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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 78 chemical substances which were the subject of premanufacture notices (PMNs). Seven of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 78 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 December 4, 2012. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on October 19, 2012.

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 November 5, 2012 (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-2012-0277, 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, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN: Docket ID Number EPA-HQ-OPPT-2012-0277. 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-2012-0277. 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 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) (April 24, 1990 SNUR). 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), 5(h)(2), 5(h)(3), and 5(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

III. Significant New Use Determination 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 78 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 84 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

  • PMN number.
  • Chemical name (generic name, if the specific name is claimed as CBI).
  • Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).
  • Basis for the TSCA section 5(e) consent order or, for non-section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA section 5(e) consent orders).
  • Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information).
  • CFR citation assigned in the regulatory text section of this rule.

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

This rule includes 7 PMN substances (P-04-80, P-06-149, P-06-153, P-07- 327, P-09-48, P-09-636, and P-10-367) that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) consent order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) consent orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 721.30 requests to use the NCELs approach for SNURs are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) consent order for the same chemical substance.

This rule also includes SNURs on 71 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” These so-called “non-section 5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-section 5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, “(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.

PMN Number P-00-535

Chemical name: 1-Octadecanol, manuf. of, distn. lights, fractionation heavies, distn. lights.

CAS number: 243640-46-2.

Basis for action: The PMN states that the substance will be used as a feedstock for esterification. Based on ecological structure activity relationship (EcoSAR) analysis of test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 part per billion (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 1 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as a feedstock for esterification 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 (Office of Pollution Prevention and Toxics (OPPTS) Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (Office for Chemical Safety and Pollution Prevention (OCSPP) Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10426.

PMN Number P-01-579

Chemical name: Acrylate ester (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a monomer. Based on EcoSAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 50 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 50 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 50 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10537

PMN Number P-02-161

Chemical name: Phosphonium, tetrakis (hydroxymethyl)-, chloride (1:1), reaction products with 1-tetradecanamine and urea.

CAS number: 359406-89-6.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a flame retardant. Based on test data on the PMN substance and EcoSAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. As described in the PMN, 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 concentrations exceeding 2 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); and an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010) would help characterize the environmental and fate effects of the PMN substance.

CFR citation: 40 CFR 721.10538.

PMN Number P-02-653

Chemical name: Bis[phenyl-2H-1,3-benzoxazine]derivative (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a resin for electronic laminates, adhesives, encapsulants, and composites. Based on EcoSAR analysis of test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish bioconcentration factor (BCF) test (OPPTS Test Guideline 850.1730); 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 721.10539.

PMN Number P-02-984

Chemical name: 1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.

CAS number: 404362-22-7.

Basis for action: The PMN states that the substance will be used as an epoxy curing agent. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substance in surface waters. As described in the PMN, 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 concentrations exceeding 5 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10540.

PMN Number P-03-481

Chemical name: 5,2,6-(Iminomethenimino)-1H-imidazo[4,5-b]pyrazine, octahydro-1,3,4,7,8,10-hexanitro-.

CAS number: 135285-90-4.

Basis for action: The PMN substance will be used as an explosive and propellant. Based on structure activity relationship (SAR) analysis of test data on analogous octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine (also called HMX or octogen); CAS No. 2691-41-0, as well as test data for hexahydro-1,3,5-trinitro-1,3,5-triazine (also called RDX, cyclonite, hexogen, or cyclotrimethylenetrinitramine); CAS No. 121-82-4, EPA identified concerns for neurotoxicity, including severe convulsions or seizures, systemic effects, reproductive and developmental effects, immunotoxicity and oncogenicity from exposure to the PMN substance. In addition, based on EcoSAR analysis of test data on analogous polynitro organic analogues, EPA predicts toxicity to aquatic organisms from the degradation product of the PMN substance at surface water concentrations that exceed 50 ppb of the degradation product. For the use described in the PMN, dermal and inhalation exposures are not expected, and releases to surface waters are not expected to result in surface water concentrations exceeding 50 ppb for the PMN degradation product. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without respiratory protection, impervious gloves, or release to surface waters without chemical destruction or conversion 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)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a combined repeated dose toxicity study with reproductive/developmental toxicity screening test, including neurotoxicity assessment and functional observations (OPPTS Test Guideline 870.3650); a combined chronic toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300); a hydroysis as a function of pH and temperature test (OPPTS Test Guideline 835.2130); and a ready biodegradability test (OPPTS Test Guideline 835.3110) would help to characterize the human health and environmental fate of the PMN substance.

CFR citation: 40 CFR 721.10541.

PMN Number P-03-624

Chemical name: Dodecanedioic acid, 1,12-dimethyl ester.

CAS number: 1731-79-9.

Basis for action: The PMN states that the substance will be used as a chemical intermediate. Based on EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 30 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 30 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 30 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10542.

PMN Number P-04-79

Chemical name: Oxetane, 3-methyl-3-[(2,2,3,3,3-pentafluoropropoxy)methyl]-.

CAS number: 449177-94-0.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a monomer in the production of reactive polymers for surface coatings and other polymer intermediates. Based on SAR analysis of test data on analogous oxetanes, EPA identified concerns for male reproductive toxicity, liver toxicity, and thyroid effects from exposure to the PMN substance. As described in the PMN, significant inhalation exposures are not expected and dermal exposures are not expected due to the use of protective gloves. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance without dermal protection where there is a potential for dermal exposures 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 combined repeated dose test with a reproductive/developmental toxicity screening (Organisation for Economic Co-operation and Development (OECD) Test Guideline 422) via gavage in rats would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10543.

