Significant New Use Rules on Certain Chemical Substances, 39267-39288 [2014-15774]

Download as PDF Vol. 79 Wednesday, No. 131 July 9, 2014 Part VI Environmental Protection Agency mstockstill on DSK4VPTVN1PROD with RULES4 40 CFR Parts 9 and 721 Significant New Use Rules on Certain Chemical Substances; Direct Final Rule VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\09JYR4.SGM 09JYR4 39268 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA–HQ–OPPT–2014–0166; FRL–9910–01] 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 43 chemical substances which were the subject of premanufacture notices (PMNs). Six of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture (including import) or process any of these 43 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 September 8, 2014. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on July 23, 2014. 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 August 8, 2014 (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 August 8, 2014, 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–2014–0166, 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. mstockstill on DSK4VPTVN1PROD with RULES4 SUMMARY: VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 • 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 (7405 M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (202) 564–9232; email address: moss.kenneth@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. This action may also affect certain entities through pre-existing import certification and export notification 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 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 intend to export a chemical substance that is the subject of a proposed or final SNUR, 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 submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/ or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. 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 E:\FR\FM\09JYR4.SGM 09JYR4 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these rules are more fully set out in the preamble to EPA’s first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data. B. What is the Agency’s authority for taking this action? Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a ‘‘significant new use.’’ EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) 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. mstockstill on DSK4VPTVN1PROD with RULES4 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 VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 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 43 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 43 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance: • PMN number. • Chemical name (generic name, if the specific name is claimed as CBI). • Chemical Abstracts Service (CAS) Registry number (if assigned for 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 and importation volume) and other uses PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 39269 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 6 PMN substances (P-11-526, P-12-241, P-12-242, P-12-557, P-12-558, and P-13-237) 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 socalled ‘‘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 protective measures required in the corresponding consent orders. This rule also includes SNURs on 36 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, ‘‘(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) 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 Numbers P-08-512 and P-08-513 Chemical names: (P-08-512) Alcohol propoxylate (generic) and (P-05-513) Alcohol propoxylate sulfate salt (generic). CAS numbers: Claimed confidential. Basis for action: The PMNs state that the generic (non-confidential) use of the substances are as a chemical intermediate (P-08-512), and for enhanced oil recovery applications (P- E:\FR\FM\09JYR4.SGM 09JYR4 mstockstill on DSK4VPTVN1PROD with RULES4 39270 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 08-513). Based on structural activity relationship (SAR) analysis of the test data on analogous neutral organics (P08-512) and anionic surfactants (P-08513), EPA predicts toxicity to aquatic organisms at concentrations that exceed 1 part per billion (ppb) of P-08-512 and 15 ppb of P-08-513 in surface waters. However, based on test data submitted on analogous chemical substances, EPA expects the actual risk to aquatic organisms in surface waters to be significantly mitigated following biological treatment at publicly owned treatment works or at on-site waste water treatment plants, injection to Class I or II wells, or incineration. As described in the PMN notices, releases are either injected into Class I or II wells, incinerated, or released to surface waters after biological treatment. 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 nonindustrial use, or any release during manufacturing, processing, or use other than injection to Class I or II wells, incineration, or release to water following biological treatment and clarification may cause significant adverse environmental effects. Based on this information, the PMN substances meets the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a Modified Shake-Flask Biodegradation Test (Cripe, C.R., Walker, W.W., Pritchard, P.H., Borquin, A.W. (1987). Shake-Flask Test for Estimation of Biodegradability of Toxic Organic Substances in the Aquatic Environment. Ecotoxicology and Environmental Safety 14:239–251) utilizing an algal toxicity test (Office of Chemical Safety and Pollution Prevention (OCSPP) Test Guideline 850.4500); an aquatic invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075) with supplemental analytics to identify degradation products, would help to characterize the environmental effects of the PMN substances. Testing is recommended to be conducted on P-08-513. EPA suggests conducting the modified shake-flask biodegradation test first as the results may impact the ecotoxicity testing recommendations. CFR citation: 40 CFR 721.10725 (P-08512) and 40 CFR 721.10726 (P-08-513). PMN Number P-11-526 Chemical name: Amphoteric fluorinated surfactant (generic). VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: August 20, 2013. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a surface active agent. Based on test data on the PMN substance and data currently available to the Agency on analogous perfluorooctanoic acid (PFOA), EPA identified concerns for potential incineration or other decomposition products or degradants of the PMN substance. EPA also has concerns that exposures to the PMN substance under certain conditions of use—particularly non-industrial, commercial, or consumer uses—could cause lung effects, based on data on analogous perfluorinated compounds. PFOA is expected to persist for years in the environment. Biodegradation and photolysis tests of analogous substances indicate little or no biodegradation or photolysis of perfluoroalkyl compounds. Bioaccumulation concerns are based on the measured presence of certain perfluoroalkyl compounds, including PFOA, in wildlife and in human blood samples. Toxicity studies on PFOA indicate developmental, reproductive and systemic toxicity in various species, as well as cancer. These factors taken together raise concerns for potential adverse chronic effects in humans and wildlife. The consent 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 human health and the environment, these 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 risks, the consent order requires: 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 a Material Safety Data Sheet (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 material impurities to EPA; and (b) within the maximum established limits of certain fluorinated PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 impurities of the PMN substance as stated in the consent order. 3. Use of the substance only as described in the consent order. 4. Submission of certain testing prior to exceeding the confidential production volume limit of the PMN substance 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 test data from certain human health, environmental fate, and ecotoxicity testing identified in the consent order would help characterize possible effects of the substances and their degradation products. The company has agreed not to exceed the first production limit without performing a Zahn-Wellens biodegradation test (OPPTS Test Guideline 835.5200) with analysis for degradation products as specified, and a hydrolysis test as a function of pH and temperature (OPPTS Test Guideline 835.2130). The PMN submitter has also agreed not to exceed the second production limit without performing a 90-day repeated dose oral toxicity study in rats with 1-generation reproduction parallel study (must include modifications) (OECD Test Guideline 421 modified) and a soil biodegradation study (OECD Test Guideline 307). The company has agreed not to exceed the third production limit without performing an ultraviolet (UV) visible light absorption study (OPPTS Test Guideline 830.7050), a direct photolysis test, if wavelengths greater than 290 nautical miles (nm) are absorbed in the previous test (OPPTS Test Guideline 830.7050) (OPPTS Test Guideline 835.2210), an indirect photolysis screening test (OPPTS Test Guideline 835.5270), an anaerobic biodegradability of organic compounds in digested sludge test (OECD Test Guideline 311), and an avian reproduction test (OPPTS Test Guideline 850.2300) in bobwhite quail. Further testing details are available in the consent order located in the docket under docket EPA–HQ– OPPT–2014–0166. The consent order does not require submission of the additional pended testing detailed in the consent order at any specified time or production volume. However, the consent order’s restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMNs will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.10727. E:\FR\FM\09JYR4.SGM 09JYR4 mstockstill on DSK4VPTVN1PROD with RULES4 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations PMN Numbers P-12-241 and P-12-242 Chemical names: (P-12-241) 2Propenoic acid, 2-methyl-, 2hydroxyethyl esters, telomers with C1826-alkyl acrylate, 1-dodecanethiol, N(hydroxymethyl)-2-methyl-2propenamide, polyfluorooctyl methacrylate, 2,2′-[1,2-diazenediylbis(1methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated (generic) and (P-12-242) 2-Propenoic acid, 2-methyl-, C16-18 esters, telomers with 3-chloro-2-hydroxypropyl methacrylate, 1-dodecanethiol, N(hydroxymethyl)-2-methyl-2propenamide, polyfluorooctyl methacrylate, and rel- (1R,2R,4R)-1,7,7trimethylbicyclo[2.2.1]hept-2-yl methacrylate, 2,2′-[1,2-diazenediylbis(1methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated (generic). CAS numbers: Claimed confidential. Effective date of TSCA section 5(e) consent order: June 5, 2013. Basis for TSCA section 5(e) consent order: The PMNs state that the generic (non-confidential) use of these substances is as a water and oil repellant. Based on analogy to other perfluorinated chemicals, including PFOA, EPA has concerns for potential fluorinated incineration or other decomposition products of the PMN substances. EPA has concerns that these perfluorinated products may be released to the environment from incomplete incineration of the PMN substances at low temperatures. EPA has preliminary evidence that suggests that, under some conditions, the PMN substances could degrade in the environment. Based on data on analogous chemicals, including PFOA, EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic to people, wild mammals, and birds. PFOA is expected to persist for years in the environment. Biodegradation and photolysis tests of analogous substances indicate little or no biodegradation or photolysis of perfluoroalkyl compounds. Bioaccumulation concerns are based on the measured presence of certain perfluoroalkyl compounds, including PFOA, in wildlife and in human blood samples. Toxicity studies on PFOA indicate developmental, reproductive and systemic toxicity in various species, as well as possible cancer concerns. These factors, taken together, raise concerns for potential adverse chronic effects in humans and wildlife. The consent order was issued under TSCA section 5(e)(1)(A) based on a finding that these substances may present an unreasonable risk of injury to VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 human health and the environment, these 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 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 a Material Safety Data Sheet (MSDS), within 90 days. 2. Manufacture of the PMN substances: (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 substances as stated in the consent order. 3. Use of the substances only as described in the consent order. 4. Submission of certain environmental fate and toxicity testing prior to exceeding the confidential production volume limit of the aggregate amount of the PMN substances described in P-12-241 and P12-242 specified in the consent order. 5. The individual annual manufacture volume for P-12-241 and P-12-242 must not reach the confidential annual production volume 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 test data from certain human health, environmental fate, and ecotoxicity testing identified in the consent order would help characterize possible effects of the substances and their degradation products. The company has agreed not to exceed the first production limit without performing a hydrolysis as a function of pH and temperature test (OPPTS Test Guideline 835.2130), a ready biodegradation test (OPPTS Test Guideline 835.3110), a UV/Visible light spectrum test (OPPTS Test Guideline 830.7050), a direct photolysis test (OPPTS Test Guideline 835.2210) and an indirect photolysis screening test (OPPTS Test Guideline 835.5270). The company has also agreed not to exceed the second production limit without performing a modified semi-continuous PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 39271 activated sludge (SCAS) with analysis of degradation products test (OPPTS Test Guideline 835.5045/), an aerobic/ anaerobic transformation in soil test (OECD Test Guideline 307), an anaerobic biodegradability of organic compounds in digested sludge test (OECD Test Guideline 311), a phototransformation of chemicals in soil test, 2002, surfaces—2 soils (draft OECD, a simulation test—aerobic sewage treatment (activated sludge units) (OECD Test Guideline 303A), an aerobic and anaerobic transformation in aquatic sediment systems test (OECD Test Guideline 308), and an acute inhalation toxicity test (OPPTS Test Guideline 870.1300). Further testing details are available in the consent order located in the docket under docket EPA–HQ–OPPT–2014–0166. The consent order does not require submission of the pended testing detailed in the consent order at any specified time or production volume. However, the consent order’s restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMNs will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.10728 (P-12241) and 40 CFR 721.10729 (P-12-242). PMN Numbers P-12-557 and P-12-558 Chemical names: (P-12-557) Tires, wastes, pyrolyzed, C6-39 oil fraction and (P-12-58) Tires, wastes, pyrolyzed, C7-56 oil fraction. CAS numbers: (P-12-557) 1410795– 89–9 and (P-12-558) 1410795-87-7. Effective date of TSCA section 5(e) consent order: July 22, 2013. Basis for TSCA section 5(e) consent order: The PMNs state that the substances will be used as naphtha used for high octane gas and cleaning fluids, kerosene used for jet fuels, distillate fuel oil used for off-highway diesel engines and power generation, and vacuum gas oil used for gasoline. Based on structure-activity relationship analysis of test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 360 ppb (for P-12-557) and 170 ppb (for P-12-558) in surface waters. The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that uncontrolled manufacture, processing, distribution in commerce, use, and disposal of these substances may present an unreasonable risk of injury to the environment. To protect against these risks, the consent order requires: E:\FR\FM\09JYR4.SGM 09JYR4 39272 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 1. Establishment and use of a hazard communication program, including human health, environmental hazard precautionary statements on each label and the MSDS. 2. Use of the substances only as described in the consent order. 3. No use of the substances resulting in surface water concentrations exceeding the concentrations of concern identified in the releases to water section of the consent order. 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 text, 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. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed. The order does not require the submission of these tests 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 721.10730 (P-12557) and 40 CFR 721.10731 (P-12-558). mstockstill on DSK4VPTVN1PROD with RULES4 PMN Number P-13-60 Chemical name: Neodymium, butadiene iso-Bu neodecanoate complexes. CAS number: 1386395–00–1. Basis for action: The PMN states that the use of the substance is as a precursor to polymerization catalyst. Based on SAR analysis of test data on analogous neodymium complexes, 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 exceeding 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 resulting in releases to surface waters exceeding 8 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPT Test Guideline 850.1400); a daphnid chronic toxicity test (OPPT 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 721.10732. PMN Number P-13-237 Chemical name: Tires, wastes, pyrolyzed, C5-15 condensate oil fraction. CAS number: Claimed confidential. Chemical substance definition: A complex combination of hydrocarbons obtained from the substance produced by the pyrolysis of rubber-based tires after removal of the carbon black fraction. It consists predominantly of hydrocarbons having carbon numbers in the range of C5 through C15. It boils in the range of approximately 36 °C to 265 °C (97 °F to 509 °F). Effective date of TSCA section 5(e) consent order: August 8, 2013. Basis for TSCA section 5(e) consent order: The PMN states that the use of the substance will be as a raw feed stock for refineries. Based on data for benzene which comprises 6% of the PMN substance, EPA identified concerns for oncogenicity, immunotoxicity, and liver and blood toxicity. Based on data for limonene, which constitutes 13% of the PMN substance, EPA identified concerns for dermal sensitization. Based on SAR analysis for neutral organic chemicals the PMN substance may be toxic to aquatic organisms at concentrations as low as 4 ppb. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health or the environment. To protect against this risk, the consent order requires: 1. An 8-hour time-weighted-average (TWA) inhalation exposure limit of 1 part per million (ppm) to the PMN substance. 2. Use of the PMN substance only as a raw feed stock for refineries. 3. No use of the substance resulting in surface water concentrations that exceed 4 ppb. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Recommended testing: EPA has determined that the results of inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket to this rule); a fish acute toxicity test, freshwater and marine PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.l010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance. The order does not require submission of these tests at any specified time or production volume. However, the order’s restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substance 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 721.10733. PMN Number P-13-248 Chemical name: Lithium salt of substituted imide (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an electrolyte. Based on test data on the PMN substance, and SAR analysis of test data on analogous lithium salts, the EPA identified concerns for irritation, possible corrosion, acute toxicity, blood and thyroid effects, neurotoxicity, and immunotoxicity from exposure to the PMN substance via inhalation and dermal exposures. As described in the PMN, occupational exposures are expected to be minimal due to the use of a National Institute of Occupational Safety and Health (NIOSH)-certified particulate respirator with an assigned protection factor (APF) of at least 10. Further, general population exposures are not expected as the PMN 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 PMN substance without a NIOSH-certified particulate respirator with an APF of at least 10, where there is a potential for inhalation exposures; or any use in a consumer product may cause serious 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 inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket to this rule) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10734. E:\FR\FM\09JYR4.SGM 09JYR4 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations PMN Number P-13-270 Chemical name: Aromatic dibenzoate (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non-confidential) use of the substance is as a catalyst component. Based on SAR analysis of test data on analogous esters, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. Based on uses 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 should there be any new use of the substance resulting in releases to surface waters exceeding 1 ppb significant adverse environmental effects could occur. 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 sediment-water chironomid life-cycle toxicity test using spiked water or spiked sediment (OECD Test Guideline 233); a hydrolysis test (OECD Test Guideline 111); and a Zahn-Wellens inherent biodegradation test (OECD Test Guideline 302B) would help characterize the potential for chronic aquatic toxicity of the PMN substance. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed to facilitate solubility in the test media, because of the PMN substance’s low water solubility. CFR citation: 40 CFR 721.10735. mstockstill on DSK4VPTVN1PROD with RULES4 PMN Number P-13-309 Chemical name: Alcohols, C9–11branched, ethoxylated propoxylated. CAS number: 1400790–00–2. Basis for action: The PMN states that the use of the substance will be as a component of a pigment dispersant blend for inks and coatings. Based on SAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 170 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 VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 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 170 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 a component of a pigment dispersant blend for inks and coatings may cause 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 (OPPT 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. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed to facilitate solubility in the test media, because of the PMN substance’s low water solubility. CFR citation: 40 CFR 721.10736. PMN Number P-13-378 Chemical name: Carboxylic anhydride, polymer with -hydrohydroxypoly(oxy-1,2-diethanediyl), compd. with 2,3,4,6,7,8,9,10octahydropyrimido-[1,2-a]azepine (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the use of the substance is as a polyurethane catalyst. Based on SAR analysis of test data on analogous aliphatic amines, 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 releases to surface waters exceeding 24 ppb may cause 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 PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 39273 acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity test mitigated by humic acid (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 environmental effects of the PMN substance. CFR citation: 40 CFR 721.10737. PMN Number P-13-453 Chemical name: Formaldehyde, polymer with 2,3-dimethylphenol, 2,4dimethylphenol, 2,5-dimethylphenol, 3,5-dimethylphenol, 3-ethylphenol, 4ethylphenol, 3-methylphenol, 4methylphenol and phenol. CAS number: 1415313–86–8. Basis for action: The PMN states that the substance will be used as a coating for electronic components. Based on SAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 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 5 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 releases to surface waters exceeding 5 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); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed to facilitate solubility in the test media, because of the PMN substance’s low water solubility. CFR citation: 40 CFR 721.10738. PMN Number P-13-465 Chemical name: Caprolactone homopolymer of substituted benzotriazole (generic). E:\FR\FM\09JYR4.SGM 09JYR4 39274 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES4 CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a UV stabilizer. Based on SAR analysis of test data on analogous benzotriazoles, esters, phenols, and amides, 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 cause 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 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. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed to facilitate solubility in the test media, due to the low water solubility of the PMN material. EPA suggests conducting the water solubility test first as the results may impact the ecotoxicity testing recommendations. CFR citation: 40 CFR 721.10739. PMN Number P-13-473 Chemical name: Tin(2+) salt of alkylcarboxylic acid (generic). CAS number: Not available. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a catalyst. Based on test data on the PMN, as well as SAR analysis of test data on analogous tin compounds, the EPA identified potential human health concerns regarding eye corrosion, dermal sensitization, and asthma, from the PMN substance via dermal exposure. Further, based on SAR analysis of test data on analogous tin salts and anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 27 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20day criterion is derived from partial life VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 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, exceed releases from the use and production volume described in the PMN. For the use and production volume described in the PMN, environmental releases did not exceed 27 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 use of the substance without the use of impervious gloves and goggles, when there is a potential dermal exposure; use of the substance other than as described in the PMN; or any increase in the annual confidential production volume could result in exposures which may cause serious human health and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i), (b)(3)(ii), and (b)(4)(ii). Recommended testing: EPA has determined that 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. EPA also recommends filtration should be avoided and that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) followed to facilitate solubility in the test media, because of the PMN substance’s low water solubility. Repeated dose health tests are not recommended because of the PMN substance’s corrosive nature. CFR citation: 40 CFR 721.10740. PMN Number P-13-563 Chemical name: Propylene glycol, alpha isocyanate, omega silane (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 for polyurethane polymers. Based on SAR analysis of analogous diisocyanates, EPA identified concerns for oncogenicity, mutagenicity, respiratory and dermal sensitization and lung and mucous membrane irritation from exposure to the PMN substance via inhalation and dermal exposures. For the use described in the PMN, EPA does not expect significant occupational or consumer exposure. Therefore, EPA has PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 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 a NIOSH-certified particulate respirator with an APF of at least 10, where there is a potential for inhalation exposures; any use other than as an intermediate; or any use of the substance in consumer products, may cause serious health 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 test (OPPTS Test Guideline 870.2600); a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); and a carcinogenicity test (OPPTS Test Guideline 870.4200) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10741. PMN Numbers P-13-617, P-13-618, and P-13-619 Chemical names: (P-13-617) Aromatic dicarboxylic acid polymer with alkanediol, alkyl alkyl-2-alkenoate,1,4dialkyl aromatic dicarboxylate, alkanedioic acid, alkanediol, .alpha.hydro-.omega.-hydroxypoly[oxy(alkylalkanediyl)], hydroxyalkyl 2-alkyl-2alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2alkenoic acid (generic), (P-13-618) Alkanedioic acid, polymer with alkyl 2alkyl-2-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2alkenoate and 2-alkyl-2-alkenoic acid (generic); and (P-13-619) Alkanedioic acid, polymer with alkyl alkylalkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic diisocyanate, alkyl alkylalkeneoate and alkyl-alkenoic acid (generic). CAS numbers: Claimed confidential. Basis for action: The PMN states that the generic (non-confidential) use of the substances will be as an adhesive. Based on SAR analysis of test data on analogous diisocyanates, EPA identified concerns for respiratory sensitization. For the use described in the PMN, EPA does not expect significant occupational or consumer inhalation exposure as the substances are not applied using a method that generates a vapor, mist, or aerosol, nor are they used in a consumer product. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the E:\FR\FM\09JYR4.SGM 09JYR4 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES4 substances may present an unreasonable risk. EPA has determined, however, that any use of the substances without a NIOSH-certified particulate respirator with an APF of at least 10, where there is a potential for inhalation exposures; any use in consumer products; or any use of the substances involving an application method that generates a vapor, mist, or aerosol may cause serious health 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 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substances. CFR citation: 40 CFR 721.10742 (P-13617); 40 CFR 721.10743 (P-03-618) and 40 CFR 721.10744 (P-13-619). PMN Number P-13-722 Chemical name: Alkoxylated quaternary alkyl ammonium fluoroalkylsulfonimide (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a polymer additive. Based on SAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 9 ppb of the PMN substance in surface waters. For the use described in the PMN, environmental releases are not expected to result in surface water concentrations that exceed 9 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 9 ppb may cause 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, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OPPTS Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed to facilitate solubility in the test media, due to the low water solubility of the PMN material. VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 CFR citation: 40 CFR 721.10745. PMN Number P-13-753 Chemical name: Isocyanate terminated urethane polymer (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adhesive and sealant. Based on SAR analysis of test data on analogous isocyanates, EPA identified concerns for respiratory and dermal sensitization to workers from exposure to the PMN substance. In addition, based on test data submitted under the TSCA section 8(e) program, the Agency identified concern for mutagenicity. For the uses described in the PMN, significant occupational dermal and inhalation exposures are not expected. Further, general population exposures are not expected as the PMN 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 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 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 721.10746. PMN Number P-13-773 Chemical name: 4-Pyrimidianamine, 2,5 dimethoxy-. CAS number: 6960–17–4. Basis for action: The PMN states that the substance will be used as an herbicide intermediate. Based on test data of the PMN substance, as well as SAR analysis of test data on analogous aromatic amines, EPA identified concerns for mutagenicity, oncogenicity, and developmental toxicity to workers exposed to the PMN substance. Further, based on SAR analysis of test data on analogous anilines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 ppb of the PMN substance in surface water. As described in the PMN, EPA does not expect significant occupational exposures and releases of the PMN substance are not expected to result in surface water concentrations that exceed 7 ppb. Therefore, EPA has not PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 39275 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 a NIOSH-certified respirator with an APF of at least 10, where there is potential inhalation exposure; any use without impervious gloves, where there is potential for dermal exposure; or any use other than as an herbicide intermediate may cause serious health and environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(B), (b)(1)(i)(C), (b)(3)(ii), (b)(4)(i) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a combined repeated dose toxicity test (OECD Test Guideline 422), with the reproduction/development toxicity screening test; a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); and an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010) would help characterize the human health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.10747. PMN Numbers P-13-796, P-13-797, P-13798, P-13-799, and P-13-800 Chemical names: (P-13-796, P-13-797, and P-13-798) Dicarbomonocyclesubstituted carbomonocycledicarboxamide (generic); (P-13-799) Dicarboheterocycle-substituted carbomonocycledicarboxamide (generic); and (P-13-800) Tricarbomonocycle-substituted carbomonocycletricarboxamide (generic). CAS numbers: Claimed confidential. Basis for action: The PMN states that the generic (non-confidential) use of the substances are as additives for polymer manufacturing. Based on SAR analysis of test data on analogous amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb (for P-13-796 and P-13-797); 14 ppb (for P-13-798); 1 ppb (for P-13-799); and 2 ppb (for P-13-800) of the PMN substance in surface waters. For the use described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed the respective concentrations for concern. 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 use of the substance resulting in releases to surface waters exceeding the respective concentrations of concern E:\FR\FM\09JYR4.SGM 09JYR4 39276 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES4 may result in significant adverse environmental effects. Based on this information, the PMN substances meets the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a ready biodegradability test (OECD Test Guideline 301); 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. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed to facilitate solubility in the test media, because of the PMN substance’s low water solubility. EPA suggests conducting the biodegradation test first as the results may impact the ecotoxicity testing recommendations. CFR citation: 40 CFR 721.10748 (P-13796, P-13-797, and P-13-798); 40 CFR 721.10749 (P-13-799); and 40 CFR 721.10750 (P-13-800). PMN Number P-13-810, P-13-811, P-13812, P-13-813, P-13-814, and P-13-815 Chemical names: Cycloalkylamino oleyl alkylamide acid salts (generic). CAS numbers: Claimed confidential. Basis for action: The PMNs state that the generic (non-confidential) use of these substances are as inhibitors for oil field applications. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations that exceed 1 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 exceeding 1 ppb of the aggregate of these PMN substances. 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 use of the substances resulting in releases to surface waters exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substances meets the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a water solubility: Column elution method; shake flask method test (OPPTS Test Guideline 830.7840) or a water solubility: Generator column method test (OPPTS Test Guideline 830.7860); a determination of the partition VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 coefficient (n-octanol/water) by shake flask method (OPPTS Test Guideline 830.7550), generator column method (OPPTS Test Guideline 830.7560), or estimation by liquid chromatography (OPPTS Test Guideline 830.7570); and log Koc determination by adsorptiondesorption using a batch equilibrium method (OECD Test Guideline 106) in representative salt water conditions would help characterize the environmental effects of the PMN substances. Based on the results of these studies, EPA would recommend either of the following as additional testing: (A) Fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a mysid acute toxicity test (OPPTS Test Guideline 850.1350); and an algal toxicity test (OCSPP Test Guideline 850.4500) or; (B) the whole sediment acute toxicity test, invertebrates, marine (OPPTS Test Guideline 850.1740). CFR citation: 40 CFR 721.10751. PMN Numbers P-13-816, P-13-817, P-13818, P-13-819, P-13-820, and P-13-821 Chemical names: Cycloalkylamino cocoalkyl alkylamide acid salts (generic). CAS numbers: Claimed confidential. Basis for action: The PMNs state that the generic (non-confidential) use of these substances is as inhibitors for oil field applications. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations that exceed 1 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 exceeding 1 ppb of the aggregate of these PMN substances. 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 use of the substances resulting in releases to surface waters exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substances meets the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a water solubility: Column elution method; shake flask method test (OPPTS Test Guideline 830.7840) or a water solubility: Generator column method test (OPPTS Test Guideline 830.7860); a determination of the partition coefficient (n-octanol/water) by shake flask method (OPPTS Test Guideline 830.7550), generator column method (OPPTS Test Guideline 830.7560), or PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 estimation by liquid chromatography (OPPTS Test Guideline 830.7570); and log Koc determination by adsorptiondesorption using a batch equilibrium method (OECD Test Guideline 106) in representative salt water conditions would help characterize the environmental effects of the PMN substances. Based on the results of these studies, EPA would recommend either of the following as additional testing: (A) Fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a mysid acute toxicity test (OPPTS Test Guideline 850.1350); and an algal toxicity test (OCSPP Test Guideline 850.4500) or; (B) the whole sediment acute toxicity test, invertebrates, marine (OPPTS Test Guideline 850.1740). CFR citation: 40 CFR 721.10752. PMN Number P-13-839 Chemical name: Methanamine, N,Ndimethyl-, reaction products with alkylamine-epichlorohydrin polymer, chlorides (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 of pre-coat solution. Based on the test data submitted with this PMN as well as the structural activity relationships analysis for analogous polycationic polymers, 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 to surface waters are not expected. 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 cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a fish acute toxicity mitigated by humic acid (OPPTS Test Guideline 850.1085); 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. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed to facilitate solubility in the E:\FR\FM\09JYR4.SGM 09JYR4 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations test media, because of the PMN substance’s low water solubility. CFR citation: 40 CFR 721.10753. mstockstill on DSK4VPTVN1PROD with RULES4 PMN Number P-13-882 Chemical name: Mixture of alkylated benzene, brominated (generic) and alkylated benzene, dibrominated (generic). CAS numbers: Claimed confidential. Basis for action: The PMN states that the use of the substance will be as a feed for a bromine recovery unit. Based on analogous chemical substances that contain bromine and alkylation potential of the PMN substance, EPA identified concerns for neurotoxicity, liver and kidney toxicities, mutagenicity, and oncogenicity, as well as concerns for developmental toxicity and dermal sensitization to workers exposed to the PMN substance. The Agency also identified the potential for human health risk due to the possible formation of dioxins. Further, based on test data on analogous benzyl halides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substance in surface water. For the use described in the PMN, EPA does not expect significant occupational inhalation or dermal exposures; significant general population inhalation or drinking water exposures; or releases of the PMN substance that result in surface water concentrations that exceed 5 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 use other than for use other than as feed for a bromine recovery unit may cause serious health and significant environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(D), (b)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); 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 721.10754. PMN Number: P-14-42 Chemical name: Substituted perfluoroether (generic). CAS Number: Claimed confidential. VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 Basis for Action: The PMN states that the generic (non-confidential) use of the substance is as a surfactant for laboratory use fluid. Based on SAR analysis of test data on analogous high molecular weight polymers, EPA identified concerns for lung toxicity if respirable droplets of the PMN substance are inhaled. Further, based on analogy to perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), EPA identified concerns for liver toxicity, acute toxicity, developmental and reproductive toxicity, and cancer, for the PMN substance, when the mean moles of each perfluoro propylene (PPO) unit is less than 5. The low molecular weight species have been identified as having the potential to be persistent, bioaccumulative, and toxic (PBT) chemicals. EPA does not have comparable toxicity information on the low molecular weight fraction of the PMN substance and unreacted starting material. EPA has concerns that this PMN substance will persist in the environment. In addition, the perfluoro degradation products could persist, bioaccumulate, and be toxic to people, wild mammals, and birds. EPA’s concerns are based on analogy to other perfluoro chemicals, including PFOA and PFOS, which are both currently under review by EPA for PBT concerns. PFOA and PFOS are expected to persist for years in the environment. Biodegradation and photolysis tests of analogous substances indicate little or no biodegradation or photolysis of perfluoroalkyl compounds. Bioaccumulation concerns are based on the measured presence of certain perfluoroalkyl compounds, including PFOA, in wildlife and in human blood samples. In addition, EPA expects the PMN substance and the perfluoro degradation products to be highly persistent, and the low molecular weight fraction is expected to be mobile and bioaccumulate in the environment. No ecotoxicological concerns were raised for the PMN substance itself. However, there is high concern for possible environmental effects to mammals and wild birds from the perfluoro degradation products of the PMN substance. As stated previously, the analog PFOA is persistent in the environment; has a long bioretention time in various species; has been detected in a number of species of wildlife, including marine mammals; and is considered toxic to mammalian and other species. The toxicological properties and presence of PFOA in the environment continue to be investigated. For the use described in PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 39277 the PMN, EPA does not expect occupational, general population, or environmental exposures to the PMN substance. 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 other than as described in the PMN, or any manufacture of the PMN substance where the mean number of moles of each perfluoro propylene oxide unit is less than 5, may result in serious health effects or significant adverse environmental effects. Based on this information, the PMN meets the concern criteria at 721.170(b)(3)(i), (b)(3)(ii), (b)(4)(ii), and (b)(4)(iii). Recommended Testing: EPA has determined that the results of the following testing on the presumed perfluoro degradation products of the PMN substance would be necessary to evaluate the potential human health effects of the PMN substance: a repeated dose metabolism and pharmacokinetics test (OPPTS Test Guideline 870.7485) in rats and mice; a 1-generation reproduction study (OECD Test Guideline 421), modified; a 90-day oral toxicity test (OPPTS Test Guideline 870.3100) in rats; a combined chronic toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300 or OECD Test Guideline 453) in rats; and an avian reproduction test (OPPTS Test Guideline 850.2300 or OECD Test Guideline 206). EPA recommends that the Company conduct the pharmacokinetics testing first to confirm species acceptability and to provide a reliable half-life for this substance. Further, EPA has determined that the results of the following physical/ chemical properties and fate and transport tests on the PMN substance would be necessary to evaluate the environmental fate and transport: A UV visible light absorption test (OPPTS Test Guideline 830.7050); a hydrolysis as a function of pH test (OPPTS Test Guideline 835.2130); a semi-continuous activated sludge (‘‘SCAS’’) test (OPPTS Test Guideline 835.5045, OPPTS Test Guideline 835.3210, or OECD Test Guideline 302A) modified for analysis for perfluoro degradation products; an aerobic transformation in soil test (OECD Test Guideline 307); an aerobic and anaerobic transformations test (OECD Test Guideline 308) in aquatic sediment systems; a direct photolysis test (OPPTS Test Guideline 835.2210); an indirect photolysis screening test (OPPTS Test Guideline 835.5270); phototransformation of chemicals on soil surfaces (Draft OECD Test Guideline E:\FR\FM\09JYR4.SGM 09JYR4 39278 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations January 2002) using 2 soils, a simulation test-aerobic sewage treatment (OECD Test Guideline 303A) activated sludge units; and an anaerobic biodegradability test (OECD Test Guideline 311) on organic compounds in digested sludge. CFR Citation: 40 CFR 721.10764. V. Rationale and Objectives of the Rule mstockstill on DSK4VPTVN1PROD with RULES4 A. Rationale During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 6 of the 43 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 36 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. • 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. VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 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. 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 September 8, 2014 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before August 8, 2014. 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 August 8, 2014, 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, PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 TSCA section 5(e) consent orders have been issued for 6 of the 43 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 39 of the 43 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per 40 CFR 720.25 and § 721.11). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing. Therefore, EPA designates July 9, 2014 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. lists those tests. Unit IV. also lists recommended testing for TSCA nonsection 5(e) SNURs. Descriptions of tests are provided for informational purposes. E:\FR\FM\09JYR4.SGM 09JYR4 mstockstill on DSK4VPTVN1PROD with RULES4 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 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. 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 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. VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 • 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 § 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 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 PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 39279 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– 2014–0166. XII. Statutory and Executive Order Reviews A. Executive Order 12866 This rule 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 rule. 