ``TSCA non-section 5(e) SNURs'' are promulgated pursuant to Sec. 721.170. EPA has determined that every activity designated as a ``significant new use'' in all TSCA non-section 5(e) SNURs issued under Sec. 721.170 satisfies the two requirements stipulated in Sec. 721.170(c)(2), i.e., these significant new use activities are different from those described in the premanufacture notice for the substance, including any amendments, [[Page 30454]] deletions, and additions of activities to the premanufacture notice, and may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified'' for the PMN substance. PMN Number P-11-150 Chemical name: Alkali transition metal oxide (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: April 14, 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a battery material. Based on test data on the PMN substance and structural activity relationship (SAR) analysis of test data on analogous respirable, poorly soluble particulates, subcategory titanium dioxide, EPA identified concerns for lung, blood, kidney, and adrenal toxicity, neurotoxicity, developmental toxicity, developmental neurotoxicity, cardiovascular and gastrointestinal effects, and immunosuppression. The Order was issued under TSCA sections 5(e)(1)(A)(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. Hazard communication. Establishment and use of a hazard communication program, including human health precautionary statements on each label and the Material Safety Data Sheet (MSDS). 2. Use of personal protective equipment including a National Institute of Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10 or compliance with a New Chemicals Exposure Limit (NCEL) of 2.4 milligrams/cubic meter (mg/m\3\) as an 8-hour time-weighted average, when there is potential inhalation exposure. 3. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the consent order of the PMN substance. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the results of a 90- day inhalation toxicity test (OPPTS Test Guideline 870.3465) with special attention to histopathology (inflammation and cell proliferation) of the lung tissues and various parameters of the bronchoalveolar lavage fluid (BALF) e.g., maker enzyme activities, total protein content, total cell count, cell differential, and cell viability. It is not necessary to look at internal organs. EPA recommends that a recovery period of 60 days be included to assess the progression or regression of any lesions would help characterize possible health effects of the substance. The submitter has agreed to complete this testing by the confidential aggregate production volume identified in the consent order. In addition, EPA has determined that the results of a carcinogenicity test (OPPTS Test Guideline 870.4200) would help characterize the potential human health effects of the PMN substance. The Order does not require this test at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.10875. PMN Numbers P-11-484 and P-11-543 Chemical names: Perfluoroalkyl substituted alkyl sulfonate (generic) (P-11-484); and Polyfluorinated alkyl quaternary ammonium chloride (generic) (P-11-543). CAS numbers: Claimed confidential. Effective date of TSCA section 5(e) consent order: October 30, 2014. Basis for TSCA section 5(e) consent order: The PMNs state that the generic (non-confidential) use of the substances will be as surfactants. Based on physical chemical properties data, as well as test data on analogous perfluorinated chemicals and potential perfluorinated degradation products including perfluorooctanoic acid (PFOA), perfluorooctanesulfonate (PFOS), perfluorohexane sulfonate (PFHS), and 1H,1H,2H,2H-perfluorooctanesulfonic acid (6-2 FTSA), EPA identified concerns for irritation to skin, eyes, lungs, mucous membranes, lung toxicity, liver toxicity, blood toxicity, male reproductive toxicity, immunosupression, and oncogenicity. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild mammals, and birds. Further, based on test data on P-11-484, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2,800 and 1 part per billion (ppb) respectively for PMN substances P-11-484 and P-11-543 respectively in surface waters. The Order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based on a finding that these substances may present an unreasonable risk of injury to the environment and human health, the substances may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substances and their potential degradation products. To protect against these exposures and risks, the consent order requires: 1. Risk notification. If as a result of the test data required, the company becomes aware that the PMN substances may present a risk of injury to human health or the environment, the company must incorporate this new information, and any information on methods for protecting against such risk into an MSDS, within 90 days. 2. Submission of certain physical/chemical property, human health and environmental toxicity, and environmental fate testing prior to exceeding the confidential production volume limits specified in the consent order. 3. Recording and reporting of certain fluorinated impurities in the starting raw material; and manufacture of the PMN substances not to exceed the maximum established impurity levels of certain fluorinated impurities. 4. Use of the PMN substances only for the confidential uses specified in the consent order, where use in consumer products that could be spray applied are prohibited. 5. Disposal of the PMN substance according to the incineration conditions specified in the consent order. 6. Comply with the release to water provisions specified in the consent order. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the results of certain environmental fate and human health and environmental toxicity testing would help characterize human health and environmental effects of the PMN substances. The submitter has agreed to conduct the testing identified in the consent agreement by the confidential triggers identified in the consent order. Further, EPA has determined that the results of an acute inhalation toxicity test (OPPTS Test Guideline 870.1300) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a post-exposure observation period of up to 3 months and BALF analysis would help characterize the human health effects from spray application of the PMN substances. The Order does [[Page 30455]] not require this testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CFR citations: 40 CFR 721.10876 (P-11-484) and 40 CFR 721.10877 (P- 11-543). PMN Number P-14-67 Chemical name: Polyfluorinatedalkylsulfonyl substituted alkane derivative (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: November 4, 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a polymer additive. EPA has concerns for potential incineration or other decomposition products of the PMN substance. These fluorinated decomposition products may be released to the environment from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers which suggest that under some conditions, the PMN substance could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild mammals, and birds. These concerns are based on data on analogous chemical substances, including PFOA and other perfluorinated alkyls, including the presumed environmental degradant. EPA also has concerns that under some conditions of use, particularly non-industrial, commercial, or consumer use, the PMN substance could cause lung effects, based on limited data on some perfluorinated compounds. Concerns for the PMN substance are for lung toxicity from waterproofing of lung membrane, based on PMN properties. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that these substances and their potential degradation products may present an unreasonable risk of injury to the environment and human health. 1. Risk notification. If as a result of the test data required, the company becomes aware that the PMN substance may present a risk of injury to human health or the environment, the company must incorporate this new information, and any information on methods for protecting against such risk into an MSDS, within 90 days. 2. Submission of certain environmental fate testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the consent order of the PMN substance. 3. No use of the PMN substance in consumer spray products. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the results of the modified aerobic activated sludge biodegradation test submitted by the company for EPA review would help characterize the possible degradation of the PMN substance. The submitter has agreed to submit the results of this test by the confidential production volume identified in the consent order. EPA had determined that the results of a phototransformation of chemicals on soil surfaces (Organisation for Economic Co-operation and Development (OECD) Draft Document January 2002) would help characterize the degradation potential of the PMN substance. The Order does not require this testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.10878. PMN Number P-14-125 Chemical name: 1-Octadecanaminium, N-(3-chloro-2-hydroxypropyl)- N,N-dimethyl-, chloride (1:1). CAS number: 3001-63-6. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a chemical intermediate for surfactant production. Based on test data on the PMN substance, as well as SAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 2 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use resulting in surface water concentrations exceeding 2 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10879. PMN Numbers P-14-153, P-14-154, P-15-79, and P-15-80 Chemical names: Fatty acid rxn products with aminoalkylamines (generic). CAS numbers: Claimed confidential. Basis for action: The PMN states that these substances will be used as chemical intermediates, additives for flotation products, and as adhesion promoters for use in asphalt applications. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters. For the uses described in the PMN, releases of the substances are not expected to result in surface water concentrations exceeding 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances, excluding the uses described in the PMNs, result in in releases to surface water concentrations exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (Office of Chemical Safety and Pollution Prevention (OCSPP) Test Guideline 850.4500); log Kow and water solubility measurements; as well as either the fish acute toxicity mitigated by humic acid test (OPPTS Test Guideline 850.1085) or the whole sediment acute toxicity invertebrates, freshwater test (OPPTS Test Guideline 850.1735) would help characterize the environmental effects of the PMN substances. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substance and mixtures (OECD Test Guideline 23) be consulted to [[Page 30456]] facilitate solubility in the test media. Testing should be tiered, starting with water solubility and log Kow measurements before proceeding with higher tier toxicity tests. CFR citation: 40 CFR 721.10880. PMN Numbers P-14-155 and P-14-156 Chemical names: Fatty acid amides (generic). CAS numbers: Claimed confidential. Basis for action: The PMNs state that the substances will be used as chemical intermediates, additives for flotation products, and adhesion promoters for use in asphalt applications. Based on SAR analysis of test data on analogous amides and aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 and 3 ppb respectively of the PMN substances P-14-155 and P- 14-156 in surface waters. For the uses described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed 2 ppb and 3 ppb of the PMN substances respectively. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances, excluding uses described in the PMNs, resulting in surface water concentrations exceeding 2 ppb (P-14-155) or 3 ppb (P-14-156) of the PMN substances may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (OCSPP Test Guideline 850.4500); log Kow and water solubility measurements; as well as either the fish acute toxicity mitigated by humic acid test (OPPTS Test Guideline 850.1085) or the whole sediment acute toxicity invertebrates, freshwater test (OPPTS Test Guideline 850.1735) would help characterize the environmental effects of the PMN substances. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substance and mixtures (OECD Test Guideline 23) be consulted to facilitate solubility in the test media, because of the PMN's low water solubility. Testing should be tiered, starting with water solubility and log Kow measurements before proceeding with higher tier toxicity tests. CFR citation: 40 CFR 721.10881. PMN Number P-14-198 Chemical name: Trialkylammonium borodibenzoate (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a color developer for general printing applications. Based on test data on the PMN substance and SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 47 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from domestic manufacture or from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 47 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing (defined by statute to include import), processing or use of the substance may present an unreasonable risk. EPA has determined, however, that any domestic manufacture or use of the substance other than as listed in the PMN may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10882. PMN Number P-14-324 Chemical name: Fatty ester derivatives, reaction products with alkanolamine, hydroxylated, borated (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the substance will be used as a lubricating oil additive. Based on SAR analysis of test data on analogous boron compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 2 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing (defined by statute to include import), processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as a lubricating oil additive may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a chronic fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10883. PMN Number P-14-397 Chemical name: Benzenepropanol, 1-benzoate. CAS number: 60045-26-3. Basis for action: The PMN states that the substance will be used as a plasticizer in adhesives for food-product packaging, a diluents-type plasticizer in plastisols, a coalescent in architectural paints and coatings, and a fragrance carrier in fragrances. Based on SAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20- day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from uses other than as described in the PMN, exceed releases from the uses described in the PMN. For the uses described in the PMN, environmental releases did not exceed 5 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as listed in the PMN may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). [[Page 30457]] Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10884. PMN Number P-14-448 Chemical name: Alcohols, C 12-22 , distn. residues. CAS number: 1476777-83-9. Basis for action: The PMN states that the use of the substance will be used in formulation of defoamers used in the production of paper. Based on structure-activity relationship SAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface waters exceed releases from the use described in the PMN. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 7 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, any use where the cumulative molecular weights of the C12 and C14 components exceed 2 percent by weight of the overall molecular weight of the PMN substance may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. Before conducting these aquatic toxicity testing, EPA recommends chemical characterization of the alkyl range for the alcohol moiety and a water solubility test (OECD Test Guideline 105) should be conducted. CFR citation: 40 CFR 721.10885. PMN Number P-14-501 and P-14-502 Chemical names: Phosphoric acid, mixed Bu and decyl and octyl and 2-(2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters (P-14-501), and Phosphoric acid, mixed Bu and decyl and octyl and 2-(2- phenoxyethoxy)ethyl and 2-phenoxyethyl esters, potassium salts (P-14- 502). CAS numbers: 1502809-48-4 (P-14-501) and 1502809-56-4 (P-14-502). Basis for action: The PMN states that substances will be used as gellants for use in oil fracturing. Based on structure-activity relationship (SAR) analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb of the PMN substances in surface waters. As described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed 4 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of substances resulting in releases to surface water concentrations exceeding 4 ppb may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances. CFR citations: 40 CFR 721.10886 (P-14-501) and 40 CFR 721.10887 (P- 14-502). PMN Numbers P-15-59, P-15-60, and P-15-104 Chemical names: Siloxanes and Silicones, 3-[(2- aminoethyl)amino)propyl Me, di-Me, reaction products with cadmium zinc selenide sulfide, lauric acid and oleylamine (P-15-59); Dodecanoic acid, reaction products with cadmium zinc selenide sulfide and oleylamine (P-15-60); and Phosphonic acid, P-tetradecyl-, reaction products with cadmium selenide (CdSe) (P-15-104). CAS numbers: 1623456-05-2 (P-15-59); 1773514-92-3 (P-15-60); and 1773514-66-1 (P-15-104). Effective date of TSCA section 5(e) consent order: May 5, 2015. Basis for TSCA section 5(e) consent order: The PMNs state that the substances will be used as a down converter for an optical filter for light emitting diodes used in displays (P-15-59) and as chemical intermediates (P-15-60 and P-15-104). Based on SAR analysis of test data on analogous respirable, poorly soluble particulates and the presence of cadmium, EPA identified concerns for lung effects, kidney effects, and oncogenicity. In addition, EPA predicts chronic toxicity to aquatic organisms from exposure to cadmium. The Order was issued under TSCA sections 5(e)(1)(A)(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 impervious gloves to prevent dermal exposures, where there is a potential for dermal exposures. 2. Submission of certain material characterization data on P-15-59 by the time triggers specified in the consent order. 3. Manufacture, process, or use the PMN substances only in a liquid formulation. 4. Manufacture, process, and use P-15-59 only as a down converter for an optical filter for light emitting diodes used in displays. 5. Manufacture, process, and use of P-15-60 and P-15-104 only as chemical intermediates. 6. Disposal of the PMN substances only by incineration in a permitted hazardous waste incinerator. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the development of data on certain material characterization data specified in the consent order on PMN substance P-15-59 would help characterize the possible effects of the PMN substance. The submitter has agreed to submit the results of these studies prior to 3 and 18 month time triggers identified in the consent order. In addition, EPA determined that the results of a metabolism and pharmacokinetics test (OPPTS Test Guideline 870.7485) would help characterize the human health and environmental effect of the PMN substance. The Order does not require this testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is [[Page 30458]] modified or revoked by EPA based on submission of that or other relevant information. CFR citations: 40 CFR 721.10888 (P-15-59), 40 CFR 721.10889 (P-15- 60), and 40 CFR 721.10890 (P-15-104). PMN Number P-15-81 Chemical name: Alkyl silicate, polymer with 2-(chloromethyl)oxirane and 4,4'0-(1-methylethylidene)bis[phenol], alkoxylated (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as an ingredient in liquid paint coating. Based on SAR analysis of test data on analogous epoxides, there were health concerns regarding skin and lung sensitization, mutagenicity, oncogenicity, developmental toxicity, male reproductive, liver, and kidney toxicity based on the epoxide oxidation product as well as irritation and lung toxicity expected from the ethoxy silane hydrolysis product from exposure to the PMN substance via dermal exposure. Further, based on SAR analysis of test data on analogous epoxides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, occupational exposures are expected to be minimal due to use of adequate dermal personal protection equipment and releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use without the use of impervious gloves, where there is a potential for dermal exposure, or any use of the substance resulting in surface water concentrations exceeding 1 ppb may result in serious human health or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(1)(i)(C), (b)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a combined repeated dose toxicity study with the reproduction/ developmental toxicity screening test (OECD Test Guideline 422); a Zahn-Wellens/EMPA test (OPPTS Test Guideline 835.3200); a fish early- life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.10891. PMN Number P-15-109 Chemical name: Reaction product of a mixture of aromatic dianhydrides and aliphatic esters with an aromatic diamine (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance is as an intermediate. Based on SAR analysis of test data on analogous anilines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 11 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 11 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 11 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (OCSPP Test Guideline 850.4500); and a ready biodegradability test (OECD Test Guideline 301) would help characterize the environmental effects of the PMN substance. EPA recommends that the fate testing be performed first as the results may mitigate the need for further toxicity testing or change the testing recommendations. CFR citation: 40 CFR 721.10892. PMN Number P-15-111 Chemical name: Fatty acids, tall-oil, reaction products with an ether and triethylenetetramine (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a hardener for coating systems. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 1 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing (defined by statute to include import), processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any domestic manufacture of the substance, or any use of the PMN substance other than as described in the PMN may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (OCSPP Test Guideline 850.4500); and a ready biodegradability test (OECD Test Guideline 301) would help characterize the environmental effects of the PMN substance. EPA recommends that the fate testing be performed first as the results may mitigate the need for further toxicity testing or change the testing recommendations. CFR citation: 40 CFR 721.10893. PMN Number P-15-120 Chemical name: Substituted benzyl acrylate (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a resin for industrial coating. Based on SAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish [[Page 30459]] early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (OCSPP Test Guideline 850.4500); and a ready biodegradability test (OECD Test Guideline 301) would help characterize the environmental effects of the PMN substance. EPA recommends that the fate testing be performed first as the results may mitigate the need for further toxicity testing or change the testing recommendations. CFR citation: 40 CFR 721.10894. PMN Number P-15-154 Chemical name: Fluoroalkyl acrylate copolymer (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: May 14, 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a textile treatment. The Order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based on a finding that the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires: 1. Risk notification. If as a result of the test data required, the company becomes aware that the PMN substances may present a risk of injury to human health or the environment, the company must incorporate this new information, and any information on methods for protecting against such risk into an MSDS, within 90 days. 2. Manufacture of the PMN substance: (a) According to the chemical composition section of the consent order, including analyzing and reporting certain starting raw material impurities to EPA; and (b) within the maximum established limits of certain fluorinated impurities of the PMN substance as stated in the consent order. 3. Submission of certain toxicity, physical-chemical property, and environmental fate testing on the PMN substance prior to exceeding the confidential production volume limits as specified in the consent order. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the results of certain toxicity and environmental fate testing would help characterize the PMN substance. The submitter has agreed to complete the testing identified in the testing section of the consent order by the confidential limits specified. In addition, EPA has determined that the results of a 90-day inhalation toxicity test in rats (OPPTS Test Guideline 870.3465/OECD Test Guideline 413) with a 60-day holding period, and certain physical chemical property and environmental fate testing identified in the consent order would help characterize the human health and fate effects of the PMN substance. The Order does not require this testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.10895. PMN Number P-15-176 Chemical name: 1-Hexanol, 6-mercapto-. CAS number: 1633-78-9. Basis for action: The PMN states that the substance will be used as a chemical intermediate to curable monomers. Based on SAR analysis of test data on analogous thiols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 8 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 8 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that results in surface water concentrations exceeding 8 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP Test Guideline 850.4500); and a ready biodegradability test (OECD Test Guideline 301B) would help characterize the environmental effects of the PMN substance. EPA recommends that the fate testing be performed first as the results may mitigate the need for further toxicity testing or change the testing recommendations. CFR citation: 40 CFR 721.10896. PMN Number P-15-177 Chemical name: Phenol, 2,2'-[1,2-disubstituted-1,2- ethanediyl]bis(iminomethylene)bis[substituted- (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a catalyst in the process to manufacture a crop protection chemical. Based on test data on the PMN substance, EPA identified concerns for blood toxicity to workers from dermal exposures to the PMN substance. As described in the PMN, occupational exposures are expected to be minimal due to use of adequate dermal personal protection equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without the use of chemical impervious gloves, where there is a potential for dermal exposure, or any use of the substance other than as described in the PMN may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(i). Recommended testing: EPA has determined that the results of a skin absorption, In vitro method (OECD Test Guideline 428) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10897. PMN Number P-15-188 Chemical name: Carbomonocycles, polymer with substituted heteromonocycle, succinate, methyl acrylate (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the substance will be used as a pigment-wetting resin for Ultra Violet (UV)-curable coatings. Based on SAR analysis of test data on analogous methacrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 7 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as [[Page 30460]] listed in the PMN may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a water solubility test (OECD Test Guideline 105); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. The water solubility testing should be conducted prior to conducting the ecotoxicity testing as the results of the water solubility may change the recommended ecotoxicity testing. CFR citation: 40 CFR 721.10898. PMN Number P-15-190 Chemical name: Halogenated alkyl trimethylaminium halide (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be for cationization of starch. Based on test data on analogous alkylating agents, there were health concerns regarding mutagenicity, oncogenicity, developmental toxicity and respiratory sensitization based from exposure to the PMN substance via inhalation exposure. In addition, based on SAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 88 ppb of the PMN substance in surface waters. As described in the PMN, exposure is expected to be minimal due to use of adequate respiratory personal protection equipment and releases of the substance are not expected to result in surface water concentrations that exceed 88 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use without the use of NIOSH-certified respirator with an APF of at least 10, where there is a potential for respiratory exposure, or any use of the substance resulting in surface water concentrations exceeding 88 ppb may result in serious human health or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(1)(i)(C), (b)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a bacterial reverse mutation test, (OPPTS Test Guideline 870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395); an acute oral toxicity test (OPPTS Test Guideline 870.1100); a repeated dose 28-day oral toxicity study in rodents (OPPTS Test Guideline 870.3050); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity mitigated by humic acid test (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.10899. PMN Number P-15-252 Chemical name: Titanium salt, reaction products with silica (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a chemical intermediate. Based on SAR analysis of test data on analogous insoluble metal oxides, EPA identified concerns for lung toxicity if inhaled based on lung overload for respirable, poorly soluble particulates. For the use described in the PMN, inhalation exposures are expected to be minimal as the PMN is handled in an enclosed process. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use in a non-enclosed process, or any use of the substance other than listed in the PMN may result in significant adverse human health effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has determined that the results of a 90- day inhalation toxicity test (OPPTS Test Guideline 870.3465) with 60- day holding period and a particle size distribution/fiber length and diameter distributions (OECD Test Guideline 110) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10900. PMN Number P-15-272 Chemical name: Formaldehyde, reaction products with aniline and aromatic mono- and di-phenol mixture (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a resin. Based on SAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP Test Guideline 850.4500); and a ready biodegradability (OECD Test Guideline 301) would help characterize the environmental effects of the PMN substance. EPA recommends that the fate testing be performed first as the results may mitigate the need for further toxicity testing or change the testing recommendations. CFR citation: 40 CFR 721.10901. PMN Number P-15-276 Chemical name: Functionalized carbon nanotubes (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the substance will be used as a thin film for electronic device applications. Based on SAR analysis of test data on analogous carbon nanotubes and other respirable poorly soluble particulates, EPA identified potential lung effects and skin penetration and toxicity induction from inhalation and dermal exposure to the PMN substance. Further, EPA predicts toxicity to aquatic organisms via releases of the PMN substance to surface water. Although there is potential for dermal exposure, EPA does not expect significant occupational exposures due to the use of impervious gloves, and because the PMN is used in a liquid and is not spray applied except in a closed system. Further, EPA does not expect environmental releases during the use identified in the PMN submission. Therefore, EPA has not determined that the proposed manufacturing, processing, and or use of the substance may present an unreasonable risk to human health or the environment. EPA has determined, however, that any use [[Page 30461]] of the substance without the use of impervious gloves, where there is potential for dermal exposure; manufacturing the PMN substance for use other than as a thin film for electronic device applications; manufacturing, processing, or using the PMN substance in a form other than a liquid; use of the PMN substance involving an application method that generates a mist, vapor, or aerosol except in a closed system; or any release of the PMN substance into surface waters or disposal other than by landfill or incineration may cause serious health effects or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (OCSPP Test Guideline 850.4500); a 90-day inhalation toxicity test (OPPTS 870.3465) with additional testing parameters beyond those noted at CFR 870.3465, for using the 90-day subchronic protocol for nanomaterial assessment; a two-year inhalation bioassay (OPPTS Test Guideline 870.4200); and a surface charge by electrophoresis (for example, using ASTM E2865-12 or NCL Method PCC-2-- Measuring the Zeta Potential of Nanoparticles) would help characterize the health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.10902. PMN Number P-15-295 Chemical name: Acrylated mixed metal oxides (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as an intermediate. Based on SAR analysis of test data on respirable poorly soluble particulates, EPA identified potential lung effects and dermal toxicity from inhalation and dermal exposure to the PMN substance. Further, EPA predicts toxicity to aquatic organisms via releases of the PMN substance to surface water. Although there is potential for dermal exposure, EPA does not expect significant occupational exposures due to the use of impervious gloves, and because the PMN is used in a liquid and is not spray applied. Further, EPA does not expect environmental releases during the use identified in the PMN submission. Therefore, EPA has not determined that the proposed manufacturing, processing, and or use of the substance may present an unreasonable risk to human health or the environment. EPA has determined, however, that any use of the substance without the use of impervious gloves, where there is potential for dermal exposure; manufacturing, processing, or using the PMN substance in a form other than as a liquid; use of the PMN substance involving an application method that generates a mist, vapor, or aerosol; any release of the PMN substance into surface waters; or disposal other than by landfill or incineration may cause serious health effects or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii) and (b))(ii). Recommended testing: EPA has determined that the results of a 90- day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60- day holding period; a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental and health effects of the PMN substance. CFR citation: 40 CFR 721.10903. PMN Number P-15-306 Chemical name: Phenol, 1,1-dimethylalkyl derivatives (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a process intermediate. Based on SAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 13 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 13 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 13 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP Test Guideline 850.4500); and a Zahn-Wellens/EMPA test (OPPTS Test Guideline 835.3200) would help characterize the environmental effects of the PMN substance. EPA recommends that the fate testing be performed first as the results may mitigate the need for further toxicity testing or change the testing recommendations. CFR citation: 40 CFR 721.10904. PMN Number P-15-319 Chemical name: Butanedioic acid, 2-methylene-, dialkyl ester (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as an intermediate for production of a lubricant additive. Based on SAR analysis of test data on analogous acrylates and esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that resulting in surface water concentrations exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP Test Guideline 850.4500); and a ready biodegradability (OECD Test Guideline 301) would help characterize the environmental effects of the PMN substance. EPA recommends that the fate testing be performed first as the results may mitigate the need for further toxicity testing or change the testing recommendations. CFR citation: 40 CFR 721.10905. PMN Number P-15-324 Chemical name: Magnesium alkaryl sulfonate (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the use of the substance will be as a detergent additive in crankcase lubricant applications. Based on submitted test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the [[Page 30462]] PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 1 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as listed in the PMN may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i). Recommended testing: EPA has determined that the results of a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10906. PMN Number P-15-326 Chemical name: Polyfluorohydrocarbon (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a specialty gas and transfer fluid. Based on test data on the PMN substance, EPA identified concerns for neurotoxicity and uncertain concern for cardiac sensitization. Further, based on SAR analysis of test data on analogous substances, EPA identified concerns for developmental toxicity. As described in the PMN, EPA does not expect significant occupational exposures due to use of adequate personal protective equipment, and consumer exposures are not expected as the PMN substance is not used in consumer products. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as listed in the PMN or any use in a consumer product may result in significant adverse human health effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(i) and (b)(3)(ii). Recommended testing: EPA has determined that the results of 90-day inhalation toxicity (OPPTS Test Guideline 870.3465) would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.10907. PMN Number P-15-328 Chemical name: Aluminum calcium oxide salt (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: June 2, 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the PMN substance will be as a cement additive. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung toxicity based on lung overload. The Order was issued under TSCA sections 5(e)(1)(A)(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. Hazard communication. Establishment and use of a hazard communication program, including human health precautionary statements on each label and the MSDS. 2. Use of personal protective equipment including a NIOSH-certified respirator with an APF of at least 10 or compliance with a NCEL of 5 mg/m\3\ as an 8-hour time-weighted average (when there is potential inhalation exposure), when there is potential inhalation exposure. 3. Manufacture, processing or use of the PMN substance only for the use specified in the consent order. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats would help characterize possible health effects of the substance. The Order does not require this testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.10908. PMN Number P-15-332 Chemical name: Polyalkyltrisiloxane (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a site-limited intermediate. Based on SAR analysis of test data on an analogous substance, there were health concerns regarding liver and kidney toxicity, thyroid effects, and reproductive and developmental toxicity from dermal and inhalation exposures to the PMN substance. Further, based on SAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb of the PMN substance in surface waters. EPA also predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. Further, as described in the PMN, exposure is expected to be minimal due to use of adequate respiratory and dermal personal protection equipment and releases of the substance are not expected to result in surface water concentrations exceeding 4 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that results in releases to surface waters exceeding 4 ppb, any use other than that as a site-limited intermediate, or any use without the use of a NIOSH-certified respirator with gas/vapor cartridges and an APF of at least 10 and impervious gloves, may result in serious human health or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a sediment-water lumbriculus toxicity test (OECD Test Guideline 225); a combined repeated dose toxicity study with the reproduction/ developmental toxicity screening test (OECD Test Guideline 422); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance. All ecotoxicity tests should analyze the PMN substance as well as the hydrolysis products. CFR citation: 40 CFR 721.10909. PMN Number P-15-356 Chemical names: Oxirane, 2,2'-[[1-[4-[1-methyl-1-[4-(2- oxiranylmethoxy)phenyl]ethyl]phenyl]ethylidene]bis(4,1- phenyleneoxymethylene)]bis- (P-15- [[Page 30463]] 356, Chemical A); and 2-Propanol, 1,3-bis[4-[1-[4-[1-methyl-1-[4-(2- oxiranylmethoxy)phenyl]ethyl]phenyl]-1-[4-(2- oxiranylmethoxy)phenyl]ethyl]phenoxy]- (P-15-356, Chemical B). CAS numbers: 115254-47-2 (P-15-356, Chemical A) and 180063-56-3 (P- 15-356, Chemical B). Basis for action: The PMN states that the substances will be used as additives in polymer formulation for electronics. Based on test data on the PMN substances and on SAR analysis of test data on analogous epoxides, EPA identified concerns for respiratory sensitization and irritation, mutagenicity, developmental toxicity, male reproduction toxicity, liver and kidney toxicity, and oncogenicity. Additionally, based on SAR analysis of test data on analogous polyepoxides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters. Further, EPA has concerns that the PMN substances are potentially PBT chemicals as described in the New Chemical Program's PBT category (64 FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates that the PMN substances will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. For the use described in the PMN, EPA expects occupational exposures to be minimal and does not expect releases to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances other than as additives in polymer formulation for electronics or any use of the substances resulting in releases to surface waters may cause serious human health or significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 721.170(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(ii). Recommended testing: EPA has determined that the results of a combined repeated dose toxicity study with the reproduction/ developmental toxicity screening test (OECD Test Guideline 422); a sediment-water chironomid life-cycle toxicity test (OECD Test Guideline 233), using spiked water or spiked sediment; a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substances. CFR citations: 40 CFR 721.10910 (P-15-356, chemical A) and 40 CFR 721.10911 (P-15-356, chemical B). PMN Number P-15-363 Chemical name: Aliphatic acrylate (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a monomer. Based on SAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10912. PMN Number P-15-378 Chemical name: Diisocyanato hexane, homopolymer, alkanoic acid- polyalkylene glycol ether with substituted alkane (3:1) reaction products-blocked (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the substance will be used as a dual cure/UV cure adhesion/barrier coating for wood substrates. Based on SAR analysis of test data on analogous diisocyanates, EPA identified concerns for respiratory sensitization. As described in the PMN, EPA does not expect significant occupational dermal or inhalation exposure due to use of adequate personal protective equipment and consumer exposures are not expected as the PMN substance is not used in consumer products. Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified particulate respirator with an APF of at least 10 where there is a potential for inhalation exposure, or any use in consumer products may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10913. PMN Number P-15-382 Chemical name: Polyitaconic acid, sodium zinc salt (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the substance will be used as an odor neutralization for pet litter and cleaning hard surface surfaces, fabrics, skin and hair; an odor neutralization for air car; and an odor neutralization for waste processing and solid waste management in paper, oil, gas, mining, agriculture, food and municipal industries. Based on SAR analysis of test data on analogous zinc salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 4 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as listed in the PMN may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test [[Page 30464]] (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10914. PMN Number P-15-411 Chemical name: Fatty acid esters with polyols polyalkyl ethers (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as an anti-rust coating solution additive. Based on SAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 30 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 30 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 30 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10915. PMN Number P-15-435 Chemical name: 2,7-Naphthalenedisulfonic acid, 4-amino-3- [substituted]-5-hydroxy-6-[(1E)-2-phenyldiazenyl]-, lithium salt (1:3) (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a direct anionic dyestuff for the printing industry. Based on the results of a 28-day oral study for the PMN substance, EPA predicts anemia, effects on the adrenals, spleen, kidney, lymph nodes and immunotoxicity. In addition, based on the lithium salt of the PMN, EPA identified concerns for developmental toxicity and neurotoxicity. Further, based on SAR analysis of test data on analogous azo reduction products, EPA identified concerns for blood effects, developmental toxicity, oncogenicity, and mutagenicity. As described in the PMN, EPA does not expect significant risk to workers due to use of adequate personal protective equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than in a liquid formulation could result in exposures which may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(1)(i)(C), (b)(3)(i) and (b)(3)(ii). Recommended testing: EPA has determined that the results of an ames assay (OPPTS Test Guideline 870.5100) with the rival modification; a mouse micronucleus assay conducted by the oral route (OPPTS Test Guideline 870.5395); and a combined repeated dose and developmental toxicity and reproductive toxicity screening test (OPPTS Test Guideline 870.3650) would help to characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.10916. PMN Number P-15-492 Chemical name: Polymethylsiloxane, distillation residues (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a site-limited intermediate. Based on SAR analysis test data on analogous silanes, EPA identified concerns for mutagenicity, liver and kidney toxicity, thyroid effects, and reproductive and developmental toxicity from dermal and inhalation exposures to the PMN substance. Further, based on SAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. For the intermediate use described in the PMN, occupational exposures are expected to be minimal due to the use of adequate respiratory and dermal personal protection equipment, and releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without the use of a NIOSH- certified respirator with gas/vapor cartridges and an APF of at least 10, where there is a potential for inhalation exposures, any use of the substance without the use of impervious gloves, where there is a potential for dermal exposures; any use of the substance other than an intermediate; or any use of the substance resulting in surface water concentrations exceeding 1 ppb may result in serious human health or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a sediment-water lumbriculus toxicity test (OECD Test Guideline 225) using spiked sediment; a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD Test Guideline 422); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance. All ecotoxicity tests should analyze for the PMN substance as well as the hydrolysis products. CFR citation: 40 CFR 721.10917. PMN Number P-15-502 Chemical name: Perfluorobutanesulfonamide and polyoxyalkylene containing polyurethane (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: November 4, 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a protective treatment. EPA has concerns for potential incineration or other decomposition products of the PMN substance. These fluorinated decomposition products may be released to the environment from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers which suggest that under some conditions, the PMN substance could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild mammals, and birds. These concerns are based on data on analogous chemical substances, including PFOA and other perfluorinated alkyls, including the presumed environmental degradant. EPA also has concerns that under some conditions of use, particularly non-industrial, commercial, or consumer use, the PMN substance could cause lung effects, based on limited data on [[Page 30465]] some perfluorinated compounds. Concerns for the PMN substance are for lung toxicity from waterproofing of lung membrane, based on PMN properties. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that the substance and its potential intermediate and/or ultimate degradation products may present an unreasonable risk of injury to the environment and human health. 1. Risk notification. If as a result of the test data required, the company becomes aware that the PMN substance may present a risk of injury to human health or the environment, the company must incorporate this new information, and any information on methods for protecting against such risk into an MSDS, within 90 days. 2. Submission of certain environmental fate testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the consent order of the PMN substance. 3. No use of the PMN substance in consumer spray products. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the results of an aerobic and anaerobic transformation in soil test (OECD Test Guideline 307) would help characterize the possible degradation of the PMN substance. The submitter has agreed to submit the results of this test by the confidential production volume identified in the consent order. EPA had determined that the results of a phototransformation of chemicals on soil surfaces (OECD Draft Document January 2002) would help characterize the degradation potential of the PMN substance. The Order does not require this testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.10918. PMN Number P-15-542 Chemical name: Quaternary ammonium compounds, (3-chloro-2- hydroxypropyl)coco alkyldimethyl, chlorides. CAS number: 690995-44-9. Basis for action: The PMN states that the substance will be used as an intermediate for surfactant production, and as a chemical intermediate for sale into commerce. Based on SAR analysis of test data on analogous cationic (quaternary ammonium) surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 24 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 24 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 24 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10919. PMN Number P-15-559 Chemical name: Modified diphenylmethane diisocyanate prepolymer with polyol (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a raw material for flexible foam. Based on SAR analysis of analogous diisocyanates, EPA identified concerns for potential dermal and respiratory sensitization from dermal and inhalation exposures, and for pulmonary toxicity from inhalation exposure, to the PMN substance where the average molecular weight is below 7,500 daltons and any molecular weight species is below 1,000 daltons. For the molecular weight distribution described in the PMN, significant occupational exposures are not expected. Therefore, EPA has not determined that the proposed manufacture of the substance may present an unreasonable risk. EPA has determined, however, that any manufacture of the PMN substance with an average molecular weight below 7,500 daltons, and where any molecular weight species is below 1,000 daltons may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10920. PMN Number P-15-573 Chemical name: 2-Furancarboxyaldehyde, 5-(chloromethyl)-. CAS number: 1623-88-7. Basis for action: The PMN states that the use of the substance will be as a chemical intermediate. Based on SAR analysis of test data on analogous aldehydes, the EPA identified human health concerns for liver toxicity, neurotoxicity, sensitization, and cancer to workers exposed through dermal and inhalation routes. For the chemical intermediate use described in the PMN, occupational exposures are expected to be minimal due to the use of adequate personal protective equipment and a continuous reaction process such that no greater than 50 kilograms of the PMN substance is present in the workplace at a given time for this use. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use without the use of a NIOSH- certified respirator with an APF of at least 50, where there is a potential for inhalation exposures; any use without the use of impervious gloves, where there is a potential for dermal exposures, any use of the substance other than as a chemical intermediate; or any use beyond the annual production volume limit of 15,000 kilograms may result in serious human health or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(1)(i)(C) and (b)(3)(ii). Recommended testing: EPA has determined that the results of a skin sensitization (OECD Test Guideline 406) would help characterize the human health effects of the PMN substance; a combined repeated dose toxicity test with the reproduction/developmental toxicity screening test (OECD Test Guideline 422) with functional observational battery (FOB); a standard test method for permeation of liquids and gases through protective clothing materials under conditions of continuous contact (ASTM Test Guideline F739) using the format specified in the standard guide for documenting the results of chemical permeation testing of materials used in protective clothing materials (ASTM Test Guideline F1194-99(2010)); and a carcinogenicity test (OECD Test Guideline 451) would help characterize [[Page 30466]] the human health effects of the PMN substance. CFR citation: 40 CFR 721.10921. PMN Number P-15-607 Chemical name: 1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9- tris(alkyl) derivs. (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as an initiator for polymerization. Based on data on the PMN substance, as well as SAR analysis of test data on analogous peroxides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 56 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 56 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as listed in the PMN may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) using a solvent where the effects of the solvent are already known or measured, would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10922. PMN Number P-15-671 Chemical name: 9-Octadecen-1-amine, hydrochloride (1:1), (9Z)-. CAS number: 41130-29-4. Basis for action: The PMN states that the substance will be used as an emulsifying agent used in the production of asphalt emulsions for chipsealing and other road maintenance techniques. Based on test data for the PMN substance, as well as SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170 (b)(4)(i) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10923. PMN Numbers P-15-689 and P-15-690 Chemical names: Vegetable fatty acid alkyl esters (generic). CAS numbers: Claimed confidential. Basis for action: The PMNs state that the substances will be used as chemical intermediates. Based on SAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early- life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substances to surface water exceeds releases from the use described in the PMN. For the chemical intermediate use described in the PMN, environmental releases did not exceed 1 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances other than as an intermediate may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help to characterize the environmental effects of the PMN substances. Depending on the results of these tests, EPA has determined that the results of an aerobic and anaerobic metabolism test (OECD Test Guideline 308) in aquatic sediment systems test; and a sediment water chironomid life- cycle toxicity test (OECD Test Guideline 233) using spiked water or spiked sediment would help to further characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.10924. 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 10 of the 55 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.). In the other 45 cases, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at Sec. 721.170 were met, as discussed in Unit IV. B. Objectives EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:EPA will receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins. EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use. EPA will be able to regulate prospective manufacturers or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7. [[Page 30467]] 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 Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html. VI. Direct Final Procedures EPA is issuing these SNURs as a direct final rule, as described in Sec. 721.160(c)(3) and Sec. 721.170(d)(4). In accordance with Sec. 721.160(c)(3)(ii) and Sec. 721.170(d)(4)(i)(B), the effective date of this rule is July 15, 2016 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before June 15, 2016. 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 June 15, 2016, 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 10 of the 55 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 41 of the 55 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 May 16, 2016 as the cutoff date for determining whether the new use is ongoing. 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. Test Data and Other Information EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are: 1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)). 2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-5(e) 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. ASTM International standards are available at http://www.astm.org/Standard/index.shtml. In the TSCA section 5(e) consent orders for several of the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study 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 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 [[Page 30468]] 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 40 CFR 721.1725(b)(1). Under these procedures a manufacturer or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in Sec. 721.1725(b)(1) with that under Sec. 721.11 into a single step. If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use. X. SNUN Submissions According to Sec. 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and Sec. 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems. XI. Economic Analysis EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2015-0810. 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. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true: 1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR. 2. The SNUR submitted by any small entity would not cost significantly more than $8,300. A copy of that certification is available in the docket for this action. This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true: A significant number of SNUNs would not be submitted by small entities in response to the SNUR. Submission of the SNUN would not cost any small entity significantly more than $8,300. [[Page 30469]] Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act (UMRA) Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.). E. Executive Order 13132 This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999). F. Executive Order 13175 This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not apply to this action. G. Executive Order 13045 This action is not subject to Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. H. Executive Order 13211 This action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act (NTTAA) In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action. J. Executive Order 12898 This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). XIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects 40 CFR Part 9 Environmental protection, Reporting and recordkeeping requirements. 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: May 3, 2016. 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. * * * * * ------------------------------------------------------------------------ 40 CFR citation OMB control No. ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Significant New Uses of Chemical Substances ------------------------------------------------------------------------ * * * * * 721.10875............................................ 2070-0012 721.10876............................................ 2070-0012 721.10877............................................ 2070-0012 721.10878............................................ 2070-0012 721.10879............................................ 2070-0012 721.10880............................................ 2070-0012 721.10881............................................ 2070-0012 721.10882............................................ 2070-0012 721.10883............................................ 2070-0012 721.10884............................................ 2070-0012 721.10885............................................ 2070-0012 721.10886............................................ 2070-0012 721.10887............................................ 2070-0012 721.10888............................................ 2070-0012 721.10889............................................ 2070-0012 721.10890............................................ 2070-0012 721.10891............................................ 2070-0012 721.10892............................................ 2070-0012 721.10893............................................ 2070-0012 721.10894............................................ 2070-0012 721.10895............................................ 2070-0012 721.10896............................................ 2070-0012 721.10897............................................ 2070-0012 721.10898............................................ 2070-0012 721.10899............................................ 2070-0012 721.10900............................................ 2070-0012 721.10901............................................ 2070-0012 721.10902............................................ 2070-0012 721.10903............................................ 2070-0012 721.10904............................................ 2070-0012 721.10905............................................ 2070-0012 721.10906............................................ 2070-0012 721.10907............................................ 2070-0012 721.10908............................................ 2070-0012 721.10909............................................ 2070-0012 721.10910............................................ 2070-0012 721.10911............................................ 2070-0012 721.10912............................................ 2070-0012 721.10913............................................ 2070-0012 721.10914............................................ 2070-0012 721.10915............................................ 2070-0012 721.10916............................................ 2070-0012 721.10917............................................ 2070-0012 721.10918............................................ 2070-0012 721.10919............................................ 2070-0012 721.10920............................................ 2070-0012 721.10921............................................ 2070-0012 721.10922............................................ 2070-0012 721.10923............................................ 2070-0012 721.10924............................................ 2070-0012 721.10925............................................ 2070-0012 * * * * * ------------------------------------------------------------------------ * * * * * [[Page 30470]] 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. 721.10875 to subpart E to read as follows: Sec. 721.10875 Alkali transition metal oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkali transition metal oxide (PMN P-11-150) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance after it has been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. (A) Requirements as specified in Sec. 721.63(a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b)(concentration set at 0.1 percent), and (c). 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 Assigned Protection Factor (APF) of at least 10 meet the requirements of Sec. 721.63(a)(4): (1) Any NIOSH-certified air-purifying elastomeric half-mask respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters. (2) Any appropriate NIOSH-certified N100 (if oil aerosols absent), R100, or P100 filtering facepiece respirator. (3) Any NIOSH-certified air-purifying full facepiece respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters. (4) Any NIOSH-certified negative pressure (demand) supplied air respirator equipped with a half-mask. (5) Any NIOSH-certified negative pressure (demand) self-contained breathing apparatus (SCBA) equipped with a half-mask. (B) 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 2.4 mg/m\3\ as an 8-hour time weighted average (TWA) verified by actual monitoring data. (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 0.1 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(viii), (g)(1)(ix), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv)(use respiratory protection, or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 2.4 mg/m\3\), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(q). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (d) and (f) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 5. Add Sec. 721.10876 to subpart E to read as follows: Sec. 721.10876 Perfluoroalkyl substituted alkyl sulfonate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluoroalkyl substituted alkyl sulfonate (PMN P-11-484) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80 (k)(analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities; and use other described in the consent order), (o)(use in a consumer product that could be spray applied), and (q). (ii) Disposal. Requirements as specified in Sec. 721.85. Incineration of wastes in an incinerator operating at the temperature of at least 1,000 degrees Celsius and a residence time of minimum of 2 seconds. Any tank or vessel washings, residues from transport vessels or tanks, and similar materials that are captured and retained in the normal course of manufacturing and processing for re-use in manufacturing of the PMN substance or products made from the PMN substance are exempt from this method of disposal. (iii) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1) apply to the PMN substance except under the terms specified in the consent order. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (i), (j), 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 paragraphs (a)(2)(i) and (iii) of this section. 0 6. Add Sec. 721.10877 to subpart E to read as follows: Sec. 721.10877 Polyfluorinated alkyl quaternary ammonium chloride (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyfluorinated alkyl quaternary ammonium chloride (PMN P-11-543) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k)(analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities; and use other described in the consent order), (o)(use in a consumer product that could be spray applied), and (q). (ii) Disposal. Requirements as specified in Sec. 721.85. Incineration of wastes in an incinerator operating at the temperature of at least 1,000 degrees Celsius and a residence time of minimum of 2 seconds. Any tank or vessel washings, residues from transport vessels or tanks, and similar materials that are captured and retained in the normal course of manufacturing and processing for re-use in manufacturing of the PMN substance or products made from the PMN substance are exempt from this method of disposal. (iii) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1) apply to the PMN substance except under the terms specified in the consent order. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. [[Page 30471]] (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (i), (j), 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 paragraphs (a)(2)(i) and (iii) of this section. 0 7. Add Sec. 721.10878 to subpart E to read as follows: Sec. 721.10878 Polyfluorinatedalkylsulfonyl substituted alkane derivative (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyfluorinatedalkylsulfonyl substituted alkane derivative (PMN P-14- 67) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance after it has been completely reacted (cured). (2) The significant new uses are: (i) Hazard communication program. Requirements as specified in Sec. 721.72. 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 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)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80 (k) and (o)(use in a consumer product that could be spray applied), and (q). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (f), (h), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (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 8. Add Sec. 721.10879 to subpart E to read as follows: Sec. 721.10879 1-Octadecanaminium, N-(3-chloro-2-hydroxypropyl)-N,N- dimethyl-, chloride (1:1). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-octadecanaminium, N-(3-chloro-2-hydroxypropyl)-N,N-dimethyl-, chloride (1:1) (PMN P-14- 125; CAS No. 3001-63-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Release to water. Requirements as specified in Sec. 721.90 (a)(4), (b)(4), and (c)(4) (N=2). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 9. Add Sec. 721.10880 to subpart E to read as follows: Sec. 721.10880 Fatty acid rxn products with aminoalkylamines (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as fatty acid rxn products with aminoalkylamines (PMNs P-14-153, P-14-154, P-15- 79, and P-15-80) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. A significant new use of the substances is any use other than as chemical intermediates, additives for flotation products, or adhesion promoters for use in asphalt applications where the surface water concentrations described under paragraph (a)(3)(i) of this section are exceeded. (ii) [Reserved]. (3) The significant new uses for any use other than as chemical intermediated, additives for flotation products, or adhesion promoters for use in asphalt applications are: (i) Release to water. Requirements as specified in Sec. 721.90 (a)(4), (b)(4), and (c)(4) (N=1). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of these substances. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 10. Add Sec. 721.10881 to subpart E to read as follows: Sec. 721.10881 Fatty acid amides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as fatty acid amides (PMNs P-14-155 and P-14-156) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. A significant new use of the substances is any use other than as chemical intermediates, additives for flotation products, or adhesion promoters for use in asphalt applications where the surface water concentrations described under paragraph (a)(3)(i) of this section are exceeded. (ii) [Reserved]. (3) The significant new uses for any use other than as chemical intermediated, additives for flotation products, or adhesion promoters for use in asphalt applications are: (i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and [[Page 30472]] (c)(4) (N=2 for P-14-155 and N=3 for P-14-156). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of these substances. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 11. Add Sec. 721.10882 to subpart E to read as follows: Sec. 721.10882 Trialkylammonium borodibenzoate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as trialkylammonium borodibenzoate (PMN P-14-198) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial commercial, and consumer activities. Requirements as specified in Sec. 721.80(f) and (j). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. 0 12. Add Sec. 721.10883 to subpart E to read as follows: Sec. 721.10883 Fatty ester derivatives, reaction products with alkanolamine, hydroxylated, borated (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty ester derivatives, reaction products with alkanolamine, hydroxylated, borated (PMN P-14-324) 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. A significant new use of the substance is a use other than as a lubricating oil additive. (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 13. Add Sec. 721.10884 to subpart E to read as follows: Sec. 721.10884 Benzenepropanol, 1-benzoate. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzenepropanol, 1- benzoate (PMN P-14-397; CAS No. 60045-26-3) 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. A significant new use of the substance is use other than as a plasticizer in adhesives for food-product packaging; a diluents-type plasticizer in plastisol; a coalescent in architectural paints and coating; and a fragrance carrier in fragrances. (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 14. Add Sec. 721.10885 to subpart E to read as follows: Sec. 721.10885 Alcohols, C 12-22 , distn. residues. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alcohols, C12-22 , distn. residues (PMN P-14-448; CAS No. 1476777-83-9) 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) Industrial commercial, and consumer activities. Requirements as specified in Sec. 721.80. A significant new use of the substance is any use where the cumulative molecular weights of the C12 and C14 components exceed 2 percent by weight of the overall molecular weight of the PMN substance. (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 15. Add Sec. 721.10886 to subpart E to read as follows: Sec. 721.10886 Phosphoric acid, mixed Bu and decyl and octyl and 2- (2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphoric acid, mixed Bu and decyl and octyl and 2-(2-phenoxyethoxy)ethyl and 2- phenoxyethyl esters (PMN P-14-501; CAS No. 1502809-48-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=4). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (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 16. Add Sec. 721.10887 to subpart E to read as follows: Sec. 721.10887 Phosphoric acid, mixed Bu and decyl and octyl and 2- (2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters, potassium salts. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphoric acid, mixed Bu and decyl and octyl and 2-(2-phenoxyethoxy)ethyl and 2- phenoxyethyl esters, potassium salts (PMN P-14-502; CAS No. [[Page 30473]] 1502809-56-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=4). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (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 17. Add Sec. 721.10888 to subpart E to read as follows: Sec. 721.10888 Siloxanes and Silicones, 3-[(2-aminoethyl)amino)propyl Me, di-Me, reaction products with cadmium zinc selenide sulfide, lauric acid and oleylamine. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as siloxanes and silicones, 3-[(2-aminoethyl)amino)propyl Me, di-Me, reaction products with cadmium zinc selenide sulfide, lauric acid and oleylamine (PMN P- 15-59; CAS No. 1623456-05-2) 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), (a)(2)(i), (a)(3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63 (a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p) (three months and eighteen months). A significant new use of the substance is manufacture, process, or use the chemical substance other than as a down converter for an optical filter for light emitting diodes used in displays, or other than in a liquid formulation. (iii) Disposal. Requirements as specified in Sec. 721.85. It is a significant new use to dispose of the chemical substance other than by incineration in a permitted hazardous waste incinerator. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i), and (j) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 18. Add Sec. 721.10889 to subpart E to read as follows: Sec. 721.10889 Dodecanoic acid, reaction products with cadmium zinc selenide sulfide and oleylamine. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as dodecanoic acid, reaction products with cadmium zinc selenide sulfide and oleylamine (PMN P-15-60; CAS No. 1773514-92-3) 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) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture, process, or use the chemical substance other than as a chemical intermediate or other than in a liquid formulation. (iii) Disposal. Requirements as specified in Sec. 721.85. It is a significant new use to dispose of the chemical substance other than by incineration in a permitted hazardous waste incinerator. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i) and (j) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 19. Add Sec. 721.10890 to subpart E to read as follows: Sec. 721.10890 Phosphonic acid, P-tetradecyl-, reaction products with cadmium selenide (CdSe). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphonic acid, P- tetradecyl-, reaction products with cadmium selenide (CdSe) (PMN P-15- 104; CAS No. 1773514-66-1) 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), (a)(2)(i), (a)(3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture, process, or use the chemical substance other than as a chemical intermediate or other than in a liquid formulation. (iii) Disposal. Requirements as specified in Sec. 721.85 It is a significant new use to dispose of the chemical substance other than by incineration in a permitted hazardous waste incinerator. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 20. Add Sec. 721.10891 to subpart E to read as follows: Sec. 721.10891 Alkyl silicate, polymer with 2-(chloromethyl)oxirane and 4,4'-(1-methylethylidene)bis[phenol], alkoxylated (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl silicate, polymer [[Page 30474]] with 2-(chloromethyl)oxirane and 4,4'-(1-methylethylidene)bis[phenol], alkoxylated (PMN P-15-81) 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 40 CFR 721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1 percent), and (c). (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 21. Add Sec. 721.108992 to subpart E to read as follows: Sec. 721.10892 Reaction product of a mixture of aromatic dianhydrides and aliphatic esters with an aromatic diamine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as reaction product of a mixture of aromatic dianhydrides and aliphatic esters with an aromatic diamine (PMN P-15-109) 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) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=11). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (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 22. Add Sec. 721.10893 to subpart E to read as follows: Sec. 721.10893 Fatty acids, tall-oil, reaction products with an ether and triethylenetetramine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, tall-oil, reaction products with an ether and triethylenetetramine (PMN P-15-111) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f) and (j). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i), are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. 0 23. Add Sec. 721.10894 to subpart E to read as follows: Sec. 721.10894 Substituted benzyl acrylate (generic) (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted benzyl acrylate (PMN P-15-120) 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) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=1). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (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 24. Add Sec. 721.10895 to subpart E to read as follows: Sec. 721.10895 Fluoroalkyl acrylate copolymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as fluoroalkyl acrylate copolymer (PMN P-15-154) 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 program. Requirements as specified in Sec. 721.72. 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 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)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k) (analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities), and (q). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e) and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (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. 721.10896 to subpart E to read as follows: [[Page 30475]] Sec. 721.10896 1-Hexanol, 6-mercapto-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-hexanol, 6- mercapto-. (PMN P-15-176; CAS No.1633-78-9) 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) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=8). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (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 26. Add Sec. 721.10897 to subpart E to read as follows: Sec. 721.10897 Phenol, 2,2'-[1,2-disubstituted-1,2- ethanediyl]bis(iminomethylene)bis[substituted- (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified generically as phenol, 2,2'-[1,2-disubstituted-1,2- ethanediyl]bis(iminomethylene)bis[substituted- (PMN P-15-177) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(2)(ii), and (a)(3). (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(j). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (d), (e), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (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. 721.10898 to subpart E to read as follows: Sec. 721.10898 Carbomonocycles, polymer with substituted heteromonocycle, succinate, methyl acrylate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbomonocycles, polymer with substituted heteromonocycle, succinate, methyl acrylate (PMN P-15-188) 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. A significant new use of the substance is any use other than as a pigment-wetting resin for UV-curable coatings. (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 28. Add Sec. 721.10899 to subpart E to read as follows: Sec. 721.10899 Halogenated alkyl trimethylaminium halide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halogenated alkyl trimethylaminium halide (PMN P-15-190) 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), (a)(6)(i), (b)(concentration set at 0.1 percent) and (c). 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 assigned protection factor (APF) of at least 10 meet the requirements of Sec. 721.63(a)(4): (A) 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. (B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet. (C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full facepiece. (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=88). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (d), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 29. Add Sec. 721.10900 to subpart E to read as follows: Sec. 721.10900 Titanium salt, reaction products with silica (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as titanium salt, reaction products with silica (PMN P-15-252) 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), (a)(6)(i), (a)(6)(ii), and (c). 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 assigned protection factor (APF) of at least 10 meet the requirements of Sec. 721.63(a)(4): (A) NIOSH-certified air-purifying elastomeric half-mask respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters. (B) NIOSH-certified N100 (if oil aerosols absent), R100, or P100 filtering facepiece respirator. [[Page 30476]] (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(g). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (d) 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 30. Add Sec. 721.10901 to subpart E to read as follows: Sec. 721.10901 Formaldehyde, reaction products with aniline and aromatic mono- and di-phenol mixture (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as formaldehyde, reaction products with aniline and aromatic mono- and di- phenol mixture (PMN P-15-272) 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) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=1). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (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 31. Add Sec. 721.10902 to subpart E to read as follows: Sec. 721.10902 Functionalized carbon nanotubes (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as functionalized carbon nanotubes (PMN P-15-276) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance after it has been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), and (a)(3). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. A significant new use is manufacture, process, or use of the PMN substance other than in a liquid formulation. A significant new use is use other than as a thin film for electronic device applications or any use involving an application method that generates a vapor, mist, or aerosol unless such application method occurs in an enclosed process. An enclosed process is defined as an operation that is designed and operated so that there is no release associated with normal or routine production processes into the environment of any substance present in the operation. An operation with inadvertent or emergency pressure relief releases remains an enclosed process so long as measures are taken to prevent worker exposure to and environmental contamination from the releases. (iii) Disposal. Requirements as specified in Sec. 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). (iv) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i), (j), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 32. Add Sec. 721.10903 to subpart E to read as follows: Sec. 721.10903 Acrylated mixed metal oxides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acrylated mixed metal oxides (PMN P-15-295) 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 it has been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), and (a)(3). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(v)(1), (v)(2), (w)(1), (w)(2), (x)(1), (x)(2), and (y)(1). (iii) Disposal. Requirements as specified in Sec. 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). (iv) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i), (j), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 33. Add Sec. 721.10904 to subpart E to read as follows: Sec. 721.10904 Phenol, 1,1-dimethylalkyl derivatives (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically phenol, 1,1-dimethylalkyl derivatives (PMN P-15-306) 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) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=13). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (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. [[Page 30477]] 0 34. Add Sec. 721.10905 to subpart E to read as follows: Sec. 721.10905 Butanedioic acid, 2-methylene-, dialkyl ester (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as butanedioic acid, 2-methylene-, dialkyl ester (PMN P-15-319) 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) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=1). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (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 35. Add Sec. 721.10906 to subpart E to read as follows: Sec. 721.10906 Magnesium alkaryl sulfonate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as magnesium alkaryl sulfonate (PMN P-15-324) 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. A significant new use of the substance is any use other than as a detergent additive in crankcase lubricant applications. (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 36. Add Sec. 721.10907 to subpart E to read as follows: Sec. 721.10907 Polyfluorohydrocarbon (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyfluorohydrocarbon (PMN P-15-326) 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(j) and (o). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. 0 37. Add Sec. 721.10908 to subpart E to read as follows: Sec. 721.10908 Aluminum calcium oxide salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aluminum calcium oxide salt (PMN P-15-328) 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 it has been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b), and (c). 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 Assigned Protection Factor (APF) of at least 10 meet the requirements of Sec. 721.63(a)(4): (A) 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. (B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting face piece, hood, or helmet. (C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full face piece. 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 5 mg/m\3\ as an 8-hour time weighted average verified by actual monitoring data. (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) trhough (f)(concentration set at 1.0 percent), (g)(1)(ii), (g)(2)(When using this substance avoid breathing the substance, and use respiratory protection, or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 5 mg/m\3\.) and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (d) and (f) through and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 38. Add Sec. 721.10909 to subpart E to read as follows: Sec. 721.10909 Polyalkyltrisiloxane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyalkyltrisiloxane (PMN P-15-332) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(i), (b)(concentration set at 1.0 percent), and (c). When determining [[Page 30478]] 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 assigned protection factor (APF) of at least 10 meet the requirements of Sec. 721.63(a)(4): (A) 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. (B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet. (C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full facepiece. (ii) Industrial commercial, and consumer activities. Requirements as specified in Sec. 721.80(h). (iii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=4). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 39. Add Sec. 721.10910 to subpart E to read as follows: Sec. 721.10910 Oxirane, 2,2'-[[1-[4-[1-methyl-1-[4-(2- oxiranylmethoxy)phenyl]ethyl]phenyl]ethylidene]bis(4,1- phenyleneoxymethylene)]bis- (P-15-356, Chemical A). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2,2'-[[1- [4-[1-methyl-1-[4-(2- oxiranylmethoxy)phenyl]ethyl]phenyl]ethylidene]bis(4,1- phenyleneoxymethylene)]bis- (PMN P-15-356, Chemical A; CAS No. 115254- 47-2) 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) Industrial, commercial and consumer activities. Requirements as specified in Sec. 721.80. A significant new use of the substance is any use other than as an additive in polymer formulation for electronics. (ii) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 40. Add Sec. 721.10911 to subpart E to read as follows: Sec. 721.10911 2-Propanol, 1,3-bis[4-[1-[4-[1-methyl-1-[4-(2- oxiranylmethoxy)phenyl]ethyl]phenyl]-1-[4-(2- oxiranylmethoxy)phenyl]ethyl]phenoxy]- (P-15-356, Chemical B). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propanol, 1,3- bis[4-[1-[4-[1-methyl-1-[4-(2-oxiranylmethoxy)phenyl]ethyl]phenyl]-1- [4-(2-oxiranylmethoxy)phenyl]ethyl]phenoxy]- (PMN P-15-356, Chemical B; CAS No. 180063-56-3) 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. A significant new use of the substance is any use other than as an additive in polymer formulation for electronics. (ii) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 41. Add Sec. 721.10912 to subpart E to read as follows: Sec. 721.10912 Aliphatic acrylate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aliphatic acrylate (PMN P-15-363) 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) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=1). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (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 42. Add Sec. 721.10913 to subpart E to read as follows: Sec. 721.10913 Diisocyanato hexane, homopolymer, alkanoic acid- polyalkylene glycol ether with substituted alkane (3:1) reaction products-blocked (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as diisocyanato hexane, homopolymer, alkanoic acid-polyalkylene glycol ether with substituted alkane (3:1) reaction products-blocked (PMN P- 15-378) 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), (a)(6)(ii), and (c). 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 assigned protection factor (APF) of at least 10 meet the requirements of Sec. 721.63(a)(4): (A) 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. (B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet. [[Page 30479]] (C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full facepiece. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(o). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (d) and (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 43. Add Sec. 721.10914 to subpart E to read as follows: Sec. 721.10914 Polyitaconic acid, sodium zinc salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyitaconic acid, sodium zinc salt (PMN P-15-382) 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. A significant new use of the substance is any use other than as an odor neutralization for pet litter and cleaning hard surface surfaces, fabrics, skin and hair; an odor neutralization for air car; and an odor neutralization for waste processing and solid waste management in paper, oil, gas, mining, agriculture, food and municipal industries. (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 44. Add Sec. 721.10915 to subpart E to read as follows: Sec. 721.10915 Fatty acid esters with polyols polyalkyl ethers (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acid esters with polyols polyalkyl ethers (PMN P-15-411) 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) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=30). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (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 45. Add Sec. 721.10916 to subpart E to read as follows: Sec. 721.10916 2,7-Naphthalenedisulfonic acid, 4-amino-3- [substituted]-5-hydroxy-6-[(1E)-2-phenyldiazenyl]-, lithium salt (1:3) (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2,7- naphthalenedisulfonic acid, 4-amino-3-[substituted]-5-hydroxy-6-[(1E)- 2-phenyldiazenyl]-, lithium salt (1:3) (PMN P-15-435) 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. A significant new use of the substance is any use other that in a liquid formulation. (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of these substances. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 46. Add Sec. 721.10917 to subpart E to read as follows: Sec. 721.10917 Polymethylsiloxane, distillation residues (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polymethylsiloxane, distillation residues (PMN P-15-492) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), and (c). 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 operations, general and local ventilation) or administrative control measure (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 respirator with an assigned protection factor (APF) of at least 10 meets the minimum requirements for Sec. 721.63(a)(4): NIOSH-certified powered air- purifying respirator with a hood or helmet and with appropriate gas- vapor (acid gas, organic vapor, or substance specific) cartridges. (ii) Industrial commercial, and consumer activities. Requirements as specified in Sec. 721.80(g). (iii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 47. Add Sec. 721.10918 to subpart E to read as follows: Sec. 721.10918 Perfluorobutanesulfonamide and polyoxyalkylene containing polyurethane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluorobutanesulfonamide and polyoxyalkylene containing polyurethane (PMN P-15-502) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance after it has been completely reacted (cured). (2) The significant new uses are: (i) Hazard communication program. A significant new use of the substance is [[Page 30480]] 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 TSCA section 5(e) consent order for the substance, the employer becomes aware that the substances 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)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (f), (h), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (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 48. Add Sec. 721.10919 to subpart E to read as follows: Sec. 721.10919 Quaternary ammonium compounds, (3-chloro-2- hydroxypropyl)coco alkyldimethyl, chlorides. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as quaternary ammonium compounds, (3-chloro-2-hydroxypropyl)coco alkyldimethyl, chlorides (PMN P-15-542; CAS No. 690995-44-9) 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) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=24). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (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 49. Add Sec. 721.10920 to subpart E to read as follows: Sec. 721.10920 Modified diphenylmethane diisocyanate prepolymer with polyol (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified diphenylmethane diisocyanate prepolymer with polyol (PMN P-15- 559) 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. A significant new use of the substance is manufacture of the substance where the average molecular weight is below 7,500 daltons, and where any molecular weight species is below 1,000 daltons. (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 50. Add Sec. 721.10921 to subpart E to read as follows: Sec. 721.10921 2-Furancarboxyaldehyde, 5-(chloromethyl)-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2- furancarboxyaldehyde, 5-(chloromethyl)- (PMN P-15-573; CAS No. 1623-88- 7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(v), and (c). 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 assigned protection factor (APF) of at least 50 meet the requirements of Sec. 721.63(a)(4): (A) NIOSH-certified powered air-purifying respirator with a tight- fitting half mask and HEPA filters. (B) NIOSH-certified continuous flow supplied-air respirator equipped with a tight-fitting half mask. (C) 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(g) (chemical intermediate use in a continuous reaction process such that no greater than 50 kilograms is present in the workplace at a given time) and (s)(15,000 kilograms). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e) and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 51. Add Sec. 721.10922 to subpart E to read as follows: Sec. 721.10922 1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9- tris(alkyl) derivs. (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 11,2,4,5,7,8-hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(alkyl) derivs. (PMN P-15-607) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. [[Page 30481]] (2) The significant new uses are: (i) Industrial commercial, and consumer activities. Requirements as specified in Sec. 721.80(j). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. 0 52. Add Sec. 721.10923 to subpart E to read as follows: Sec. 721.10923 9-Octadecen-1-amine, hydrochloride (1:1), (9Z)-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 9-octadecen-1- amine, hydrochloride (1:1), (9Z)- (PMN P-15-671; CAS No. 41130-29-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=1). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (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 53. Add Sec. 721.10924 to subpart E to read as follows: Sec. 721.10924 Vegetable fatty acid alkyl esters (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as vegetable fatty acid alkyl esters (PMNs P-15-689 and P-15-690) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(g). (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of these substances. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. [FR Doc. 2016-11121 Filed 5-13-16; 8:45 am] BILLING CODE 6560-50-P
![30452 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations
ENVIRONMENTAL PROTECTION • Mail: Document Control Office addition, any persons who export or
AGENCY (7407M), Office of Pollution Prevention intend to export a chemical substance
and Toxics (OPPT), Environmental that is the subject of a proposed or final
40 CFR Parts 9 and 721 Protection Agency, 1200 Pennsylvania rule are subject to the export
Ave. NW., Washington, DC 20460–0001. notification provisions of TSCA section
[EPA–HQ–OPPT–2015–0810; FRL–9944–77] • Hand Delivery: To make special 12(b) (15 U.S.C. 2611(b)) (see § 721.20),
arrangements for hand delivery or and must comply with the export
RIN 2070–AB27
delivery of boxed information, please notification requirements in 40 CFR part
Significant New Use Rules on Certain follow the instructions at http:// 707, subpart D.