PMN Number P-04-80

Chemical name: Oxetane, 3-methyl-3-[[(3,3,4,4,5,5,6,6,6-nonafluorohexyl)oxy]methyl]-.

CAS number: 475678-78-5.

Effective date of TSCA section 5(e) consent order: December 28, 2004.

Basis for TSCA section 5(e) consent order: The PMN states that the substance will be used as a monomer in the production of reactive polymers for surface coating materials and other polymer intermediates. EPA has 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). Also, based on SAR analysis of test data on analogous oxetanes, EPA identified concerns for male reproductive toxicity and systemic effects from exposures to the PMN substance. Further, based on EcoSAR analysis of analogous oxetanes, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substance in surface waters. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that this substance may present an unreasonable risk of injury to human health and the environment, the substance may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substance and its potential degradation products. To protect against these risks, the consent order requires:

1. Use of personal protective equipment including dermal protection (where there is a potential for dermal exposure).

2. Establishment and use of a hazard communication program.

3. No release of the PMN substance into the waters of the United States.

The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of a combined repeated dose toxicity test with a reproductive/developmental toxicity screening test (OPPTS Test Guideline 870.3650 or OECD Test Guideline 422) in rats by gavage would help characterize possible human health effects of the PMN substance. The PMN submitter has agreed not to exceed the confidential production limit specified in the consent order without performing this test. In addition, EPA has determined the results of a log Kow test (OECD Test Guideline 117), and (depending upon the results of the log Kow test) a fish BCF test (OPPTS Test Guideline 850.1730); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500), would help characterize the persistence, bioaccumulation, and environmental effects of the PMN substance. The consent order does not require submission of this additional recommended testing at any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10544.

PMN Number P-04-313

Chemical name: Aminotriazine modified cresol novolec resin (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a glass epoxy laminate. Based on EcoSAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 10 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 10 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish BCF test (OPPTS Test Guideline 850.1730), and either an aerobic and anaerobic transformation in aquatic sediment systems test (OECD Test Guideline 308) or a shake flask die-away test (OPPTS Test Guideline 835.3170) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10545.

PMN Number P-04-340

Chemical name: Pentenylated polyethylene glycol sulfate salt (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a polymerization additive. Based on EcoSAR analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10546.

PMN Number P-04-587

Chemical name: Dialkyl dimethyl ammonium methylcarbonate (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a chemical intermediate. Based on EcoSAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 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 chemical intermediate use described in the PMN, environmental releases did not exceed 5 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance other than as a chemical intermediate 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) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10547.

PMN Number P-04-624

Chemical name: Mixed alkyl phosphate esters alkoxylated (generic).

CAS number: Not available.

Basis for action: The PMN substance will be used as a component in a lubricant blend. Based on EcoSAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 40 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 40 ppb. Therefore, EPA has not determined that manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 40 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10548.

PMN Number P-04-635

Chemical name: Ethane, 1,1,2,2-tetrafluoro-1-(2,2,2-trifluoroethoxy)-.

CAS number: 406-78-0.

Basis for action: The PMN states that the substance will be used for cleaning electronic components, precision cleaning, dewatering of electronic components and other parts following aqueous cleaning, and as a carrier/lubricant coating for hard disk drives and other precision parts. Based on test data on the PMN substance, EPA identified concerns for neurotoxicity. For the industrial use described in the PMN, the substance is imported and no significant worker exposures are expected. Therefore, EPA has not determined that the proposed processing or use of the substance presents an unreasonable risk. EPA has determined, however, that domestic manufacture, use in non-industrial products, or use other than as described in the PMN may cause serious chronic health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i).

Recommended testing: EPA has determined that inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket under docket ID number EPA-HQ-OPPT-2012-0277) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10549.

PMN Number P-05-324

Chemical name: Rare earth salt of a carboxylic acid (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a paint component. Based on SAR analysis of test data on analogous lanthanides, EPA identified concerns for developmental toxicity, kidney toxicity, and blood toxicity (specifically, anticoagulant activity). In addition, based on EcoSAR analysis of test data on analogous organic and inorganic salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substance in surface waters. For the use described in the PMN, significant worker and general population exposures are not expected, and releases of the substance are not expected to result in surface water concentrations that exceed 5 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance other than as described in the PMN, or any use resulting in surface water concentrations exceeding 5 ppb 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)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of an acute oral toxicity test (OPPTS Test Guideline 870.1100); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) via the intraperitoneal route; a repeated dose 28-day oral toxicity test in rodents (OPPTS Test Guideline 870.3050), including a neurotoxicity functional observational battery, as described in the neurotoxicity screening battery (OPPTS Test Guideline 870.6200); a prenatal developmental toxicity test (OPPTS Test Guideline 870.3700) in one species, via the oral route; either a porous pot test (OPPTS Test Guideline 835.3220) or an aerobic sewage treatment simulation test (OECD Test Guideline 303A); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10550.

PMN Number P-05-613

Chemical name: Bisphenol S mono ether (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a color developer. Based on SAR analysis of test data on analogous epoxides, EPA identified concerns for respiratory sensitization, mutagenicity, oncogenicity, developmental toxicity, male reproductive toxicity, liver toxicity, and kidney toxicity. In addition, based on test data on the PMN substance and EcoSAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface water. For the use described in the PMN, occupational exposures during manufacture are not expected as the PMN substance is imported. Occupational exposures during processing and use are not expected to be significant due to expected use of appropriate personal protective equipment, and the substance is not released to surface waters during processing or use. Therefore, EPA has not determined that the proposed processing or use of the substance presents an unreasonable risk. EPA has determined, however, that domestic manufacture, any use of the substance other than as described in the PMN, or any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(ii), (b)(4)(i), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a combined repeated dose toxicity with the reproduction/development toxicity screening test (OPPTS Test Guideline 870.3650); a carcinogenicity test (OPPTS Test Guideline 870.4200); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10551.