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. E:\FR\FM\09JYR4.SGM 09JYR4 39280 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 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) mstockstill on DSK4VPTVN1PROD with RULES4 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 rule. This rule is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA’s experience promulgating SNURs (discussed in the certification), EPA believes that the following are true: • A significant number of SNUNs would not be submitted by small entities in response to the SNUR. • Submission of the SNUN would not cost any small entity significantly more than $8,300. Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities. VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 D. Unfunded Mandates Reform Act (UMRA) I. National Technology Transfer and Advancement Act (NTTAA) 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 rule. As such, EPA has determined that this rule 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.). 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). F. Executive Order 13175 This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This rule 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 rule. 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. PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 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). XIV. 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: June 27, 2014. 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: ■ E:\FR\FM\09JYR4.SGM 09JYR4 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations § 9.1 OMB approvals under the Paperwork Reduction Act. * * * * * 40 CFR citation * * OMB control No. * * * Significant New Uses of Chemical Substances * * 721.10725 721.10726 721.10727 721.10728 721.10729 721.10730 721.10731 721.10732 721.10733 721.10734 721.10735 721.10736 721.10737 721.10738 721.10739 721.10740 721.10741 721.10742 721.10743 721.10744 721.10745 721.10746 721.10747 721.10748 721.10749 721.10750 721.10751 721.10752 721.10753 721.10754 721.10764 * * * * * 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 * * * 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 § 721.10725 to subpart E to read as follows: ■ mstockstill on DSK4VPTVN1PROD with RULES4 § 721.10725 Alcohol propoxylate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alcohol propoxylate (PMN P-08-512) 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(l) (ii) Disposal. Requirements as specified in § 721.85(a)(1), (a)(3) (Class I VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 or II wells), (b)(1), (b)(3) (Class I or II wells), (c)(1), and (c)(3) (Class I or II wells). (iii) Release to water. Requirements as specified in § 721.90(a)(2)(ii), (b)(2)(ii), and (c)(2)(ii). (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 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. ■ 5. Add § 721.10726 to subpart E to read as follows: § 721.10726 Alcohol propoxylate sulfate salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alcohol propoxylate sulfate salt (PMN P-08-513) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(l) (ii) Disposal. Requirements as specified in § 721.85(a)(1), (a)(3) (Class I or II wells), (b)(1), (b)(3) (Class I or II wells), (c)(1), and (c)(3) (Class I or II wells). (iii) Release to water. Requirements as specified in § 721.90(a)(2)(ii), (b)(2)(ii), and (c)(2)(ii). (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 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. ■ 6. Add § 721.10727 to subpart E to read as follows: § 721.10727 Amphoteric fluorinated surfactant (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as amphoteric fluorinated surfactant (PMN P-11-526) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 39281 (2) The significant new uses are: (i) Hazard communication program. A significant new use of this substance is any manner or method of manufacture or processing associated with any use of this substance without providing risk notification as follows: (A) If as a result of the test data required under the TSCA section 5(e) consent order for this substance, the employer becomes aware that this 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 this 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)(a significant new use is any use other than as allowed by the section 5(e) consent order which includes 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), (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. 7. Add § 721.10728 to subpart E to read as follows: ■ E:\FR\FM\09JYR4.SGM 09JYR4 39282 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES4 § 721.10728 2-Propenoic acid, 2-methyl-, 2hydroxyethyl esters, telomers with C18–26alkyl acrylate, 1-dodecanethiol, N(hydroxymethyl)-2-methyl-2-propenamide, polyfluorooctyl methacrylate, 2,2′-[1,2diazenediylbis(1-methylethylidene)]bis[4,5dihydro-1H-imidazole]hydrochloride (1:2)initiated (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, 2methyl-, 2-hydroxyethyl esters, telomers with C18-26-alkyl acrylate, 1dodecanethiol, N-(hydroxymethyl)-2methyl-2-propenamide, polyfluorooctyl methacrylate, 2,2′-[1,2-diazenediylbis(1methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated (PMN P-12-241) 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. A significant new use of this substance is any manner or method of manufacture or processing associated with any use of this substance without providing risk notification as follows: (A) If as a result of the test data required under the TSCA section 5(e) consent order for this substance, the employer becomes aware that this 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 this 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) (a significant new use is any use other than as allowed by the section 5(e) consent order which includes analysis and reporting and limitations of maximum VerDate Mar<15>2010 21:42 Jul 08, 2014 Jkt 232001 impurity levels of certain fluorinated impurities), (q), and (t). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (d), (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 § 721.10729 to subpart E to read as follows: § 721.10729 2-Propenoic acid, 2-methyl-, C16-18 esters, telomers with 3-chloro-2hydroxypropyl methacrylate, 1dodecanethiol, N-(hydroxymethyl)-2-methyl2-propenamide, polyfluorooctyl methacrylate, and rel- (1R,2R,4R)-1,7,7trimethylbicyclo[2.2.1]hept-2-yl methacrylate, 2,2′-[1,2-diazenediylbis(1methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, 2methyl-, C16-18 esters, telomers with 3chloro-2-hydroxypropyl methacrylate, 1-dodecanethiol, N-(hydroxymethyl)-2methyl-2-propenamide, polyfluorooctyl methacrylate, and rel-(1R,2R,4R)-1,7,7trimethylbicyclo[2.2.1]hept-2-yl methacrylate, 2,2′-[1,2-diazenediylbis(1methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated (PMN P-12-242) 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. A significant new use of this substance is any manner or method of manufacture or processing associated with any use of this substance without providing risk notification as follows: (A) If as a result of the test data required under the TSCA section 5(e) consent order for this substance, the employer becomes aware that this 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 this substance is not PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 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) (a significant new use is any use other than as allowed by the section 5(e) consent order which includes analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities), (q), and (t). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (d), (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. ■ 9. Add § 721.10730 to subpart E to read as follows: § 721.10730 Tires, wastes, pyrolyzed, C639 oil fraction. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as tires, wastes, pyrolyzed, C6-39 oil fraction (P-12-557; CAS No. 1410795– 89–9) 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 chemical substance that has been blended into finished petroleum products or sent to a petroleum refinery for use as a chemical intermediate. (2) The significant new uses are: (i) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). E:\FR\FM\09JYR4.SGM 09JYR4 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k). (iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=360). (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), (g), (h), (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. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(1) of this section. ■ 10. Add § 721.10731 to subpart E to read as follows: mstockstill on DSK4VPTVN1PROD with RULES4 § 721.10731 Tires, wastes, pyrolyzed, C756 oil fraction. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as tires, wastes, pyrolyzed, C7–56 oil fraction (P-12-558; CAS No. 1410795– 87–7) 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 chemical substance that has been blended into finished petroleum products or sent to a petroleum refinery for use as a chemical intermediate. (2) The significant new uses are: (i) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k). (iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=170). (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), (g), (h), (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. (3) Determining whether a specific use is subject to this section. The provisions VerDate Mar<15>2010 21:42 Jul 08, 2014 Jkt 232001 of § 721.1725(b)(1) apply to paragraph (a)(1) of this section. ■ 11. Add § 721.10732 to subpart E to read as follows: § 721.10732 Neodymium, butadiene iso-Bu neodecanoate complexes. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as neodymium, butadiene iso-Bu neodecanoate complexes (PMN P-13-60; CAS No. 1386395–00–1) 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) Releases 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), (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. ■ 12. Add § 721.10733 to subpart E to read as follows: § 721.10733 Tires, wastes, pyrolyzed, C515 condensate oil fraction. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as tires, wastes, pyrolyzed, C5-15 condensate oil fraction (PMN P-13-237; chemical substance definition: A complex combination of hydrocarbons obtained from the substance produced by the pyrolysis of rubber-based tires after removal of the carbon black fraction. It consists predominantly of hydrocarbons having carbon numbers in the range of C5 through C15. It boils in the range of approximately 36 °C to 265 °C (97 °F to 509 °F).) 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 substances that have been blended into finished petroleum products or sent to a petroleum refinery for use as a chemical intermediate, or stored as described in the Distribution section of the order. (2) The significant new uses are: (i) Protection in the workplace. The significant new use is any exposure exceeding an 8 hour time weighted PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 39283 average (TWA) exposure limit of 1 part per million (ppm). (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. A significant new use is any use other than as a raw feedstock for refineries. (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), (b), (c), (i), (k), and records documenting that exposures do not exceed an 8 hour time weighted average (TWA) exposure limit of 1 part per million 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 significant new use rule. ■ 13. Add § 721.10734 to subpart E to read as follows: § 721.10734 Lithium salt of substituted imide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as lithium salt of substituted imide (PMN P-13-248) 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 1.0 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): (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\09JYR4.SGM 09JYR4 39284 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / 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), (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. ■ 14. Add § 721.10735 to subpart E to read as follows: § 721.10735 (generic). Aromatic dibenzoate (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic dibenzoate (PMN P-13-270) 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) Releases 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. ■ 15. Add § 721.10736 to subpart E to read as follows: mstockstill on DSK4VPTVN1PROD with RULES4 § 721.10736 Alcohols, C9-11-branched, ethoxylated propoxylated. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alcohols, C9–11-branched, ethoxylated propoxylated (PMN P-13-309; CAS No. 1400790–00–2) 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 § 721.80. A significant new use is any use other than as a VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 component of a pigment dispersant blend for inks and 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 (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 § 721.10737 to subpart E to read as follows: § 721.10737 Carboxylic anhydride, polymer with -hydro—hydroxypoly(oxy-1,2diethanediyl), compd. with 2,3,4,6,7,8,9,10octahydropyrimido-[1,2-a]azepine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carboxylic anhydride, polymer with -hydro— hydroxypoly(oxy-1,2-diethanediyl), compd. with 2,3,4,6,7,8,9,10octahydropyrimido-[1,2-a]azepine (PMN P-13-378) 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) Releases 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. ■ 17. Add § 721.10738 to subpart E to read as follows: § 721.10738 Formaldehyde, polymer with 2,3-dimethylphenol, 2,4-dimethylphenol, 2,5-dimethylphenol, 3,5-dimethylphenol, 3ethylphenol, 4-ethylphenol, 3-methylphenol, 4-methylphenol and phenol. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as formaldehyde, polymer with 2,3dimethylphenol, 2,4-dimethylphenol, 2,5-dimethylphenol, 3,5dimethylphenol, 3-ethylphenol, 4ethylphenol, 3-methylphenol, 4- PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 methylphenol and phenol (PMN P-13453; CAS No. 1415313–86–8) 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=5). (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. ■ 18. Add § 721.10739 to subpart E to read as follows: § 721.10739 Caprolactone homopolymer of substituted benzotriazole (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as caprolactone homopolymer of substituted benzotriazole (PMN P-13-465) 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. ■ 19. Add § 721.10740 to subpart E to read as follows: § 721.10740 Tin(2+) salt of alkylcarboxylic acid (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tin(2+) salt of alkylcarboxylic acid (PMN P-13-473) 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: E:\FR\FM\09JYR4.SGM 09JYR4 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) and (s). (ii) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(iii), and (a)(3). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 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)(1) of this section. ■ 20. Add § 721.10741 to subpart E to read as follows: mstockstill on DSK4VPTVN1PROD with RULES4 § 721.10741 Polyalkylene glycol, alpha isocyanate, omega silane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyalkylene glycol, alpha isocyanate, omega silane (PMN P-13563) 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), (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 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. VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g) and (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), (b), (c), (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. ■ 21. Add § 721.10742 to subpart E to read as follows: § 721.10742 Aromatic dicarboxylic acid polymer with alkanediol, alkyl alkyl-2alkenoate, 1,4-dialkyl aromatic dicarboxylate, alkanedioic acid, alkanedioic acid. alkanediol, .alpha.-hydro-.omega.hydroxypoly[oxy(alkyl-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic acid (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic dicarboxylic acid polymer with alkanediol, alkyl alkyl-2-alkenoate,1,4-dialkyl aromatic dicarboxylate, alkanedioic acid, alkanedioic acid. alkanediol, .alpha.hydro-.omega.-hydroxypoly[oxy(alkylalkanediyl)], hydroxyalkyl 2-alkyl-2alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2alkenoic acid (PMN P-13-617) 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), (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 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. PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 39285 (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(o) and (y)(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), (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. ■ 22. Add § 721.10743 to subpart E to read as follows: § 721.10743 Alkanedioic acid, polymer with alkyl 2-alkyl-2-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic acid (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanedioic acid, polymer with alkyl 2-alkyl-2-alkenoate, alkanedioic acid, alkanediol, .alpha.hydro-.omega.-hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2alkenoic acid (PMN P-13-618) 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), (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 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 E:\FR\FM\09JYR4.SGM 09JYR4 39286 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 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(o) and (y)(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), (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. ■ 23. Add § 721.10744 to subpart E to read as follows: mstockstill on DSK4VPTVN1PROD with RULES4 § 721.10744 Alkanedioic acid, polymer with alkyl alkyl-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic diisocyanate, alkyl alkylalkeneoate and alkyl-alkenoic acid (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanedioic acid, polymer with alkyl alkyl-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic diisocyanate, alkyl alkylalkeneoate and alkyl-alkenoic acid (PMN P-13-619) 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), (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 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 VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 (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(o) and (y)(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), (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. ■ 24. Add § 721.10745 to subpart E to read as follows: § 721.10745 Alkoxylated quaternary alkyl ammonium fluoroalkylsulfonimide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkoxylated quaternary alkyl ammonium fluoroalkylsulfonimide (PMN P-13-722) 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=9). (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. ■ 25. Add § 721.10746 to subpart E to read as follows: § 721.10746 Isocyanate terminated urethane polymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanate terminated urethane polymer (PMN P-13-753) is subject to reporting under this section PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 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), (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 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(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), (b), (c), (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. ■ 26. Add § 721.10747 to subpart E to read as follows: § 721.10747 4-Pyrimidianamine, 2,5 dimethoxy-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 4-pyrimidianamine, 2,5 dimethoxy(PMN P-13-773; CAS No. 6960–17–4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(ii), (a)(6)(v), (b) (concentration set at 0.1 percent) and (c). When determining which persons are E:\FR\FM\09JYR4.SGM 09JYR4 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations reasonably likely to be exposed as required for § 721.63(a)(1) and (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. A significant new use is any use other than as an herbicide intermediate. (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. ■ 27. Add § 721.10748 to subpart E to read as follows: mstockstill on DSK4VPTVN1PROD with RULES4 § 721.10748 Dicarbomonocyclesubstituted carbomonocycledicarboxamide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as dicarbomonocyclesubstituted carbomonocycledicarboxamide (PMNs P-13-796, P-13-797, and P-13-798) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=4 for P-13-796 and P-13-797; and N=14 for P-13-798). (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 39287 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 significant new use rule. ■ 28. Add § 721.10749 to subpart E to read as follows: (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 significant new use rule. ■ 30. Add § 721.10751 to subpart E to read as follows: § 721.10749 Dicarboheterocyclesubstituted carbomonocycledicarboxamide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as cycloalkylamino oleyl alkylamide acid salts (PMNs P-13-810, P-13-811, P-13-812, P-13-813, P-13-814, and P-13-815) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=1, for the aggregate of the PMN substances P-13-810, P-13-811, P-13812, P-13-813, P-13-814, and P-13-815). (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 § 721.10752 to subpart E to read as follows: (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dicarboheterocyclesubstituted carbomonocycledicarboxamide (PMN P13-799) 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 significant new use rule. ■ 29. Add § 721.10750 to subpart E to read as follows: § 721.10750 Tricarbomonocyclesubstituted carbomonocycletricarboxamide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tricarbomonocyclesubstituted carbomonocycletricarboxamide (PMN P13-800) 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. PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 § 721.10751 Cycloalkylamino oleyl alkylamide acid salts (generic). § 721.10752 Cycloalkylamino cocoalkyl alkylamide acid salts (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as cycloalkylamino cocoalkyl alkylamide acid salts (PMNs P-13-816, P-13-817, P-13-818, P-13-819, P-13-820, and P-13-821) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=1, for the aggregate of the PMN substances P-13-816, P-13-817, P-13818, P-13-819, P-13-820, and P-13-821). (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. E:\FR\FM\09JYR4.SGM 09JYR4 39288 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations (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. ■ 32. Add § 721.10753 to subpart E to read as follows: § 721.10753 Methanamine, N,N-dimethyl-, reaction products with alkylamineepichlorohydrin polymer, chlorides (generic). mstockstill on DSK4VPTVN1PROD with RULES4 (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as methanamine, N,Ndimethyl-, reaction products with alkylamine-epichlorohydrin polymer, chlorides (PMN P-13-839) 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 VerDate Mar<15>2010 20:52 Jul 08, 2014 Jkt 232001 provisions of § 721.185 apply to this section. ■ 33. Add § 721.10754 to subpart E to read as follows: § 721.10754 Mixture of alkylated benzene, brominated (generic) and alkylated benzene, dibrominated (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixture of alkylated benzene, brominated and alkylated benzene, dibrominated (PMN P-13-882) 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 is any use other than as feed for a bromine recovery unit. (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. 34. Add § 721.10764 to subpart E to read as follows: ■ PO 00000 Frm 00022 Fmt 4701 Sfmt 9990 § 721.10764 (generic) Substituted perfluoroether (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted perfluoroether (PMN P-14-42) 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 this substance is: (1) Use of the substance for any application other than the confidential use identified in the Premanufacture Notice (PMN) or (2) Manufacture of the PMN substance where the mean number of moles of each perfluoro propylene oxide (‘‘PPO’’) unit is less than 5. (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 § 721.180 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. [FR Doc. 2014–15774 Filed 7–8–14; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\09JYR4.SGM 09JYR4