Chemical Substances www.epa.gov/dockets/contacts.html.
Additional instructions on B. What should I consider as I prepare
AGENCY: Environmental Protection commenting or visiting the docket, my comments for EPA?
Agency (EPA). along with more information about 1. Submitting CBI. Do not submit this
ACTION: Direct final rule. dockets generally, is available at http:// information to EPA through
www.epa.gov/dockets. regulations.gov or email. Clearly mark
SUMMARY: EPA is promulgating FOR FURTHER INFORMATION CONTACT: the part or all of the information that
significant new use rules (SNURs) under For technical information contact: you claim to be CBI. For CBI
the Toxic Substances Control Act Kenneth Moss, Chemical Control information in a disk or CD–ROM that
(TSCA) for 55 chemical substances Division (7405M), Office of Pollution you mail to EPA, mark the outside of the
which were the subject of Prevention and Toxics, Environmental disk or CD–ROM as CBI and then
premanufacture notices (PMNs). Ten of Protection Agency, 1200 Pennsylvania identify electronically within the disk or
these chemical substances are subject to Ave. NW., Washington, DC 20460–0001; CD–ROM the specific information that
TSCA section 5(e) consent orders issued telephone number: (202) 564–9232; is claimed as CBI. In addition to one
by EPA. This action requires persons email address: Moss.Kenneth@epa.gov. complete version of the comment that
who intend to manufacture (defined by For general information contact: The includes information claimed as CBI, a
statute to include import) or process any TSCA-Hotline, ABVI-Goodwill, 422 copy of the comment that does not
of these 55 chemical substances for an South Clinton Ave., Rochester, NY contain the information claimed as CBI
activity that is designated as a 14620; telephone number: (202) 554– must be submitted for inclusion in the
significant new use by this rule to notify 1404; email address: TSCA-Hotline@ public docket. Information so marked
EPA at least 90 days before commencing epa.gov. will not be disclosed except in
that activity. The required notification SUPPLEMENTARY INFORMATION: accordance with procedures set forth in
will provide EPA with the opportunity 40 CFR part 2.
to evaluate the intended use and, if I. General Information 2. Tips for preparing your comments.
necessary, to prohibit or limit that A. Does this action apply to me? When preparing and submitting your
activity before it occurs. comments, see the commenting tips at
You may be potentially affected by
DATES: This rule is effective on July 15, http://www.epa.gov/dockets/
this action if you manufacture (defined
2016. For purposes of judicial review, comments.html.
by statute to include import), process, or
this rule shall be promulgated at 1 p.m. use the chemical substances contained II. Background
(e.s.t.) on May 31, 2016. in this rule. The following list of North
Written adverse or critical comments, A. What action is the Agency taking?
American Industrial Classification
or notice of intent to submit adverse or System (NAICS) codes is not intended EPA is promulgating these SNURs
critical comments, on one or more of to be exhaustive, but rather provides a using direct final procedures. These
these SNURs must be received on or guide to help readers determine whether SNURs will require persons to notify
before June 15, 2016 (see Unit VI. of the this document applies to them. EPA at least 90 days before commencing
SUPPLEMENTARY INFORMATION). If EPA Potentially affected entities may the manufacture or processing of a
receives written adverse or critical include: chemical substance for any activity
comments, or notice of intent to submit • Manufacturers, or processors of one designated by these SNURs as a
adverse or critical comments, on one or or more subject chemical substances significant new use. Receipt of such
more of these SNURs before June 15, (NAICS codes 325 and 324110), e.g., notices allows EPA to assess risks that
2016, EPA will withdraw the relevant chemical manufacturing and petroleum may be presented by the intended uses
sections of this direct final rule before refineries. and, if appropriate, to regulate the
its effective date. This action may also affect certain proposed use before it occurs.
For additional information on related entities through pre-existing import Additional rationale and background to
reporting requirement dates, see Units certification and export notification these rules are more fully set out in the
I.A., VI., and VII. of the SUPPLEMENTARY rules under TSCA. Chemical importers preamble to EPA’s first direct final
INFORMATION. are subject to the TSCA section 13 (15 SNUR published in the Federal Register
ADDRESSES: Submit your comments, U.S.C. 2612) import certification issue of April 24, 1990 (55 FR 17376)
identified by docket identification (ID) requirements promulgated at 19 CFR (FRL–3658–5). Consult that preamble
number EPA–HQ–OPPT–2015–0810, by 12.118 through 12.127 and 19 CFR for further information on the
one of the following methods: 127.28. Chemical importers must certify objectives, rationale, and procedures for
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• Federal eRulemaking Portal: http:// that the shipment of the chemical SNURs and on the basis for significant
www.regulations.gov. Follow the online substance complies with all applicable new use designations, including
instructions for submitting comments. rules and orders under TSCA. Importers provisions for developing test data.
Do not submit electronically any of chemicals subject to these SNURs
information you consider to be must certify their compliance with the B. What is the Agency’s authority for
Confidential Business Information (CBI) SNUR requirements. The EPA policy in taking this action?
or other information whose disclosure is support of import certification appears Section 5(a)(2) of TSCA (15 U.S.C.
restricted by statute. at 40 CFR part 707, subpart B. In 2604(a)(2)) authorizes EPA to determine
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modified or revoked by EPA based on 850.4500) would help characterize the to 28 days in duration. EPA predicts
submission of that or other relevant human health and environmental effects toxicity to aquatic organisms may occur
information. of the PMN substance. if releases of the substance to surface
CFR citations: 40 CFR 721.10888 (P– CFR citation: 40 CFR 721.10891. water, from uses other than as described
15–59), 40 CFR 721.10889 (P–15–60), in the PMN, exceed releases from the
PMN Number P–15–109
and 40 CFR 721.10890 (P–15–104). use described in the PMN. For the use
Chemical name: Reaction product of a described in the PMN, environmental
PMN Number P–15–81 mixture of aromatic dianhydrides and releases did not exceed 1 ppb for more
Chemical name: Alkyl silicate, aliphatic esters with an aromatic than 20 days per year. Therefore, EPA
polymer with 2-(chloromethyl)oxirane diamine (generic). has not determined that the proposed
and 4,4′0-(1- CAS number: Claimed confidential. manufacturing (defined by statute to
methylethylidene)bis[phenol], Basis for action: The PMN states that include import), processing, or use of
alkoxylated (generic). the generic (non-confidential) use of the the substance may present an
CAS number: Claimed confidential. substance is as an intermediate. Based unreasonable risk. EPA has determined,
Basis for action: The PMN states that on SAR analysis of test data on however, that any domestic
the generic (non-confidential) use of the analogous anilines, EPA predicts manufacture of the substance, or any
substance will be as an ingredient in toxicity to aquatic organisms may occur use of the PMN substance other than as
liquid paint coating. Based on SAR at concentrations that exceed 11 ppb of described in the PMN may result in
analysis of test data on analogous the PMN substance in surface waters. As significant adverse environmental
epoxides, there were health concerns described in the PMN, releases of the effects. Based on this information, the
regarding skin and lung sensitization, substance are not expected to result in PMN substance meets the concern
mutagenicity, oncogenicity, surface water concentrations that exceed criteria at § 721.170(b)(4)(ii).
developmental toxicity, male 11 ppb. Therefore, EPA has not Recommended testing: EPA has
reproductive, liver, and kidney toxicity determined that the proposed determined that the results of a fish
based on the epoxide oxidation product manufacturing, processing, or use of the early-life stage toxicity test (OPPTS Test
as well as irritation and lung toxicity substance may present an unreasonable Guideline 850.1400); a daphnid chronic
expected from the ethoxy silane risk. EPA has determined, however, that toxicity test (OPPTS Test Guideline
hydrolysis product from exposure to the any use of the substance resulting in 850.1300); an algal toxicity test (OCSPP
PMN substance via dermal exposure. surface water concentrations exceeding Test Guideline 850.4500); and a ready
Further, based on SAR analysis of test 11 ppb may result in significant adverse biodegradability test (OECD Test
data on analogous epoxides, EPA environmental effects. Based on this Guideline 301) would help characterize
predicts toxicity to aquatic organisms information, the PMN substance meets the environmental effects of the PMN
may occur at concentrations that exceed the concern criteria at substance. EPA recommends that the
1 ppb of the PMN substance in surface § 721.170(b)(4)(ii). fate testing be performed first as the
waters. As described in the PMN, Recommended testing: EPA has results may mitigate the need for further
occupational exposures are expected to determined that the results of a fish toxicity testing or change the testing
be minimal due to use of adequate early-life stage toxicity test (OPPTS Test recommendations.
dermal personal protection equipment Guideline 850.1400); a daphnid chronic CFR citation: 40 CFR 721.10893.
and releases of the substance are not toxicity test (OPPTS Test Guideline
expected to result in surface water 850.1300); an algal toxicity test (OCSPP PMN Number P–15–120
concentrations that exceed 1 ppb. Test Guideline 850.4500); and a ready Chemical name: Substituted benzyl
Therefore, EPA has not determined that biodegradability test (OECD Test acrylate (generic).
the proposed manufacturing, Guideline 301) would help characterize CAS number: Claimed confidential.
processing, or use of the substance may the environmental effects of the PMN Basis for action: The PMN states that
present an unreasonable risk. EPA has substance. EPA recommends that the the generic (non-confidential) use of the
determined, however, that any use fate testing be performed first as the substance will be as a resin for
without the use of impervious gloves, results may mitigate the need for further industrial coating. Based on SAR
where there is a potential for dermal toxicity testing or change the testing analysis of test data on analogous
exposure, or any use of the substance recommendations. acrylates, EPA predicts toxicity to
resulting in surface water CFR citation: 40 CFR 721.10892. aquatic organisms may occur at
concentrations exceeding 1 ppb may concentrations that exceed 1 ppb of the
result in serious human health or PMN Number P–15–111 PMN substance in surface waters. As
significant adverse environmental Chemical name: Fatty acids, tall-oil, described in the PMN, releases of the
effects. Based on this information, the reaction products with an ether and substance are not expected to result in
PMN substance meets the concern triethylenetetramine (generic). surface water concentrations that exceed
criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii) CAS number: Claimed confidential. 1 ppb. Therefore, EPA has not
and (b)(4)(ii). Basis for action: The PMN states that determined that the proposed
Recommended testing: EPA has the generic (non-confidential) use of the manufacturing, processing, or use of the
determined that the results of a substance will be as a hardener for substance may present an unreasonable
combined repeated dose toxicity study coating systems. Based on SAR analysis risk. EPA has determined, however, that
with the reproduction/developmental of test data on analogous aliphatic any use of the substance resulting in
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toxicity screening test (OECD Test amines, EPA predicts toxicity to aquatic surface water concentrations exceeding
Guideline 422); a Zahn-Wellens/EMPA organisms may occur at concentrations 1 ppb may result in significant adverse
test (OPPTS Test Guideline 835.3200); a that exceed 1 ppb of the PMN substance environmental effects. Based on this
fish early-life stage toxicity test (OPPTS in surface waters for greater than 20 information, the PMN substance meets
Test Guideline 850.1400); a daphnid days per year. This 20-day criterion is the concern criteria at
chronic toxicity test (OPPTS Test derived from partial life cycle tests § 721.170(b)(4)(ii).
Guideline 850.1300); and an algal (daphnid chronic and fish early life Recommended testing: EPA has
toxicity test (OCSPP Test Guideline stage tests) that typically range from 21 determined that the results of a fish
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![Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 30459
early-life stage toxicity test (OPPTS Test results of a 90-day inhalation toxicity bis(iminomethylene)bis[substituted-
Guideline 850.1400); a daphnid chronic test in rats (OPPTS Test Guideline (generic).
toxicity test (OPPTS Test Guideline 870.3465/OECD Test Guideline 413) CAS number: Claimed confidential.
850.1300); an algal toxicity test (OCSPP with a 60-day holding period, and Basis for action: The PMN states that
Test Guideline 850.4500); and a ready certain physical chemical property and the generic (non-confidential) use of the
biodegradability test (OECD Test environmental fate testing identified in substance will be as a catalyst in the
Guideline 301) would help characterize the consent order would help process to manufacture a crop
the environmental effects of the PMN characterize the human health and fate protection chemical. Based on test data
substance. EPA recommends that the effects of the PMN substance. The Order on the PMN substance, EPA identified
fate testing be performed first as the does not require this testing at any concerns for blood toxicity to workers
results may mitigate the need for further specified time or production volume. from dermal exposures to the PMN
toxicity testing or change the testing However, the Order’s restrictions on substance. As described in the PMN,
recommendations. manufacture, processing, distribution in occupational exposures are expected to
CFR citation: 40 CFR 721.10894. commerce, use, and disposal of the be minimal due to use of adequate
PMN substances will remain in effect dermal personal protection equipment.
PMN Number P–15–154 Therefore, EPA has not determined that
until the Order is modified or revoked
Chemical name: Fluoroalkyl acrylate by EPA based on submission of that or the proposed manufacturing,
copolymer (generic). other relevant information. processing, or use of the substance may
CAS number: Claimed confidential. CFR citation: 40 CFR 721.10895. present an unreasonable risk. EPA has
Effective date of TSCA section 5(e) determined, however, that any use of
consent order: May 14, 2015. PMN Number P–15–176 the substance without the use of
Basis for TSCA section 5(e) consent Chemical name: 1-Hexanol, 6- chemical impervious gloves, where
order: The PMN states that the generic mercapto-. there is a potential for dermal exposure,
(non-confidential) use of the substance CAS number: 1633–78–9. or any use of the substance other than
will be as a textile treatment. The Order Basis for action: The PMN states that as described in the PMN may cause
was issued under TSCA sections the substance will be used as a chemical serious health effects. Based on this
5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and intermediate to curable monomers. information, the PMN substance meets
5(e)(1)(A)(ii)(II) based on a finding that Based on SAR analysis of test data on the concern criteria at § 721.170(b)(3)(i).
the substance may present an analogous thiols, EPA predicts toxicity Recommended testing: EPA has
unreasonable risk of injury to human to aquatic organisms may occur at determined that the results of a skin
health and the environment. To protect concentrations that exceed 8 ppb of the absorption, In vitro method (OECD Test
against these risks, the consent order PMN substance in surface waters. As Guideline 428) would help characterize
requires: described in the PMN, releases of the the human health effects of the PMN
1. Risk notification. If as a result of substance are not expected to result in substance.
the test data required, the company surface water concentrations that exceed CFR citation: 40 CFR 721.10897.
becomes aware that the PMN substances 8 ppb. Therefore, EPA has not
may present a risk of injury to human PMN Number P–15–188
determined that the proposed
health or the environment, the company manufacturing, processing, or use of the Chemical name: Carbomonocycles,
must incorporate this new information, substance may present an unreasonable polymer with substituted
and any information on methods for risk. EPA has determined, however, that heteromonocycle, succinate, methyl
protecting against such risk into an any use of the substance that results in acrylate (generic).
MSDS, within 90 days. surface water concentrations exceeding CAS number: Claimed confidential.
2. Manufacture of the PMN substance: 8 ppb may result in significant adverse Basis for action: The PMN states that
(a) According to the chemical environmental effects. Based on this the substance will be used as a pigment-
composition section of the consent information, the PMN substance meets wetting resin for Ultra Violet (UV)-
order, including analyzing and reporting the concern criteria at curable coatings. Based on SAR analysis
certain starting raw material impurities § 721.170(b)(4)(ii). of test data on analogous methacrylates,
to EPA; and (b) within the maximum Recommended testing: EPA has EPA predicts toxicity to aquatic
established limits of certain fluorinated determined that the results of a fish organisms may occur at concentrations
impurities of the PMN substance as acute toxicity test, freshwater and that exceed 7 ppb of the PMN substance
stated in the consent order. marine (OPPTS Test Guideline in surface waters for greater than 20
3. Submission of certain toxicity, 850.1075); an aquatic invertebrate acute days per year. This 20-day criterion is
physical-chemical property, and toxicity test, freshwater daphnids derived from partial life cycle tests
environmental fate testing on the PMN (OPPTS Test Guideline 850.1010); an (daphnid chronic and fish early life
substance prior to exceeding the algal toxicity test (OCSPP Test stage tests) that typically range from 21
confidential production volume limits Guideline 850.4500); and a ready to 28 days in duration. EPA predicts
as specified in the consent order. biodegradability test (OECD Test toxicity to aquatic organisms may occur
The SNUR designates as a ‘‘significant Guideline 301B) would help if releases of the substance to surface
new use’’ the absence of these protective characterize the environmental effects of water, from uses other than as described
measures. the PMN substance. EPA recommends in the PMN, exceed releases from the
Recommended testing: EPA has that the fate testing be performed first as use described in the PMN. For the use
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determined that the results of certain the results may mitigate the need for described in the PMN, environmental
toxicity and environmental fate testing further toxicity testing or change the releases did not exceed 7 ppb for more
would help characterize the PMN testing recommendations. than 20 days per year. Therefore, EPA
substance. The submitter has agreed to CFR citation: 40 CFR 721.10896. has not determined that the proposed
complete the testing identified in the manufacturing, processing, or use of the
testing section of the consent order by PMN Number P–15–177 substance may present an unreasonable
the confidential limits specified. In Chemical name: Phenol, 2,2′-[1,2- risk. EPA has determined, however, that
addition, EPA has determined that the disubstituted-1,2-ethanediyl] any use of the substance other than as
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PMN substance in surface waters for characterize the health effects of the test data on an analogous substance,
greater than 20 days per year. This 20- PMN substance. there were health concerns regarding
day criterion is derived from partial life CFR citation: 40 CFR 721.10907. liver and kidney toxicity, thyroid
cycle tests (daphnid chronic and fish effects, and reproductive and
PMN Number P–15–328
early life stage tests) that typically range developmental toxicity from dermal and
from 21 to 28 days in duration. EPA Chemical name: Aluminum calcium inhalation exposures to the PMN
predicts toxicity to aquatic organisms oxide salt (generic). substance. Further, based on SAR
may occur if releases of the substance to CAS number: Claimed confidential. analysis of test data on analogous
surface water, from uses other than as Effective date of TSCA section 5(e) neutral organics, EPA predicts toxicity
described in the PMN, exceed releases consent order: June 2, 2015. to aquatic organisms may occur at
from the use described in the PMN. For Basis for TSCA section 5(e) consent concentrations that exceed 4 ppb of the
the use described in the PMN, order: The PMN states that the generic PMN substance in surface waters. EPA
environmental releases did not exceed 1 (non-confidential) use of the PMN also predicts toxicity to aquatic
ppb for more than 20 days per year. substance will be as a cement additive. organisms may occur if releases of the
Therefore, EPA has not determined that Based on SAR analysis of test data on substance to surface water, from uses
the proposed manufacturing, analogous respirable, poorly soluble other than as described in the PMN,
processing, or use of the substance may particulates, EPA identified concerns for exceed releases from the use described
present an unreasonable risk. EPA has lung toxicity based on lung overload. in the PMN. Further, as described in the
determined, however, that any use of The Order was issued under TSCA PMN, exposure is expected to be
the substance other than as listed in the sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) minimal due to use of adequate
PMN may result in significant adverse based on a finding that the substance respiratory and dermal personal
environmental effects. Based on this may present an unreasonable risk of protection equipment and releases of
information, the PMN substance meets injury to human health. To protect the substance are not expected to result
the concern criteria at § 721.170(b)(4)(i). against these risks, the consent order in surface water concentrations
Recommended testing: EPA has requires: exceeding 4 ppb. Therefore, EPA has not
determined that the results of a daphnid 1. Hazard communication. determined that the proposed
chronic toxicity test (OPPTS Test Establishment and use of a hazard manufacturing, processing, or use of the
Guideline 850.1300) would help communication program, including substance may present an unreasonable
characterize the environmental effects of human health precautionary statements risk. EPA has determined, however, that
the PMN substance. on each label and the MSDS. any use of the substance that results in
CFR citation: 40 CFR 721.10906. 2. Use of personal protective releases to surface waters exceeding 4
equipment including a NIOSH-certified ppb, any use other than that as a site-
PMN Number P–15–326
respirator with an APF of at least 10 or limited intermediate, or any use without
Chemical name: compliance with a NCEL of 5 mg/m3 as the use of a NIOSH-certified respirator
Polyfluorohydrocarbon (generic). an 8-hour time-weighted average (when with gas/vapor cartridges and an APF of
CAS number: Claimed confidential. there is potential inhalation exposure), at least 10 and impervious gloves, may
Basis for action: The PMN states that when there is potential inhalation result in serious human health or
the generic (non-confidential) use of the exposure. significant adverse environmental
substance will be as a specialty gas and 3. Manufacture, processing or use of effects. Based on this information, the
transfer fluid. Based on test data on the the PMN substance only for the use PMN substance meets the concern
PMN substance, EPA identified specified in the consent order. criteria at § 721.170 (b)(3)(ii) and
concerns for neurotoxicity and The SNUR designates as a ‘‘significant (b)(4)(ii).