PMN Number P-05-774

Chemical name: Oxirane, 2-(1-chlorocyclopropyl)-2-[(2-chlorophenyl)methyl]-.

CAS number: 134818-68-1.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on test data on the PMN substance, EPA identified concerns for dermal sensitization. In addition, based on SAR analysis of test data on analogous epoxides and chlorobenzenes, EPA identified concerns for carcinogenicity, mutagenicity, systemic toxicity, neurotoxicity, and reproductive toxicity from worker exposures. Further, based on test data on the PMN substance and EcoSAR analysis of test data on analogous monoepoxides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. For the site-limited intermediate use described in the PMN, significant worker dermal exposure is unlikely due to the use of impervious personal protective equipment and releases of the substance are not expected to result in surface water concentrations that exceed 2 ppb. Therefore, EPA has not determined that manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without workers wearing impervious gloves, where there is a potential for dermal exposures; use of the substance other than as a site-limited chemical intermediate, or any use of the substance resulting in surface water concentrations exceeding 2 ppb 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)(i), (b)(3)(ii), (b)(4)(i), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a porous pot test (OPPTS Test Guideline 835.3220); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) by the intraperitoneal route; a combined repeated dose toxicity test (OPPTS Test Guideline 870.3650) with the reproduction/development toxicity screening test and neurotoxicity endpoints; a carcinogenicity test (OPPTS Test Guideline 870.4200); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10552.

PMN Number P-06-149

Chemical name: Potassium titanium oxide.

CAS number: 12673-69-7.

Effective date of TSCA section 5(e) consent order: March 18, 2008.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance is as a physical characteristics modifier for industrial use in certain solid composite articles. Based on test data on the PMN substance and SAR analysis of test data on analogous respirable, poorly soluble particulates (subcategory titanium dioxide), EPA identified concerns for lung toxicity and fibrosis in workers exposed to the PMN substance by the inhalation route. The Order was issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order requires:

1. Use of personal protective equipment including a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10, or compliance with a NCEL of 1.5 mg/m [3] as a time weighted average (when there is a potential for inhalation exposures).

2. Establishment and use of a hazard communication program.

3. No manufacture of the PMN substance with a particle size less than 100 nanometers.

The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA determined that the results of the following study would help characterize the human health effects of the PMN substance: A 90-day inhalation toxicity test with special attention to histopathology (inflammation and cell proliferation) of the lung tissues and to various parameters of the broncoalveolar lavage fluid (BALF), e.g., marker enzyme activities, total protein content, total cell count, cell differential, and cell viability (OPPTS Test Guideline 870.3465).

CFR citation: 40 CFR 721.10553.

PMN Number P-06-153

Chemical name: Iso-tridecanol (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: October 13, 2006.

Basis for TSCA section 5(e) consent order: The PMN states that the substance will be used as a reactant. Based on test data on the PMN substance, and EcoSAR analysis of test data on analogous neutral organic compounds, EPA predicts toxicity to aquatic organisms at concentrations that exceed 8 ppb of the PMN substance in surface waters. Further, aquatic toxicity, persistence, and bioaccumulation potential vary depending on the isoindex (i.e., the average number of branches per alkyl unit) of the PMN substance. EPA has determined that as the isoindex increases, persistence and bioaccumulation values increase. At the isoindex value of 2.32 for the intended PMN substance, the substance is not considered a PBT chemical and aquatic toxicity risk is mitigated by the decrease in persistence. However, as the isoindex increases above 3, EPA estimates that the PMN substance will persist in the environment more than two months and EPA estimates a bioaccumulation factor of greater than or equal to 1000. If the isoindex is less than three, the PMN is not expected to persist. The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that this substance may present an unreasonable risk of injury to the environment. To protect against these risks, the consent order requires manufacture of the PMN substance according to the chemical composition section of the consent order, with no greater than an average of three branches per alkyl unit and routine analysis of the PMN substance to verify compliance with the average number of alkyl units restriction. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. The consent order does not require the submission of this testing at any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10554.

PMN Number P-06-370

Chemical name: Benzoic acid nonyl ester, branched and linear.

CAS number: 670241-72-2.

Basis for action: The PMN states that the substance will be used as a softener for polyvinyl chloride. Based on test data on the PMN substance, EPA identified concerns for developmental toxicity from exposure to the PMN substance. In addition, based on test data on the PMN substance and EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 ppb of the PMN substance in surface waters. As described in the PMN, dermal exposures are not expected due to the use of impervious gloves and no domestic manufacture, and releases of the PMN substance are not expected to result in surface water concentrations that exceed 6 ppb. Therefore, EPA has not determined that the proposed processing or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance without impervious gloves, where there is a potential for dermal exposures; any domestic manufacture; or any use of the substance resulting in surface water concentrations exceeding 6 ppb 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)(3)(i), (b)(4)(i), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a 90-day subchronic dermal toxicity test in rats (OPPTS Test Guideline 870.3250) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the human health and environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10555.

