Significant New Use Rules on Certain Chemical Substances, 30451-30481 [2016-11121]

Download as PDF Vol. 81 Monday, No. 94 May 16, 2016 Part III Environmental Protection Agency asabaliauskas on DSK3SPTVN1PROD with RULES 40 CFR Parts 9 and 721 Significant New Use Rules on Certain Chemical Substances; Final Rule VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\16MYR3.SGM 16MYR3 30452 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 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 Environmental Protection Agency (EPA). ACTION: Direct final rule. AGENCY: EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 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: https:// 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. asabaliauskas on DSK3SPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 • 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 https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (202) 564–9232; email address: Moss.Kenneth@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture (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 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 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 § 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 https://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 E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 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 § 721.5. asabaliauskas on DSK3SPTVN1PROD with RULES C. Applicability of General Provisions General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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 nonconfidential 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 § 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 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 30453 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 § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 721.30 requests to use the NCELs approach for SNURs 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 § 721.170. EPA has determined that every activity designated as a ‘‘significant new use’’ in all TSCA nonsection 5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 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, E:\FR\FM\16MYR3.SGM 16MYR3 30454 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES 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/m3) as an 8hour 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, VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 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 E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 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). asabaliauskas on DSK3SPTVN1PROD with RULES 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 nonindustrial, 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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: 1Octadecanaminium, N-(3-chloro-2hydroxypropyl)-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 PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 30455 result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 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 § 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 E:\FR\FM\16MYR3.SGM 16MYR3 30456 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations PMN Number P–14–198 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. asabaliauskas on DSK3SPTVN1PROD with RULES 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 § 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. VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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 20day 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 § 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 20day criterion is derived from partial life cycle tests (daphnid chronic and fish PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 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 § 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, 1benzoate. 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 § 721.170(b)(4)(ii). E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 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. asabaliauskas on DSK3SPTVN1PROD with RULES PMN Number P–14–448 Chemical name: Alcohols, C12–22, 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 structureactivity 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 § 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. VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 PMN Number P–14–501 and P–14–502 Chemical names: Phosphoric acid, mixed Bu and decyl and octyl and 2-(2phenoxyethoxy)ethyl and 2phenoxyethyl 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 structureactivity 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 § 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-[(2aminoethyl)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. PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 30457 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 E:\FR\FM\16MYR3.SGM 16MYR3 30458 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES 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-(1methylethylidene)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 § 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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 § 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 PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 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 § 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 § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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, 6mercapto-. 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 § 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′-[1,2disubstituted-1,2-ethanediyl] PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 30459 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 § 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 pigmentwetting 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 E:\FR\FM\16MYR3.SGM 16MYR3 30460 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES listed in the PMN may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 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 NIOSHcertified 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 § 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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 § 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 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 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 § 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 E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES 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 § 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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 § 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, 1,1dimethylalkyl 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 § 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); PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 30461 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, 2methylene-, 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 § 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 E:\FR\FM\16MYR3.SGM 16MYR3 30462 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES PMN substance in surface waters for greater than 20 days per year. This 20day 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 § 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 § 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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/m3 