Agencies

[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Rules and Regulations]
[Pages 39267-39288]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15774]



[[Page 39267]]

Vol. 79

Wednesday,

No. 131

July 9, 2014

Part VI





Environmental Protection Agency





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40 CFR Parts 9 and 721





Significant New Use Rules on Certain Chemical Substances; Direct Final 
Rule

Federal Register / Vol. 79 , No. 131 / Wednesday, July 9, 2014 / 
Rules and Regulations

[[Page 39268]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2014-0166; FRL-9910-01]
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 43 chemical substances 
which were the subject of premanufacture notices (PMNs). Six of these 
chemical substances are subject to TSCA section 5(e) consent orders 
issued by EPA. This action requires persons who intend to manufacture 
(including import) or process any of these 43 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 September 8, 2014. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
July 23, 2014.
    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 August 8, 2014 (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 August 8, 2014, 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-2014-0166, 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 (7405 M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-9232; email address: moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this rule. The 
following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification 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 SNUR, 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 submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

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

[[Page 39269]]

EPA at least 90 days before commencing the manufacture or processing of 
a chemical substance for any activity designated by these SNURs as a 
significant new use. Receipt of such notices allows EPA to assess risks 
that may be presented by the intended uses and, if appropriate, to 
regulate the proposed use before it occurs. Additional rationale and 
background to these rules are more fully set out in the preamble to 
EPA's first direct final SNUR published in the Federal Register issue 
of April 24, 1990 (55 FR 17376). Consult that preamble for further 
information on the objectives, rationale, and procedures for SNURs and 
on the basis for significant new use designations, including provisions 
for developing test data.