PMN Numbers P-06-450, P-06-451, and P-06-452

Chemical names: (P-06-450) Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 12-15-alkyl ethers; (P-06-451) Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 10-16-alkyl ethers; and (P-06-452) Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 12-16-alkyl ethers.

CAS numbers: (P-06-450) 675869-02-0; (P-06-451) 620610-66-4; and (P-06-452) 675869-05-3.

Basis for action: The consolidated PMN states that the substances will be used as wetting agents for low foam spray metal cleaning. Based on EcoSAR analysis of test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 ppb of the PMN substances in surface waters. At the combined production volume stated in the notice, releases of the PMN substances are not expected to result in surface water concentrations that exceed 10 ppb. 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 increase in the combined annual manufacture and import volume of 45,000 kilograms (kgs) of the substances could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075) on any of the three PMN substances would help characterize the environmental effects of the PMN substances.

CFR citations: 40 CFR 721.10556 (P-06-450); 40 CFR 721.10557 (P-06-451); and 40 CFR 721.10558 (P-06-452).

PMN Number P-06-793

Chemical name: Morpholine, 4-C 6-12 acyl derivs.

CAS number: 887947-29-7.

Basis for action: The PMN states that the substance will be used as a pesticide dispersant/solvent. Based on test data on the PMN substance, EPA identified concerns for systemic effects from dermal exposures. As described in the PMN, worker dermal exposures are not expected due to the use of impervious skin protection and hazard communication warnings for systemic effects. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without impervious dermal protection, where there is a potential for dermal exposures, or any use of the substance without hazard communication warnings for systemic effects may cause serious health effects. Based on this information, the PMN meets the concern criteria at § 721.170(b)(3)(i).

Recommended testing: EPA has determined that the results of 90-day subchronic dermal toxicity test (OPPTS Test Guideline 870.3250) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10559.

PMN Numbers P-07-143 and P-07-144

Chemical names: Alkanoldioic dialkyl esters (generic).

CAS numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as lubricant additives. Based on EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb of the PMN substances in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early-life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substances to surface water exceed releases from the use described in the PMNs. For the use described in the PMNs, environmental releases did not exceed 3 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances presents an unreasonable risk. EPA has determined, however, that any use of the substances other than as described in the PMNs may cause significant adverse environmental effects. Based on this information the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) would help characterize the environmental effects of the PMN substances. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10560.

PMN Number P-07-327

Chemical name: Substituted phenol (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: September 17, 2008.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as an antioxidant. Based on EcoSAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms at concentrations that exceed 1 ppb of the PMN substance in surface waters. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that the substance may present an unreasonable risk of injury to the environment, may be produced in substantial quantities, and may reasonably be anticipated to enter the environment in substantial quantities. To protect against these risks, the consent order requires:

1. Establishment and use of a hazard communication program.

2. No release of the PMN substance into the waters of the United States.

The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of certain human health toxicity testing specified in the consent order would help characterize the human health effects of the substance. The PMN submitter has agreed not to exceed the confidential production volume limit without performing an in vitro mouse lymphoma assay (mammalian cell mutation test) (OPPTS Test Guideline 870.5300) and a repeated dose 28-day oral toxicity test (OPPTS Test Guideline 870.3050) to include a neurotoxicity battery (OPPTS Test Guideline 870.6200).

In addition, 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. The consent order does not require submission of this aquatic toxicity testing by any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use and disposal of the PMN will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10561.

PMN Number P-07-375

Chemical name: Aluminum trihydrate and silane homopolymer (generic).

CAS number: Not available.

Basis for action: The PMN states that the use of the substance will be as a flame retardant. Based on test data on an analogous insoluble high molecular weight polymer, EPA identified concerns for lung toxicity if the PMN substance is inhaled. At an annual production volume of 100,000 kgs, worker exposure is limited and consumer 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 any increase of the annual 100,000 kg production volume may result in increased exposure to the PMN substance which may cause significant adverse human 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 a 60-day holding period would help characterize the health effects of the PMN substance.

CFR citation: 40 CFR 721.10562.

PMN Number P-07-496

Chemical name: 2-Oxiranemethanamine, N-[3-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-.

CAS number: 71604-74-5.

Basis for action: The PMN substance will be used as a preparation of pre-impregnated cloth/fiber tapes for aerospace composite articles. Based on SAR analysis of test data on analogous epoxides, EPA identified concerns for oncogenicity, mutagenicity, developmental toxicity, reproductive toxicity, and liver toxicity from exposure to the PMN substance. As described in the PMN, worker dermal exposure to the PMN substance will be minimal due to the use of impervious gloves, and no significant inhalation exposure is 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 without the use of impervious gloves, where there is potential for dermal exposure, or any use of the substance other than as a preparation of pre-impregnated cloth/fiber tapes for aerospace composite articles may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii).

Recommended testing: EPA has determined that the results of a 90-day subchronic dermal toxicity test in rats (OPPTS Test Guideline 870.3250) and a dermal carcinogenicity test (OPPTS Test Guideline 870.4200) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10563.