uncertain concern for cardiac new use’’ the absence of these protective Recommended testing: EPA has
sensitization. Further, based on SAR measures. determined that the results of a
analysis of test data on analogous Recommended testing: EPA has sediment-water lumbriculus toxicity test
substances, EPA identified concerns for determined that a 90-day inhalation (OECD Test Guideline 225); a combined
developmental toxicity. As described in toxicity test (OPPTS Test Guideline repeated dose toxicity study with the
the PMN, EPA does not expect 870.3465) in rats would help reproduction/developmental toxicity
significant occupational exposures due characterize possible health effects of screening test (OECD Test Guideline
to use of adequate personal protective the substance. The Order does not 422); a fish acute toxicity test,
equipment, and consumer exposures are require this testing at any specified time freshwater and marine (OPPTS Test
not expected as the PMN substance is or production volume. However, the Guideline 850.1075); an aquatic
not used in consumer products. Order’s restrictions on manufacture, invertebrate acute toxicity test,
Therefore, EPA has not determined that processing, distribution in commerce, freshwater daphnids (OPPTS Test
the proposed manufacturing, use, and disposal of the PMN substances Guideline 850.1010); and an algal
processing, or use of the substance may will remain in effect until the Order is toxicity test (OCSPP Test Guideline
present an unreasonable risk. EPA has modified or revoked by EPA based on 850.4500) would help characterize the
determined, however, that any use of submission of that or other relevant human health and environmental effects
the substance other than as listed in the information. of the PMN substance. All ecotoxicity
PMN or any use in a consumer product CFR citation: 40 CFR 721.10908. tests should analyze the PMN substance
may result in significant adverse human as well as the hydrolysis products.
asabaliauskas on DSK3SPTVN1PROD with RULES
health effects. Based on this PMN Number P–15–332
CFR citation: 40 CFR 721.10909.
information, the PMN substance meets Chemical name: Polyalkyltrisiloxane
the concern criteria at § 721.170 (b)(3)(i) (generic). PMN Number P–15–356
and (b)(3)(ii). CAS number: Claimed confidential. Chemical names: Oxirane, 2,2′-[[1-[4-
Recommended testing: EPA has Basis for action: The PMN states that [1-methyl-1-[4-(2-
determined that the results of 90-day the generic (non-confidential) use of the oxiranylmethoxy)phenyl]ethyl]phenyl]
inhalation toxicity (OPPTS Test substance will be as a site-limited ethylidene]bis(4,1-
Guideline 870.3465) would help intermediate. Based on SAR analysis of phenyleneoxymethylene)]bis- (P–15–
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356, Chemical A); and 2-Propanol, 1,3- environmental effects of the PMN use of the substance may present an
bis[4-[1-[4-[1-methyl-1-[4-(2- substances. unreasonable risk. EPA has determined,
oxiranylmethoxy)phenyl]ethyl]phenyl]- CFR citations: 40 CFR 721.10910 (P– however, that any use of the substance
1-[4-(2-oxiranylmethoxy)phenyl]ethyl] 15–356, chemical A) and 40 CFR without a NIOSH-certified particulate
phenoxy]- (P–15–356, Chemical B). 721.10911 (P–15–356, chemical B). respirator with an APF of at least 10
CAS numbers: 115254–47–2 (P–15– where there is a potential for inhalation
PMN Number P–15–363
356, Chemical A) and 180063–56–3 (P– exposure, or any use in consumer
15–356, Chemical B). Chemical name: Aliphatic acrylate products may cause serious health
Basis for action: The PMN states that (generic). effects. Based on this information, the
CAS number: Claimed confidential. PMN substance meets the concern
the substances will be used as additives
Basis for action: The PMN states that criteria at § 721.170(b)(3)(ii).
in polymer formulation for electronics.
the generic (non-confidential) use of the Recommended testing: EPA has
Based on test data on the PMN
substance will be as a monomer. Based determined that the results of a skin
substances and on SAR analysis of test
on SAR analysis of test data on sensitization test (OPPTS Test Guideline
data on analogous epoxides, EPA
analogous acrylates, EPA predicts 870.2600) and a 90-day inhalation
identified concerns for respiratory
toxicity to aquatic organisms may occur toxicity test (OPPTS Test Guideline
sensitization and irritation,
at concentrations that exceed 1 ppb of 870.3465) would help characterize the
mutagenicity, developmental toxicity,
the PMN substance in surface waters. As human health effects of the PMN
male reproduction toxicity, liver and
described in the PMN, releases of the substance.
kidney toxicity, and oncogenicity.
substance are not expected to result in CFR citation: 40 CFR 721.10913.
Additionally, based on SAR analysis of
surface water concentrations that exceed
test data on analogous polyepoxides, PMN Number P–15–382
1 ppb. Therefore, EPA has not
EPA predicts toxicity to aquatic Chemical name: Polyitaconic acid,
determined that the proposed
organisms may occur at concentrations sodium zinc salt (generic).
manufacturing, processing, or use of the
that exceed 1 ppb of the PMN CAS number: Claimed confidential.
substance may present an unreasonable
substances in surface waters. Further, Basis for action: The PMN states that
risk. EPA has determined, however, that
EPA has concerns that the PMN the substance will be used as an odor
any use of the substance resulting in
substances are potentially PBT neutralization for pet litter and cleaning
surface water concentrations exceeding
chemicals as described in the New hard surface surfaces, fabrics, skin and
1 ppb may result in significant adverse
Chemical Program’s PBT category (64 hair; an odor neutralization for air car;
environmental effects. Based on this
FR 60194; November 4, 1999) (FRL– and an odor neutralization for waste
information, the PMN substance meets
6097–7). EPA estimates that the PMN processing and solid waste management
the concern criteria at
substances will persist in the in paper, oil, gas, mining, agriculture,
§ 721.170(b)(4)(ii).
environment more than 2 months and Recommended testing: EPA has food and municipal industries. Based on
estimates a bioaccumulation factor of determined that the results of a fish SAR analysis of test data on analogous
greater than or equal to 1,000. For the acute toxicity test, freshwater and zinc salts, EPA predicts toxicity to
use described in the PMN, EPA expects marine (OPPTS Test Guideline aquatic organisms may occur at
occupational exposures to be minimal 850.1075); an acute invertebrate toxicity concentrations that exceed 4 ppb of the
and does not expect releases to surface test, freshwater daphnids (OPPTS Test PMN substance in surface waters for
waters. Therefore, EPA has not Guideline 850.1010); and an algal greater than 20 days per year. This 20-
determined that the proposed toxicity test (OCSPP Test Guideline day criterion is derived from partial life
manufacturing, processing, or use of the 850.4500) would help characterize the cycle tests (daphnid chronic and fish
substances may present an unreasonable environmental effects of the PMN early life stage tests) that typically range
risk. EPA has determined, however, that substance. from 21 to 28 days in duration. EPA
any use of the substances other than as CFR citation: 40 CFR 721.10912. predicts toxicity to aquatic organisms
additives in polymer formulation for may occur if releases of the substance to
electronics or any use of the substances PMN Number P–15–378 surface water, from uses other than as
resulting in releases to surface waters Chemical name: Diisocyanato hexane, described in the PMN, exceed releases
may cause serious human health or homopolymer, alkanoic acid- from the use described in the PMN. For
significant adverse environmental polyalkylene glycol ether with the use described in the PMN,
effects. Based on this information, the substituted alkane (3:1) reaction environmental releases did not exceed 4
PMN substances meet the concern products-blocked (generic). ppb for more than 20 days per year.
criteria at § 721.170(b)(1)(i)(C), (b)(3)(i), CAS number: Claimed confidential. Therefore, EPA has not determined that
(b)(3)(ii), and (b)(4)(ii). Basis for action: The PMN states that the proposed manufacturing,
Recommended testing: EPA has the substance will be used as a dual processing, or use of the substance may
determined that the results of a cure/UV cure adhesion/barrier coating present an unreasonable risk. EPA has
combined repeated dose toxicity study for wood substrates. Based on SAR determined, however, that any use of
with the reproduction/developmental analysis of test data on analogous the substance other than as listed in the
toxicity screening test (OECD Test diisocyanates, EPA identified concerns PMN may result in significant adverse
Guideline 422); a sediment-water for respiratory sensitization. As environmental effects. Based on this
chironomid life-cycle toxicity test described in the PMN, EPA does not information, the PMN substance meets
asabaliauskas on DSK3SPTVN1PROD with RULES
(OECD Test Guideline 233), using expect significant occupational dermal the concern criteria at
spiked water or spiked sediment; a fish or inhalation exposure due to use of § 721.170(b)(4)(ii).
early-life stage toxicity test (OPPTS Test adequate personal protective equipment Recommended testing: EPA has
Guideline 850.1400); a daphnid chronic and consumer exposures are not determined that the results of a fish
toxicity test (OPPTS Test Guideline expected as the PMN substance is not early-life stage toxicity test (OPPTS Test
850.1300); and an algal toxicity test used in consumer products. Therefore, Guideline 850.1400); a daphnid chronic
(OCSPP Test Guideline 850.4500) would EPA has not determined that the toxicity test (OPPTS Test Guideline
help characterize the human health and proposed manufacture, processing, or 850.1300); and an algal toxicity test
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(OCSPP Test Guideline 850.4500) would and mutagenicity. As described in the gloves, where there is a potential for
help characterize the environmental PMN, EPA does not expect significant dermal exposures; any use of the
effects of the PMN substance. risk to workers due to use of adequate substance other than an intermediate; or
CFR citation: 40 CFR 721.10914. personal protective equipment. any use of the substance resulting in
Therefore, EPA has not determined that surface water concentrations exceeding
PMN Number P–15–411
the proposed manufacturing, 1 ppb may result in serious human
Chemical name: Fatty acid esters with processing, or use of the substance may health or significant adverse
polyols polyalkyl ethers (generic). present an unreasonable risk. EPA has environmental effects. Based on this
CAS number: Claimed confidential. determined, however, that any use of information, the PMN substance meets
Basis for action: The PMN states that the substance other than in a liquid the concern criteria at § 721.170(b)(3)(ii)
the generic (non-confidential) use of the formulation could result in exposures and (b)(4)(ii).
substance will be as an anti-rust coating which may cause serious health effects. Recommended testing: EPA has
solution additive. Based on SAR Based on this information, the PMN determined that the results of a
analysis of test data on analogous substance meets the concern criteria at sediment-water lumbriculus toxicity test
nonionic surfactants, EPA predicts § 721.170(b)(1)(i)(C), (b)(3)(i) and (OECD Test Guideline 225) using spiked
toxicity to aquatic organisms may occur (b)(3)(ii). sediment; a combined repeated dose
at concentrations that exceed 30 ppb of Recommended testing: EPA has toxicity study with the reproduction/
the PMN substance in surface waters. As determined that the results of an ames developmental toxicity screening test
described in the PMN, releases of the assay (OPPTS Test Guideline 870.5100) (OECD Test Guideline 422); a fish early-
substance are not expected to result in with the rival modification; a mouse life stage toxicity test (OPPTS Test
surface water concentrations that exceed micronucleus assay conducted by the Guideline 850.1400); a daphnid chronic
30 ppb. Therefore, EPA has not oral route (OPPTS Test Guideline toxicity test (OPPTS Test Guideline
determined that the proposed 870.5395); and a combined repeated 850.1300); and an algal toxicity test
manufacturing, processing, or use of the dose and developmental toxicity and (OCSPP Test Guideline 850.4500) would
substance may present an unreasonable reproductive toxicity screening test help characterize the human health and
risk. EPA has determined, however, that (OPPTS Test Guideline 870.3650) would environmental effects of the PMN
any use of the substance resulting in help to characterize the health effects of substance. All ecotoxicity tests should
surface water concentrations exceeding the PMN substance. analyze for the PMN substance as well
30 ppb may result in significant adverse CFR citation: 40 CFR 721.10916. as the hydrolysis products.
environmental effects. Based on this PMN Number P–15–492 CFR citation: 40 CFR 721.10917.
information, the PMN substance meets
Chemical name: Polymethylsiloxane, PMN Number P–15–502
the concern criteria at
§ 721.170(b)(4)(ii). distillation residues (generic). Chemical name:
Recommended testing: EPA has CAS number: Claimed confidential. Perfluorobutanesulfonamide and
determined that the results of a fish Basis for action: The PMN states that polyoxyalkylene containing
acute toxicity test, freshwater and the generic (non-confidential) use of the polyurethane (generic).
marine (OPPTS Test Guideline substance will be as a site-limited CAS number: Claimed confidential.
850.1075); an acute invertebrate toxicity intermediate. Based on SAR analysis Effective date of TSCA section 5(e)
test, freshwater daphnids (OPPTS Test test data on analogous silanes, EPA consent order: November 4, 2015.
Guideline 850.1010); and an algal identified concerns for mutagenicity, Basis for TSCA section 5(e) consent
toxicity test (OCSPP Test Guideline liver and kidney toxicity, thyroid order: The PMN states that the generic
850.4500) would help characterize the effects, and reproductive and (non-confidential) use of the substance
environmental effects of the PMN developmental toxicity from dermal and will be as a protective treatment. EPA
substance. inhalation exposures to the PMN has concerns for potential incineration
CFR citation: 40 CFR 721.10915. substance. Further, based on SAR or other decomposition products of the
analysis of test data on analogous PMN substance. These fluorinated
PMN Number P–15–435 neutral organics, EPA predicts toxicity decomposition products may be
Chemical name: 2,7- to aquatic organisms may occur at released to the environment from
Naphthalenedisulfonic acid, 4-amino-3- concentrations that exceed 1 ppb of the incomplete incineration of the PMN
[substituted]-5-hydroxy-6-[(1E)-2- PMN substance in surface waters. For substance at low temperatures. EPA has
phenyldiazenyl]-, lithium salt (1:3) the intermediate use described in the preliminary evidence, including data on
(generic). PMN, occupational exposures are some fluorinated polymers which
CAS number: Claimed confidential. expected to be minimal due to the use suggest that under some conditions, the
Basis for action: The PMN states that of adequate respiratory and dermal PMN substance could degrade in the
the generic (non-confidential) use of the personal protection equipment, and environment. EPA has concerns that
substance will be as a direct anionic releases of the substance are not these degradation products will persist
dyestuff for the printing industry. Based expected to result in surface water in the environment, could
on the results of a 28-day oral study for concentrations that exceed 1 ppb. bioaccumulate or biomagnify, and could
the PMN substance, EPA predicts Therefore, EPA has not determined that be toxic (PBT) to people, wild
anemia, effects on the adrenals, spleen, the proposed manufacturing, mammals, and birds. These concerns are
kidney, lymph nodes and processing, or use of the substance may based on data on analogous chemical
asabaliauskas on DSK3SPTVN1PROD with RULES
immunotoxicity. In addition, based on present an unreasonable risk. EPA has substances, including PFOA and other
the lithium salt of the PMN, EPA determined, however, that any use of perfluorinated alkyls, including the
identified concerns for developmental the substance without the use of a presumed environmental degradant.
toxicity and neurotoxicity. Further, NIOSH-certified respirator with gas/ EPA also has concerns that under some
based on SAR analysis of test data on vapor cartridges and an APF of at least conditions of use, particularly non-
analogous azo reduction products, EPA 10, where there is a potential for industrial, commercial, or consumer
identified concerns for blood effects, inhalation exposures, any use of the use, the PMN substance could cause
developmental toxicity, oncogenicity, substance without the use of impervious lung effects, based on limited data on
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Therefore, the promulgation of the expected to affect energy supply, undesignated center heading
SNUR would not have a significant distribution, or use and because this ‘‘Significant New Uses of Chemical
economic impact on a substantial action is not a significant regulatory Substances’’ to read as follows:
number of small entities. action under Executive Order 12866.
§ 9.1 OMB approvals under the Paperwork
D. Unfunded Mandates Reform Act I. National Technology Transfer and Reduction Act.
(UMRA) Advancement Act (NTTAA) * * * * *
Based on EPA’s experience with In addition, since this action does not
proposing and finalizing SNURs, State, involve any technical standards, 40 CFR citation OMB control No.
local, and Tribal governments have not NTTAA section 12(d) (15 U.S.C. 272
been impacted by these rulemakings, note), does not apply to this action.
* * * * *
and EPA does not have any reasons to
J. Executive Order 12898
believe that any State, local, or Tribal Significant New Uses of Chemical
government will be impacted by this This action does not entail special
Substances
action. As such, EPA has determined considerations of environmental justice
that this action does not impose any related issues as delineated by
enforceable duty, contain any unfunded Executive Order 12898, entitled * * * * *
mandate, or otherwise have any effect ‘‘Federal Actions to Address 721.10875 ....................... 2070–0012
on small governments subject to the Environmental Justice in Minority 721.10876 ....................... 2070–0012
requirements of UMRA sections 202, Populations and Low-Income 721.10877 ....................... 2070–0012
203, 204, or 205 (2 U.S.C. 1501 et seq.). Populations’’ (59 FR 7629, February 16, 721.10878 ....................... 2070–0012
1994). 721.10879 ....................... 2070–0012
E. Executive Order 13132 721.10880 ....................... 2070–0012
XIII. Congressional Review Act 721.10881 ....................... 2070–0012
This action will not have a substantial
direct effect on States, on the Pursuant to the Congressional Review 721.10882 ....................... 2070–0012
Act (5 U.S.C. 801 et seq.), EPA will 721.10883 ....................... 2070–0012
relationship between the national
submit a report containing this rule and 721.10884 ....................... 2070–0012
government and the States, or on the 721.10885 ....................... 2070–0012
distribution of power and other required information to the U.S.
721.10886 ....................... 2070–0012
responsibilities among the various Senate, the U.S. House of
721.10887 ....................... 2070–0012
levels of government, as specified in Representatives, and the Comptroller
721.10888 ....................... 2070–0012
Executive Order 13132, entitled General of the United States prior to 721.10889 ....................... 2070–0012
‘‘Federalism’’ (64 FR 43255, August 10, publication of the rule in the Federal 721.10890 ....................... 2070–0012
1999). Register. This action is not a ‘‘major 721.10891 ....................... 2070–0012
rule’’ as defined by 5 U.S.C. 804(2). 721.10892 ....................... 2070–0012
F. Executive Order 13175 721.10893 ....................... 2070–0012
List of Subjects
This action does not have Tribal 721.10894 ....................... 2070–0012
implications because it is not expected 40 CFR Part 9 721.10895 ....................... 2070–0012
to have substantial direct effects on 721.10896 ....................... 2070–0012
Environmental protection, Reporting
Indian Tribes. This action does not 721.10897 ....................... 2070–0012
and recordkeeping requirements.
significantly nor uniquely affect the 721.10898 ....................... 2070–0012
40 CFR Part 721 721.10899 ....................... 2070–0012
communities of Indian Tribal
721.10900 ....................... 2070–0012
governments, nor does it involve or Environmental protection, Chemicals, 721.10901 ....................... 2070–0012
impose any requirements that affect Hazardous substances, Reporting and 721.10902 ....................... 2070–0012
Indian Tribes. Accordingly, the recordkeeping requirements. 721.10903 ....................... 2070–0012
requirements of Executive Order 13175, Dated: May 3, 2016. 721.10904 ....................... 2070–0012
entitled ‘‘Consultation and Coordination Maria J. Doa, 721.10905 ....................... 2070–0012
with Indian Tribal Governments’’ (65 FR 721.10906 ....................... 2070–0012
Director, Chemical Control Division, Office
67249, November 9, 2000), do not apply of Pollution Prevention and Toxics. 721.10907 ....................... 2070–0012
to this action. 721.10908 ....................... 2070–0012
Therefore, 40 CFR parts 9 and 721 are 721.10909 ....................... 2070–0012
G. Executive Order 13045 amended as follows: 721.10910 ....................... 2070–0012
This action is not subject to Executive 721.10911 ....................... 2070–0012
Order 13045, entitled ‘‘Protection of PART 9—[AMENDED] 721.10912 ....................... 2070–0012
Children from Environmental Health 721.10913 ....................... 2070–0012
■ 1. The authority citation for part 9 721.10914 ....................... 2070–0012
Risks and Safety Risks’’ (62 FR 19885, continues to read as follows:
April 23, 1997), because this is not an 721.10915 ....................... 2070–0012
Authority: 7 U.S.C. 135 et seq., 136–136y; 721.10916 ....................... 2070–0012
economically significant regulatory
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 721.10917 ....................... 2070–0012
action as defined by Executive Order
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 721.10918 ....................... 2070–0012
12866, and this action does not address U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 721.10919 ....................... 2070–0012
environmental health or safety risks 1321, 1326, 1330, 1342, 1344, 1345 (d) and 721.10920 ....................... 2070–0012
disproportionately affecting children. (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 721.10921 ....................... 2070–0012
asabaliauskas on DSK3SPTVN1PROD with RULES
1971–1975 Comp. p. 973; 42 U.S.C. 241, 721.10922 ....................... 2070–0012
H. Executive Order 13211 242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 721.10923 ....................... 2070–0012
This action is not subject to Executive 300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 721.10924 ....................... 2070–0012
Order 13211, entitled ‘‘Actions 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 721.10925 ....................... 2070–0012
Concerning Regulations That 6901–6992k, 7401–7671q, 7542, 9601–9657,
Significantly Affect Energy Supply, 11023, 11048. * * * * *
Distribution, or Use’’ (66 FR 28355, May ■ 2. In § 9.1, add the following sections
22, 2001), because this action is not in numerical order under the * * * * *
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PART 721—[AMENDED] time weighted average (TWA) verified (iii) Release to water. Requirements as
by actual monitoring data. specified in § 721.90(a)(1), (b)(1), and
■ 3. The authority citation for part 721 (ii) Hazard communication program. (c)(1) apply to the PMN substance
continues to read as follows: Requirements as specified in § 721.72(a) except under the terms specified in the
Authority: 15 U.S.C. 2604, 2607, and through (e)(concentration set at 0.1 consent order.
2625(c). percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (b) Specific requirements. The
(g)(1)(iv), (g)(1)(viii), (g)(1)(ix), (g)(2)(ii), provisions of subpart A of this part
■ 4. Add § 721.10875 to subpart E to (g)(2)(iii), (g)(2)(iv)(use respiratory apply to this section except as modified
read as follows: protection, or maintain workplace by this paragraph.
§ 721.10875 Alkali transition metal oxide airborne concentrations at or below an (1) Recordkeeping. Recordkeeping
(generic). 8-hour time-weighted average of 2.4 mg/ requirements as specified in
(a) Chemical substance and m3), and (g)(5). § 721.125(a), (b), (c), (i), (j), and (k) are
significant new uses subject to reporting. (iii) Industrial, commercial, and applicable to manufacturers and
(1) The chemical substance identified consumer activities. Requirements as processors of this substance.
generically as alkali transition metal specified in § 721.80(q). (2) Limitations or revocation of
oxide (PMN P–11–150) is subject to (b) Specific requirements. The certain notification requirements. The
reporting under this section for the provisions of subpart A of this part provisions of § 721.185 apply to this
significant new uses described in apply to this section except as modified section.
paragraph (a)(2) of this section. The by this paragraph. (3) Determining whether a specific use
(1) Recordkeeping. Recordkeeping is subject to this section. The provisions
requirements of this rule do not apply
requirements as specified in of § 721.1725(b)(1) apply to paragraphs
to quantities of the PMN substance after
§ 721.125(a) through (d) and (f) through (a)(2)(i) and (iii) of this section.
it has been completely reacted (cured).