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 PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 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 sitelimited 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 § 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-(2oxiranylmethoxy)phenyl]ethyl]phenyl] ethylidene]bis(4,1phenyleneoxymethylene)]bis- (P–15– E:\FR\FM\16MYR3.SGM 16MYR3 asabaliauskas on DSK3SPTVN1PROD with RULES Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 356, Chemical A); and 2-Propanol, 1,3bis[4-[1-[4-[1-methyl-1-[4-(2oxiranylmethoxy)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 § 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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 § 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 acidpolyalkylene 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 PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 30463 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 § 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 20day 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 § 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 E:\FR\FM\16MYR3.SGM 16MYR3 30464 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10914. asabaliauskas on DSK3SPTVN1PROD with RULES 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 § 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: 2,7Naphthalenedisulfonic acid, 4-amino-3[substituted]-5-hydroxy-6-[(1E)-2phenyldiazenyl]-, 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, VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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 § 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 PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 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 § 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 earlylife 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 nonindustrial, commercial, or consumer use, the PMN substance could cause lung effects, based on limited data on E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES 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-2hydroxypropyl)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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 (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 § 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 § 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 PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 30465 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 NIOSHcertified 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 § 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 E:\FR\FM\16MYR3.SGM 16MYR3 30466 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations the human health effects of the PMN substance. CFR citation: 40 CFR 721.10921. asabaliauskas on DSK3SPTVN1PROD with RULES PMN Number P–15–607 Chemical name: 1,2,4,5,7,8Hexoxonane, 3,6,9-trimethyl-, 3,6,9tris(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 § 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-1amine, 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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 § 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 § 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. PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 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 § 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 § 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. E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations • 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 https://www.epa.gov/opptintr/ existingchemicals/pubs/tscainventory/ index.html. asabaliauskas on DSK3SPTVN1PROD with RULES VI. Direct Final Procedures EPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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 §§ 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 § 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. PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 30467 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 https:// 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 https:// www.oecdbookshop.org or SourceOECD at https://www.sourceoecd.org. ASTM International standards are available at https://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 nonexempt 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 E:\FR\FM\16MYR3.SGM 16MYR3 30468 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES 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 § 721.1725(b)(1) with that under § 721.11 into a single step. If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 determine whether that higher volume would be a significant new use. X. SNUN Submissions According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710–25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and § 721.25. E–PMN software is available electronically at https:// 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, PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 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. E:\FR\FM\16MYR3.SGM 16MYR3 30469 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities. expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866. 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.). 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. 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). asabaliauskas on DSK3SPTVN1PROD with RULES 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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] 1. The authority citation for part 9 continues to read as follows: ■ Authority: 7 U.S.C. 135 et seq., 136–136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971–1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 6901–6992k, 7401–7671q, 7542, 9601–9657, 11023, 11048. 2. In § 9.1, add the following sections in numerical order under the undesignated center heading ‘‘Significant New Uses of Chemical Substances’’ to read as follows: § 9.1 OMB approvals under the Paperwork Reduction Act. * * * * * 40 CFR citation * * OMB control No. * * Significant New Uses of Chemical Substances * 721.10875 721.10876 721.10877 721.10878 721.10879 721.10880 721.10881 721.10882 721.10883 721.10884 721.10885 721.10886 721.10887 721.10888 721.10889 721.10890 721.10891 721.10892 721.10893 721.10894 721.10895 721.10896 721.10897 721.10898 721.10899 721.10900 721.10901 721.10902 721.10903 721.10904 721.10905 721.10906 721.10907 721.10908 721.10909 721.10910 721.10911 721.10912 721.10913 721.10914 721.10915 721.10916 721.10917 721.10918 721.10919 721.10920 721.10921 721.10922 721.10923 721.10924 721.10925 * * * ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... * * Frm 00019 Fmt 4701 Sfmt 4700 * E:\FR\FM\16MYR3.SGM * * 16MYR3 * * * ■ PO 00000 * * * 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 * 30470 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations PART 721—[AMENDED] 3. The authority citation for part 721 continues to read as follows: ■ Authority: 15 U.S.C. 2604, 2607, and 2625(c). 