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Rule

Significant New Use Rules on Certain Chemical Substances

Action

Direct Final Rule.

Summary

EPA 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.

Unified Agenda

Significant New Use Rule (SNUR); Chemical-Specific SNURs To Extend Provisions of Section 5(e) Orders

26 actions from June 6th, 1994 to July 2011

  • June 6th, 1994
    • NPRM: Aromatic Amino Ether (P90-1840)
    • 59 FR 29255
  • December 19th, 1994
    • NPRM: Alkenyl Ether of Alkanetriol Polymer (93-458)
    • 59 FR 65289
  • June 26th, 1997
    • NPRM: Certain Chemical Substances (91-1299/95-1667 91-1298 91-1297)
  • June 9th, 2008
    • NPRM; Certain Chemical Substances -- (P01-759, P05-555, P07-283)
  • November 5th, 2008
    • Direct Final Action: Certain Chemical Substances, Batch FY08-1
  • June 24th, 2009
    • Direct Final Action, Certain Chemical Substances, Batch FY09-1
  • July 8th, 2009
    • Final; Certain Chemical Substances -- (P01-759, P05-555, P07-283)
  • September 18th, 2009
    • Direct Final Action: Certain Chemical Substances, Batch FY09-2
  • November 6th, 2009
  • December 31st, 2009
  • February 1st, 2010
  • February 3rd, 2010
  • June 24th, 2010
  • July 28th, 2010
    • NPRM; Carbon Nanotubes; Reopening Comment Period
  • September 17th, 2010
  • September 20th, 2010
  • May 6th, 2011
  • May 11th, 2011
  • May 13th, 2011
  • June 2011
    • Direct Final Action Batch FY11-01
  • June 2011
    • NPRM Batch 11-1
  • June 2011
    • NPRM: Biotech SNUR (J-10-02)
  • June 2011
    • NPRM: Modification of 721.9719 (P95-1098)
  • July 2011
    • Final: Alkenyl Ether of Alkanetriol Polymer (93-458)
  • July 2011
    • Final: Aromatic Amino Ether (P90-1840)
  • July 2011
    • Final: Certain Chemical Substances (91-1299/95-1667 91-1298 91-1297)
 

Table of Contents Back to Top

DATES: Back to Top

This 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 the SUPPLEMENTARY INFORMATION).

For additional information on related reporting requirement dates, see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Back to Top

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2013-0100, by one of the following methods:

  • Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments.
  • Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
  • Hand Delivery: 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.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: Back to Top

For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: moss.kenneth@epa.gov.

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: Back to Top

I. General Information Back to Top

A. 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.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. Background Back to Top

A. What action is the agency taking?

EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture, 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 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, import, or process the chemical substance for that use. Persons who must report are described in § 721.5.

C. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 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 the Federal Register its reasons for not taking action.

III. Significant New Use Determination Back to Top

Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

  • The projected volume of manufacturing and processing of a chemical substance.
  • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
  • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
  • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.

To determine what would constitute a significant new use for the 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 Rule Back to Top

EPA 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.
  • Chemical name (generic name, if the specific name is claimed as CBI).
  • Chemical Abstracts Service (CAS) number (if assigned for non-confidential chemical identities).
  • Basis for the SNUR.
  • Toxicity concerns.
  • Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information).
  • CFR citation assigned in the regulatory text section of this rule.

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.

The regulatory text section of this rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e., limits on manufacture and importation volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.

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).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance is as an adhesive system component. Based on structural activity relationship (SAR) analysis of test data on analogous diisocyanates, EPA identified concerns for dermal and respiratory sensitization and for pulmonary toxicity to workers exposed to free isocyanates. Also, based on ecological structural activity relationship (EcoSAR) analysis on analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 61 parts per billion (ppb) of the PMN substance in surface waters. As described in the PMN, significant worker exposure or 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 other than as described in the PMN (manufacture with all isocyanate groups reacted within the polymer), or any use of the substance resulting in surface water concentrations exceeding 61 ppb could result in exposures which may cause serious health effects or significant adverse environmental effects.

Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a water solubility: Column elution method; shake flask method test (OPPTS 830.7840), an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010), a fish acute toxicity test, freshwater and marine test (OPPTS Test Guideline 850.1075), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10661.

PMN Number P-11-204

Chemical name: Acetaldehyde, substituted-, reaction products with 2-butyne-1, 4-diol (generic).

CAS number: Not available.