B. What is the Agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
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.  
[emsp14]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.  [emsp14]721.1(c), persons subject to these SNURs must comply 
with the same SNUN requirements and EPA regulatory procedures as 
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these 
requirements include the information submission requirements of TSCA 
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN, EPA 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 43 
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 43 chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order 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 and importation 
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 6 PMN substances (P-11-526, P-12-241, P-12-242, 
P-12-557, P-12-558, and P-13-237) 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.  [emsp14]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.
    This rule also includes SNURs on 36 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.  
[emsp14]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.  [emsp14]721.170 satisfies the two requirements stipulated in 
Sec.  721.170(c)(2), i.e., these significant new use activities, ``(i) 
are different from those described in the premanufacture notice for the 
substance, including any amendments, deletions, and additions of 
activities to the premanufacture notice, and (ii) 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 Numbers P-08-512 and P-08-513

    Chemical names: (P-08-512) Alcohol propoxylate (generic) and (P-05-
513) Alcohol propoxylate sulfate salt (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances are as a chemical intermediate (P-
08-512), and for enhanced oil recovery applications (P-

[[Page 39270]]

08-513). Based on structural activity relationship (SAR) analysis of 
the test data on analogous neutral organics (P-08-512) and anionic 
surfactants (P-08-513), EPA predicts toxicity to aquatic organisms at 
concentrations that exceed 1 part per billion (ppb) of P-08-512 and 15 
ppb of P-08-513 in surface waters. However, based on test data 
submitted on analogous chemical substances, EPA expects the actual risk 
to aquatic organisms in surface waters to be significantly mitigated 
following biological treatment at publicly owned treatment works or at 
on-site waste water treatment plants, injection to Class I or II wells, 
or incineration. As described in the PMN notices, releases are either 
injected into Class I or II wells, incinerated, or released to surface 
waters after biological treatment. 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 
non-industrial use, or any release during manufacturing, processing, or 
use other than injection to Class I or II wells, incineration, or 
release to water following biological treatment and clarification may 
cause significant adverse environmental effects. Based on this 
information, the PMN substances meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
Modified Shake-Flask Biodegradation Test (Cripe, C.R., Walker, W.W., 
Pritchard, P.H., Borquin, A.W. (1987). Shake-Flask Test for Estimation 
of Biodegradability of Toxic Organic Substances in the Aquatic 
Environment. Ecotoxicology and Environmental Safety 14:239-251) 
utilizing an algal toxicity test (Office of Chemical Safety and 
Pollution Prevention (OCSPP) Test Guideline 850.4500); an aquatic 
invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 
850.1010); and a fish acute toxicity test, freshwater and marine (OPPTS 
Test Guideline 850.1075) with supplemental analytics to identify 
degradation products, would help to characterize the environmental 
effects of the PMN substances. Testing is recommended to be conducted 
on P-08-513. EPA suggests conducting the modified shake-flask 
biodegradation test first as the results may impact the ecotoxicity 
testing recommendations.
    CFR citation: 40 CFR 721.10725 (P-08-512) and 40 CFR 721.10726 (P-
08-513).

PMN Number P-11-526

    Chemical name: Amphoteric fluorinated surfactant (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: August 20, 2013.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a surface 
active agent. Based on test data on the PMN substance and data 
currently available to the Agency on analogous perfluorooctanoic acid 
(PFOA), EPA identified concerns for potential incineration or other 
decomposition products or degradants of the PMN substance. EPA also has 
concerns that exposures to the PMN substance under certain conditions 
of use--particularly non-industrial, commercial, or consumer uses--
could cause lung effects, based on data on analogous perfluorinated 
compounds. PFOA is expected to persist for years in the environment. 
Biodegradation and photolysis tests of analogous substances indicate 
little or no biodegradation or photolysis of perfluoroalkyl compounds. 
Bioaccumulation concerns are based on the measured presence of certain 
perfluoroalkyl compounds, including PFOA, in wildlife and in human 
blood samples. Toxicity studies on PFOA indicate developmental, 
reproductive and systemic toxicity in various species, as well as 
cancer. These factors taken together raise concerns for potential 
adverse chronic effects in humans and wildlife. The consent 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 human health and the environment, 
these 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 risks, the consent order requires:
    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 a Material Safety Data Sheet (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 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. Use of the substance only as described in the consent order.
    4. Submission of certain testing prior to exceeding the 
confidential production volume limit of the PMN substance 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 test data from 
certain human health, environmental fate, and ecotoxicity testing 
identified in the consent order would help characterize possible 
effects of the substances and their degradation products. The company 
has agreed not to exceed the first production limit without performing 
a Zahn-Wellens biodegradation test (OPPTS Test Guideline 835.5200) with 
analysis for degradation products as specified, and a hydrolysis test 
as a function of pH and temperature (OPPTS Test Guideline 835.2130). 
The PMN submitter has also agreed not to exceed the second production 
limit without performing a 90-day repeated dose oral toxicity study in 
rats with 1-generation reproduction parallel study (must include 
modifications) (OECD Test Guideline 421 modified) and a soil 
biodegradation study (OECD Test Guideline 307). The company has agreed 
not to exceed the third production limit without performing an 
ultraviolet (UV) visible light absorption study (OPPTS Test Guideline 
830.7050), a direct photolysis test, if wavelengths greater than 290 
nautical miles (nm) are absorbed in the previous test (OPPTS Test 
Guideline 830.7050) (OPPTS Test Guideline 835.2210), an indirect 
photolysis screening test (OPPTS Test Guideline 835.5270), an anaerobic 
biodegradability of organic compounds in digested sludge test (OECD 
Test Guideline 311), and an avian reproduction test (OPPTS Test 
Guideline 850.2300) in bobwhite quail. Further testing details are 
available in the consent order located in the docket under docket EPA-
HQ-OPPT-2014-0166. The consent order does not require submission of the 
additional pended testing detailed in the consent order at any 
specified time or production volume. However, the consent order's 
restrictions on manufacture, processing, distribution in commerce, use, 
and disposal of the PMNs will remain in effect until the consent order 
is modified or revoked by EPA based on submission of that or other 
relevant information.
    CFR citation: 40 CFR 721.10727.

[[Page 39271]]

PMN Numbers P-12-241 and P-12-242

    Chemical names: (P-12-241) 2-Propenoic acid, 2-methyl-, 2-
hydroxyethyl esters, telomers with C18-26-alkyl acrylate, 1-
dodecanethiol, N-(hydroxymethyl)-2-methyl-2-propenamide, 
polyfluorooctyl methacrylate, 2,2'-[1,2-diazenediylbis(1-
methylethylidene)]bis[4,5-dihydro-1H-imidazole]hydrochloride (1:2)-
initiated (generic) and (P-12-242) 2-Propenoic acid, 2-methyl-, C16-18 
esters, telomers with 3-chloro-2-hydroxypropyl methacrylate, 1-
dodecanethiol, N-(hydroxymethyl)-2-methyl-2-propenamide, 
polyfluorooctyl methacrylate, and rel- (1R,2R,4R)-1,7,7-
trimethylbicyclo[2.2.1]hept-2-yl methacrylate, 2,2'-[1,2-
diazenediylbis(1-methylethylidene)]bis[4,5-dihydro-1H-
imidazole]hydrochloride (1:2)-initiated (generic).
    CAS numbers: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: June 5, 2013.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
generic (non-confidential) use of these substances is as a water and 
oil repellant. Based on analogy to other perfluorinated chemicals, 
including PFOA, EPA has concerns for potential fluorinated incineration 
or other decomposition products of the PMN substances. EPA has concerns 
that these perfluorinated products may be released to the environment 
from incomplete incineration of the PMN substances at low temperatures. 
EPA has preliminary evidence that suggests that, under some conditions, 
the PMN substances could degrade in the environment. Based on data on 
analogous chemicals, including PFOA, EPA has concerns that these 
degradation products will persist in the environment, could 
bioaccumulate or biomagnify, and could be toxic to people, wild 
mammals, and birds. PFOA is expected to persist for years in the 
environment. Biodegradation and photolysis tests of analogous 
substances indicate little or no biodegradation or photolysis of 
perfluoroalkyl compounds. Bioaccumulation concerns are based on the 
measured presence of certain perfluoroalkyl compounds, including PFOA, 
in wildlife and in human blood samples. Toxicity studies on PFOA 
indicate developmental, reproductive and systemic toxicity in various 
species, as well as possible cancer concerns. These factors, taken 
together, raise concerns for potential adverse chronic effects in 
humans and wildlife. The consent order was issued under TSCA section 
5(e)(1)(A) based on a finding that these substances may present an 
unreasonable risk of injury to human health and the environment, these 
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 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 a Material Safety Data Sheet (MSDS), within 90 
days.
    2. Manufacture of the PMN substances: (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 substances as stated in the consent order.
    3. Use of the substances only as described in the consent order.
    4. Submission of certain environmental fate and toxicity testing 
prior to exceeding the confidential production volume limit of the 
aggregate amount of the PMN substances described in P-12-241 and P-12-
242 specified in the consent order.
    5. The individual annual manufacture volume for P-12-241 and P-12-
242 must not reach the confidential annual production volume 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 test data from 
certain human health, environmental fate, and ecotoxicity testing 
identified in the consent order would help characterize possible 
effects of the substances and their degradation products. The company 
has agreed not to exceed the first production limit without performing 
a hydrolysis as a function of pH and temperature test (OPPTS Test 
Guideline 835.2130), a ready biodegradation test (OPPTS Test Guideline 
835.3110), a UV/Visible light spectrum test (OPPTS Test Guideline 
830.7050), a direct photolysis test (OPPTS Test Guideline 835.2210) and 
an indirect photolysis screening test (OPPTS Test Guideline 835.5270). 
The company has also agreed not to exceed the second production limit 
without performing a modified semi-continuous activated sludge (SCAS) 
with analysis of degradation products test (OPPTS Test Guideline 
835.5045/), an aerobic/anaerobic transformation in soil test (OECD Test 
Guideline 307), an anaerobic biodegradability of organic compounds in 
digested sludge test (OECD Test Guideline 311), a phototransformation 
of chemicals in soil test, 2002, surfaces--2 soils (draft OECD, a 
simulation test--aerobic sewage treatment (activated sludge units) 
(OECD Test Guideline 303A), an aerobic and anaerobic transformation in 
aquatic sediment systems test (OECD Test Guideline 308), and an acute 
inhalation toxicity test (OPPTS Test Guideline 870.1300). Further 
testing details are available in the consent order located in the 
docket under docket EPA-HQ-OPPT-2014-0166. The consent order does not 
require submission of the pended testing detailed in the consent order 
at any specified time or production volume. However, the consent 
order's restrictions on manufacture, processing, distribution in 
commerce, use, and disposal of the PMNs will remain in effect until the 
consent order is modified or revoked by EPA based on submission of that 
or other relevant information.
    CFR citation: 40 CFR 721.10728 (P-12-241) and 40 CFR 721.10729 (P-
12-242).

PMN Numbers P-12-557 and P-12-558

    Chemical names: (P-12-557) Tires, wastes, pyrolyzed, C6-39 oil 
fraction and (P-12-58) Tires, wastes, pyrolyzed, C7-56 oil fraction.
    CAS numbers: (P-12-557) 1410795-89-9 and (P-12-558) 1410795-87-7.
    Effective date of TSCA section 5(e) consent order: July 22, 2013.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
substances will be used as naphtha used for high octane gas and 
cleaning fluids, kerosene used for jet fuels, distillate fuel oil used 
for off-highway diesel engines and power generation, and vacuum gas oil 
used for gasoline. Based on structure-activity relationship analysis of 
test data on analogous neutral organic chemicals, EPA predicts toxicity 
to aquatic organisms may occur at concentrations that exceed 360 ppb 
(for P-12-557) and 170 ppb (for P-12-558) in surface waters. The 
consent order was issued under TSCA sections 5(e)(1)(A)(i) and 
5(e)(1)(A)(ii)(I) based on a finding that uncontrolled manufacture, 
processing, distribution in commerce, use, and disposal of these 
substances may present an unreasonable risk of injury to the 
environment. To protect against these risks, the consent order 
requires:

[[Page 39272]]

    1. Establishment and use of a hazard communication program, 
including human health, environmental hazard precautionary statements 
on each label and the MSDS.
    2. Use of the substances only as described in the consent order.
    3. No use of the substances resulting in surface water 
concentrations exceeding the concentrations of concern identified in 
the releases to water section of the consent order.
    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 text, 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. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed. The order 
does not require the submission of these tests 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 721.10730 (P-12-557) and 40 CFR 721.10731 (P-
12-558).

PMN Number P-13-60

    Chemical name: Neodymium, butadiene iso-Bu neodecanoate complexes.
    CAS number: 1386395-00-1.
    Basis for action: The PMN states that the use of the substance is 
as a precursor to polymerization catalyst. Based on SAR analysis of 
test data on analogous neodymium complexes, 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 exceeding 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 resulting in releases to surface waters exceeding 8 
ppb may cause 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 (OPPT Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPT 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 721.10732.

PMN Number P-13-237

    Chemical name: Tires, wastes, pyrolyzed, C5-15 condensate oil 
fraction.
    CAS number: Claimed confidential.
    Chemical substance definition: A complex combination of 
hydrocarbons obtained from the substance produced by the pyrolysis of 
rubber-based tires after removal of the carbon black fraction. It 
consists predominantly of hydrocarbons having carbon numbers in the 
range of C5 through C15. It boils in the range of approximately 36 
[deg]C to 265 [deg]C (97[emsp14][deg]F to 509[emsp14][deg]F).
    Effective date of TSCA section 5(e) consent order: August 8, 2013.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
use of the substance will be as a raw feed stock for refineries. Based 
on data for benzene which comprises 6% of the PMN substance, EPA 
identified concerns for oncogenicity, immunotoxicity, and liver and 
blood toxicity. Based on data for limonene, which constitutes 13% of 
the PMN substance, EPA identified concerns for dermal sensitization. 
Based on SAR analysis for neutral organic chemicals the PMN substance 
may be toxic to aquatic organisms at concentrations as low as 4 ppb. 
The order was issued under TSCA sections 5(e)(1)(A)(i) and 
5(e)(1)(A)(ii)(I) based on a finding that this substance may present an 
unreasonable risk of injury to human health or the environment. To 
protect against this risk, the consent order requires:
    1. An 8-hour time-weighted-average (TWA) inhalation exposure limit 
of 1 part per million (ppm) to the PMN substance.
    2. Use of the PMN substance only as a raw feed stock for 
refineries.
    3. No use of the substance resulting in surface water 
concentrations that exceed 4 ppb.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of 
inhalation monitoring data, collected according to the EPA draft 
Inhalation Monitoring Data Collection Guidelines (located in the docket 
to this rule); 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.l010); and an algal 
toxicity test (OCSPP Test Guideline 850.4500) would help characterize 
the human health and environmental effects of the PMN substance. The 
order does not require submission of these tests at any specified time 
or production volume. However, the order's restrictions on manufacture, 
processing, distribution in commerce, use, and disposal of the PMN 
substance 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 721.10733.