PMN Number P-08-39

Chemical name: Mixed amino diaryl sulfone isomers (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a hardening agent. Based on SAR analysis of test data on analogous dianilines, EPA identified concerns for immunotoxicity, oncogenicity, blood effects, liver effects, and hypersensitivity from exposures to the PMN substance. In addition, based on EcoSAR analysis of analogous dianilines, EPA predicts toxicity to aquatic organisms at concentrations that exceed 8 ppb of the PMN substance in surface waters. For the non-consumer use described in the PMN, significant worker exposures are not expected as the PMN is used in liquid form, and releases of the substance to surface waters are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance in consumer products, any use of the substance in the form of a powder, or any use of the substance resulting in surface water concentrations exceeding 8 ppb 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), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a rat acute oral retinopathy screening test; a pigmented rat 90-day subchronic toxicity test (OPPTS Test Guidelines 870.3100 or 870.3465) by either the oral or inhalation route, including histopathological examination of the eyes (by both light and electron microscopy) and reproductive organs; a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10564.

PMN Number P-08-263

Chemical name: Ethanol, 2,2′-[[3-[(2-hydroxyethyl)amino]propyl]imino]bis-, N-(hydrogenated tallow alkyl) derivs.

CAS number: 90367-25-2.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a raw material to manufacture a surfactant blend. 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 of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a simulation test—aerobic sewage treatment: activated sludge units (OPPTS Test Guideline 835.3240); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity mitigated by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10565.

PMN Number P-08-292

Chemical name: 1-Propanamine, N- (1-methylethyl) -,3- (C 12-15-alkyloxy) derivs.

CAS number: 944835-56-7.

Basis for action: The PMN states that the substance will be used as a lubricant additive intermediate. 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 of the substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10566.

PMN Number P-08-300

Chemical name: Amidoamine salt (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a laundry product additive. 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 of the substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10567.

PMN Number P-08-464

Chemical name: Diethanolamine salt of polymeric acid (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a pigment dispersant in latex paints. Based on EcoSAR analysis of test data on analogous inorganic phosphates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb of the substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 4 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 4 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10568.

PMN Number P-08-471

Chemical name: Tricyclic quaternary amine salt (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on EcoSAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 100 ppb of the substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 100 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10569.

PMN Number P-08-537

Chemical name: Cyclic amine reaction product with acetophenone and formaldehyde acid salt (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an acid inhibitor. Based on test data on the PMN substance and EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 8 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 8 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 8 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of 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 721.10570.

PMN Number P-08-611

Chemical name: 1,3-Benzenediol, polymer with 1,1′-methylenebis[isocyanatobenzene].

CAS number: 1008753-84-1.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a rubber additive. Based on 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 EcoSAR analysis of test data on analogous esters and phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. For the use scenarios described in the PMN, which were supported by product composition tests and simulated use condition tests, significant worker exposure is 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 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 1 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 dermal sensitization test (OPPTS Test Guideline 870.2600); a 90-day subchronic inhalation toxicity test (OPPTS Test Guideline 870.3465); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10571.

PMN Number P-08-680

Chemical name: Benzamide, N-[[4-[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxy-.

CAS number: 221667-31-8.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adjuvant for agricultural products. Based on test data on the PMN substance, EPA identified concerns for urinary tract toxicity from exposure to the PMN substance. As described in the PMN, worker dermal and inhalation exposures will be minimal due to the use of impervious gloves, a NIOSH-certified respirator with an APF of at least 10, and establishment of a hazard communication program. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without impervious gloves, where there is a potential for dermal exposures; any use of the substance without a NIOSH-certified respirator with an APF of at least 10, where there is a potential for inhalation exposures; or without establishing the hazard communication program may result in serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i).

Recommended testing: EPA has determined that inhalation monitoring data would help characterize the health effects of the PMN substance. EPA's draft Inhalation Monitoring Data Collection Guidelines are available in the docket for this rule under docket ID number EPA-HQ-OPPT-2012-0277.

CFR citation: 40 CFR 721.10572.

PMN Number P-08-737

Chemical name: Magnesium hydroxide surface treated with substituted alkoxy silanes (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a flame retardant. Based on test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung toxicity and immunotoxicity if the PMN substance is inhaled. For the use described in the PMN, and at the annual 100,000 kg production volume stated in the PMN, worker inhalation exposure will be minimal due to adequate personal protective equipment. 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 increase of the annual 100,000 kg production volume, or use without workers wearing a NIOSH-certified respirator with an APF of at least 10, or use without an appropriate hazard communication program 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 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-day holding period would help characterize the health effects of the PMN substance.

CFR citation: 40 CFR 721.10573.

PMN Number P-09-48

Chemical name: Alkylcarboxy polyester acrylate reaction products with mixed metal oxides (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: August 31, 2009.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a film coating additive. Based on particle size data on the PMN substance, and SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for inflammation of the lungs, lung fibrosis and lung cancer, as well as internal organ effects. In addition, based on EcoSAR analysis of test data on analogous acrylate substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 55 ppb of the PMN substance in surface waters. The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires:

1. Use of impervious gloves (when there is a potential for dermal exposure).

2. Establishment and use of a hazard communication program.

3. No manufacturing, processing, or use of the PMN substance in non-enclosed processes when the PMN substance is in the powder form.

4. No use involving an application method that generates a vapor, mist, aerosol, or a dust.

5. Transport of the PMN substance to processors using only reusable tote tanks cleaned not more than once per year.

6. Use of the PMN substance only for the confidential use specified in the consent order.

7. Disposal of the PMN substance, any waste streams from manufacture of the PMN substance, and any waste streams from processing of the PMN substance only by incineration in a Resource Conservation and Recovery Act (RCRA)-approved hazardous waste incinerator.

8. Waste streams from use of the PMN substance must either be disposed of by incineration in a RCRA-approved hazardous waste incinerator, or be recycled via polymer reclamation.