Basis for action: The PMN states that the use of the substance is as a brightener for nickel electroplating. Based on EcoSAR analysis of test data on analogous halo alcohols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 ppb of the substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 7 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed processing or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (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).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance is as an additive for rubber and batteries. Based on available information on analogous chemical substances, EPA identified concerns for lung effects to workers exposed to the PMN substance. As described in the PMN, no significant inhalation exposures are expected to workers due to the manufacturing, processing, and use processes described in the PMN and the use of adequate personal protective equipment. EPA expects that some fraction of the carbon nanotubes, if released into the environment, will eventually become suspended in water. Sublethal effects have been observed for carbon nanotubes in fish at levels as low as 100 ppb. Observed effects included respiratory stress, ventilation rate, gill mucus secretion, gill damage, and aggressive behavior. As described in the PMN, no environmental exposures are expected, because the PMN substance is not released to surface water. 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 other than as described in the PMN; manufacturing, processing, or use in a powder form; or any use of the substance resulting in surface water releases may cause serious health effects or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of the following tests would help characterize the health and environmental effects of the PMN substance: (1) A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a post-exposure observation period of up to 3 months, bronchoalveolar lavage fluid (BALF) analysis, particle size distribution information and other toxicologically relevant properties, data on histopathology of pulmonary and ex-pulmonary organs/tissues (cardiovascular, central nervous system, liver, kidney, etc.), pulmonary deposition (lung burden), clearance half-life (biopersistence) and translocation of the test material, and a determination of cardiovascular toxicity; (2) analysis by Scanning Transmission Electron Microscopy (STEM), Transmission Electron Microscopy (TEM), or Scanning Electron Microscopy (SEM) of number of walls (range and average), tube ends (open, capped, circular, other), tube width/diameter (measure inner and outer diameters or range), tube length (range) including a description of any deformities found in the tubes (bumps, branching, gaps, etc.); (3) percent (range) of functional groups found on the tubes (include the method of determination); and (4) particle size determined by count not by weight or volume (preferably using STEM).

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).

CAS numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of these substances are as binders. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb for the aggregate of the PMN substances in surface waters. As described in the PMNs, releases to surface waters are not expected. 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 resulting in surface water concentrations exceeding 1 ppb for the aggregate of the PMN substances 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 an aquatic invertebrate acute toxicity test (OPPTS Test Guideline 850.1010), fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. The tests should be conducted on either the P-12-411 or P-12-413 substance.

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.

CAS number: 69701-99-1.

Basis for action: The PMN states that the use of the substance is as a reactive intermediate for use in ultraviolet (UV), electron beam (EB) and conventionally cured coating and ink formulations. Based on test data submitted on the PMN substance and EcoSAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 26 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 26 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN or any increase of the annual production volume of 50,000 kilograms could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early life-stage toxicity test (OPPTS Test Guidelines 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10665.

PMN Number P-12-437

Chemical name: Quaternary ammonium compounds, bis(fattyalkyl) dimethyl, salts with tannins (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance is as a component in drilling fluid. Based on EcoSAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 11 ppb of the PMN substance in surface waters. As described in the PMN, releases of the 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 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).

Recommended testing: EPA has determined that the results of an activated sludge sorption isotherm test (OPPTS Test Guideline 835.1110), a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075), a fish acute toxicity test mitigated by humic acid (OPPTS Test Guidelines 850.1085), an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the fate and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10666.

PMN Number P-12-560

Chemical name: Slimes and sludges, aluminum and iron casting, wastewater treatment, solid waste.

CAS number: 1391739-82-4.

Chemical substance definition: The waste solids produced from the treatment of wastewaters during aluminum and iron casting, machining and finishing operations. It may contain aluminum, barium, chromium, copper, iron, lead, manganese, nickel, and zinc.

Basis for action: The PMN states that the use of the substance is as a feedstock to provide mineral content for cement manufacturing. Based on test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung effects from lung overload associated with inhalation of the PMN substance when in powder form. EPA also identified concerns for neurotoxicity, immunotoxicity, and blood effects from any lead that is bioavailable; respiratory sensitization and immunotoxicity from any nickel, lead, aluminum, copper, and iron that is bioavailable; and digestive system effects from any copper that reaches the gastrointestinal tract. These concerns are for effects to workers from inhalation exposure to the PMN substance. For the uses described in the PMN, significant inhalation worker exposure is not expected as the PMN substance is not manufactured, processed, or used in powder form. 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 the manufacture, processing, or use of the substance in powder form may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with 60-day holding period would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10667.

PMN Number P-13-18

Chemical name: Trisodium diethylene triaminepolycarboxylate (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance is as a stabilizing agent for polymers. Based on the PMN substance's chelating potential of calcium, magnesium, iron, and other divalent cations and test data on analogous chemical substances such as pentacarboxylic acid chelators (TSCA section 8(e) submission # 10980, CAS No. 140-01-2), ethylenediamine tetramethylene phosphonic acid, ethylene diamine tetramethylene phosphonic acid (EDTMPA), ethylenediaminetetraacetic acid (EDTA), and nitrilotriacetic acid (NTA), EPA identified concerns for blood toxicity, effects on the heart, inhibited muscle functioning, bone toxicity, bone cancer, developmental toxicity, and kidney toxicity. These concerns are for effects to workers from inhalation exposure to the PMN. EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, use of the substance other than as described in the PMN may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(c), (b)(3)(i), and (b)(3)(ii).