PMN Number P-13-248

    Chemical name: Lithium salt of substituted imide (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an electrolyte. Based on 
test data on the PMN substance, and SAR analysis of test data on 
analogous lithium salts, the EPA identified concerns for irritation, 
possible corrosion, acute toxicity, blood and thyroid effects, 
neurotoxicity, and immunotoxicity from exposure to the PMN substance 
via inhalation and dermal exposures. As described in the PMN, 
occupational exposures are expected to be minimal due to the use of a 
National Institute of Occupational Safety and Health (NIOSH)-certified 
particulate respirator with an assigned protection factor (APF) of at 
least 10. Further, general population exposures are not expected as the 
PMN 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 PMN substance without a NIOSH-certified particulate 
respirator with an APF of at least 10, where there is a potential for 
inhalation exposures; or any use in a consumer product may cause 
serious 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 
inhalation monitoring data, collected according to the EPA draft 
Inhalation Monitoring Data Collection Guidelines (located in the docket 
to this rule) would help characterize the human health effects of the 
PMN substance.
    CFR citation: 40 CFR 721.10734.

[[Page 39273]]

PMN Number P-13-270

    Chemical name: Aromatic dibenzoate (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a catalyst component. Based on 
SAR analysis of test data on analogous esters, EPA predicts chronic 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb of the PMN substance in surface waters. Based on uses 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 should there be any new use of the substance resulting in 
releases to surface waters exceeding 1 ppb significant adverse 
environmental effects could occur. 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 
sediment-water chironomid life-cycle toxicity test using spiked water 
or spiked sediment (OECD Test Guideline 233); a hydrolysis test (OECD 
Test Guideline 111); and a Zahn-Wellens inherent biodegradation test 
(OECD Test Guideline 302B) would help characterize the potential for 
chronic aquatic toxicity of the PMN substance. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed to 
facilitate solubility in the test media, because of the PMN substance's 
low water solubility.
    CFR citation: 40 CFR 721.10735.

PMN Number P-13-309

    Chemical name: Alcohols, C9-11-branched, ethoxylated propoxylated.
    CAS number: 1400790-00-2.
    Basis for action: The PMN states that the use of the substance will 
be as a component of a pigment dispersant blend for inks and coatings. 
Based on SAR analysis of test data on analogous nonionic surfactants, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 170 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 170 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 a component of a pigment dispersant blend for 
inks and coatings may cause 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 (OPPT 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. EPA also 
recommends that the guidance document on aquatic toxicity testing of 
difficult substances and mixtures (OECD Test Guideline 23) be followed 
to facilitate solubility in the test media, because of the PMN 
substance's low water solubility.
    CFR citation: 40 CFR 721.10736.

PMN Number P-13-378

    Chemical name: Carboxylic anhydride, polymer with -hydro-
hydroxypoly(oxy-1,2-diethanediyl), compd. with 2,3,4,6,7,8,9,10-
octahydropyrimido-[1,2-a]azepine (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the use of the substance is 
as a polyurethane catalyst. Based on SAR analysis of test data on 
analogous aliphatic amines, 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 
releases to surface waters exceeding 24 ppb may cause 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); a fish acute toxicity test mitigated by humic acid (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 environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10737.

PMN Number P-13-453

    Chemical name: Formaldehyde, polymer with 2,3-dimethylphenol, 2,4-
dimethylphenol, 2,5-dimethylphenol, 3,5-dimethylphenol, 3-ethylphenol, 
4-ethylphenol, 3-methylphenol, 4-methylphenol and phenol.
    CAS number: 1415313-86-8.
    Basis for action: The PMN states that the substance will be used as 
a coating for electronic components. Based on SAR analysis of test data 
on analogous phenols, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 5 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 5 
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 
releases to surface waters exceeding 5 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); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substance. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed to 
facilitate solubility in the test media, because of the PMN substance's 
low water solubility.
    CFR citation: 40 CFR 721.10738.

PMN Number P-13-465

    Chemical name: Caprolactone homopolymer of substituted 
benzotriazole (generic).

[[Page 39274]]

    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a UV stabilizer. Based on 
SAR analysis of test data on analogous benzotriazoles, esters, phenols, 
and amides, 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 cause 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 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. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed to 
facilitate solubility in the test media, due to the low water 
solubility of the PMN material. EPA suggests conducting the water 
solubility test first as the results may impact the ecotoxicity testing 
recommendations.
    CFR citation: 40 CFR 721.10739.

PMN Number P-13-473

    Chemical name: Tin(2+) salt of alkylcarboxylic acid (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a catalyst. Based on test 
data on the PMN, as well as SAR analysis of test data on analogous tin 
compounds, the EPA identified potential human health concerns regarding 
eye corrosion, dermal sensitization, and asthma, from the PMN substance 
via dermal exposure. Further, based on SAR analysis of test data on 
analogous tin salts and anionic surfactants, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 27 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, exceed releases 
from the use and production volume described in the PMN. For the use 
and production volume described in the PMN, environmental releases did 
not exceed 27 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 use of the substance without the use of impervious gloves 
and goggles, when there is a potential dermal exposure; use of the 
substance other than as described in the PMN; or any increase in the 
annual confidential production volume could result in exposures which 
may cause serious human health and significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(3)(i), (b)(3)(ii), and (b)(4)(ii).
    Recommended testing: EPA has determined that 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. EPA also recommends 
filtration should be avoided and that the guidance document on aquatic 
toxicity testing of difficult substances and mixtures (OECD Test 
Guideline 23) followed to facilitate solubility in the test media, 
because of the PMN substance's low water solubility. Repeated dose 
health tests are not recommended because of the PMN substance's 
corrosive nature.
    CFR citation: 40 CFR 721.10740.

PMN Number P-13-563

    Chemical name: Propylene glycol, alpha isocyanate, omega silane 
(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 
for polyurethane polymers. Based on SAR analysis of analogous 
diisocyanates, EPA identified concerns for oncogenicity, mutagenicity, 
respiratory and dermal sensitization and lung and mucous membrane 
irritation from exposure to the PMN substance via inhalation and dermal 
exposures. For the use described in the PMN, EPA does not expect 
significant occupational or consumer exposure. 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 a NIOSH-certified 
particulate respirator with an APF of at least 10, where there is a 
potential for inhalation exposures; any use other than as an 
intermediate; or any use of the substance in consumer products, may 
cause serious health 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 test (OPPTS Test Guideline 870.2600); a 90-day inhalation 
toxicity test (OPPTS Test Guideline 870.3465); and a carcinogenicity 
test (OPPTS Test Guideline 870.4200) would help characterize the human 
health effects of the PMN substance.
    CFR citation: 40 CFR 721.10741.

PMN Numbers P-13-617, P-13-618, and P-13-619

    Chemical names: (P-13-617) Aromatic dicarboxylic acid polymer with 
alkanediol, alkyl alkyl-2-alkenoate,1,4-dialkyl aromatic dicarboxylate, 
alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, 
aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic 
acid (generic), (P-13-618) Alkanedioic acid, polymer with alkyl 2-
alkyl-2-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2-
alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-
alkyl-2-alkenoic acid (generic); and (P-13-619) Alkanedioic acid, 
polymer with alkyl alkyl-alkenoate, alkanedioic acid, alkanediol, 
.alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic 
diisocyanate, alkyl alkyl-alkeneoate and alkyl-alkenoic acid (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substances will be as an adhesive. Based on 
SAR analysis of test data on analogous diisocyanates, EPA identified 
concerns for respiratory sensitization. For the use described in the 
PMN, EPA does not expect significant occupational or consumer 
inhalation exposure as the substances are not applied using a method 
that generates a vapor, mist, or aerosol, nor are they used in a 
consumer product. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the

[[Page 39275]]

substances may present an unreasonable risk. EPA has determined, 
however, that any use of the substances without a NIOSH-certified 
particulate respirator with an APF of at least 10, where there is a 
potential for inhalation exposures; any use in consumer products; or 
any use of the substances involving an application method that 
generates a vapor, mist, or aerosol may cause serious health 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 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substances.
    CFR citation: 40 CFR 721.10742 (P-13-617); 40 CFR 721.10743 (P-03-
618) and 40 CFR 721.10744 (P-13-619).

PMN Number P-13-722

    Chemical name: Alkoxylated quaternary alkyl ammonium 
fluoroalkylsulfonimide (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a polymer additive. Based 
on SAR analysis of test data on analogous cationic surfactants, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 9 ppb of the PMN substance in surface waters. For the use 
described in the PMN, environmental releases are not expected to result 
in surface water concentrations that exceed 9 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 9 ppb may cause 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, freshwater daphnids 
(OPPTS Test Guideline 850.1010); and an algal toxicity test (OPPTS Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substance. EPA also recommends that the guidance document on 
aquatic toxicity testing of difficult substances and mixtures (OECD 
Test Guideline 23) be followed to facilitate solubility in the test 
media, due to the low water solubility of the PMN material.
    CFR citation: 40 CFR 721.10745.

PMN Number P-13-753

    Chemical name: Isocyanate terminated urethane polymer (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive and sealant. 
Based on SAR analysis of test data on analogous isocyanates, EPA 
identified concerns for respiratory and dermal sensitization to workers 
from exposure to the PMN substance. In addition, based on test data 
submitted under the TSCA section 8(e) program, the Agency identified 
concern for mutagenicity. For the uses described in the PMN, 
significant occupational dermal and inhalation exposures are not 
expected. Further, general population exposures are not expected as the 
PMN 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 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 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 721.10746.

PMN Number P-13-773

    Chemical name: 4-Pyrimidianamine, 2,5 dimethoxy-.
    CAS number: 6960-17-4.
    Basis for action: The PMN states that the substance will be used as 
an herbicide intermediate. Based on test data of the PMN substance, as 
well as SAR analysis of test data on analogous aromatic amines, EPA 
identified concerns for mutagenicity, oncogenicity, and developmental 
toxicity to workers exposed to the PMN substance. Further, based on SAR 
analysis of test data on analogous anilines, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 7 ppb of the 
PMN substance in surface water. As described in the PMN, EPA does not 
expect significant occupational exposures and releases of the PMN 
substance are not expected to result in surface water concentrations 
that exceed 7 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 a NIOSH-certified respirator with an APF of at least 
10, where there is potential inhalation exposure; any use without 
impervious gloves, where there is potential for dermal exposure; or any 
use other than as an herbicide intermediate may cause serious health 
and environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(1)(i)(B), (b)(1)(i)(C), 
(b)(3)(ii), (b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
combined repeated dose toxicity test (OECD Test Guideline 422), with 
the reproduction/development toxicity screening test; a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465); and an 
aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 
Test Guideline 850.1010) would help characterize the human health and 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10747.

PMN Numbers P-13-796, P-13-797, P-13-798, P-13-799, and P-13-800

    Chemical names: (P-13-796, P-13-797, and P-13-798) 
Dicarbomonocycle-substituted carbomonocycledicarboxamide (generic); (P-
13-799) Dicarboheterocycle-substituted carbomonocycledicarboxamide 
(generic); and (P-13-800) Tricarbomonocycle-substituted 
carbomonocycletricarboxamide (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substances are as additives for polymer 
manufacturing. Based on SAR analysis of test data on analogous amides, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 4 ppb (for P-13-796 and P-13-797); 14 ppb (for P-13-798); 1 
ppb (for P-13-799); and 2 ppb (for P-13-800) of the PMN substance in 
surface waters. For the use described in the PMNs, releases of the 
substances are not expected to result in surface water concentrations 
that exceed the respective concentrations for concern. 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 use of the substance resulting in releases to surface 
waters exceeding the respective concentrations of concern

[[Page 39276]]

may result in significant adverse environmental effects. Based on this 
information, the PMN substances meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OECD Test Guideline 301); 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. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed to 
facilitate solubility in the test media, because of the PMN substance's 
low water solubility. EPA suggests conducting the biodegradation test 
first as the results may impact the ecotoxicity testing 
recommendations.
    CFR citation: 40 CFR 721.10748 (P-13-796, P-13-797, and P-13-798); 
40 CFR 721.10749 (P-13-799); and 40 CFR 721.10750 (P-13-800).

PMN Number P-13-810, P-13-811, P-13-812, P-13-813, P-13-814, and P-13-
815

    Chemical names: Cycloalkylamino oleyl alkylamide acid salts 
(generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMNs state that the generic (non-
confidential) use of these substances are as inhibitors for oil field 
applications. Based on SAR analysis of test data on analogous aliphatic 
amines, EPA predicts chronic toxicity to aquatic organisms may occur at 
concentrations that exceed 1 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 exceeding 1 ppb of 
the aggregate of these PMN substances. 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 use of the substances resulting in releases to surface 
waters exceeding 1 ppb may result in significant adverse environmental 
effects. Based on this information, the PMN substances meets the 
concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a water 
solubility: Column elution method; shake flask method test (OPPTS Test 
Guideline 830.7840) or a water solubility: Generator column method test 
(OPPTS Test Guideline 830.7860); a determination of the partition 
coefficient (n-octanol/water) by shake flask method (OPPTS Test 
Guideline 830.7550), generator column method (OPPTS Test Guideline 
830.7560), or estimation by liquid chromatography (OPPTS Test Guideline 
830.7570); and log Koc determination by adsorption-desorption using a 
batch equilibrium method (OECD Test Guideline 106) in representative 
salt water conditions would help characterize the environmental effects 
of the PMN substances. Based on the results of these studies, EPA would 
recommend either of the following as additional testing:
    (A) Fish acute toxicity test, freshwater and marine (OPPTS Test 
Guideline 850.1075); a mysid acute toxicity test (OPPTS Test Guideline 
850.1350); and an algal toxicity test (OCSPP Test Guideline 850.4500) 
or;
    (B) the whole sediment acute toxicity test, invertebrates, marine 
(OPPTS Test Guideline 850.1740).
    CFR citation: 40 CFR 721.10751.

