Source: https://www.regulations.gov/?_escaped_fragment_=documentDetail;D=EPA-HQ-OPPT-2013-0399-0001
Timestamp: 2016-09-27 10:28:25
Document Index: 332134152

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[EPA-HQ-OPPT-2013-0399; FRL-9393-4]
SummaryEPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 53 chemical substances which were the subject of premanufacture notices (PMNs). Seven of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture or process any of these 53 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 October 7, 2013. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on August 21, 2013.
AddressesSubmit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2013-0399, by one of the following methods: Federal eRulemaking Portal: Follow the online instructions for submitting comments.
Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN: Docket ID Number EPA-HQ-OPPT-2013-0399. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2013-0399. EPA's policy is that all comments received will be included in the docket without change and may be made available at , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.
For Further Information Contact For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: . 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 § 14;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 § 14;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 53 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 53 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance: PMN number.
CFR citation assigned in the regulatory text section of this rule.This rule includes PMN substances, P-09-198 and P-09-199, whose reported chemical names include the term “carbon nanotube” or “CNT”. Because of a lack of established nomenclature for carbon nanotubes, the TSCA Inventory names for carbon nanotubes are currently in generic form, e.g., carbon nanotube (CNT), multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT). EPA uses the specific structural characteristics provided by the PMN submitter to more specifically characterize the Inventory listing for an individual CNT. All submitters of new chemical notices for CNTs in this SNUR have claimed those specific structural characteristics as CBI. EPA is publishing the generic chemical name along with the PMN number to identify that a distinct chemical substance was the subject of the PMN without revealing the confidential chemical identity of the PMN substance. Confidentiality claims preclude a more detailed description of the identity of these CNTs. If an intended manufacturer or processor of CNTs is unsure of whether its CNTs are subject to this SNUR or any other SNUR, the company can either contact EPA or obtain a written determination from EPA pursuant to the bona fide procedures at § 721.11. EPA is using the specific structural characteristics, for all CNTs submitted as new chemical substances under TSCA, to help develop standard nomenclature for placing these chemical substances on the TSCA Inventory. EPA has compiled a generic list of those structural characteristics entitled “Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature.” A copy of this list is available in the docket for these SNURs under docket ID number EPA-HQ-OPPT-2013-0399. If EPA develops a more specific generic chemical name for these materials, that name will be made publicly available.
This rule also includes SNURs on 46 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 “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 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-09-198 and P-09-199 Chemical names: Multi-walled carbon nanotubes (generic).
CFR citation: 40 CFR 721.10671.PMN Numbers P-09-447 and P-09-448 Chemical name: Sodium olefin sulfonate derivative (generic).
Recommended testing: EPA has determined that a daphnid chronic toxicity test (OPPTS Test Guidelines 850.1300) and a fish early life stage toxicity test (OPPTS Test Guidelines 850.1400) on either P-09-447 or P-09-448, would help characterize the environmental effects of the PMN substances. 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 721.10672.PMN Numbers P-12-539, P-13-107, and P-13-109 Chemical names: Alkanes, C21-34—branched and linear, chloro (P-12-539), Alkanes, C22-30—branched and linear, chloro (P-13-107); and Alkanes, C24-28, chloro (P-13-109).
CFR citations: 40 CFR 721.10673 (P-12-539); 40 CFR 721.10674 (P-13-107); and 40 CFR 721.10675 (P-13-109).PMN Number P-12-551 Chemical name: Aromatic hydrocarbon mixture (generic).
CFR citation: 40 CFR 721.10676.PMN Number P-12-584 Chemical name: Alkyl phosphonate (generic).
Recommended testing: EPA has determined that the results of a combined repeated dose toxicity with the reproduction/development toxicity screening test (OPPTS Test Guideline 870.3650); an algal toxicity test (OCSPP Test Guideline 850.4500); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075) would help characterize the human health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10677.PMN Number P-13-10 Chemical name: 1,4-Cyclohexanedicarboxylic acid, 1,4-dimethyl ester, hydrogenolysis products.
CFR citation: 40 CFR 721.10678.PMN Number P-13-30 Chemical name: Carboxylic acid, substituted alkylstannylene ester, reaction products with inorganic acid tetra alkyl ester (generic).
CFR citation: 40 CFR 721.10679.PMN Numbers P-13-44, P-13-46, P-13-47, P-13-50, and P-13-51 Chemical names: Fatty acid amides (generic).