Recommended testing: EPA has determined that a 90-day oral toxicity in rodents test (OPPTS Test Guideline 870.3100) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10668.

PMN Number P-13-78

Chemical name: Tertiary amine alkyl ether (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a catalyst for producing polyurethane foam. Based on test data on analogous chemical substances, EPA identified concerns for acute toxicity, irritation/corrosion to all exposed tissues, kidney toxicity, liver toxicity, effects to the adrenal system, and male reproductive toxicity to workers and the general population exposed to the PMN substance. For the use described in the PMN, significant worker and general population exposure is 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 use of the PMN substance other than for the use described in the PMN may result in 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 combined repeated dose toxicity with the reproduction/development toxicity screening test (OPPTS Test Guideline 870.3650) would help characterize the health effects of the PMN substance.

CFR citation: 40 CFR 721.10669.

PMN Number P-13-108

Chemical name: Bromine, manufacture of, by-products from, distillation residues.

CAS number: Not available.

Chemical substance definition: The complex residuum obtained during the production of bromine using brine and waste streams from the production of halogenated hydrocarbons. It consists predominantly of halogenated hydrocarbons and ketones, having carbon numbers predominantly in the range of C3-C17. The boiling point is approximately 98°C to 350°C (208 °F to 662 °F).

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 to aquatic 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).

Recommended testing: EPA has determined that the results of the following tests would help characterize the health and environmental effects of the PMN substance:

(1) Modified semi-continuous activated sludge (SCAS) with analysis for degradation products (OPPTS Test Guideline 835.5045, or Organisation for Economic Co-operation and Development (OECD) Test Guideline 302A); (2) direct photolysis (OPPTS Test Guideline 835.2210), if wavelengths greater than 290 nano meters (nm) are absorbed, determined using OPPTS Test Guideline 830.7050; (3) indirect photolysis (OPPTS Test Guideline 835.5270); (4) hydrolysis as a function of pH and temperature (OPPTS Test Guideline 835.2130 or OECD Test Guideline 111); (5) aerobic and anaerobic transformation in soil (OECD Test Guideline 307); (6) phototransformation on soil surfaces (Draft OECD Jan. 2002); (7) aerobic and anaerobic transformation in aquatic sediment systems (OECD Test Guideline 308); (8) fish BCF (OECD Test Guideline 305) or earthworm bioaccumulation (OECD Test Guideline 317); (9) combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD Test Guideline 422); (10) fish early life-stage toxicity test (OPPTS Test Guideline 850.1400); (11) daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and (12) algal toxicity test (OCSPP Test Guideline 850.4500). EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10670.

V. Rationale and Objectives of the Rule Back to Top

A. Rationale

In 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. Objectives

EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

  • EPA will receive notice of any person's intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins.
  • EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for the described significant new use.
  • 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 Procedures Back to Top

EPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), the effective date of this rule is July 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.

If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before June 10, 2013, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.

This rule establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment.

VII. Applicability of the Significant New Use Designation Back to Top

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. The identities of 13 of the 15 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per § 720.25 and § 721.11). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

Therefore EPA designates May 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 the Federal Register document of April 24, 1990 (55 FR 17376) for a more detailed discussion of the cutoff date for ongoing uses.

VIII. Test Data and Other Information Back to Top

EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are:

1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)).

2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).

In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. 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.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

  • Human exposure and environmental release that may result from the significant new use of the chemical substances.
  • Potential benefits of the chemical substances.
  • Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

IX. Procedural Determinations Back to Top

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1).

Under these procedures a manufacturer, importer, or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer, importer, or processor must show that it has a bona fide intent to manufacture, import, or process the chemical substance and must identify the specific use for which it intends to manufacture, import, or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture, import, or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers, importers, and processors can combine the bona fide submission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture, 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 Submissions Back to Top

According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and § 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis Back to Top

EPA 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 Reviews Back to Top

A. Executive Order 12866

This 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 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.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true:

1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

2. The SNUR submitted by any small entity would not cost significantly more than $8,300.

A copy of that certification is available in the docket for this rule.

This rule is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:

  • A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
  • Submission of the SNUN would not cost any small entity significantly more than $8,300.

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

D. Unfunded Mandates Reform Act (UMRA)

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this rule. As such, EPA has determined that this rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).

F. Executive Order 13175

This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This rule does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this rule.

G. Executive Order 13045

This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

H. Executive Order 13211

This action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

XIII. Congressional Review Act Back to Top

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects Back to Top

Dated: May 2, 2013.