PMN Numbers P-13-816, P-13-817, P-13-818, P-13-819, P-13-820, and P-13-
821

    Chemical names: Cycloalkylamino cocoalkyl alkylamide acid salts 
(generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMNs state that the generic (non-
confidential) use of these substances is as inhibitors for oil field 
applications. Based on SAR analysis of test data on analogous aliphatic 
amines, EPA predicts chronic toxicity to aquatic organisms may occur at 
concentrations that exceed 1 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 exceeding 1 ppb of 
the aggregate of these PMN substances. 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 use of the substances resulting in releases to surface 
waters exceeding 1 ppb may result in significant adverse environmental 
effects. Based on this information, the PMN substances meets the 
concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a water 
solubility: Column elution method; shake flask method test (OPPTS Test 
Guideline 830.7840) or a water solubility: Generator column method test 
(OPPTS Test Guideline 830.7860); a determination of the partition 
coefficient (n-octanol/water) by shake flask method (OPPTS Test 
Guideline 830.7550), generator column method (OPPTS Test Guideline 
830.7560), or estimation by liquid chromatography (OPPTS Test Guideline 
830.7570); and log Koc determination by adsorption-desorption using a 
batch equilibrium method (OECD Test Guideline 106) in representative 
salt water conditions would help characterize the environmental effects 
of the PMN substances. Based on the results of these studies, EPA would 
recommend either of the following as additional testing:
    (A) Fish acute toxicity test, freshwater and marine (OPPTS Test 
Guideline 850.1075); a mysid acute toxicity test (OPPTS Test Guideline 
850.1350); and an algal toxicity test (OCSPP Test Guideline 850.4500) 
or;
    (B) the whole sediment acute toxicity test, invertebrates, marine 
(OPPTS Test Guideline 850.1740).
    CFR citation: 40 CFR 721.10752.

PMN Number P-13-839

    Chemical name: Methanamine, N,N-dimethyl-, reaction products with 
alkylamine-epichlorohydrin polymer, chlorides (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 of pre-coat 
solution. Based on the test data submitted with this PMN as well as the 
structural activity relationships analysis for analogous polycationic 
polymers, 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 to surface 
waters are not expected. 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 
cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(i) and (ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a fish 
acute toxicity mitigated by humic acid (OPPTS Test Guideline 850.1085); 
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. EPA also 
recommends that the guidance document on aquatic toxicity testing of 
difficult substances and mixtures (OECD Test Guideline 23) be followed 
to facilitate solubility in the

[[Page 39277]]

test media, because of the PMN substance's low water solubility.
    CFR citation: 40 CFR 721.10753.

PMN Number P-13-882

    Chemical name: Mixture of alkylated benzene, brominated (generic) 
and alkylated benzene, dibrominated (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMN states that the use of the substance will 
be as a feed for a bromine recovery unit. Based on analogous chemical 
substances that contain bromine and alkylation potential of the PMN 
substance, EPA identified concerns for neurotoxicity, liver and kidney 
toxicities, mutagenicity, and oncogenicity, as well as concerns for 
developmental toxicity and dermal sensitization to workers exposed to 
the PMN substance. The Agency also identified the potential for human 
health risk due to the possible formation of dioxins. Further, based on 
test data on analogous benzyl halides, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 5 ppb of the PMN 
substance in surface water. For the use described in the PMN, EPA does 
not expect significant occupational inhalation or dermal exposures; 
significant general population inhalation or drinking water exposures; 
or releases of the PMN substance that result in surface water 
concentrations that exceed 5 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 use 
other than for use other than as feed for a bromine recovery unit may 
cause serious health and significant environmental effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(1)(i)(D), (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465); 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 721.10754.

PMN Number: P-14-42

    Chemical name: Substituted perfluoroether (generic).
    CAS Number: Claimed confidential.
    Basis for Action: The PMN states that the generic (non-
confidential) use of the substance is as a surfactant for laboratory 
use fluid. Based on SAR analysis of test data on analogous high 
molecular weight polymers, EPA identified concerns for lung toxicity if 
respirable droplets of the PMN substance are inhaled. Further, based on 
analogy to perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate 
(PFOS), EPA identified concerns for liver toxicity, acute toxicity, 
developmental and reproductive toxicity, and cancer, for the PMN 
substance, when the mean moles of each perfluoro propylene (PPO) unit 
is less than 5. The low molecular weight species have been identified 
as having the potential to be persistent, bioaccumulative, and toxic 
(PBT) chemicals. EPA does not have comparable toxicity information on 
the low molecular weight fraction of the PMN substance and unreacted 
starting material. EPA has concerns that this PMN substance will 
persist in the environment. In addition, the perfluoro degradation 
products could persist, bioaccumulate, and be toxic to people, wild 
mammals, and birds. EPA's concerns are based on analogy to other 
perfluoro chemicals, including PFOA and PFOS, which are both currently 
under review by EPA for PBT concerns. PFOA and PFOS are expected to 
persist for years in the environment. Biodegradation and photolysis 
tests of analogous substances indicate little or no biodegradation or 
photolysis of perfluoroalkyl compounds. Bioaccumulation concerns are 
based on the measured presence of certain perfluoroalkyl compounds, 
including PFOA, in wildlife and in human blood samples. In addition, 
EPA expects the PMN substance and the perfluoro degradation products to 
be highly persistent, and the low molecular weight fraction is expected 
to be mobile and bioaccumulate in the environment. No ecotoxicological 
concerns were raised for the PMN substance itself. However, there is 
high concern for possible environmental effects to mammals and wild 
birds from the perfluoro degradation products of the PMN substance. As 
stated previously, the analog PFOA is persistent in the environment; 
has a long bioretention time in various species; has been detected in a 
number of species of wildlife, including marine mammals; and is 
considered toxic to mammalian and other species. The toxicological 
properties and presence of PFOA in the environment continue to be 
investigated. For the use described in the PMN, EPA does not expect 
occupational, general population, or environmental exposures to the PMN 
substance. 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 other than as described in the PMN, or any manufacture of the 
PMN substance where the mean number of moles of each perfluoro 
propylene oxide unit is less than 5, may result in serious health 
effects or significant adverse environmental effects. Based on this 
information, the PMN meets the concern criteria at 721.170(b)(3)(i), 
(b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
    Recommended Testing: EPA has determined that the results of the 
following testing on the presumed perfluoro degradation products of the 
PMN substance would be necessary to evaluate the potential human health 
effects of the PMN substance: a repeated dose metabolism and 
pharmacokinetics test (OPPTS Test Guideline 870.7485) in rats and mice; 
a 1-generation reproduction study (OECD Test Guideline 421), modified; 
a 90-day oral toxicity test (OPPTS Test Guideline 870.3100) in rats; a 
combined chronic toxicity/carcinogenicity test (OPPTS Test Guideline 
870.4300 or OECD Test Guideline 453) in rats; and an avian reproduction 
test (OPPTS Test Guideline 850.2300 or OECD Test Guideline 206). EPA 
recommends that the Company conduct the pharmacokinetics testing first 
to confirm species acceptability and to provide a reliable half-life 
for this substance. Further, EPA has determined that the results of the 
following physical/chemical properties and fate and transport tests on 
the PMN substance would be necessary to evaluate the environmental fate 
and transport: A UV visible light absorption test (OPPTS Test Guideline 
830.7050); a hydrolysis as a function of pH test (OPPTS Test Guideline 
835.2130); a semi-continuous activated sludge (``SCAS'') test (OPPTS 
Test Guideline 835.5045, OPPTS Test Guideline 835.3210, or OECD Test 
Guideline 302A) modified for analysis for perfluoro degradation 
products; an aerobic transformation in soil test (OECD Test Guideline 
307); an aerobic and anaerobic transformations test (OECD Test 
Guideline 308) in aquatic sediment systems; a direct photolysis test 
(OPPTS Test Guideline 835.2210); an indirect photolysis screening test 
(OPPTS Test Guideline 835.5270); phototransformation of chemicals on 
soil surfaces (Draft OECD Test Guideline

[[Page 39278]]

January 2002) using 2 soils, a simulation test-aerobic sewage treatment 
(OECD Test Guideline 303A) activated sludge units; and an anaerobic 
biodegradability test (OECD Test Guideline 311) on organic compounds in 
digested sludge.
    CFR Citation: 40 CFR 721.10764.

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 6 of the 43 
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 36 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.
     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 September 8, 2014 without further notice, unless EPA 
receives written adverse or critical comments, or notice of intent to 
submit adverse or critical comments before August 8, 2014.
    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 August 8, 2014, 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 6 of the 43 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 39 of the 43 chemical substances subject to this rule 
have been claimed as confidential and EPA has received no post-PMN bona 
fide submissions (per 40 CFR 720.25 and Sec.  721.11). Based on this, 
the Agency believes that it is highly unlikely that any of the 
significant new uses described in the regulatory text of this rule are 
ongoing.
    Therefore, EPA designates July 9, 2014 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 TSCA non-section 5(e) SNURs. Descriptions of tests are 
provided for informational purposes.

[[Page 39279]]

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.
    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 SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim 
under 40 CFR part 2 procedures, EPA is required to keep this 
information confidential. EPA promulgated a procedure to deal with the 
situation where a specific significant new use is CBI, at Sec.  
721.1725(b)(1).
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a proposed use would be a significant new use 
under the rule. The manufacturer or processor must show that it has a 
bona fide intent to manufacture or process the chemical substance and 
must identify the specific use for which it intends to manufacture or 
process the chemical substance. If EPA concludes that the person has 
shown a bona fide intent to manufacture or process the chemical 
substance, EPA will tell the person whether the use identified in the 
bona fide submission would be a significant new use under the rule. 
Since most of the chemical identities of the chemical substances 
subject to these SNURs are also CBI, manufacturers and processors can 
combine the bona fide submission under the procedure in Sec.  
721.1725(b)(1) with that under Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture or process the chemical substance so long as the 
significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

X. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 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-2014-0166.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This rule 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 rule. 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.

[[Page 39280]]

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 rule.
    This rule is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit XI. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300.

Therefore, the promulgation of the SNUR would not have a significant 
economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this rule. As 
such, EPA has determined that this rule 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 rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This rule 
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 
rule.

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).

XIV. 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: June 27, 2014.
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:

[[Page 39281]]

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
          40 CFR citation                      OMB control No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
              721.10725                            2070-0012
              721.10726                            2070-0012
              721.10727                            2070-0012
              721.10728                            2070-0012
              721.10729                            2070-0012
              721.10730                            2070-0012
              721.10731                            2070-0012
              721.10732                            2070-0012
              721.10733                            2070-0012
              721.10734                            2070-0012
              721.10735                            2070-0012
              721.10736                            2070-0012
              721.10737                            2070-0012
              721.10738                            2070-0012
              721.10739                            2070-0012
              721.10740                            2070-0012
              721.10741                            2070-0012
              721.10742                            2070-0012
              721.10743                            2070-0012
              721.10744                            2070-0012
              721.10745                            2070-0012
              721.10746                            2070-0012
              721.10747                            2070-0012
              721.10748                            2070-0012
              721.10749                            2070-0012
              721.10750                            2070-0012
              721.10751                            2070-0012
              721.10752                            2070-0012
              721.10753                            2070-0012
              721.10754                            2070-0012
              721.10764                            2070-0012
 
                                * * * * *
------------------------------------------------------------------------

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).


0
4. Add Sec.  721.10725 to subpart E to read as follows:


Sec.  721.10725  Alcohol propoxylate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alcohol 
propoxylate (PMN P-08-512) 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(l)
    (ii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(a)(3) (Class I or II wells), (b)(1), (b)(3) (Class I or II wells), 
(c)(1), and (c)(3) (Class I or II wells).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(2)(ii), (b)(2)(ii), and (c)(2)(ii).
    (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 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.

0
5. Add Sec.  721.10726 to subpart E to read as follows:


Sec.  721.10726  Alcohol propoxylate sulfate salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alcohol 
propoxylate sulfate salt (PMN P-08-513) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(l)
    (ii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(a)(3) (Class I or II wells), (b)(1), (b)(3) (Class I or II wells), 
(c)(1), and (c)(3) (Class I or II wells).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(2)(ii), (b)(2)(ii), and (c)(2)(ii).
    (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 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.