(i) are applicable to manufacturers and ■ 6. Add § 721.10877 to subpart E to
(2) The significant new uses are:
processors of this substance. read as follows:
(i) Protection in the workplace. (A)
(2) Limitations or revocation of
Requirements as specified in § 721.10877 Polyfluorinated alkyl
certain notification requirements. The
§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v), quaternary ammonium chloride (generic).
provisions of § 721.185 apply to this
(a)(6)(vi), (b)(concentration set at 0.1 (a) Chemical substance and
section.
percent), and (c). When determining (3) Determining whether a specific use significant new uses subject to reporting.
which persons are reasonably likely to is subject to this section. The provisions (1) The chemical substance identified
be exposed as required for of § 721.1725(b)(1) apply to paragraph generically as polyfluorinated alkyl
§ 721.63(a)(4), engineering control (a)(2)(iii) of this section. quaternary ammonium chloride (PMN
measures (e.g., enclosure or P–11–543) is subject to reporting under
■ 5. Add § 721.10876 to subpart E to
confinement of the operation, general this section for the significant new uses
read as follows:
and local ventilation) or administrative described in paragraph (a)(2) of this
control measures (e.g., workplace § 721.10876 Perfluoroalkyl substituted section.
policies and procedures) shall be alkyl sulfonate (generic). (2) The significant new uses are:
considered and implemented to prevent (a) Chemical substance and (i) Industrial, commercial, and
exposure, where feasible. The following significant new uses subject to reporting. consumer activities. Requirements as
National Institute for Occupational (1) The chemical substance identified specified in § 721.80(k)(analysis and
Safety and Health (NIOSH)-certified generically as perfluoroalkyl substituted reporting and limitations of maximum
respirators with an Assigned Protection alkyl sulfonate (PMN P–11–484) is impurity levels of certain fluorinated
Factor (APF) of at least 10 meet the subject to reporting under this section impurities; and use other described in
requirements of § 721.63(a)(4): for the significant new uses described in the consent order), (o)(use in a
(1) Any NIOSH-certified air-purifying paragraph (a)(2) of this section. consumer product that could be spray
elastomeric half-mask respirator (2) The significant new uses are: applied), and (q).
equipped with N100 (if oil aerosols (i) Industrial, commercial, and (ii) Disposal. Requirements as
absent), R100, or P100 filters. consumer activities. Requirements as specified in § 721.85. Incineration of
(2) Any appropriate NIOSH-certified specified in § 721.80 (k)(analysis and wastes in an incinerator operating at the
N100 (if oil aerosols absent), R100, or reporting and limitations of maximum temperature of at least 1,000 degrees
P100 filtering facepiece respirator. impurity levels of certain fluorinated Celsius and a residence time of
(3) Any NIOSH-certified air-purifying impurities; and use other described in minimum of 2 seconds. Any tank or
full facepiece respirator equipped with the consent order), (o)(use in a vessel washings, residues from transport
N100 (if oil aerosols absent), R100, or consumer product that could be spray vessels or tanks, and similar materials
P100 filters. applied), and (q). that are captured and retained in the
(4) Any NIOSH-certified negative (ii) Disposal. Requirements as normal course of manufacturing and
pressure (demand) supplied air specified in § 721.85. Incineration of processing for re-use in manufacturing
respirator equipped with a half-mask. wastes in an incinerator operating at the of the PMN substance or products made
(5) Any NIOSH-certified negative temperature of at least 1,000 degrees from the PMN substance are exempt
pressure (demand) self-contained Celsius and a residence time of from this method of disposal.
breathing apparatus (SCBA) equipped minimum of 2 seconds. Any tank or (iii) Release to water. Requirements as
asabaliauskas on DSK3SPTVN1PROD with RULES
with a half-mask. vessel washings, residues from transport specified in § 721.90(a)(1), (b)(1), and
(B) As an alternative to the respiratory vessels or tanks, and similar materials (c)(1) apply to the PMN substance
requirements listed here, a manufacturer that are captured and retained in the except under the terms specified in the
or processor may choose to follow the normal course of manufacturing and consent order.
New Chemical Exposure Limit (NCEL) processing for re-use in manufacturing (b) Specific requirements. The
provisions listed in the TSCA section of the PMN substance or products made provisions of subpart A of this part
5(e) consent order for this substance. from the PMN substance are exempt apply to this section except as modified
The NCEL is 2.4 mg/m3 as an 8-hour from this method of disposal. by this paragraph.
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(1) Recordkeeping. Recordkeeping (ii) Industrial, commercial, and described in paragraph (a)(2) of this
requirements as specified in consumer activities. Requirements as section.
§ 721.125(a), (b), (c), (i), (j), and (k) are specified in § 721.80 (k) and (o)(use in (2) The significant new uses are:
applicable to manufacturers and a consumer product that could be spray (i) Industrial, commercial, and
processors of this substance. applied), and (q). consumer activities. Requirements as
(2) Limitations or revocation of (b) Specific requirements. The specified in § 721.80. A significant new
certain notification requirements. The provisions of subpart A of this part use of the substances is any use other
provisions of § 721.185 apply to this apply to this section except as modified than as chemical intermediates,
section. by this paragraph. additives for flotation products, or
(3) Determining whether a specific use (1) Recordkeeping. Recordkeeping adhesion promoters for use in asphalt
is subject to this section. The provisions requirements as specified in applications where the surface water
of § 721.1725(b)(1) apply to paragraphs § 721.125(a), (b), (c), (f), (h), and (i) are concentrations described under
(a)(2)(i) and (iii) of this section. applicable to manufacturers and paragraph (a)(3)(i) of this section are
■ 7. Add § 721.10878 to subpart E to processors of this substance. exceeded.
read as follows: (2) Limitations or revocation of (ii) [Reserved].
certain notification requirements. The (3) The significant new uses for any
§ 721.10878 Polyfluorinatedalkylsulfonyl provisions of § 721.185 apply to this use other than as chemical
substituted alkane derivative (generic). intermediated, additives for flotation
section.
(a) Chemical substance and (3) Determining whether a specific use products, or adhesion promoters for use
significant new uses subject to reporting. is subject to this section. The provisions in asphalt applications are:
(1) The chemical substance identified of § 721.1725(b)(1) apply to paragraph (i) Release to water. Requirements as
generically as (a)(2)(ii) of this section. specified in § 721.90 (a)(4), (b)(4), and
polyfluorinatedalkylsulfonyl substituted (c)(4) (N=1).
■ 8. Add § 721.10879 to subpart E to
alkane derivative (PMN P–14–67) is (ii) [Reserved].
read as follows:
subject to reporting under this section (b) Specific requirements. The
for the significant new uses described in § 721.10879 1-Octadecanaminium, N-(3- provisions of subpart A of this part
paragraph (a)(2) of this section. The chloro-2-hydroxypropyl)-N,N-dimethyl-, apply to this section except as modified
requirements of this rule do not apply chloride (1:1). by this paragraph.
to quantities of the PMN substance after (a) Chemical substance and (1) Recordkeeping. Recordkeeping
it has been completely reacted (cured). significant new uses subject to reporting. requirements as specified in
(2) The significant new uses are: (1) The chemical substance identified as § 721.125(a), (b), (c), (i), and (k) are
(i) Hazard communication program. 1-octadecanaminium, N-(3-chloro-2- applicable to manufacturers and
Requirements as specified in § 721.72. A hydroxypropyl)-N,N-dimethyl-, chloride processors of these substances.
significant new use of the substance is (1:1) (PMN P–14–125; CAS No. 3001– (2) Limitations or revocation of
any manner or method of manufacture 63–6) is subject to reporting under this certain notification requirements. The
or processing associated with any use of section for the significant new uses provisions of § 721.185 apply to this
the substance without providing risk described in paragraph (a)(2) of this section.
notification as follows: section. ■ 10. Add § 721.10881 to subpart E to
(A) If as a result of the test data (2) The significant new uses are: read as follows:
required under TSCA section 5(e) (i) Release to water. Requirements as
consent order for the substance, the specified in § 721.90 (a)(4), (b)(4), and § 721.10881 Fatty acid amides (generic).
employer becomes aware that the (c)(4) (N=2). (a) Chemical substance and
substance may present a risk of injury (ii) [Reserved]. significant new uses subject to reporting.
to human health or the environment, the (b) Specific requirements. The (1) The chemical substances identified
employer must incorporate this new provisions of subpart A of this part generically as fatty acid amides (PMNs
information, and any information on apply to this section except as modified P–14–155 and P–14–156) are subject to
methods for protecting against such risk, by this paragraph. reporting under this section for the
into a MSDS as described in § 721.72(c) (1) Recordkeeping. Recordkeeping significant new uses described in
within 90 days from the time the requirements as specified in paragraph (a)(2) of this section.
employer becomes aware of the new § 721.125(a), (b), (c), and (k) are (2) The significant new uses are:
information. If the substance is not applicable to manufacturers and (i) Industrial, commercial, and
being manufactured, processed, or used processors of this substance. consumer activities. Requirements as
in the employer’s workplace, the (2) Limitations or revocation of specified in § 721.80. A significant new
employer must add the new information certain notification requirements. The use of the substances is any use other
to a MSDS before the substance is provisions of § 721.185 apply to this than as chemical intermediates,
reintroduced into the workplace. section. additives for flotation products, or
(B) The employer must ensure that ■ 9. Add § 721.10880 to subpart E to adhesion promoters for use in asphalt
persons who will receive the PMN read as follows: applications where the surface water
substance from the employer, or who concentrations described under
have received the PMN substance from § 721.10880 Fatty acid rxn products with paragraph (a)(3)(i) of this section are
the employer within 5 years from the aminoalkylamines (generic). exceeded.
asabaliauskas on DSK3SPTVN1PROD with RULES
date the employer becomes aware of the (a) Chemical substance and (ii) [Reserved].
new information described in paragraph significant new uses subject to reporting. (3) The significant new uses for any
(a)(2)(i)(A) of this section, are provided (1) The chemical substances identified use other than as chemical
an MSDS containing the information generically as fatty acid rxn products intermediated, additives for flotation
required under paragraph (a)(2)(i)(A) of with aminoalkylamines (PMNs P–14– products, or adhesion promoters for use
this section within 90 days from the 153, P–14–154, P–15–79, and P–15–80) in asphalt applications are:
time the employer becomes aware of the are subject to reporting under this (i) Release to water. Requirements as
new information. section for the significant new uses specified in § 721.90(a)(4), (b)(4), and
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(c)(4) (N=2 for P–14–155 and N=3 for P– specified in § 721.80. A significant new specified in § 721.80. A significant new
14–156). use of the substance is a use other than use of the substance is any use where
(ii) [Reserved]. as a lubricating oil additive. the cumulative molecular weights of the
(b) Specific requirements. The (ii) [Reserved]. C12 and C14 components exceed 2
provisions of subpart A of this part (b) Specific requirements. The percent by weight of the overall
apply to this section except as modified provisions of subpart A of this part molecular weight of the PMN substance.
by this paragraph. apply to this section except as modified (ii) [Reserved].
(1) Recordkeeping. Recordkeeping by this paragraph. (b) Specific requirements. The
requirements as specified in (1) Recordkeeping. Recordkeeping provisions of subpart A of this part
§ 721.125(a), (b), (c), (i), and (k) are requirements as specified in apply to this section except as modified
applicable to manufacturers and § 721.125(a), (b), (c), and (i) are by this paragraph.
processors of these substances. applicable to manufacturers and (1) Recordkeeping. Recordkeeping
(2) Limitations or revocation of processors of this substance. requirements as specified in
certain notification requirements. The (2) Limitations or revocation of § 721.125(a), (b), (c), and (i) are
provisions of § 721.185 apply to this certain notification requirements. The applicable to manufacturers and
section. provisions of § 721.185 apply to this processors of this substance.
■ 11. Add § 721.10882 to subpart E to section. (2) Limitations or revocation of
read as follows: ■ 13. Add § 721.10884 to subpart E to certain notification requirements. The
read as follows: provisions of § 721.185 apply to this
§ 721.10882 Trialkylammonium section.
borodibenzoate (generic). § 721.10884 Benzenepropanol, 1-benzoate.
■ 15. Add § 721.10886 to subpart E to
(a) Chemical substance and (a) Chemical substance and read as follows:
significant new uses subject to reporting. significant new uses subject to reporting.
(1) The chemical substance identified (1) The chemical substance identified as § 721.10886 Phosphoric acid, mixed Bu
generically as trialkylammonium benzenepropanol, 1-benzoate (PMN P– and decyl and octyl and 2-(2-
borodibenzoate (PMN P–14–198) is 14–397; CAS No. 60045–26–3) is subject phenoxyethoxy)ethyl and 2-phenoxyethyl
subject to reporting under this section to reporting under this section for the esters.
for the significant new uses described in significant new uses described in (a) Chemical substance and
paragraph (a)(2) of this section. paragraph (a)(2) of this section. significant new uses subject to reporting.
(2) The significant new uses are: (2) The significant new uses are: (1) The chemical substance identified as
(i) Industrial commercial, and (i) Industrial commercial, and phosphoric acid, mixed Bu and decyl
consumer activities. Requirements as consumer activities. Requirements as and octyl and 2-(2-phenoxyethoxy)ethyl
specified in § 721.80(f) and (j). specified in § 721.80. A significant new and 2-phenoxyethyl esters (PMN P–14–
(ii) [Reserved]. use of the substance is use other than as 501; CAS No. 1502809–48–4) is subject
(b) Specific requirements. The a plasticizer in adhesives for food- to reporting under this section for the
provisions of subpart A of this part product packaging; a diluents-type significant new uses described in
apply to this section except as modified plasticizer in plastisol; a coalescent in paragraph (a)(2) of this section.
by this paragraph. architectural paints and coating; and a (2) The significant new uses are:
(1) Recordkeeping. Recordkeeping fragrance carrier in fragrances. (i) Release to water. Requirements as
requirements as specified in (ii) [Reserved]. specified in § 721.90(a)(4), (b)(4), and
§ 721.125(a), (b), (c), and (i) are (b) Specific requirements. The (c)(4) (N=4).
applicable to manufacturers and provisions of subpart A of this part (ii) [Reserved].
processors of this substance. apply to this section except as modified (b) Specific requirements. The
(2) Limitations or revocation of by this paragraph. provisions of subpart A of this part
certain notification requirements. The (1) Recordkeeping. Recordkeeping apply to this section except as modified
provisions of § 721.185 apply to this requirements as specified in by this paragraph.
section. § 721.125(a), (b), (c), and (i) are (1) Recordkeeping. Recordkeeping
(3) Determining whether a specific use applicable to manufacturers and requirements as specified in
is subject to this section. The provisions processors of this substance. § 721.125(a), (b), (c), and (k) are
of § 721.1725(b)(1) apply to paragraph (2) Limitations or revocation of applicable to manufacturers and
(a)(2)(i) of this section. certain notification requirements. The processors of this substance.
■ 12. Add § 721.10883 to subpart E to provisions of § 721.185 apply to this (2) Limitations or revocation of
read as follows: section. certain notification requirements. The
■ 14. Add § 721.10885 to subpart E to provisions of § 721.185 apply to this
§ 721.10883 Fatty ester derivatives, read as follows: section.
reaction products with alkanolamine,
■ 16. Add § 721.10887 to subpart E to
hydroxylated, borated (generic). § 721.10885 Alcohols, C12–22, distn.
residues.
read as follows:
(a) Chemical substance and
significant new uses subject to reporting. (a) Chemical substance and § 721.10887 Phosphoric acid, mixed Bu
(1) The chemical substance identified significant new uses subject to reporting. and decyl and octyl and 2-(2-
generically as fatty ester derivatives, (1) The chemical substance identified as phenoxyethoxy)ethyl and 2-phenoxyethyl
asabaliauskas on DSK3SPTVN1PROD with RULES
reaction products with alkanolamine, alcohols, C12–22, distn. residues (PMN P– esters, potassium salts.
hydroxylated, borated (PMN P–14–324) 14–448; CAS No. 1476777–83–9) is (a) Chemical substance and
is subject to reporting under this section subject to reporting under this section significant new uses subject to reporting.
for the significant new uses described in for the significant new uses described in (1) The chemical substance identified as
paragraph (a)(2) of this section. paragraph (a)(2) of this section. phosphoric acid, mixed Bu and decyl
(2) The significant new uses are: (2) The significant new uses are: and octyl and 2-(2-phenoxyethoxy)ethyl
(i) Industrial commercial, and (i) Industrial commercial, and and 2-phenoxyethyl esters, potassium
consumer activities. Requirements as consumer activities. Requirements as salts (PMN P–14–502; CAS No.
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1502809–56–4) is subject to reporting a permitted hazardous waste provisions of § 721.185 apply to this
under this section for the significant incinerator. section.
new uses described in paragraph (a)(2) (b) Specific requirements. The ■ 19. Add § 721.10890 to subpart E to
of this section. provisions of subpart A of this part read as follows:
(2) The significant new uses are: apply to this section except as modified
(i) Release to water. Requirements as by this paragraph. § 721.10890 Phosphonic acid, P-
specified in § 721.90(a)(4), (b)(4), and (1) Recordkeeping. Recordkeeping tetradecyl-, reaction products with cadmium
(c)(4) (N=4). requirements as specified in selenide (CdSe).
(ii) [Reserved]. § 721.125(a) through (e), (i), and (j) are (a) Chemical substance and
(b) Specific requirements. The applicable to manufacturers and significant new uses subject to reporting.
provisions of subpart A of this part processors of this substance. (1) The chemical substance identified as
apply to this section except as modified (2) Limitations or revocation of phosphonic acid, P-tetradecyl-, reaction
by this paragraph. certain notification requirements. The products with cadmium selenide (CdSe)
(1) Recordkeeping. Recordkeeping provisions of § 721.185 apply to this (PMN P–15–104; CAS No. 1773514–66–
requirements as specified in section. 1) is subject to reporting under this
§ 721.125(a), (b), (c), and (k) are ■ 18. Add § 721.10889 to subpart E to section for the significant new uses
applicable to manufacturers and read as follows: described in paragraph (a)(2) of this
processors of this substance. section.
(2) Limitations or revocation of § 721.10889 Dodecanoic acid, reaction (2) The significant new uses are:
certain notification requirements. The products with cadmium zinc selenide (i) Protection in the workplace.
provisions of § 721.185 apply to this sulfide and oleylamine. Requirements as specified in
section. (a) Chemical substance and § 721.63(a)(1), (a)(2)(i), (a)(3), (b), and
■ 17. Add § 721.10888 to subpart E to
significant new uses subject to reporting. (c). When determining which persons
read as follows: (1) The chemical substance identified as are reasonably likely to be exposed as
dodecanoic acid, reaction products with required for § 721.63(a)(1) engineering
§ 721.10888 Siloxanes and Silicones, cadmium zinc selenide sulfide and control measures (e.g., enclosure or
3-[(2-aminoethyl)amino)propyl Me, di-Me, oleylamine (PMN P–15–60; CAS No. confinement of the operation, general
reaction products with cadmium zinc 1773514–92–3) is subject to reporting and local ventilation) or administrative
selenide sulfide, lauric acid and oleylamine. under this section for the significant control measures (e.g., workplace
(a) Chemical substance and new uses described in paragraph (a)(2) policies and procedures) shall be
significant new uses subject to reporting. of this section. considered and implemented to prevent
(1) The chemical substance identified as (2) The significant new uses are: exposure, where feasible.
siloxanes and silicones, 3-[(2- (i) Protection in the workplace. (ii) Industrial, commercial, and
aminoethyl)amino)propyl Me, di-Me, Requirements as specified in consumer activities. Requirements as
reaction products with cadmium zinc § 721.63(a)(1), (a)(2)(i), (a)(3), (b), and specified in § 721.80. It is a significant
selenide sulfide, lauric acid and (c). When determining which persons new use to manufacture, process, or use
oleylamine (PMN P–15–59; CAS No. are reasonably likely to be exposed as the chemical substance other than as a
1623456–05–2) is subject to reporting required for § 721.63(a)(1) engineering chemical intermediate or other than in
under this section for the significant control measures (e.g., enclosure or a liquid formulation.
new uses described in paragraph (a)(2) confinement of the operation, general (iii) Disposal. Requirements as
of this section. and local ventilation) or administrative specified in § 721.85 It is a significant
(2) The significant new uses are: control measures (e.g., workplace new use to dispose of the chemical
(i) Protection in the workplace. policies and procedures) shall be substance other than by incineration in
Requirements as specified in considered and implemented to prevent a permitted hazardous waste
§ 721.63(a)(1), (a)(2)(i), (a)(3), (b), and exposure, where feasible. incinerator.
(c). When determining which persons (ii) Industrial, commercial, and (b) Specific requirements. The
are reasonably likely to be exposed as consumer activities. Requirements as provisions of subpart A of this part
required for § 721.63 (a)(1) engineering specified in § 721.80. It is a significant apply to this section except as modified
control measures (e.g., enclosure or new use to manufacture, process, or use by this paragraph.
confinement of the operation, general the chemical substance other than as a (1) Recordkeeping. Recordkeeping
and local ventilation) or administrative chemical intermediate or other than in requirements as specified in
control measures (e.g., workplace a liquid formulation. § 721.125(a) through (e), (i), and (k) are
policies and procedures) shall be (iii) Disposal. Requirements as applicable to manufacturers and
considered and implemented to prevent specified in § 721.85. It is a significant processors of this substance.
exposure, where feasible. new use to dispose of the chemical (2) Limitations or revocation of
(ii) Industrial, commercial, and substance other than by incineration in certain notification requirements. The
consumer activities. Requirements as a permitted hazardous waste provisions of § 721.185 apply to this
specified in § 721.80(p) (three months incinerator. section.
and eighteen months). A significant new (b) Specific requirements. The ■ 20. Add § 721.10891 to subpart E to
use of the substance is manufacture, provisions of subpart A of this part read as follows:
process, or use the chemical substance apply to this section except as modified
asabaliauskas on DSK3SPTVN1PROD with RULES
other than as a down converter for an by this paragraph. § 721.10891 Alkyl silicate, polymer with 2-
optical filter for light emitting diodes (1) Recordkeeping. Recordkeeping (chloromethyl)oxirane and 4,4′-(1-
used in displays, or other than in a requirements as specified in methylethylidene)bis[phenol], alkoxylated
liquid formulation. § 721.125(a) through (e), (i) and (j) are (generic).
(iii) Disposal. Requirements as applicable to manufacturers and (a) Chemical substance and
specified in § 721.85. It is a significant processors of this substance. significant new uses subject to reporting.
new use to dispose of the chemical (2) Limitations or revocation of (1) The chemical substance identified
substance other than by incineration in certain notification requirements. The generically as alkyl silicate, polymer
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with 2-(chloromethyl)oxirane and 4,4′- (1) The chemical substance identified P–15–154) is subject to reporting under
(1-methylethylidene)bis[phenol], generically as fatty acids, tall-oil, this section for the significant new uses
alkoxylated (PMN P–15–81) is subject to reaction products with an ether and described in paragraph (a)(2) of this
reporting under this section for the triethylenetetramine (PMN P–15–111) is section.
significant new uses described in subject to reporting under this section (2) The significant new uses are:
paragraph (a)(2) of this section. for the significant new uses described in (i) Hazard communication program.