Maria J. Doa,

Director, Chemical Control Division, Office of Pollution Prevention and Toxics.

Therefore, 40 CFR parts 9 and 721 are amended as follows:

begin regulatory text

PART 9—[AMENDED] Back to Top

1.The authority citation for part 9 continues to read as follows:

Authority:

7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

2.In § 9.1, add the following sections in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:

§ 9.1 OMB approvals under the Paperwork Reduction Act.

* * * * *

40 CFR Citation OMB Control no.
*****  
Significant New Uses of Chemical Substances  
*****  
721.10661 2070-0012.
721.10662 2070-0012.
721.10663 2070-0012.
721.10664 2070-0012.
721.10665 2070-0012.
721.10666 2070-0012.
721.10667 2070-0012.
721.10668 2070-0012.
721.10669 2070-0012.
721.10670 2070-0012.
*****  

* * * * *

PART 721—[AMENDED] Back to Top

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

Authority:

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

4.Add § 721.10661 to subpart E to read as follows:

§ 721.10661 Methylenebis[isocyanatobenzene], polymer with alkanedoic acid, alkylene glycols, alkoxylated alkanepolyol and substituted trialkoxysilane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as methylenebis[isocyanatobenzene], polymer with alkanedoic acid, alkylene glycols, alkoxylated alkanepolyol and substituted trialkoxysilane (PMN P-11-60) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (manufacture with all isocyanate groups reacted within the polymer).

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 61).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

5.Add § 721.10662 to subpart E to read as follows:

§ 721.10662 Acetaldehyde, substituted-, reaction products with 2-butyne-1, 4-diol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acetaldehyde, substituted-, reaction products with 2-butyne-1, 4-diol (PMN P-11-204) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (brightener for nickel electroplating).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

6.Add § 721.10663 to subpart E to read as follows:

§ 721.10663 Functionalized multi-walled carbon nanotubes (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as functionalized multi-walled carbon nanotubes (PMN P-12-44) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j), (v)(1), (w)(1), and (x)(1).

(ii) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (d), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to this section.

7.Add § 721.10664 to subpart E to read as follows:

§ 721.10664 Alkenedioic acid dialkyl ester, reaction products with alkenoic acid alkyl esters and diamine (generic).

(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as alkenedioic acid dialkyl ester, reaction products with alkenoic acid alkyl esters and diamine (PMNs P-12-408, P-12-409, P-12-410, P-12-411, P-12-412, and P-12-413) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (where N = 1 parts per billion (ppb) for the aggregate of the PMN substances, P-12-408, P-12-409, P-12-410, P-12-411, P-12-412, and P-12-413).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

8.Add § 721.10665 to subpart E to read as follows:

§ 721.10665 2-Propenoic acid, (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl ester (PMN P-12-414; CAS No. 69701-99-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) 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).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

9.Add § 721.10666 to subpart E to read as follows:

§ 721.10666 Quaternary ammonium compounds, bis(fattyalkyl) dimethyl, salts with tannins (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as quaternary ammonium compounds, bis(fattyalkyl) dimethyl, salts with tannins (PMN P-12-437) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j).

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 11).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to this section.

10.Add § 721.10667 to subpart E to read as follows:

§ 721.10667 Slimes and sludges, aluminum and iron casting, wastewater treatment, solid waste.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as slimes and sludges, aluminum and iron casting, wastewater treatment, solid waste (PMN P-12-560; CAS No. 1391739-82-4; chemical substance definition: The waste solids produced from the treatment of wastewaters during aluminum and iron casting, machining and finishing operations. It may contain aluminum, barium, chromium, copper, iron, lead, manganese, nickel, and zinc.) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(v)(1), (w)(1), and (x)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

11.Add § 721.10668 to subpart E to read as follows:

§ 721.10668 Trisodium diethylene triaminepolycarboxylate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as trisodium diethylene triaminepolycarboxylate (PMN P-13-18) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to this section.

12.Add § 721.10669 to subpart E to read as follows:

§ 721.10669 Tertiary amine alkyl ether (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tertiary amine alkyl ether (PMN P-13-78) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (a catalyst for producing polyurethane foam).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

13.Add § 721.10670 to subpart E to read as follows:

§ 721.10670 Bromine, manufacture of, by-products from, distillation residues.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as bromine, manufacture of, by-products from, distillation residues (PMN P-13-108; chemical substance definition: The complex residuum obtained during the production of bromine using brine and waste streams from the production of halogenated hydrocarbons. It consists predominantly of halogenated hydrocarbons and ketones, having carbon numbers predominantly in the range of C3-C17. The boiling point is approximately 98°C to 350°C (208°F to 662°F).) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

end regulatory text

[FR Doc. 2013-11061 Filed 5-8-13; 8:45 am]

BILLING CODE 6560-50-P

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