Basis for action: The PMNs state that the use of the substances will be as adhesive promoters for asphalt applications and emulsifiers for asphalt applications. Based on the EcoSAR analysis of test data on analogous aliphatic amines and amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances respectively 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 PMN substances to surface waters exceed releases from the uses described in the PMNs. For the use described in the PMNs, environmental releases did not exceed the respective concentrations of concern 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 substances other than as an adhesive promoter for asphalt applications or as emulsifiers for asphalt applications, as described in the PMNs, could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed. Testing may be performed on any one of the PMN substances (P-13-44, P-13-46, P-13-47, P-13-50, or P-13-51).
CFR citation: 40 CFR 721.10680.PMN Numbers P-13-55 and P-13-56 Chemical names: Alkaneamide, halo-dialkylthienyl-alkoxydialkyl-, manuf. of by-products from (generic).
CFR citation: 40 CFR 721.10681.PMN Numbers P-13-63, P-13-64, P-13-65, P-13-69, P-13-70, P-13-71, P-13-72, P-13-73, P-13-74, P-13-75, P-13-76, and P-13-77 Chemical names: Fatty acid amide hydrochlorides (generic).
Basis for action: The PMNs state that the substances will be used as surfactants for asphalt emulsions. Based on the EcoSAR analysis of test data on analogous aliphatic amines and amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb (for P-13-63 P-13-64, P-13-65, P-13-69, P-13-70, P-13-71 P-13-72, P-13-73, and P-13-74) and 2 ppb (for P-13-75, P-13-76, and P-13-77) of the PMN substances respectively 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 PMN substances to surface water exceed releases from the use described in the PMNs. For the use described in the PMNs, environmental releases did not exceed the respective concentrations of concern 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 substances other than as surfactants for use in asphalt emulsions, as described in the PMNs, could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.10682.PMN Number P-13-131 Chemical name: Dialkylamino cocoalkyl alkylamide acid salt (generic).
CFR citation: 40 CFR 721.10683.PMN Number P-13-135 Chemical name: Substituted benzenamine schiff base (generic).
CFR citation: 40 CFR 721.10684.PMN Number P-13-170 Chemical name: Phosphoric acid, mixed esters (generic).
CFR citation: 40 CFR 721.10685.PMN Numbers P-13-180, P-13-181, P-13-182, P-13-183, P-13-184, and P-13-185 Chemical names: Fatty acid amides (generic).
Basis for action: The PMNs state that the use of the substances is as adhesive promoters for asphalt applications and emulsifiers for asphalt applications. Based on the EcoSAR analysis of test data on analogous aliphatic amines and amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb (for P-13-180, P-13-182, and P-13-185); 2 ppb (for P-13-181 and P-13-183); and 4 ppb (for P-13-184) of the PMN substances in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early-life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substances to surface water exceed releases from the use described in the PMNs. For the use described in the PMNs, environmental releases did not exceed the respective concentrations of concern 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 substances other than as adhesive promoters for asphalt applications or emulsifiers for asphalt applications, as described in the PMNs, could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.10686.PMN Numbers P-13-201, P-13-203, P-13-204, P-13-205, P-13-206, P-13-207, P-13-208, and P-13-209 Chemical names: Fatty acid amide hydrochlorides (generic).
CFR citation: 40 CFR 721.10687.PMN Number P-13-221 Chemical name: Copper, chloro[tris(2-chloroethyl) phosphite-.kappa.P]-.
CFR citation: 40 CFR 721.10688.PMN Number P-13-225 Chemical name: Organo zinc salts (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the substance is as a stabilizer for thermoplastics. Based on the EcoSAR analysis of test data on analogous organic zinc compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 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 3 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 3 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 daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10689.PMN Number P-13-232 Chemical name: Benzenedicarboxylic acid, polymer with substituted alkanediol, dodecanedioic acid, 1,2-ethanediol, alkanedioic acid, alkanediol,.alpha.-hydro-.omega.-hydroxypoly[oxyalkanediyl], 1,3-isobenzofurandione, methylene diphenyl diisocyanate, 2-oxepanone, 2,2'-oxybis[ethanol] and polymethylene polyphenylene isocyanate (generic).
CFR citation: 40 CFR 721.10690.PMN Number P-13-267 Chemical name: Fatty acid amide (generic).
Basis for action: The PMN states that the use of the substance is as a polymer additive. Based on the EcoSAR analysis of test data on analogous 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 PMN 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)(ii). Recommended testing: EPA has determined that an algal toxicity test (OCSPP Test Guideline 850.4500), a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and the shake flask die-away test (OPPTS Test Guideline 835.3170) would help characterize the environmental effects of the PMN substance. EPA recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10691.PMN Number P-13-288 Chemical name: Fluorinated alkyl dianiline (generic).