9. No release of the PMN substance into the waters of the United States.

The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test in rats with a post-exposure observation period of up to 60 days, including bronchoalveolar lavage fluid analysis (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413); determination of incineration removal efficiency, full dissolution test using transformed PMN substance following incineration (OECD ENV/JM/MONO(2001)); and particle size distribution, aspect ratio, and crystalline structure of transformed PMN substance following incineration (OPPTS Test Guideline 830.7520) would help characterize the human health effects, environmental fate, and physical chemical properties of the PMN substance. The consent order does not require submission of this testing at any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10574.

PMN Number P-09-480

Chemical name: 1-Propanone, 1,1′-(oxydi-4,1-phenylene)bis[2-hydroxy-2-methyl-.

CAS number: 71868-15-0.

Basis for action: The PMN states that the use of the substance will be used as a co-photoinitiator for ultra-violet (UV)-curable pigmented inks, co-photo initiator for photoresists, optical fibers and printed plates, and co-photoinitiator for UV-curable coatings and a co-photoinitiator for UV-curable adhesives and other coatings. Based on test data on the PMN substance, EPA identified concerns for reproductive toxicity effects from exposure to the PMN substance. In addition, based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 14 ppb of the PMN substance in surface waters. For the use described in the PMN, worker exposure will be minimal due to the use of a NIOSH-certified respirator with an APF of at least 50, adequate hazard communication, and no domestic manufacture of the PMN substance, and environmental effects will be minimal as releases of the substance to surface waters are not expected. Therefore, EPA has not determined that the proposed processing or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified respirator with an APF of at least 50, where there is potential inhalation exposure; any domestic manufacture; without adequate hazard communication; or any use of the substance resulting in surface water concentrations exceeding 14 ppb 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)(3)(i) and (b)(4)(i).

Recommended testing: EPA has determined that the results of a two-generation reproductive toxicity (OECD Test Guideline 416); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the human health and environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10575.

PMN Number P-09-486

Chemical name: Polyalkenyl, N,N′-bistriazole (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non confidential) use of the substance will be as a lubricant additive. Based on EcoSAR analysis of analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 140 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 140 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10576.

PMN Number P-09-636

Chemical name: Benzenamine, 5-(1,1-dimethylethyl)-2-[(2-ethylhexyl)thio]-,4-methylbenzenesulfonate (1:1).

CAS number: 852360-51-1.

Effective date of TSCA section 5(e) consent order: June 4, 2010.

Basis for TSCA section 5(e) consent order: The PMN states that the substance will be used as a chemical intermediate. EPA has identified health and environmental concerns because the substance may be a PBT chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemical Program's PBT category. EPA estimates that the PMN substance will persist in the environment more than two months and estimates a bioaccumulation factor of greater than or equal to 5,000. Also, based on test data on the PMN substance and SAR analysis for anilines, EPA predict toxicity to aquatic organisms at concentrations that exceed 1 ppb and developmental toxicity to workers from exposures during uses other than as a site-limited chemical intermediate. The consent order was issued under TSCA section 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires:

1. Establishment and use of a hazard communication program.

2. Use of the PMN substance only as a site-limited intermediate.

3. No release of the PMN substance into the waters of the United States.

The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of human health, aquatic toxicity, and environmental fate testing would help characterize the effects of the PMN substance. The PMN submitter has agreed not to exceed the first production volume limit of 15,000 kgs prior to submitting testing to determine the log Kow value (by either the liquid chromatography test (OPPTS Test Guideline 830.7575) or the generator column method (OPPTS Test Guideline 830.7560)); and the ready biodegradability test (OPPTS Test Guideline 835.3110) by any of six methods described in the consent order: Depending on the results of the first tier testing, the PMN submitter has agreed not to exceed the second production volume limit of 170,000 kgs prior to submitting testing to determine biodegradation and bioaccumulation potential. Further, depending upon the results of the second tier testing, the PMN submitter has agreed not to exceed the third production volume limit of 496,000 kgs prior to submitting: a combined repeated dose toxicity test with a reproductive/developmental toxicity screening test (OECD Test Guideline 422) in rats; a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) via the intraperitoneal route; a sediment/water microcosm biodegradation test (OPPTS Test Guideline 835.3180); fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300).

CFR citation: 40 CFR 721.10577.

PMN Number P-10-231

Chemical name: Unsaturated polyester imide (generic).

CAS number: Not available.

Basis for action: The PMN states that the use of the substance will be as electrical insulating varnish for motors, generators and transformers. Based on EcoSAR analysis of aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 52 ppb of the PMN substance in surface waters. As described in the PMN, 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 concentrations exceeding 52 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline: 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline: 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10578.

PMN Number P-10-367

Chemical name: Carbon black derived from the pyrolysis of rubber tire shreds (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: May 16, 2011.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as carbon black for general industrial use. Based on test data on carbon black and SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for immunotoxicity, pulmonary toxicity, and carcinogenicity. In addition, based on aquatic toxicity data on carbon black, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1,000 ppb of the PMN substance in surface waters. The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires:

1. Manufacture of the PMN substance using only the process described in the PMN.

2. Manufacturing, processing, or use of the PMN substance in compliance with the Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (PEL) for carbon black of 3.5 mg/m [3] .

3. Manufacture of the PMN substance to meet the NIOSH recommended time weighted average (TWA) for polyaromatic hydrocarbons (PAH) in carbon black of 0.1 mg/m [3] as described in the NIOSH Pocket Guide to Chemical Hazards Appendix C (see http://www.cdc.gov/niosh/npg/nengapdza.html).