(2) The significant new uses are: paragraph (a)(2) of this section. Requirements as specified in § 721.72. A
(i) Protection in the workplace. (2) The significant new uses are: significant new use of the substance is
Requirements as specified in 40 CFR (i) Industrial, commercial, and any manner or method of manufacture
721.63(a)(1), (a)(2)(i), (a)(3), (b) consumer activities. Requirements as or processing associated with any use of
(concentration set at 0.1 percent), and specified in § 721.80(f) and (j). the substance without providing risk
(c). (ii) [Reserved]. notification as follows:
(ii) Release to water. Requirements as (b) Specific requirements. The (A) If as a result of the test data
specified in § 721.90(a)(4), (b)(4), and provisions of subpart A of this part required under TSCA section 5(e)
(c)(4) (N=1). apply to this section except as modified consent order for the substance, the
(b) Specific requirements. The by this paragraph. employer becomes aware that the
provisions of subpart A of this part (1) Recordkeeping. Recordkeeping substance may present a risk of injury
apply to this section except as modified requirements as specified in to human health or the environment, the
by this paragraph. § 721.125(a), (b), (c), and (i), are employer must incorporate this new
(1) Recordkeeping. Recordkeeping applicable to manufacturers and information, and any information on
requirements as specified in processors of this substance. methods for protecting against such risk,
§ 721.125(a), (b), (c), (i), and (k) are (2) Limitations or revocation of into a MSDS as described in § 721.72(c)
applicable to manufacturers and certain notification requirements. The within 90 days from the time the
processors of this substance. provisions of § 721.185 apply to this
(2) Limitations or revocation of employer becomes aware of the new
section. information. If the substance is not
certain notification requirements. The (3) Determining whether a specific use
provisions of § 721.185 apply to this being manufactured, processed, or used
is subject to this section. The provisions in the employer’s workplace, the
section. of § 721.1725(b)(1) apply to paragraph employer must add the new information
■ 21. Add § 721.108992 to subpart E to (a)(2)(i) of this section. to a MSDS before the substance is
read as follows: ■ 23. Add § 721.10894 to subpart E to reintroduced into the workplace.
§ 721.10892 Reaction product of a mixture read as follows: (B) The employer must ensure that
of aromatic dianhydrides and aliphatic persons who will receive the PMN
§ 721.10894 Substituted benzyl acrylate
esters with an aromatic diamine (generic).
(generic) substance from the employer, or who
(a) Chemical substance and have received the PMN substance from
(a) Chemical substance and
significant new uses subject to reporting. the employer within 5 years from the
significant new uses subject to reporting.
(1) The chemical substance identified date the employer becomes aware of the
(1) The chemical substance identified
generically as reaction product of a new information described in paragraph
generically as substituted benzyl
mixture of aromatic dianhydrides and (a)(2)(i)(A) of this section, are provided
acrylate (PMN P–15–120) is subject to
aliphatic esters with an aromatic an MSDS containing the information
reporting under this section for the
diamine (PMN P–15–109) is subject to required under paragraph (a)(2)(i)(A) of
significant new uses described in
reporting under this section for the this section within 90 days from the
paragraph (a)(2) of this section.
significant new uses described in time the employer becomes aware of the
(2) The significant new uses are:
paragraph (a)(2) of this section. new information.
(i) Release to water. Requirements as
(2) The significant new uses are: (ii) Industrial, commercial, and
(i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and
consumer activities. Requirements as
specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=1).
specified in § 721.80(k) (analysis and
(c)(4) (N=11). (ii) [Reserved].
(b) Specific requirements. The reporting and limitations of maximum
(ii) [Reserved]. impurity levels of certain fluorinated
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified impurities), and (q).
provisions of subpart A of this part (b) Specific requirements. The
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping provisions of subpart A of this part
by this paragraph. apply to this section except as modified
(1) Recordkeeping. Recordkeeping requirements as specified in
§ 721.125(a), (b), (c), and (k) are by this paragraph.
requirements as specified in (1) Recordkeeping. Recordkeeping
§ 721.125(a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance. requirements as specified in
applicable to manufacturers and § 721.125(a) through (e) and (i) are
processors of this substance. (2) Limitations or revocation of
certain notification requirements. The applicable to manufacturers and
(2) Limitations or revocation of processors of this substance.
certain notification requirements. The provisions of § 721.185 apply to this
section. (2) Limitations or revocation of
provisions of § 721.185 apply to this certain notification requirements. The
section. ■ 24. Add § 721.10895 to subpart E to
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provisions of § 721.185 apply to this
■ 22. Add § 721.10893 to subpart E to read as follows:
section.
read as follows: § 721.10895 Fluoroalkyl acrylate (3) Determining whether a specific use
§ 721.10893 Fatty acids, tall-oil, reaction copolymer (generic). is subject to this section. The provisions
products with an ether and (a) Chemical substance and of § 721.1725(b)(1) apply to paragraph
triethylenetetramine (generic). significant new uses subject to reporting. (a)(2)(ii) of this section.
(a) Chemical substance and (1) The chemical substance identified as ■ 25. Add § 721.10896 to subpart E to
significant new uses subject to reporting. fluoroalkyl acrylate copolymer (PMN read as follows:
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§ 721.10896 1-Hexanol, 6-mercapto-. ■ 27. Add § 721.10898 to subpart E to factor (APF) of at least 10 meet the
(a) Chemical substance and read as follows: requirements of § 721.63(a)(4):
significant new uses subject to reporting. (A) NIOSH-certified power air-
§ 721.10898 Carbomonocycles, polymer purifying respirator with a hood or
(1) The chemical substance identified as with substituted heteromonocycle,
1-hexanol, 6-mercapto-. (PMN P–15– helmet and with appropriate gas/vapor
succinate, methyl acrylate (generic).
176; CAS No.1633–78–9) is subject to (acid gas, organic vapor, or substance
(a) Chemical substance and specific) cartridges in combination with
reporting under this section for the
significant new uses subject to reporting. HEPA filters.
significant new uses described in
(1) The chemical substance identified (B) NIOSH-certified continuous flow
paragraph (a)(2) of this section.
(2) The significant new uses are: generically as carbomonocycles, supplied-air respirator equipped with a
(i) Release to water. Requirements as polymer with substituted loose fitting facepiece, hood, or helmet.
specified in § 721.90(a)(4), (b)(4), and heteromonocycle, succinate, methyl (C) NIOSH-certified negative pressure
(c)(4) (N=8). acrylate (PMN P–15–188) is subject to (demand) supplied-air respirator with a
(ii) [Reserved]. reporting under this section for the full facepiece.
(b) Specific requirements. The significant new uses described in (ii) Release to water. Requirements as
provisions of subpart A of this part paragraph (a)(2) of this section. specified in § 721.90(a)(4), (b)(4), and
apply to this section except as modified (2) The significant new uses are: (c)(4) (N=88).
by this paragraph. (i) Industrial, commercial, and (b) Specific requirements. The
(1) Recordkeeping. Recordkeeping consumer activities. Requirements as provisions of subpart A of this part
requirements as specified in specified in § 721.80. A significant new apply to this section except as modified
§ 721.125(a), (b), (c), and (k) are use of the substance is any use other by this paragraph.
applicable to manufacturers and than as a pigment-wetting resin for UV- (1) Recordkeeping. Recordkeeping
processors of this substance. curable coatings. requirements as specified in
(2) Limitations or revocation of (ii) [Reserved]. § 721.125(a), (b), (c), (d), and (k) are
certain notification requirements. The (b) Specific requirements. The applicable to manufacturers and
provisions of § 721.185 apply to this provisions of subpart A of this part processors of this substance.
section. apply to this section except as modified (2) Limitations or revocation of
by this paragraph. certain notification requirements. The
■ 26. Add § 721.10897 to subpart E to
(1) Recordkeeping. Recordkeeping provisions of § 721.185 apply to this
read as follows: requirements as specified in section.
§ 721.10897 Phenol, 2,2′-[1,2-disubstituted- § 721.125(a), (b), (c), and (i) are ■ 29. Add § 721.10900 to subpart E to
1,2-ethanediyl] applicable to manufacturers and read as follows:
bis(iminomethylene)bis[substituted- processors of this substance.
(generic). (2) Limitations or revocation of § 721.10900 Titanium salt, reaction
(a) Chemical substance and certain notification requirements. The products with silica (generic).
significant new uses subject to reporting. provisions of § 721.185 apply to this (a) Chemical substance and
(1) The chemical substance generically section. significant new uses subject to reporting.
identified generically as phenol, 2,2′- ■ 28. Add § 721.10899 to subpart E to (1) The chemical substance identified
[1,2-disubstituted-1,2-ethanediyl] read as follows: generically as titanium salt, reaction
bis(iminomethylene)bis[substituted- products with silica (PMN P–15–252) is
(PMN P–15–177) is subject to reporting § 721.10899 Halogenated alkyl subject to reporting under this section
under this section for the significant trimethylaminium halide (generic). for the significant new uses described in
new uses described in paragraph (a)(2) (a) Chemical substance and paragraph (a)(2) of this section.
of this section. significant new uses subject to reporting. (2) The significant new uses are:
(2) The significant new uses are: (1) The chemical substance identified (i) Protection in the workplace.
(i) Protection in the workplace. generically as halogenated alkyl Requirements as specified in
Requirements as specified in trimethylaminium halide (PMN P–15– § 721.63(a)(4), (a)(6)(i), (a)(6)(ii), and (c).
§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), and 190) is subject to reporting under this When determining which persons are
(a)(3). section for the significant new uses reasonably likely to be exposed as
(ii) Industrial, commercial, and described in paragraph (a)(2) of this required for § 721.63(a)(4), engineering
consumer activities. Requirements as section. control measures (e.g., enclosure or
specified in § 721.80(j). (2) The significant new uses are: confinement of the operation, general
(b) Specific requirements. The (i) Protection in the workplace. and local ventilation) or administrative
provisions of subpart A of this part Requirements as specified in control measures (e.g., workplace
apply to this section except as modified § 721.63(a)(4), (a)(6)(i), (b)(concentration policies and procedures) shall be
by this paragraph. set at 0.1 percent) and (c). When considered and implemented to prevent
(1) Recordkeeping. Recordkeeping determining which persons are exposure, where feasible. The following
requirements as specified in reasonably likely to be exposed as National Institute for Occupational
§ 721.125(a), (b), (c), (d), (e), and (i) are required for § 721.63(a)(4), engineering Safety and Health (NIOSH)-certified
applicable to manufacturers and control measures (e.g., enclosure or respirators with an assigned protection
processors of this substance. confinement of the operation, general factor (APF) of at least 10 meet the
asabaliauskas on DSK3SPTVN1PROD with RULES
(2) Limitations or revocation of and local ventilation) or administrative requirements of § 721.63(a)(4):
certain notification requirements. The control measures (e.g., workplace (A) NIOSH-certified air-purifying
provisions of § 721.185 apply to this policies and procedures) shall be elastomeric half-mask respirator
section. considered and implemented to prevent equipped with N100 (if oil aerosols
(3) Determining whether a specific use exposure, where feasible. The following absent), R100, or P100 filters.
is subject to this section. The provisions National Institute for Occupational (B) NIOSH-certified N100 (if oil
of § 721.1725(b)(1) apply to paragraph Safety and Health (NIOSH)-certified aerosols absent), R100, or P100 filtering
(a)(2)(ii) of this section. respirators with an assigned protection facepiece respirator.
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(ii) Industrial, commercial, and § 721.63(a)(1), (a)(2)(i), and (a)(3). When substance after it has been completely
consumer activities. Requirements as determining which persons are reacted (cured).
specified in § 721.80(g). reasonably likely to be exposed as (2) The significant new uses are:
(ii) [Reserved]. required for § 721.63(a)(1), engineering (i) Protection in the workplace.
(b) Specific requirements. The control measures (e.g., enclosure or Requirements as specified in
provisions of subpart A of this part confinement of the operation, general § 721.63(a)(1), (a)(2)(i), and (a)(3). When
apply to this section except as modified and local ventilation) or administrative determining which persons are
by this paragraph. control measures (e.g., workplace reasonably likely to be exposed as
(1) Recordkeeping. Recordkeeping policies and procedures) shall be required for § 721.63(a)(1), engineering
requirements as specified in considered and implemented to prevent control measures (e.g., enclosure or
§ 721.125(a) through (d) and (i) are exposure, where feasible. confinement of the operation, general
applicable to manufacturers and (ii) Industrial, commercial, and and local ventilation) or administrative
processors of this substance. consumer activities. Requirements as control measures (e.g., workplace
(2) Limitations or revocation of specified in § 721.80. A significant new policies and procedures) shall be
certain notification requirements. The considered and implemented to prevent
use is manufacture, process, or use of
provisions of § 721.185 apply to this exposure, where feasible.
the PMN substance other than in a
section. (ii) Industrial, commercial, and
liquid formulation. A significant new
■ 30. Add § 721.10901 to subpart E to
use is use other than as a thin film for consumer activities. Requirements as
read as follows: electronic device applications or any specified in § 721.80(v)(1), (v)(2), (w)(1),
use involving an application method (w)(2), (x)(1), (x)(2), and (y)(1).
§ 721.10901 Formaldehyde, reaction (iii) Disposal. Requirements as
products with aniline and aromatic mono- that generates a vapor, mist, or aerosol
specified in § 721.85(a)(1), (a)(2), (b)(1),
and di-phenol mixture (generic). unless such application method occurs
(b)(2), (c)(1), and (c)(2).
(a) Chemical substance and in an enclosed process. An enclosed (iv) Release to water. Requirements as
significant new uses subject to reporting. process is defined as an operation that specified in § 721.90(a)(1), (b)(1), and
(1) The chemical substance identified is designed and operated so that there (c)(1).
generically as formaldehyde, reaction is no release associated with normal or (b) Specific requirements. The
products with aniline and aromatic routine production processes into the provisions of subpart A of this part
mono- and di-phenol mixture (PMN environment of any substance present in apply to this section except as modified
P–15–272) is subject to reporting under the operation. An operation with by this paragraph.
this section for the significant new uses inadvertent or emergency pressure relief (1) Recordkeeping. Recordkeeping
described in paragraph (a)(2) of this releases remains an enclosed process so requirements as specified in
section. long as measures are taken to prevent § 721.125(a) through (e), (i), (j), and (k)
(2) The significant new uses are: worker exposure to and environmental are applicable to manufacturers and
(i) Release to water. Requirements as contamination from the releases. processors of this substance.
specified in § 721.90(a)(4), (b)(4), and (iii) Disposal. Requirements as (2) Limitations or revocation of
(c)(4) (N=1). specified in § 721.85(a)(1), (a)(2), (b)(1), certain notification requirements. The
(ii) [Reserved]. (b)(2), (c)(1), and (c)(2). provisions of § 721.185 apply to this
(b) Specific requirements. The (iv) Release to water. Requirements as section.
provisions of subpart A of this part specified in § 721.90(a)(1), (b)(1), and ■ 33. Add § 721.10904 to subpart E to
apply to this section except as modified (c)(1). read as follows:
by this paragraph. (b) Specific requirements. The
(1) Recordkeeping. Recordkeeping provisions of subpart A of this part § 721.10904 Phenol, 1,1-dimethylalkyl
requirements as specified in apply to this section except as modified
derivatives (generic).
§ 721.125(a), (b), (c), and (k) are by this paragraph. (a) Chemical substance and
applicable to manufacturers and significant new uses subject to reporting.
(1) Recordkeeping. Recordkeeping
processors of this substance. (1) The chemical substance identified
(2) Limitations or revocation of requirements as specified in
generically phenol, 1,1-dimethylalkyl
certain notification requirements. The § 721.125(a) through (e), (i), (j), and (k)
derivatives (PMN P–15–306) is subject
provisions of § 721.185 apply to this are applicable to manufacturers and
to reporting under this section for the
section. processors of this substance.
significant new uses described in
(2) Limitations or revocation of
■ 31. Add § 721.10902 to subpart E to paragraph (a)(2) of this section.
certain notification requirements. The (2) The significant new uses are:
read as follows:
provisions of § 721.185 apply to this (i) Release to water. Requirements as
§ 721.10902 Functionalized carbon section. specified in § 721.90(a)(4), (b)(4), and
nanotubes (generic). ■ 32. Add § 721.10903 to subpart E to (c)(4) (N=13).
(a) Chemical substance and read as follows: (ii) [Reserved].
significant new uses subject to reporting. (b) Specific requirements. The
(1) The chemical substance identified § 721.10903 Acrylated mixed metal oxides provisions of subpart A of this part
generically as functionalized carbon (generic). apply to this section except as modified
nanotubes (PMN P–15–276) is subject to (a) Chemical substance and by this paragraph.
reporting under this section for the significant new uses subject to reporting. (1) Recordkeeping. Recordkeeping
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significant new uses described in (1) The chemical substance identified requirements as specified in
paragraph (a)(2) of this section. The generically as acrylated mixed metal § 721.125(a), (b), (c), and (k) are
requirements of this rule do not apply oxides (PMN P–15–295) is subject to applicable to manufacturers and
to quantities of the PMN substance after reporting under this section for the processors of this substance.
it has been completely reacted (cured). significant new uses described in (2) Limitations or revocation of
(2) The significant new uses are: paragraph (a)(2) of this section. The certain notification requirements. The
(i) Protection in the workplace. requirements of this section do not provisions of § 721.185 apply to this
Requirements as specified in apply to quantities of the PMN section.
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■ 34. Add § 721.10905 to subpart E to § 721.10907 Polyfluorohydrocarbon (A) NIOSH-certified power air-
read as follows: (generic). purifying respirator with a hood or
(a) Chemical substance and helmet and with appropriate gas/vapor
§ 721.10905 Butanedioic acid, 2- significant new uses subject to reporting. (acid gas, organic vapor, or substance
methylene-, dialkyl ester (generic).
(1) The chemical substance identified specific) cartridges in combination with
(a) Chemical substance and generically as polyfluorohydrocarbon HEPA filters.
significant new uses subject to reporting. (PMN P–15–326) is subject to reporting (B) NIOSH-certified continuous flow
(1) The chemical substance identified under this section for the significant supplied-air respirator equipped with a
generically as butanedioic acid, 2- new uses described in paragraph (a)(2) loose fitting face piece, hood, or helmet.
methylene-, dialkyl ester (PMN P–15– of this section. (C) NIOSH-certified negative pressure
319) is subject to reporting under this (2) The significant new uses are: (demand) supplied-air respirator with a
section for the significant new uses (i) Industrial commercial, and full face piece.
described in paragraph (a)(2) of this consumer activities. Requirements as As an alternative to the respiratory
section. specified in § 721.80(j) and (o). requirements listed here, a manufacturer
(2) The significant new uses are: (ii) [Reserved]. or processor may choose to follow the
(i) Release to water. Requirements as (b) Specific requirements. The New Chemical Exposure Limit (NCEL)
specified in § 721.90(a)(4), (b)(4), and provisions of subpart A of this part provisions listed in the TSCA section
(c)(4) (N=1). apply to this section except as modified 5(e) consent order for this substance.
(ii) [Reserved]. by this paragraph. The NCEL is 5 mg/m3 as an 8-hour time
(b) Specific requirements. The (1) Recordkeeping. Recordkeeping weighted average verified by actual
provisions of subpart A of this part requirements as specified in monitoring data.
apply to this section except as modified § 721.125(a), (b), (c), and (i) are (ii) Hazard communication program.
by this paragraph. applicable to manufacturers and Requirements as specified in § 721.72(a)
(1) Recordkeeping. Recordkeeping processors of this substance. trhough (f)(concentration set at 1.0
requirements as specified in (2) Limitations or revocation of percent), (g)(1)(ii), (g)(2)(When using
§ 721.125(a), (b), (c), and (k) are certain notification requirements. The this substance avoid breathing the
applicable to manufacturers and provisions of § 721.185 apply to this substance, and use respiratory
processors of this substance. section. protection, or maintain workplace
(2) Limitations or revocation of (3) Determining whether a specific use airborne concentrations at or below an
certain notification requirements. The is subject to this section. The provisions 8-hour time-weighted average of 5 mg/
provisions of § 721.185 apply to this of § 721.1725(b)(1) apply to paragraph m3.) and (g)(5).
section. (a)(2)(i) of this section. (iii) Industrial, commercial, and
■ 37. Add § 721.10908 to subpart E to consumer activities. Requirements as
■ 35. Add § 721.10906 to subpart E to
read as follows: specified in § 721.80(k).
read as follows:
(b) Specific requirements. The
§ 721.10908 Aluminum calcium oxide salt provisions of subpart A of this part
§ 721.10906 Magnesium alkaryl sulfonate
(generic).
(generic). apply to this section except as modified
(a) Chemical substance and by this paragraph.
(a) Chemical substance and significant new uses subject to reporting.
significant new uses subject to reporting. (1) Recordkeeping. Recordkeeping
(1) The chemical substance identified requirements as specified in
(1) The chemical substance identified generically as aluminum calcium oxide
generically as magnesium alkaryl § 721.125(a) through (d) and (f) through
salt (PMN P–15–328) is subject to and (i) are applicable to manufacturers
sulfonate (PMN P–15–324) is subject to reporting under this section for the
reporting under this section for the and processors of this substance.
significant new uses described in (2) Limitations or revocation of
significant new uses described in paragraph (a)(2) of this section. The
paragraph (a)(2) of this section. certain notification requirements. The
requirements of this section do not provisions of § 721.185 apply to this
(2) The significant new uses are: apply to quantities of the PMN
(i) Industrial commercial, and section.
substance after it has been completely (3) Determining whether a specific use
consumer activities. Requirements as reacted (cured). is subject to this section. The provisions
specified in § 721.80. A significant new (2) The significant new uses are: of § 721.1725(b)(1) apply to paragraph
use of the substance is any use other (i) Protection in the workplace. (a)(2)(iii) of this section.
than as a detergent additive in crankcase Requirements as specified in
lubricant applications. ■ 38. Add § 721.10909 to subpart E to
§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v), read as follows:
(ii) [Reserved]. (a)(6)(vi), (b), and (c). When determining
(b) Specific requirements. The which persons are reasonably likely to § 721.10909 Polyalkyltrisiloxane (generic).
provisions of subpart A of this part be exposed as required for § 721.63 (a) Chemical substance and
apply to this section except as modified (a)(4), engineering control measures significant new uses subject to reporting.
by this paragraph. (e.g., enclosure or confinement of the (1) The chemical substance identified
(1) Recordkeeping. Recordkeeping operation, general and local ventilation) generically as polyalkyltrisiloxane
requirements as specified in or administrative control measures (e.g., (PMN P–15–332) is subject to reporting
§ 721.125(a), (b), (c), and (i) are workplace policies and procedures) under this section for the significant
asabaliauskas on DSK3SPTVN1PROD with RULES
applicable to manufacturers and shall be considered and implemented to new uses described in paragraph (a)(2)
processors of this substance. prevent exposure, where feasible. The of this section.