CFR citation: 40 CFR 721.10692.PMN Number P-13-338 Chemical name: Diphenylmethane diisocyanate polymer with alkanoic diacid and alkanediol (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a polymer intermediate for adhesive manufacture. Based on analogous diisocyanates, EPA identified concerns for dermal and respiratory sensitization, irritation, and lung effects. For the use described in the PMN, EPA does not expect significant occupational or consumer inhalation exposure as the substance is not applied using a method that generates a vapor, mist, or aerosol or used in a consumer product. 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 in consumer products or any use of the substance involving an application method that generates a vapor, mist, or aerosol may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii). Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10693.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 7 of the 53 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 § 14;721.160 (see Unit VI.).
In the other 46 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 § 14;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 October 7, 2013 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before September 6, 2013.
Therefore EPA designates August 7, 2013 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 § 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-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 at least 14 weeks (earlier TSCA section 5(e) consent orders required submissions at least 12 weeks) before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend 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 § 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 §§ 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-2013-0399.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).XIII. 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 * * * * * 721.106712070-0012
721.106722070-0012
721.106732070-0012
721.106742070-0012
721.106752070-0012
721.106762070-0012
721.106772070-0012
721.106782070-0012
721.106792070-0012
721.106802070-0012
721.106812070-0012
721.106822070-0012
721.106832070-0012
721.106842070-0012
721.106852070-0012
721.106862070-0012
721.106872070-0012
721.106882070-0012
721.106892070-0012
721.106902070-0012
721.106912070-0012
721.106922070-0012
721.106932070-0012
§ 721.10671 Multi-walled carbon nanotubes (generic).
§ 721.10672 Sodium olefin sulfonate derivative (generic).
§ 721.10673 Alkanes, C21-34—branched and linear, chloro.
§ 721.10674 Alkanes, C22-30—branched and linear, chloro.
§ 721.10675 Alkanes, C24-28, chloro.
§ 721.10676 Aromatic hydrocarbon mixture (generic).
§ 721.10677 Alkyl phosphonate (generic).
§ 721.10678 1,4-Cyclohexanedicarboxylic acid, 1,4-dimethyl ester, hydrogenolysis products.
§ 721.10679 Carboxylic acid, substituted alkylstannylene ester, reaction products with inorganic acid tetra alkyl ester (generic).
§ 721.10680 Fatty acid amides (generic).
§ 721.10681 Alkaneamide, halo-dialkylthienyl-alkoxydialkyl-, manuf. of by-products from (generic).
§ 721.10682 Fatty acid amide hydrochlorides (generic).
§ 721.10683 Dialkylamino cocoalkyl alkylamide acid salt (generic).
§ 721.10684 Substituted benzenamine schiff base (generic).
§ 721.10685 Phosphoric acid, mixed esters (generic).
§ 721.10686 Fatty acid amides (generic).
§ 721.10687 Fatty acid amide hydrochlorides (generic).
§ 721.10688 Copper, chloro[tris(2-chloroethyl) phosphite-.kappa.P]-.
§ 721.10689 Organo zinc salts (generic).
§ 721.10690 Benzenedicarboxylic acid, polymer with substituted alkanediol, dodecanedioic acid, 1,2-ethanediol, alkanedioic acid, alkanediol,.alpha.-hydro-.omega.-hydroxypoly[oxyalkanediyl], 1,3-isobenzofurandione, methylene diphenyl diisocyanate, 2-oxepanone, 2,2'-oxybis[ethanol] and polymethylene polyphenylene isocyanate (generic).
§ 721.10691 Fatty acid amide (generic).
§ 721.10692 Fluorinated alkyl dianiline (generic).
§ 721.10693 Diphenylmethane diisocyanate polymer with alkanoic diacid and alkanediol (generic).
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.[FR Doc. 2013-18982 Filed 8-6-13; 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 Sep 6 2013, at 11:59 PM ET ID: EPA-HQ-OPPT-2013-0399-0001 Tracking Number: View original printed format: Document Information Date Posted: Aug 7, 2013RIN: Not AssignedCFR: 40 CFR Parts 9 and 721Federal Register Number: 2013-18982 Show More Details Submitter Information Comments1 Comments Received* See attached letter from the Chlorinated Paraffins Industry Association (CPIA) indicating an intent to submit adverse comments on select substances in SNUR. View Comment Docket Information This document is contained in EPA-HQ-OPPT-2013-0399 Related Dockets: NoneRelated RINs: NoneRelated Documents: Significant New Use Rule on Certain Chemical SubstancesSignificant New Use Rules: Certain Chemical SubstancesSignificant New Uses; Removals: 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!