4. Submission of data demonstrating compliance with the NIOSH TWA for PAH as described in the testing section of the consent order.

5. No release of the PMN substance into the waters of the United States.

The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of certain human health testing would help characterize the human health effects of the PMN substance. The PMN submitter has agreed not to exceed the confidential production volume specified in the consent order prior to performing a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with (1) a post-exposure observation period of up to 3 months; (2) bronchoalveolar lavage fluid (BALF) analysis, aggregate/agglomeration state, shape, size/size particle distribution and surface properties of materials as administered; (3) aggregation/agglomeration state, shape, size/size particle distribution; and surface properties of materials of the delivered materials after administration; and (4) determination of cardiovascular toxicity, heart histopathology, and data on pulmonary deposition. Further, the PMN submitter must submit additional worker exposure monitoring data to determine whether worker exposures exceed the NIOSH REL for PAH. In addition, EPA has determined that the results of a 2-year carcinogenicity test (OPPTS Test Guideline 870.4300) would help characterize the human health effects of the PMN substance. The consent order does not require submission of this test at any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10579.

PMN Number P-10-452

Chemical name: Poly[oxy(methyl-1,2-ethanediyl)], alpha, alpha'-[1,4-cyclohexanediylbis(methylene)]bis[omega-(2-aminomethylethoxy)-.

CAS number: 1220986-58-2.

Basis for action: The PMN states that the use for this substance will be as an epoxy curing agent. Based on EcoSAR on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 98 ppb of the PMN substance in surface waters. As described in the PMN notice, releases of the PMN substance are not expected to result in surface water concentrations that exceed 98 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 98 ppb, may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a porous pot test (OPPTS Test Guideline 835.3220); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline: 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline: 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10580.

PMN Numbers P-10-524 and P-10-525

Chemical names: Brominated polyurethane prepolymers of methylene diphenyl diisocyanate (MDI) (generic).

CAS numbers: Not available.

Basis for action: The consolidated PMN states that the generic (non-confidential) use of the substances will be as components of polyurethane coatings for non-consumer use. Based on test data on analogous isocyanates, EPA identified concerns for dermal sensitization, respiratory sensitization, and irritation. For the non-consumer use described in the PMNs, worker inhalation exposures will be minimal due to the use of a NIOSH-certified respirator with an APF of at least 10. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances without a NIOSH-certified respirator with an APF of at least 10, where there is a potential of inhalation exposures, or any consumer use of the substances may result in human exposures which may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of a dermal sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS 870.3465) in rodents would help characterize the human health effects of the PMN substances.

CFR citation: 40 CFR 721.10581.

PMN Number P-10-571

Chemical name: Quaternary ammonium compound (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an inhibitor for oil field applications. Based on EcoSAR on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 47 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 47 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 47 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental and fate effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10582.

PMN Number P-10-588

Chemical name: Benzenamine, 4,4'-[1,3-phenylenebis(1-methylethylidene)]bis-.

CAS number: 2687-27-6.

Basis for action: The PMN states that the use will be as a precursor to a polyimide resin. Based on SAR analysis of test data on analogous aromatic amines, EPA identified concerns for chronic organ effects, developmental toxicity and reproductive toxicity from exposures to the PMN substance. In addition, based on EcoSAR analysis of test data on analogous aromatic amines, EPA predicts toxicity to aquatic organisms at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, inhalation exposures are expected to be minimal due to the use of a NIOSH-certified particulate respirator with an APF of at least 1,000 and releases 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 without a NIOSH-certified particulate respirator with an APF of at least 1,000, where there is potential for inhalation exposures, or any use of the substance resulting in surface water concentrations exceeding 1 ppb 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)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a log Kow test (OPPTS Test Guideline 830.7550, 830.7560 or 830.7570; or OECD Test Guideline 123); a ready biodegradability test (OPPTS Test Guideline 835.3110); and a combined repeated dose toxicity with the reproduction/development toxicity screening test (OPPTS Test Guideline 835.3650) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10583.

PMN Number P-11-29

Chemical name: Cyclopentene, 1,3,3,4,4,5,5-heptafluoro-.

CAS number: 1892-03-1.

Basis for action: The PMN states that the substance will be used as a dry etching agent for production of semiconductors. Based on test data on the PMN substance and SAR analysis of test data on analogous halogenated hydrocarbons, EPA identified concerns for chronic toxicity from exposure to the PMN substance. In addition, based on EcoSAR analysis of analogous neutral organic compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 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. Significant exposures are not expected at a production volume of less than 10,000 kg per year. In addition, there is no consumer use or domestic manufacture for the PMN substance. Further, for the use described in the PMN, environmental releases did not exceed 2 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 any domestic manufacture; any use of the substance other than as a dry etching agent for production of semiconductors; any use in a consumer product; or exceedance of the annual import limit of 10,000 kg per year could change exposure potential and 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)(3)(i), (b)(3)(ii), (b)(4)(i), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a 90-day repeated dose inhalation test (OPPTS Test Guideline 870.3465); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the human health and environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10584.

PMN Numbers P-11-43 and P-11-44

Chemical names: (P-11-43) Disiloxane, 1-butyl-1,1,3,3-tetramethyl- and (P-11-44) Disiloxane, 1,3-dibutyl-1,1,3,3-tetramethyl-.

CAS numbers: (P-11-43) 121263-51-2 and (P-11-44) 4619-08-3.