4. Add § 721.10875 to subpart E to read as follows: ■ asabaliauskas on DSK3SPTVN1PROD with RULES § 721.10875 (generic). Alkali transition metal oxide (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 § 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 § 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 § 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/m3 as an 8-hour VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 time weighted average (TWA) verified by actual monitoring data. (ii) Hazard communication program. Requirements as specified in § 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/ m3), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 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 § 721.125(a) through (d) and (f) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 5. Add § 721.10876 to subpart E to read as follows: § 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 § 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 § 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. PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 (iii) Release to water. Requirements as specified in § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraphs (a)(2)(i) and (iii) of this section. ■ 6. Add § 721.10877 to subpart E to read as follows: § 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 § 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 § 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 § 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. E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations (1) Recordkeeping. Recordkeeping requirements as specified in § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraphs (a)(2)(i) and (iii) of this section. ■ 7. Add § 721.10878 to subpart E to read as follows: asabaliauskas on DSK3SPTVN1PROD with RULES § 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 § 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 § 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. VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. ■ 8. Add § 721.10879 to subpart E to read as follows: § 721.10879 1-Octadecanaminium, N-(3chloro-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-2hydroxypropyl)-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 § 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 § 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 § 721.185 apply to this section. ■ 9. Add § 721.10880 to subpart E to read as follows: § 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 PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 30471 described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. 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 § 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 § 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 § 721.185 apply to this section. ■ 10. Add § 721.10881 to subpart E to read as follows: § 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 § 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 § 721.90(a)(4), (b)(4), and E:\FR\FM\16MYR3.SGM 16MYR3 30472 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations (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 § 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 § 721.185 apply to this section. ■ 11. Add § 721.10882 to subpart E to read as follows: § 721.10882 Trialkylammonium borodibenzoate (generic). § 721.10884 (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 § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. ■ 12. Add § 721.10883 to subpart E to read as follows: asabaliauskas on DSK3SPTVN1PROD with RULES § 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 specified in § 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 § 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 § 721.185 apply to this section. ■ 13. Add § 721.10884 to subpart E to read as follows: 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 § 721.80. A significant new use of the substance is use other than as a plasticizer in adhesives for foodproduct 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 § 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 § 721.185 apply to this section. ■ 14. Add § 721.10885 to subpart E to read as follows: § 721.10885 residues. Alcohols, C12–22, distn. (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 PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 specified in § 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 § 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 § 721.185 apply to this section. ■ 15. Add § 721.10886 to subpart E to read as follows: § 721.10886 Phosphoric acid, mixed Bu and decyl and octyl and 2-(2phenoxyethoxy)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 § 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 § 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 § 721.185 apply to this section. ■ 16. Add § 721.10887 to subpart E to read as follows: § 721.10887 Phosphoric acid, mixed Bu and decyl and octyl and 2-(2phenoxyethoxy)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. E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 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 § 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 § 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 § 721.185 apply to this section. ■ 17. Add § 721.10888 to subpart E to read as follows: asabaliauskas on DSK3SPTVN1PROD with RULES § 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-[(2aminoethyl)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 § 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 § 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 § 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 § 721.85. It is a significant new use to dispose of the chemical substance other than by incineration in VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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 § 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 § 721.185 apply to this section. ■ 18. Add § 721.10889 to subpart E to read as follows: § 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 § 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 § 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 § 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 § 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 § 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 PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 30473 provisions of § 721.185 apply to this section. ■ 19. Add § 721.10890 to subpart E to read as follows: § 721.10890 Phosphonic acid, Ptetradecyl-, 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 § 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 § 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 § 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 § 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 § 721.125(a) through (e), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 20. Add § 721.10891 to subpart E to read as follows: § 721.10891 Alkyl silicate, polymer with 2(chloromethyl)oxirane and 4,4′-(1methylethylidene)bis[phenol], alkoxylated (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl silicate, polymer E:\FR\FM\16MYR3.SGM 16MYR3 30474 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 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 § 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 § 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 21. Add § 721.108992 to subpart E to read as follows: asabaliauskas on DSK3SPTVN1PROD with RULES § 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 § 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 § 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 § 721.185 apply to this section. ■ 22. Add § 721.10893 to subpart E to read as follows: § 721.10893 Fatty acids, tall-oil, reaction products with an ether and triethylenetetramine (generic). (a) Chemical substance and significant new uses subject to reporting. VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 (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 § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. ■ 23. Add § 721.10894 to subpart E to read as follows: § 721.10894 (generic) Substituted benzyl acrylate (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 § 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 § 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 § 721.185 apply to this section. ■ 24. Add § 721.10895 to subpart E to read as follows: § 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 PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 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 § 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 § 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 § 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 § 721.125(a) through (e) and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. ■ 25. Add § 721.10896 to subpart E to read as follows: E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations § 721.10896 1-Hexanol, 6-mercapto-. asabaliauskas on DSK3SPTVN1PROD with RULES § 721.10897 Phenol, 2,2′-[1,2-disubstituted1,2-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 § 721.63(a)(1), (a)(2)(i), (a)(2)(ii), and (a)(3). (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 27. Add § 721.10898 to subpart E to read as follows: ■ (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 § 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 § 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 § 721.185 apply to this section. ■ 26. Add § 721.10897 to subpart E to read as follows: § 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 § 721.80. A significant new use of the substance is any use other than as a pigment-wetting resin for UVcurable 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 § 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 § 721.185 apply to this section. ■ 28. Add § 721.10899 to subpart E to read as follows: § 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 § 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 § 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 PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 30475 factor (APF) of at least 10 meet the requirements of § 721.63(a)(4): (A) NIOSH-certified power airpurifying 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 § 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 § 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 § 721.185 apply to this section. ■ 29. Add § 721.10900 to subpart E to read as follows: § 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 § 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 § 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 § 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. E:\FR\FM\16MYR3.SGM 16MYR3 30476 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 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 § 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 § 721.185 apply to this section. ■ 30. Add § 721.10901 to subpart E to read as follows: § 721.10901 Formaldehyde, reaction products with aniline and aromatic monoand 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 § 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 § 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 § 721.185 apply to this section. ■ 31. Add § 721.10902 to subpart E to read as follows: asabaliauskas on DSK3SPTVN1PROD with RULES § 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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 § 721.63(a)(1), (a)(2)(i), and (a)(3). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 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 § 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). (iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (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 § 721.185 apply to this section. ■ 32. Add § 721.10903 to subpart E to read as follows: § 721.10903 (generic). Acrylated mixed metal oxides (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 PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 substance after it has been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), and (a)(3). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(v)(1), (v)(2), (w)(1), (w)(2), (x)(1), (x)(2), and (y)(1). (iii) Disposal. Requirements as specified in § 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). (iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (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 § 721.185 apply to this section. ■ 33. Add § 721.10904 to subpart E to read as follows: § 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 § 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 § 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 § 721.185 apply to this section. E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations § 721.10907 (generic). 34. Add § 721.10905 to subpart E to read as follows: ■ § 721.10905 Butanedioic acid, 2methylene-, dialkyl ester (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as butanedioic acid, 2methylene-, 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 § 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 § 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 § 721.185 apply to this section. ■ 35. Add § 721.10906 to subpart E to read as follows: asabaliauskas on DSK3SPTVN1PROD with RULES § 721.10906 (generic). Magnesium alkaryl sulfonate (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 § 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 § 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 § 721.185 apply to this section. ■ 36. Add § 721.10907 to subpart E to read as follows: VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 Polyfluorohydrocarbon (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 § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. ■ 37. Add § 721.10908 to subpart E to read as follows: § 721.10908 (generic). Aluminum calcium oxide salt (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 § 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 § 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 § 721.63(a)(4): PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 30477 (A) NIOSH-certified power airpurifying 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/m3 as an 8-hour time weighted average verified by actual monitoring data. (ii) Hazard communication program. Requirements as specified in § 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/ m3.) and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 38. Add § 721.10909 to subpart E to read as follows: § 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 § 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 E:\FR\FM\16MYR3.SGM 16MYR3 30478 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations which persons are reasonably likely to be exposed as required for § 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. 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 § 721.63(a)(4): (A) NIOSH-certified power airpurifying 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 § 721.80(h). (iii) Release to water. Requirements as specified in § 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 § 721.125(a) through (e), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 39. Add § 721.10910 to subpart E to read as follows: asabaliauskas on DSK3SPTVN1PROD with RULES § 721.10910 Oxirane, 2,2′-[[1-[4-[1-methyl1-[4-(2-oxiranylmethoxy)phenyl] ethyl]phenyl]ethylidene]bis(4,1phenyleneoxymethylene)]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-(2oxiranylmethoxy)phenyl]ethyl]phenyl] ethylidene]bis(4,1phenyleneoxymethylene)]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 VerDate Sep<11>2014 20:44 May 13, 2016 Jkt 238001 specified in § 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 § 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 40. Add § 721.10911 to subpart E to read as follows: § 721.10911 2-Propanol, 1,3-bis[4-[1-[4-[1methyl-1-[4-(2oxiranylmethoxy)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-(2oxiranylmethoxy)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 § 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 § 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 41. Add § 721.10912 to subpart E to read as follows: § 721.10912 Aliphatic acrylate (generic). (a) Chemical substance and significant new uses subject to reporting. PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 (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 § 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 § 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 § 721.185 apply to this section. ■ 42. Add § 721.10913 to subpart E to read as follows: § 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 acidpolyalkylene 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 § 721.63(a)(4), (a)(6)(ii), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. 