Source: http://www.regulations.gov/?_escaped_fragment_=documentDetail;D=EPA-HQ-OPPT-2014-0166-0001
Timestamp: 2016-09-29 23:59:37
Document Index: 240279484

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[EPA-HQ-OPPT-2014-0166; FRL-9910-01]
SummaryEPA 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.
DatesThis 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.
AddressesSubmit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2014-0166, by one of the following methods: Federal eRulemaking Portal: 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.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at . Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at . 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: . For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: . Supplementary InformationI. General InformationA. 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 § 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.
viii. Make sure to submit your comments by the comment period deadline identified.II. BackgroundA. What action is the Agency taking?EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these rules are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.B. What is the Agency's authority for taking this action?Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) 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.C. Applicability of General ProvisionsGeneral provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.III. Significant New Use DeterminationSection 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.
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 RuleEPA 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.
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 non-section 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).
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-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 § 721.170(b)(4)(ii).
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).
CFR citation: 40 CFR 721.10727.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).
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.
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:
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.
CFR citation: 40 CFR 721.10732.PMN Number P-13-237 Chemical name: Tires, wastes, pyrolyzed, C5-15 condensate oil fraction.
CFR citation: 40 CFR 721.10733.PMN Number P-13-248 Chemical name: Lithium salt of substituted imide (generic).
CFR citation: 40 CFR 721.10734.PMN Number P-13-270 Chemical name: Aromatic dibenzoate (generic).
CFR citation: 40 CFR 721.10735.PMN Number P-13-309 Chemical name: Alcohols, C9-11-branched, ethoxylated propoxylated.
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).
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.
CFR citation: 40 CFR 721.10738.PMN Number P-13-465 Chemical name: Caprolactone homopolymer of substituted benzotriazole (generic).
CFR citation: 40 CFR 721.10739.PMN Number P-13-473 Chemical name: Tin(2+) salt of alkylcarboxylic acid (generic).
CFR citation: 40 CFR 721.10740.PMN Number P-13-563 Chemical name: Propylene glycol, alpha isocyanate, omega silane (generic).
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).
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 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).
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).
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.
CFR citation: 40 CFR 721.10745.PMN Number P-13-753 Chemical name: Isocyanate terminated urethane polymer (generic).
CFR citation: 40 CFR 721.10746.PMN Number P-13-773 Chemical name: 4-Pyrimidianamine, 2,5 dimethoxy-.
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).
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 may result in significant adverse environmental effects. Based on this information, the PMN substances meets the concern criteria at § 721.170(b)(4)(ii).
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).
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).
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).
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 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).
CFR citation: 40 CFR 721.10754.PMN Number: P-14-42 Chemical name: Substituted perfluoroether (generic).
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 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 RuleA. RationaleDuring 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. ObjectivesEPA 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 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 . VI. Direct Final ProceduresEPA 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.
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 DesignationTo 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.
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 InformationEPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are:
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. 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 and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at or SourceOECD at . 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.
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 SubmissionsAccording to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and § 721.25. E-PMN software is available electronically at . XI. Economic AnalysisEPA 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 ReviewsA. Executive Order 12866This 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. 553(b)(3)(B)) to amend this table without further notice and comment.
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. 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. 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. 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. 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. 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 ActPursuant 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).
* * * * * Significant New Uses of Chemical Substances * * * * * 721.107252070-0012
721.107262070-0012
721.107272070-0012
721.107282070-0012
721.107292070-0012
721.107302070-0012
721.107312070-0012
721.107322070-0012
721.107332070-0012
721.107342070-0012
721.107352070-0012
721.107362070-0012
721.107372070-0012
721.107382070-0012
721.107392070-0012
721.107402070-0012
721.107412070-0012
721.107422070-0012
721.107432070-0012
721.107442070-0012
721.107452070-0012
721.107462070-0012
721.107472070-0012
721.107482070-0012
721.107492070-0012
721.107502070-0012
721.107512070-0012
721.107522070-0012
721.107532070-0012
721.107542070-0012
721.107642070-0012
* * * * * Part 721 Amended
§ 721.10725 Alcohol propoxylate (generic).
§ 721.10726 Alcohol propoxylate sulfate salt (generic).
§ 721.10727 Amphoteric fluorinated surfactant (generic).
§ 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).
§ 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).
§ 721.10730 Tires, wastes, pyrolyzed, C6-39 oil fraction.
§ 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:
§ 721.10732 Neodymium, butadiene iso-Bu neodecanoate complexes.
§ 721.10733 Tires, wastes, pyrolyzed, C5-15 condensate oil fraction.
§ 721.10734 Lithium salt of substituted imide (generic).
§ 721.10735 Aromatic dibenzoate (generic).
§ 721.10736 Alcohols, C9-11-branched, ethoxylated propoxylated.
§ 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).
§ 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.
§ 721.10739 Caprolactone homopolymer of substituted benzotriazole (generic).
§ 721.10740 Tin(2+) salt of alkylcarboxylic acid (generic).
§ 721.10741 Polyalkylene glycol, alpha isocyanate, omega silane (generic).
§ 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).
§ 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).
§ 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).
§ 721.10745 Alkoxylated quaternary alkyl ammonium fluoroalkylsulfonimide (generic).
§ 721.10746 Isocyanate terminated urethane polymer (generic).
§ 721.10747 4-Pyrimidianamine, 2,5 dimethoxy-.
(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 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):
(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.
§ 721.10748 Dicarbomonocycle-substituted carbomonocycledicarboxamide (generic).
§ 721.10749 Dicarboheterocycle-substituted carbomonocycledicarboxamide (generic).
§ 721.10750 Tricarbomonocycle-substituted carbomonocycletricarboxamide (generic).
§ 721.10751 Cycloalkylamino oleyl alkylamide acid salts (generic).
§ 721.10752 Cycloalkylamino cocoalkyl alkylamide acid salts (generic).
§ 721.10753 Methanamine, N,N-dimethyl-, reaction products with alkylamine-epichlorohydrin polymer, chlorides (generic).
§ 721.10754 Mixture of alkylated benzene, brominated (generic) and alkylated benzene, dibrominated (generic).
§ 721.10764 Substituted perfluoroether (generic)
(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
Attachments View All (0) View document: No documents available. Attachments View All (0) Comment Now! Comment Period Closed Aug 8 2014, at 11:59 PM ET ID: EPA-HQ-OPPT-2014-0166-0001 Tracking Number: View original printed format: Document Information Date Posted: Jul 9, 2014RIN: 2070-AB27CFR: 40 CFR Parts 9 and 721Federal Register Number: 2014-15774 Show More Details Submitter Information Comments4 Comments Received* See attached file(s) View Comment See attached file(s) View Comment See attached file(s) View Comment Docket Information This document is contained in EPA-HQ-OPPT-2014-0166 Related Dockets: EPA-HQ-OPPT-2013-0739EPA-HQ-OPPT-2014-0277EPA-HQ-OPPT-2014-0760Related RINs: NoneRelated Documents: Significant New Use Rules: Certain Chemical Substances... Related Comments: View all * This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document. Document text and images courtesy of the Federal Register Home Search Advanced Search Browse By Category Learn About Us eRulemaking Program Media Toolkit Agencies Awards & Recognition Enhancements & Fixes Resources Site Data Regulatory Agenda Agency Reports Required by Statute API Overview Developers Help How to use Regulations.gov FAQs Glossary Connect With Contact Us Privacy and Security Notice User Notice Accessibility Statement Partner Sites We the People Federal Register Reginfo Congress.gov USA.gov E-Gov Opengov Participate Today!