0
6. Add Sec.  721.10727 to subpart E to read as follows:


Sec.  721.10727  Amphoteric fluorinated surfactant (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
amphoteric fluorinated surfactant (PMN P-11-526) 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. A significant new use of this 
substance is any manner or method of manufacture or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the TSCA section 
5(e) consent order for this substance, the employer becomes aware that 
this 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 this 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)(a significant new use is any use other 
than as allowed by the section 5(e) consent order which includes 
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), (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
7. Add Sec.  721.10728 to subpart E to read as follows:

[[Page 39282]]

Sec.  721.10728  2-Propenoic acid, 2-methyl-, 2-hydroxyethyl esters, 
telomers with C18-26-alkyl acrylate, 1-dodecanethiol, N-
(hydroxymethyl)-2-methyl-2-propenamide, polyfluorooctyl methacrylate, 
2,2'-[1,2-diazenediylbis(1-methylethylidene)]bis[4,5-dihydro-1H-
imidazole]hydrochloride (1:2)-initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, 2-hydroxyethyl esters, telomers with C18-26-
alkyl acrylate, 1-dodecanethiol, N-(hydroxymethyl)-2-methyl-2-
propenamide, polyfluorooctyl methacrylate, 2,2'-[1,2-diazenediylbis(1-
methylethylidene)]bis[4,5-dihydro-1H-imidazole]hydrochloride (1:2)-
initiated (PMN P-12-241) 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. A significant new use of this 
substance is any manner or method of manufacture or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the TSCA section 
5(e) consent order for this substance, the employer becomes aware that 
this 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 this 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) (a significant new use is any use other 
than as allowed by the section 5(e) consent order which includes 
analysis and reporting and limitations of maximum impurity levels of 
certain fluorinated impurities), (q), and (t).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (d), (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.  721.10729 to subpart E to read as follows:


Sec.  721.10729  2-Propenoic acid, 2-methyl-, C16-18 esters, telomers 
with 3-chloro-2-hydroxypropyl methacrylate, 1-dodecanethiol, N-
(hydroxymethyl)-2-methyl-2-propenamide, polyfluorooctyl methacrylate, 
and rel- (1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl 
methacrylate, 2,2'-[1,2-diazenediylbis(1-methylethylidene)]bis[4,5-
dihydro-1H-imidazole]hydrochloride (1:2)-initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, C16-18 esters, telomers with 3-chloro-2-
hydroxypropyl methacrylate, 1-dodecanethiol, N-(hydroxymethyl)-2-
methyl-2-propenamide, polyfluorooctyl methacrylate, and rel-(1R,2R,4R)-
1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate, 2,2'-[1,2-
diazenediylbis(1-methylethylidene)]bis[4,5-dihydro-1H-
imidazole]hydrochloride (1:2)-initiated (PMN P-12-242) 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. A significant new use of this 
substance is any manner or method of manufacture or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the TSCA section 
5(e) consent order for this substance, the employer becomes aware that 
this 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 this 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) (a significant new use is any use other 
than as allowed by the section 5(e) consent order which includes 
analysis and reporting and limitations of maximum impurity levels of 
certain fluorinated impurities), (q), and (t).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (d), (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
9. Add Sec.  721.10730 to subpart E to read as follows:


Sec.  721.10730  Tires, wastes, pyrolyzed, C6-39 oil fraction.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as tires, wastes, 
pyrolyzed, C6-39 oil fraction (P-12-557; CAS No. 1410795-89-9) 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 chemical substance that has been 
blended into finished petroleum products or sent to a petroleum 
refinery for use as a chemical intermediate.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).

[[Page 39283]]

    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=360).
    (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), (g), (h), (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(1) of 
this section.

0
10. Add Sec.  721.10731 to subpart E to read as follows:


Sec.  721.10731  Tires, wastes, pyrolyzed, C7-56 oil fraction.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as tires, wastes, 
pyrolyzed, C7-56 oil fraction (P-12-558; CAS No. 1410795-87-7) 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 chemical substance that has been 
blended into finished petroleum products or sent to a petroleum 
refinery for use as a chemical intermediate.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=170).
    (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), (g), (h), (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(1) of 
this section.

0
11. Add Sec.  721.10732 to subpart E to read as follows:


Sec.  721.10732  Neodymium, butadiene iso-Bu neodecanoate complexes.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as neodymium, 
butadiene iso-Bu neodecanoate complexes (PMN P-13-60; CAS No. 1386395-
00-1) 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) Releases 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), (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
12. Add Sec.  721.10733 to subpart E to read as follows:


Sec.  721.10733  Tires, wastes, pyrolyzed, C5-15 condensate oil 
fraction.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as tires, wastes, 
pyrolyzed, C5-15 condensate oil fraction (PMN P-13-237; chemical 
substance definition: A complex combination of hydrocarbons obtained 
from the substance produced by the pyrolysis of rubber-based tires 
after removal of the carbon black fraction. It consists predominantly 
of hydrocarbons having carbon numbers in the range of C5 through C15. 
It boils in the range of approximately 36 [deg]C to 265 [deg]C 
(97[emsp14][deg]F to 509[emsp14][deg]F).) 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 substances that have been blended into finished 
petroleum products or sent to a petroleum refinery for use as a 
chemical intermediate, or stored as described in the Distribution 
section of the order.
    (2) The significant new uses are:
    (i) Protection in the workplace. The significant new use is any 
exposure exceeding an 8 hour time weighted average (TWA) exposure limit 
of 1 part per million (ppm).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. A significant new use is any use other 
than as a raw feedstock for refineries.
    (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), (b), (c), (i), (k), and records documenting that exposures 
do not exceed an 8 hour time weighted average (TWA) exposure limit of 1 
part per million 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 significant new use rule.

0
13. Add Sec.  721.10734 to subpart E to read as follows:


Sec.  721.10734  Lithium salt of substituted imide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as lithium 
salt of substituted imide (PMN P-13-248) 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 1.0 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.

[[Page 39284]]

    (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), (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.

0
14. Add Sec.  721.10735 to subpart E to read as follows:


Sec.  721.10735  Aromatic dibenzoate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aromatic dibenzoate (PMN P-13-270) 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) Releases 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
15. Add Sec.  721.10736 to subpart E to read as follows:


Sec.  721.10736  Alcohols, C9-11-branched, ethoxylated propoxylated.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alcohols, C9-11-
branched, ethoxylated propoxylated (PMN P-13-309; CAS No. 1400790-00-2) 
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 is any use other 
than as a component of a pigment dispersant blend for inks and 
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 (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.  721.10737 to subpart E to read as follows:


Sec.  721.10737  Carboxylic anhydride, polymer with -hydro--
hydroxypoly(oxy-1,2-diethanediyl), compd. with 2,3,4,6,7,8,9,10-
octahydropyrimido-[1,2-a]azepine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carboxylic anhydride, polymer with -hydro--hydroxypoly(oxy-1,2-
diethanediyl), compd. with 2,3,4,6,7,8,9,10-octahydropyrimido-[1,2-
a]azepine (PMN P-13-378) 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) Releases 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
17. Add Sec.  721.10738 to subpart E to read as follows:


Sec.  721.10738  Formaldehyde, polymer with 2,3-dimethylphenol, 2,4-
dimethylphenol, 2,5-dimethylphenol, 3,5-dimethylphenol, 3-ethylphenol, 
4-ethylphenol, 3-methylphenol, 4-methylphenol and phenol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as formaldehyde, 
polymer with 2,3-dimethylphenol, 2,4-dimethylphenol, 2,5-
dimethylphenol, 3,5-dimethylphenol, 3-ethylphenol, 4-ethylphenol, 3-
methylphenol, 4-methylphenol and phenol (PMN P-13-453; CAS No. 1415313-
86-8) 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=5).
    (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
18. Add Sec.  721.10739 to subpart E to read as follows:


Sec.  721.10739  Caprolactone homopolymer of substituted benzotriazole 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
caprolactone homopolymer of substituted benzotriazole (PMN P-13-465) 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
19. Add Sec.  721.10740 to subpart E to read as follows:


Sec.  721.10740  Tin(2+) salt of alkylcarboxylic acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as tin(2+) 
salt of alkylcarboxylic acid (PMN P-13-473) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:

[[Page 39285]]

    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) and (s).
    (ii) Protection in the workplace. Requirements as specified in 
Sec.  721.63(a)(1), (a)(2)(i), (a)(2)(iii), and (a)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (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)(1) of 
this section.

0
20. Add Sec.  721.10741 to subpart E to read as follows:


Sec.  721.10741  Polyalkylene glycol, alpha isocyanate, omega silane 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyalkylene glycol, alpha isocyanate, omega silane (PMN P-13-563) 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), (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 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(g) and (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), (b), (c), (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
21. Add Sec.  721.10742 to subpart E to read as follows:


Sec.  721.10742  Aromatic dicarboxylic acid polymer with alkanediol, 
alkyl alkyl-2-alkenoate, 1,4-dialkyl aromatic dicarboxylate, 
alkanedioic acid, alkanedioic acid. alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, 
aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic 
acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aromatic dicarboxylic acid polymer with alkanediol, alkyl alkyl-2-
alkenoate,1,4-dialkyl aromatic dicarboxylate, alkanedioic acid, 
alkanedioic acid. alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, 
aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic 
acid (PMN P-13-617) 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), (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 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(o) and (y)(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), (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
22. Add Sec.  721.10743 to subpart E to read as follows:


Sec.  721.10743  Alkanedioic acid, polymer with alkyl 2-alkyl-2-
alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2-
alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-
alkyl-2-alkenoic acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanedioic acid, polymer with alkyl 2-alkyl-2-alkenoate, alkanedioic 
acid, alkanediol, .alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-1 2-
alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, aromatic diisocyanate, 
alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic acid (PMN P-13-618) 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), (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 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

[[Page 39286]]

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(o) and (y)(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), (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
23. Add Sec.  721.10744 to subpart E to read as follows:


Sec.  721.10744  Alkanedioic acid, polymer with alkyl alkyl-alkenoate, 
alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic diisocyanate, alkyl 
alkyl-alkeneoate and alkyl-alkenoic acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanedioic acid, polymer with alkyl alkyl-alkenoate, alkanedioic acid, 
alkanediol, .alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-1,2-
alkanediyl)], aromatic diisocyanate, alkyl alkyl-alkeneoate and alkyl-
alkenoic acid (PMN P-13-619) 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), (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 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(o) and (y)(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), (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
24. Add Sec.  721.10745 to subpart E to read as follows:


Sec.  721.10745  Alkoxylated quaternary alkyl ammonium 
fluoroalkylsulfonimide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkoxylated quaternary alkyl ammonium fluoroalkylsulfonimide (PMN P-13-
722) 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=9).
    (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
25. Add Sec.  721.10746 to subpart E to read as follows:


Sec.  721.10746  Isocyanate terminated urethane polymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
isocyanate terminated urethane polymer (PMN P-13-753) 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), (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 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(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), (b), (c), (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
26. Add Sec.  721.10747 to subpart E to read as follows:


Sec.  721.10747  4-Pyrimidianamine, 2,5 dimethoxy-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 4-pyrimidianamine, 
2,5 dimethoxy- (PMN P-13-773; CAS No. 6960-17-4) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(ii), (a)(6)(v), (b) 
(concentration set at 0.1 percent) and (c). When determining which 
persons are

[[Page 39287]]

reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(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. A significant new use is any use other 
than as an herbicide intermediate.
    (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.

0
27. Add Sec.  721.10748 to subpart E to read as follows:


Sec.  721.10748  Dicarbomonocycle-substituted 
carbomonocycledicarboxamide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
dicarbomonocycle-substituted carbomonocycledicarboxamide (PMNs P-13-
796, P-13-797, and P-13-798) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=4 for P-13-796 and P-13-797; and 
N=14 for P-13-798).
    (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 significant new use rule.

0
28. Add Sec.  721.10749 to subpart E to read as follows:


Sec.  721.10749  Dicarboheterocycle-substituted 
carbomonocycledicarboxamide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
dicarboheterocycle-substituted carbomonocycledicarboxamide (PMN P-13-
799) 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 significant new use rule.

0
29. Add Sec.  721.10750 to subpart E to read as follows:


Sec.  721.10750  Tricarbomonocycle-substituted 
carbomonocycletricarboxamide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
tricarbomonocycle-substituted carbomonocycletricarboxamide (PMN P-13-
800) 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 significant new use rule.

0
30. Add Sec.  721.10751 to subpart E to read as follows:


Sec.  721.10751  Cycloalkylamino oleyl alkylamide acid salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
cycloalkylamino oleyl alkylamide acid salts (PMNs P-13-810, P-13-811, 
P-13-812, P-13-813, P-13-814, and P-13-815) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=1, for the aggregate of the PMN 
substances P-13-810, P-13-811, P-13-812, P-13-813, P-13-814, and P-13-
815).
    (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.  721.10752 to subpart E to read as follows:


Sec.  721.10752  Cycloalkylamino cocoalkyl alkylamide acid salts 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
cycloalkylamino cocoalkyl alkylamide acid salts (PMNs P-13-816, P-13-
817, P-13-818, P-13-819, P-13-820, and P-13-821) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=1, for the aggregate of the PMN 
substances P-13-816, P-13-817, P-13-818, P-13-819, P-13-820, and P-13-
821).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.

[[Page 39288]]

    (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
32. Add Sec.  721.10753 to subpart E to read as follows:


Sec.  721.10753  Methanamine, N,N-dimethyl-, reaction products with 
alkylamine-epichlorohydrin polymer, chlorides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
methanamine, N,N-dimethyl-, reaction products with alkylamine-
epichlorohydrin polymer, chlorides (PMN P-13-839) 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
33. Add Sec.  721.10754 to subpart E to read as follows:


Sec.  721.10754  Mixture of alkylated benzene, brominated (generic) and 
alkylated benzene, dibrominated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as mixture 
of alkylated benzene, brominated and alkylated benzene, dibrominated 
(PMN P-13-882) 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 is any use other 
than as feed for a bromine recovery unit.
    (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
34. Add Sec.  721.10764 to subpart E to read as follows:


Sec.  721.10764  Substituted perfluoroether (generic)

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted perfluoroether (PMN P-14-42) 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 this substance 
is: (1) Use of the substance for any application other than the 
confidential use identified in the Premanufacture Notice (PMN) or (2) 
Manufacture of the PMN substance where the mean number of moles of each 
perfluoro propylene oxide (``PPO'') unit is less than 5.
    (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.  721.180 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.

[FR Doc. 2014-15774 Filed 7-8-14; 8:45 am]
BILLING CODE 6560-50-P
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