Source: http://www.regulations.gov/?_escaped_fragment_=documentDetail;D=EPA-HQ-OPPT-2013-0100-0001
Timestamp: 2016-02-12 12:11:09
Document Index: 350362773

Matched Legal Cases: ['art 707', '§ 721', 'art 707', 'art 2', '§ 721', 'art 721', 'art 700', '§ 721', 'art 720', 'art 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', 'art 9', 'art 9', 'art 1320', 'art 9', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', 'arts 9']

[EPA-HQ-OPPT-2013-0100 FRL-9384-8]
SummaryEPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 15 chemical substances which were the subject of premanufacture notices (PMNs). This action requires persons who intend to manufacture, import, or process any of these 15 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 July 8, 2013. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on May 23, 2013.
Written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs must be received on or before June 10, 2013 (see Unit VI. of theSUPPLEMENTARY INFORMATION).
AddressesSubmit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2013-0100, by one of the following methods:
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-2013-0100. 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-2013-0100. EPA's policy is that all comments received will be included in the docket without change and may be made available online at http://www.regulations.gov, 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: 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 InformationI. General InformationA. Does this action apply to me?You may be potentially affected by this action if you manufacture, import, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: Manufacturers, importers, 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 this rule on or after June 10, 2013 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, import, 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 theFederal Registerissue 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, import, 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 sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 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 sections 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 theFederal Registerits 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 15 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 15 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 a PMN substance whose reported chemical name includes 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 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, importer, 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-2013-0100. If EPA develops a more specific generic chemical name for these materials, that name will be made publicly available.
None of the 15 PMN substances included in this rule are 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-5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-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 Number P-11-60 Chemical name: Methylenebis[isocyanatobenzene], polymer with alkanedoic acid, alkylene glycols, alkoxylated alkanepolyol and substituted trialkoxysilane (generic).
CFR citation: 40 CFR 721.10661.PMN Number P-11-204 Chemical name: Acetaldehyde, substituted-, reaction products with 2-butyne-1, 4-diol (generic).
Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400), a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), and an algal toxicity test (OCSPP Test Guideline 850.4500), would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10662.PMN Number P-12-44 Chemical name: Functionalized multi-walled carbon nanotubes (generic).
CFR citation: 40 CFR 721.10663.PMN Numbers P-12-408, P-12-409, P-12-410, P-12-411, P-12-412, and P-12-413 Chemical name: Alkenedioic acid dialkyl ester, reaction products with alkenoic acid alkyl esters and diamine (generic).
CFR citation: 40 CFR 721.10664.PMN Number P-12-414 Chemical name: 2-Propenoic acid, (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl ester.
CFR citation: 40 CFR 721.10665.PMN Number P-12-437 Chemical name: Quaternary ammonium compounds, bis(fattyalkyl) dimethyl, salts with tannins (generic).
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 ofthe substance other than as described in the PMN or resulting in surface water concentrations exceeding 11 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.10666.PMN Number P-12-560 Chemical name: Slimes and sludges, aluminum and iron casting, wastewater treatment, solid waste.
CFR citation: 40 CFR 721.10667.PMN Number P-13-18 Chemical name: Trisodium diethylene triaminepolycarboxylate (generic).
CFR citation: 40 CFR 721.10668.PMN Number P-13-78 Chemical name: Tertiary amine alkyl ether (generic).
CFR citation: 40 CFR 721.10669.PMN Number P-13-108 Chemical name: Bromine, manufacture of, by-products from, distillation residues.
Basis for action: The PMN states that the use of the substance is as feed for bromine recovery. EPA identified health and environmental concerns because the substance may be a persistent, bio-accumulative, and toxic (PBT) chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemical Program's PBT category (64 FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates that the substance will persist in the environment for more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Also, based on test data on analogous bromobenzene and derivatives and brominated organic compounds, EPA identified concerns for liver toxicity, reproductive toxicity, developmental toxicity, mutagenicity, neurotoxicity, oncogenicity, and endocrine disruption. Further, based on EcoSAR analysis of test data on analogous neutral organic substances, EPA predicts toxicity toaquatic organisms may occur at concentrations that exceed 1 ppb of the substance in surface waters. As described in the PMN, significant worker exposures are not expected and the substance is not released to surface waters. 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 releases may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
CFR citation: 40 CFR 721.10670.V. Rationale and Objectives of the RuleA. RationaleIn these 15 cases, 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, import, or process a listed chemical substance for the described significant new use before that activity begins.
EPA will be able to regulate prospective manufacturers, importers, 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.Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html. VI. Direct Final 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 July 8, 2013 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before June 10, 2013.
Therefore EPA designates May 9, 2013 as the cutoff date for determining whether the new use is ongoing. Persons who begin commercial manufacture, import, 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 theFederal Registerdocument of April 24, 1990 (55 FR 17376) 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:
1. Development of test data is required where the chemical substancesubject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)).
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. Unit IV. lists recommended testing for these non-5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The OECD test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. When physical/chemical properties of test material and/or material characterization tests are recommended for nanoscale substances that are the subject of this rule, you should take into consideration the characterizations identified in the Guidance Manual for the Testing of Manufactured Nanomaterials: OECD's Sponsorship Programme, which is available at http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2009)20/rev&doclanguage=en. 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.
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, import, 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 http://www.epa.gov/opptintr/newchems. XI. Economic AnalysisEPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, 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-2013-0100.XII. Statutory and Executive Order ReviewsA. Executive Order 12866This rule establishes SNURs for several new chemical substances that were the subject of PMNs. 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 theFederal 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. Asa 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.
List of Subjects 40 CFR Part 9 Environmental protection, Reporting and recordkeeping requirements.
***** Significant New Uses of Chemical Substances ***** 721.106612070-0012.
721.106622070-0012.
721.106632070-0012.
721.106642070-0012.
721.106652070-0012.
721.106662070-0012.
721.106672070-0012.
721.106682070-0012.
721.106692070-0012.
721.106702070-0012.
4. Add § 721.10661 to subpart E to read as follows:
5. Add § 721.10662 to subpart E to read as follows:
6. Add § 721.10663 to subpart E to read as follows:
7. Add § 721.10664 to subpart E to read as follows:
8. Add § 721.10665 to subpart E to read as follows:
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (reactive intermediate for use in ultraviolet (UV), electron beam (EB), and conventionally cured coating and ink formulations) and (s) (50,000 kilograms).
9. Add § 721.10666 to subpart E to read as follows:
10. Add § 721.10667 to subpart E to read as follows:
11. Add § 721.10668 to subpart E to read as follows:
12. Add § 721.10669 to subpart E to read as follows:
13. Add § 721.10670 to subpart E to read as follows:
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.[FR Doc. 2013-11061 Filed 5-8-13; 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 Jun 10 2013, at 11:59 PM ET ID: EPA-HQ-OPPT-2013-0100-0001 Tracking Number: View original printed format: Document Information Date Posted: May 9, 2013RIN: Not AssignedCFR: 40 CFR Parts 9 and 721Federal Register Number: 2013-11061 Show More Details Submitter Information Comments0 Comments Received* Docket Information This document is contained in EPA-HQ-OPPT-2013-0100 Related Dockets: NoneRelated RINs: NoneRelated Documents: None 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!