(2) Limitations or revocation of following National Institute for (2) The significant new uses are:
certain notification requirements. The Occupational Safety and Health (i) Protection in the workplace.
provisions of § 721.185 apply to this (NIOSH)-certified respirators with an Requirements as specified in
section. Assigned Protection Factor (APF) of at § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4),
■ 36. Add § 721.10907 to subpart E to least 10 meet the requirements of (a)(6)(i), (b)(concentration set at 1.0
read as follows: § 721.63(a)(4): percent), and (c). When determining
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which persons are reasonably likely to specified in § 721.80. A significant new (1) The chemical substance identified
be exposed as required for use of the substance is any use other generically as aliphatic acrylate (PMN
§ 721.63(a)(4), engineering control than as an additive in polymer P–15–363) is subject to reporting under
measures (e.g., enclosure or formulation for electronics. this section for the significant new uses
confinement of the operation, general (ii) Release to water. Requirements as described in paragraph (a)(2) of this
and local ventilation) or administrative specified in § 721.90(a)(1), (b)(1), and section.
control measures (e.g., workplace (c)(1). (2) The significant new uses are:
policies and procedures) shall be (b) Specific requirements. The (i) Release to water. Requirements as
considered and implemented to prevent provisions of subpart A of this part specified in § 721.90(a)(4), (b)(4), and
exposure, where feasible. The following apply to this section except as modified (c)(4) (N=1).
National Institute for Occupational by this paragraph. (ii) [Reserved].
Safety and Health (NIOSH)-certified (1) Recordkeeping. Recordkeeping (b) Specific requirements. The
respirators with an assigned protection requirements as specified in provisions of subpart A of this part
factor (APF) of at least 10 meet the § 721.125(a), (b), (c), (i), and (k) are apply to this section except as modified
requirements of § 721.63(a)(4): applicable to manufacturers and by this paragraph.
processors of this substance. (1) Recordkeeping. Recordkeeping
(A) NIOSH-certified power air-
(2) Limitations or revocation of requirements as specified in
purifying respirator with a hood or
certain notification requirements. The § 721.125(a), (b), (c), and (k) are
helmet and with appropriate gas/vapor
provisions of § 721.185 apply to this applicable to manufacturers and
(acid gas, organic vapor, or substance
section. processors of this substance.
specific) cartridges in combination with (2) Limitations or revocation of
HEPA filters. ■ 40. Add § 721.10911 to subpart E to certain notification requirements. The
(B) NIOSH-certified continuous flow read as follows: provisions of § 721.185 apply to this
supplied-air respirator equipped with a section.
loose fitting facepiece, hood, or helmet. § 721.10911 2-Propanol, 1,3-bis[4-[1-[4-[1-
methyl-1-[4-(2- ■ 42. Add § 721.10913 to subpart E to
(C) NIOSH-certified negative pressure
(demand) supplied-air respirator with a oxiranylmethoxy)phenyl]ethyl]phenyl]-1-[4- read as follows:
(2-oxiranylmethoxy)phenyl]ethyl]phenoxy]-
full facepiece. (P–15–356, Chemical B). § 721.10913 Diisocyanato hexane,
(ii) Industrial commercial, and homopolymer, alkanoic acid-polyalkylene
consumer activities. Requirements as (a) Chemical substance and glycol ether with substituted alkane (3:1)
specified in § 721.80(h). significant new uses subject to reporting. reaction products-blocked (generic).
(iii) Release to water. Requirements as (1) The chemical substance identified as (a) Chemical substance and
specified in § 721.90(a)(4), (b)(4), and 2-propanol, 1,3-bis[4-[1-[4-[1-methyl-1- significant new uses subject to reporting.
(c)(4) (N=4). [4-(2- (1) The chemical substance identified
(b) Specific requirements. The oxiranylmethoxy)phenyl]ethyl]phenyl]- generically as diisocyanato hexane,
provisions of subpart A of this part 1-[4-(2-oxiranylmethoxy)phenyl] homopolymer, alkanoic acid-
apply to this section except as modified ethyl]phenoxy]- (PMN P–15–356, polyalkylene glycol ether with
by this paragraph. Chemical B; CAS No. 180063–56–3) is substituted alkane (3:1) reaction
(1) Recordkeeping. Recordkeeping subject to reporting under this section products-blocked (PMN P–15–378) is
requirements as specified in for the significant new uses described in subject to reporting under this section
§ 721.125(a) through (e), (i), and (k) are paragraph (a)(2) of this section. for the significant new uses described in
applicable to manufacturers and (2) The significant new uses are: paragraph (a)(2) of this section.
processors of this substance. (i) Industrial, commercial and (2) The significant new uses are:
(2) Limitations or revocation of consumer activities. Requirements as (i) Protection in the workplace.
certain notification requirements. The specified in § 721.80. A significant new Requirements as specified in
provisions of § 721.185 apply to this use of the substance is any use other § 721.63(a)(4), (a)(6)(ii), and (c). When
section. than as an additive in polymer determining which persons are
formulation for electronics. reasonably likely to be exposed as
■ 39. Add § 721.10910 to subpart E to
(ii) Release to water. Requirements as required for § 721.63(a)(4), engineering
read as follows: specified in § 721.90(a)(1), (b)(1), and control measures (e.g., enclosure or
§ 721.10910 Oxirane, 2,2′-[[1-[4-[1-methyl- (c)(1). confinement of the operation, general
1-[4-(2-oxiranylmethoxy)phenyl] (b) Specific requirements. The and local ventilation) or administrative
ethyl]phenyl]ethylidene]bis(4,1- provisions of subpart A of this part control measures (e.g., workplace
phenyleneoxymethylene)]bis- (P–15–356, apply to this section except as modified policies and procedures) shall be
Chemical A). by this paragraph. considered and implemented to prevent
(a) Chemical substance and (1) Recordkeeping. Recordkeeping exposure, where feasible. The following
significant new uses subject to reporting. requirements as specified in National Institute for Occupational
(1) The chemical substance identified as § 721.125(a), (b), (c), (i), and (k) are Safety and Health (NIOSH)-certified
oxirane, 2,2′-[[1-[4-[1-methyl-1-[4-(2- applicable to manufacturers and respirators with an assigned protection
oxiranylmethoxy)phenyl]ethyl]phenyl] processors of this substance. factor (APF) of at least 10 meet the
ethylidene]bis(4,1- (2) Limitations or revocation of requirements of § 721.63(a)(4):
phenyleneoxymethylene)]bis- (PMN certain notification requirements. The (A) NIOSH-certified power air-
asabaliauskas on DSK3SPTVN1PROD with RULES
P–15–356, Chemical A; CAS No. provisions of § 721.185 apply to this purifying respirator with a hood or
115254–47–2) is subject to reporting section. helmet and with appropriate gas/vapor
under this section for the significant ■ 41. Add § 721.10912 to subpart E to (acid gas, organic vapor, or substance
new uses described in paragraph (a)(2) read as follows: specific) cartridges in combination with
of this section. HEPA filters.
(2) The significant new uses are: § 721.10912 Aliphatic acrylate (generic). (B) NIOSH-certified continuous flow
(i) Industrial, commercial and (a) Chemical substance and supplied-air respirator equipped with a
consumer activities. Requirements as significant new uses subject to reporting. loose fitting facepiece, hood, or helmet.
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(C) NIOSH-certified negative pressure 411) is subject to reporting under this subject to reporting under this section
(demand) supplied-air respirator with a section for the significant new uses for the significant new uses described in
full facepiece. described in paragraph (a)(2) of this paragraph (a)(2) of this section.
(ii) Industrial, commercial, and section. (2) The significant new uses are:
consumer activities. Requirements as (2) The significant new uses are: (i) Protection in the workplace.
specified in § 721.80(o). (i) Release to water. Requirements as Requirements as specified in
(b) Specific requirements. The specified in § 721.90(a)(4), (b)(4), and § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4),
provisions of subpart A of this part (c)(4) (N=30). (a)(6)(ii), (a)(6)(v), (a)(6)(vi), and (c).
apply to this section except as modified (ii) [Reserved]. When determining which persons are
by this paragraph. (b) Specific requirements. The reasonably likely to be exposed as
(1) Recordkeeping. Recordkeeping provisions of subpart A of this part required for § 721.63(a)(4), engineering
requirements as specified in apply to this section except as modified control measures (e.g., enclosure or
§ 721.125(a) through (d) and (i) are by this paragraph. confinement of the operations, general
applicable to manufacturers and (1) Recordkeeping. Recordkeeping and local ventilation) or administrative
processors of this substance. requirements as specified in control measure (e.g., workplace
(2) Limitations or revocation of § 721.125(a), (b), (c), and (k) are policies and procedures) shall be
certain notification requirements. The applicable to manufacturers and considered and implemented to prevent
provisions of § 721.185 apply to this processors of this substance. exposure, where feasible. The following
section. (2) Limitations or revocation of National Institute for Occupational
■ 43. Add § 721.10914 to subpart E to certain notification requirements. The Safety and Health (NIOSH)-certified
read as follows: provisions of § 721.185 apply to this respirator with an assigned protection
section. factor (APF) of at least 10 meets the
§ 721.10914 Polyitaconic acid, sodium zinc minimum requirements for
■ 45. Add § 721.10916 to subpart E to
salt (generic).
read as follows: § 721.63(a)(4): NIOSH-certified powered
(a) Chemical substance and air-purifying respirator with a hood or
significant new uses subject to reporting. § 721.10916 2,7-Naphthalenedisulfonic helmet and with appropriate gas-vapor
(1) The chemical substance identified acid, 4-amino-3-[substituted]-5-hydroxy-6- (acid gas, organic vapor, or substance
generically as polyitaconic acid, sodium [(1E)-2-phenyldiazenyl]-, lithium salt (1:3)
(generic).
specific) cartridges.
zinc salt (PMN P–15–382) is subject to (ii) Industrial commercial, and
reporting under this section for the (a) Chemical substance and consumer activities. Requirements as
significant new uses described in significant new uses subject to reporting. specified in § 721.80(g).
paragraph (a)(2) of this section. (1) The chemical substance identified (iii) Release to water. Requirements as
(2) The significant new uses are: generically as 2,7-naphthalenedisulfonic specified in § 721.90(a)(4), (b)(4), and
(i) Industrial commercial, and acid, 4-amino-3-[substituted]-5-hydroxy- (c)(4) (N=1).
consumer activities. Requirements as 6-[(1E)-2-phenyldiazenyl]-, lithium salt (b) Specific requirements. The
specified in § 721.80. A significant new (1:3) (PMN P–15–435) is subject to provisions of subpart A of this part
use of the substance is any use other reporting under this section for the apply to this section except as modified
than as an odor neutralization for pet significant new uses described in by this paragraph.
litter and cleaning hard surface surfaces, paragraph (a)(2) of this section. (1) Recordkeeping. Recordkeeping
fabrics, skin and hair; an odor (2) The significant new uses are: requirements as specified in
neutralization for air car; and an odor (i) Industrial, commercial, and § 721.125(a) through (e), (i), and (k) are
neutralization for waste processing and consumer activities. Requirements as applicable to manufacturers and
solid waste management in paper, oil, specified in § 721.80. A significant new processors of this substance.
gas, mining, agriculture, food and use of the substance is any use other (2) Limitations or revocation of
municipal industries. that in a liquid formulation. certain notification requirements. The
(ii) [Reserved]. (ii) [Reserved]. provisions of § 721.185 apply to this
(b) Specific requirements. The (b) Specific requirements. The section.
provisions of subpart A of this part provisions of subpart A of this part ■ 47. Add § 721.10918 to subpart E to
apply to this section except as modified apply to this section except as modified read as follows:
by this paragraph. by this paragraph.
(1) Recordkeeping. Recordkeeping (1) Recordkeeping. Recordkeeping § 721.10918 Perfluorobutanesulfonamide
requirements as specified in requirements as specified in and polyoxyalkylene containing
§ 721.125(a), (b), (c), and (i) are § 721.125(a), (b), (c), and (i) are polyurethane (generic).
applicable to manufacturers and applicable to manufacturers and (a) Chemical substance and
processors of this substance. processors of these substances. significant new uses subject to reporting.
(2) Limitations or revocation of (2) Limitations or revocation of (1) The chemical substance identified
certain notification requirements. The certain notification requirements. The generically as
provisions of § 721.185 apply to this provisions of § 721.185 apply to this perfluorobutanesulfonamide and
section. section. polyoxyalkylene containing
■ 44. Add § 721.10915 to subpart E to ■ 46. Add § 721.10917 to subpart E to polyurethane (PMN P–15–502) is
read as follows: read as follows: subject to reporting under this section
asabaliauskas on DSK3SPTVN1PROD with RULES
for the significant new uses described in
§ 721.10915 Fatty acid esters with polyols § 721.10917 Polymethylsiloxane, paragraph (a)(2) of this section. The
polyalkyl ethers (generic). distillation residues (generic). requirements of this rule do not apply
(a) Chemical substance and (a) Chemical substance and to quantities of the PMN substance after
significant new uses subject to reporting. significant new uses subject to reporting. it has been completely reacted (cured).
(1) The chemical substance identified (1) The chemical substance identified (2) The significant new uses are:
generically as fatty acid esters with generically as polymethylsiloxane, (i) Hazard communication program. A
polyols polyalkyl ethers (PMN P–15– distillation residues (PMN P–15–492) is significant new use of the substance is
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![30480 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations
any manner or method of manufacture reporting under this section for the (chloromethyl)- (PMN P–15–573; CAS
or processing associated with any use of significant new uses described in No. 1623–88–7) is subject to reporting
the substance without providing risk paragraph (a)(2) of this section. under this section for the significant
notification as follows: (2) The significant new uses are: new uses described in paragraph (a)(2)
(A) If as a result of the test data (i) Release to water. Requirements as of this section.
required under TSCA section 5(e) specified in § 721.90(a)(4), (b)(4), and (2) The significant new uses are:
consent order for the substance, the (c)(4) (N=24). (i) Protection in the workplace.
employer becomes aware that the (ii) [Reserved]. Requirements as specified in
substances may present a risk of injury (b) Specific requirements. The § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4),
to human health or the environment, the provisions of subpart A of this part (a)(6)(v), and (c). When determining
employer must incorporate this new apply to this section except as modified which persons are reasonably likely to
information, and any information on by this paragraph. be exposed as required for
methods for protecting against such risk, (1) Recordkeeping. Recordkeeping § 721.63(a)(4), engineering control
into a MSDS as described in § 721.72(c) requirements as specified in measures (e.g., enclosure or
within 90 days from the time the § 721.125(a), (b), (c), and (k) are confinement of the operation, general
employer becomes aware of the new applicable to manufacturers and and local ventilation) or administrative
information. If the substance is not processors of this substance. control measures (e.g., workplace
being manufactured, processed, or used (2) Limitations or revocation of policies and procedures) shall be
in the employer’s workplace, the certain notification requirements. The considered and implemented to prevent
employer must add the new information provisions of § 721.185 apply to this exposure, where feasible. The following
to a MSDS before the substance is section. National Institute for Occupational
reintroduced into the workplace. ■ 49. Add § 721.10920 to subpart E to Safety and Health (NIOSH)-certified
(B) The employer must ensure that read as follows: respirators with an assigned protection
persons who will receive the PMN factor (APF) of at least 50 meet the
substance from the employer, or who § 721.10920 Modified diphenylmethane requirements of § 721.63(a)(4):
diisocyanate prepolymer with polyol (A) NIOSH-certified powered air-
have received the PMN substance from
(generic).
the employer within 5 years from the purifying respirator with a tight-fitting
date the employer becomes aware of the (a) Chemical substance and half mask and HEPA filters.
new information described in paragraph significant new uses subject to reporting. (B) NIOSH-certified continuous flow
(a)(2)(i)(A) of this section, are provided (1) The chemical substance identified supplied-air respirator equipped with a
an MSDS containing the information generically as modified tight-fitting half mask.
required under paragraph (a)(2)(i)(A) of diphenylmethane diisocyanate (C) NIOSH-certified negative pressure
this section within 90 days from the prepolymer with polyol (PMN P–15– (demand) supplied-air respirator
time the employer becomes aware of the 559) is subject to reporting under this equipped with a full facepiece.
new information. section for the significant new uses (ii) Industrial commercial, and
(ii) Industrial, commercial, and described in paragraph (a)(2) of this consumer activities. Requirements as
consumer activities. Requirements as section. specified in § 721.80(g) (chemical
specified in § 721.80(k). (2) The significant new uses are: intermediate use in a continuous
(b) Specific requirements. The (i) Industrial, commercial, and reaction process such that no greater
provisions of subpart A of this part consumer activities. Requirements as than 50 kilograms is present in the
apply to this section except as modified specified in § 721.80. A significant new workplace at a given time) and
by this paragraph. use of the substance is manufacture of (s)(15,000 kilograms).
(1) Recordkeeping. Recordkeeping the substance where the average (b) Specific requirements. The
requirements as specified in molecular weight is below 7,500 provisions of subpart A of this part
§ 721.125(a), (b), (c), (f), (h), and (i) are daltons, and where any molecular apply to this section except as modified
applicable to manufacturers and weight species is below 1,000 daltons. by this paragraph.
processors of this substance. (ii) [Reserved]. (1) Recordkeeping. Recordkeeping
(2) Limitations or revocation of (b) Specific requirements. The requirements as specified in
certain notification requirements. The provisions of subpart A of this part § 721.125(a) through (e) and (i) are
provisions of § 721.185 apply to this apply to this section except as modified applicable to manufacturers and
section. by this paragraph. processors of this substance.
(3) Determining whether a specific (1) Recordkeeping. Recordkeeping (2) Limitations or revocation of
use is subject to this section. The requirements as specified in certain notification requirements. The
provisions of § 721.1725(b)(1) apply to § 721.125(a), (b), (c), and (i) are provisions of § 721.185 apply to this
paragraph (a)(2)(ii) of this section. applicable to manufacturers and section.
■ 48. Add § 721.10919 to subpart E to
processors of this substance. ■ 51. Add § 721.10922 to subpart E to
read as follows: (2) Limitations or revocation of read as follows:
certain notification requirements. The
§ 721.10919 Quaternary ammonium provisions of § 721.185 apply to this § 721.10922 1,2,4,5,7,8-Hexoxonane, 3,6,9-
compounds, (3-chloro-2- section. trimethyl-, 3,6,9-tris(alkyl) derivs. (generic).
hydroxypropyl)coco alkyldimethyl, ■ 50. Add § 721.10921 to subpart E to (a) Chemical substance and
asabaliauskas on DSK3SPTVN1PROD with RULES
chlorides. significant new uses subject to reporting.
read as follows:
(a) Chemical substance and (1) The chemical substance identified
significant new uses subject to reporting. § 721.10921 2-Furancarboxyaldehyde, generically as 11,2,4,5,7,8-hexoxonane,
(1) The chemical substance identified as 5-(chloromethyl)-. 3,6,9-trimethyl-, 3,6,9-tris(alkyl) derivs.
quaternary ammonium compounds, (a) Chemical substance and (PMN P–15–607) is subject to reporting
(3-chloro-2-hydroxypropyl)coco significant new uses subject to reporting. under this section for the significant
alkyldimethyl, chlorides (PMN P–15– (1) The chemical substance identified as new uses described in paragraph (a)(2)
542; CAS No. 690995–44–9) is subject to 2-furancarboxyaldehyde, 5- of this section.
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![Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 30481
(2) The significant new uses are: (1:1), (9Z)- (PMN P–15–671; CAS No. generically as vegetable fatty acid alkyl
(i) Industrial commercial, and 41130–29–4) is subject to reporting esters (PMNs P–15–689 and P–15–690)
consumer activities. Requirements as under this section for the significant are subject to reporting under this
specified in § 721.80(j). new uses described in paragraph (a)(2) section for the significant new uses
(ii) [Reserved]. of this section. described in paragraph (a)(2) of this
(b) Specific requirements. The (2) The significant new uses are: section.
provisions of subpart A of this part (i) Release to water. Requirements as
apply to this section except as modified specified in § 721.90(a)(4), (b)(4), and (2) The significant new uses are:
by this paragraph. (c)(4) (N=1). (i) Industrial, commercial, and
(1) Recordkeeping. Recordkeeping (ii) [Reserved]. consumer activities. Requirements as
requirements as specified in (b) Specific requirements. The specified in § 721.80(g).
§ 721.125(a), (b), (c), and (i) are provisions of subpart A of this part
applicable to manufacturers and apply to this section except as modified (ii) [Reserved].
processors of this substance. by this paragraph. (b) Specific requirements. The
(2) Limitations or revocation of (1) Recordkeeping. Recordkeeping provisions of subpart A of this part
certain notification requirements. The requirements as specified in apply to this section except as modified
provisions of § 721.185 apply to this § 721.125(a), (b), (c), and (k) are by this paragraph.
section. applicable to manufacturers and
(3) Determining whether a specific use (1) Recordkeeping. Recordkeeping
processors of this substance.
is subject to this section. The provisions (2) Limitations or revocation of requirements as specified in
of § 721.1725(b)(1) apply to paragraph certain notification requirements. The § 721.125(a), (b), (c), and (i) are
(a)(2)(i) of this section. provisions of § 721.185 apply to this applicable to manufacturers and
■ 52. Add § 721.10923 to subpart E to section. processors of these substances.
read as follows: ■ 53. Add § 721.10924 to subpart E to (2) Limitations or revocation of
read as follows: certain notification requirements. The
§ 721.10923 9-Octadecen-1-amine,
hydrochloride (1:1), (9Z)-.
provisions of § 721.185 apply to this
§ 721.10924 Vegetable fatty acid alkyl
esters (generic). section.
(a) Chemical substance and
significant new uses subject to reporting. (a) Chemical substance and [FR Doc. 2016–11121 Filed 5–13–16; 8:45 am]
(1) The chemical substance identified as significant new uses subject to reporting. BILLING CODE 6560–50–P
9-octadecen-1-amine, hydrochloride (1) The chemical substances identified
asabaliauskas on DSK3SPTVN1PROD with RULES
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Document Created: 2016-05-14 01:17:36
Document Modified: 2016-05-14 01:17:36
| 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 July 15, 2016. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on May 31, 2016. | |
| 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 | 81 FR 30451 | |
| 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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