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 § 721.63(a)(4): (A) NIOSH-certified power airpurifying 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. E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations (C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full facepiece. (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 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 § 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 § 721.185 apply to this section. ■ 43. Add § 721.10914 to subpart E to read as follows: asabaliauskas on DSK3SPTVN1PROD with RULES § 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 § 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 § 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 § 721.185 apply to this section. ■ 44. Add § 721.10915 to subpart E to read as follows: 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 § 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 § 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 § 721.185 apply to this section. ■ 45. Add § 721.10916 to subpart E to read as follows: § 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-hydroxy6-[(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 § 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 § 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 § 721.185 apply to this section. ■ 46. Add § 721.10917 to subpart E to read as follows: § 721.10915 Fatty acid esters with polyols polyalkyl ethers (generic). § 721.10917 Polymethylsiloxane, distillation residues (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– (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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 30479 subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (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 § 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 § 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 § 721.80(g). (iii) Release to water. Requirements as specified in § 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 § 721.125(a) through (e), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 47. Add § 721.10918 to subpart E to read as follows: § 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 E:\FR\FM\16MYR3.SGM 16MYR3 30480 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES 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 § 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 § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. ■ 48. Add § 721.10919 to subpart E to read as follows: § 721.10919 Quaternary ammonium compounds, (3-chloro-2hydroxypropyl)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 VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 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 § 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 § 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 § 721.185 apply to this section. ■ 49. Add § 721.10920 to subpart E to read as follows: § 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 § 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 § 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 § 721.185 apply to this section. ■ 50. Add § 721.10921 to subpart E to read as follows: § 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- PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 (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 § 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 § 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 § 721.63(a)(4): (A) NIOSH-certified powered airpurifying 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 § 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 § 721.125(a) through (e) and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 51. Add § 721.10922 to subpart E to read as follows: § 721.10922 1,2,4,5,7,8-Hexoxonane, 3,6,9trimethyl-, 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. E:\FR\FM\16MYR3.SGM 16MYR3 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations (2) The significant new uses are: (i) Industrial commercial, and consumer activities. Requirements as specified in § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. ■ 52. Add § 721.10923 to subpart E to read as follows: § 721.10923 9-Octadecen-1-amine, hydrochloride (1:1), (9Z)-. asabaliauskas on DSK3SPTVN1PROD with RULES (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 9-octadecen-1-amine, hydrochloride VerDate Sep<11>2014 18:55 May 13, 2016 Jkt 238001 (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 § 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 § 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 § 721.185 apply to this section. ■ 53. Add § 721.10924 to subpart E to read as follows: § 721.10924 Vegetable fatty acid alkyl esters (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified PO 00000 Frm 00031 Fmt 4701 Sfmt 9990 30481 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 § 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 § 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 § 721.185 apply to this section. [FR Doc. 2016–11121 Filed 5–13–16; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\16MYR3.SGM 16MYR3

Agencies

[Federal Register Volume 81, Number 94 (Monday, May 16, 2016)]
[Rules and Regulations]
[Pages 30451-30481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11121]



[[Page 30451]]

Vol. 81

Monday,

No. 94

May 16, 2016

Part III





Environmental Protection Agency





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40 CFR Parts 9 and 721





 Significant New Use Rules on Certain Chemical Substances; Final Rule

Federal Register / Vol. 81 , No. 94 / Monday, May 16, 2016 / Rules 
and Regulations

[[Page 30452]]


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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.

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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: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-9232; email 
address: Moss.Kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
(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 https://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, C12-22, 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 
https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

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 https://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 https://www.oecdbookshop.org or SourceOECD at 
https://www.sourceoecd.org. ASTM International standards are available 
at https://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 https://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, C12-22, 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
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