Basis for action: The PMN states that the use of the substances will be as reducing agents for organic substrates and as chemical intermediates. Based on EcoSAR analysis of test data on analogous neutral organic compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters. As described in the PMNs, the substances are not released to surface waters. 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 may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish 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 substances. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citations: 40 CFR 721.10585 (P-11-43) and 40 CFR 721.18586 (P-11-44).

PMN Number P-11-81

Chemical name: 1H-Pyrazole, 3,4-dimethyl-.

CAS number: 2820-37-3.

Basis for action: The PMN states that the use of the substance will be as an intermediate. Based on EcoSAR analysis of test data on analogous pyrazoles, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 19 ppb of the PMN substance in surface waters. As described in the PMN, 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 concentrations exceeding 19 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: either a ready biodegradability test (OPPTS Test Guideline 835.3110) or a porous pot test (OPPTS Test Guideline 835.3220); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental and fate effects of the PMN substance.

CFR citation: 40 CFR 721.10587.

PMN Number P-11-98

Chemical name: Phenol, 2-[1-[[3-(1H-imidazol-1-yl)propyl]imino]ethyl]-.

CAS number: 1253404-90-8.

Basis for action: The PMN states that the generic (non-confidential) use will be as an epoxy catalyst. Based on EcoSAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, 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 concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guidelines 835.3110); a hydrolysis as a function of pH test (OPPTS Test Guideline 835.2110); an aerobic treatment simulation test (OECD Test Guideline 303A); a fish acute toxicity test, freshwater and marine (OPPTS Test Guidelines 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental and fate effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10588.

PMN Numbers P-11-106 and P-11-107

Chemical names: (P-11-106) Unsaturated fatty acids, amides with polyethylenepolyamine (generic) and (P-11-107) Fatty acids, amides with triethylentetramine (generic).

CAS numbers: Not available.

Basis for action: The PMNs state that substances will be used as a surfactant in asphalt emulsion (P-11-106) and an anti-stripping agent in asphalt (P-11-107). 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 of the PMN substances in surface waters. As described in the PMN, the substances are not released to surface waters. 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 may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citations: 40 CFR 721.10589 (P-11-106) and 40 CFR 721.10590 (P-11-107).

PMN Number P-11-110

Chemical name: Tertiary ammonium compound (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an inhibitor for oil field applications. 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 of the PMN substance in surface waters. As described in the PMN, 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 concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage test, freshwater and marine (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and a mysid chronic toxicity test (OPPTS Test Guideline 850.1350) in salt water would help characterize the environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10591.

PMN Number P-11-130

Chemical name: 1-Butanol, 4-amino-.

CAS number: 13325-10-5.

Basis for action: The PMN states that the PMN substance will be used as an intermediate. Based on SAR analysis of test data on analogous aliphatic amines, EPA identified concerns for neurotoxicity, liver toxicity, and kidney toxicity from exposures to the PMN substance. For the intermediate use described in the PMN, significant worker exposures 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, use of the substance other than as an intermediate 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 ready biodegradability test (OPPTS Test Guideline 835.3110); an acute oral toxicity test (OPPTS Test Guideline 870.1100); a repeated dose 28-day oral toxicity in rodents (OPPTS Test Guideline 870.3050) including a neurotoxicity functional observational battery, as described in the neurotoxicity screening battery (OPPTS Test Guideline 870.6200); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); and a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) via the intraperitoneal route would help characterize the human health and fate effects of the PMN substance.

CFR citation: 40 CFR 721.10592.

PMN Number P-11-162

Chemical name: 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester.

CAS number: 70293-55-9.

Basis for action: The PMN states that the substance will be uses as an adhesive monomer. Based on EcoSAR analysis of test data on analogous esters and methacrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 20 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 20 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 20 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10593.

PMN Number P-11-173

Chemical name: Hexanedioic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,6-hexanediol, hydrazine, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and 1,1'-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis[2-propanol], iso-Bu alc.-blocked, compds. with triethylamine.

CAS number: 1138156-39-4.

Basis for action: The PMN states that the generic (non-confidential) use for the substance will be as a coating for wooden floors. Based on EcoSAR analysis of test data on analogous amphoteric polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 150 ppb for the PMN substance in surface waters. As described in the PMN, releases of the substance to surface waters are not expected to result in surface water concentrations that exceed 150 ppb, due to pretreatment by primary, secondary, and tertiary waste treatment, or treatment in a lined, self-contained solar evaporation pond. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 150 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10594.

PMN Number P-11-230

Chemical name: Octadecen-1-aminium, N-ethyl-N,N-dimethy-, ethyl sulfate (1:1).

CAS number: 1256282-88-8.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an antistatic agent for acrylic yarn. Based on EcoSAR analysis of test data on cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb of the PMN substance in surface waters. As described in the PMN, 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 concentrations exceeding 4 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075) in clean dilution water; a fish acute toxicity test mitigated by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10595.

PMN Number P-11-234

Chemical name: Oligomeric phenolic ether (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on EcoSAR analysis of test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, 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 concentrations exceeding 1 ppb may cause significant adverse environmental effects and result in substantial human exposure via drinking water or fish ingestion. 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 ready biodegradability test (OPPTS Test Guideline 835.3110); an acute toxicity test (OPPTS Test Guideline 870.1000); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395); a repeated dose 28-day oral toxicity test in rodents (OPPTS Test Guideline 870.3050); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a fish BCF test (OPPTS Test Guideline 850.1730); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10596.

PMN Number P-11-252

Chemical name: Benzeneacetonitrile, alkoxy-[[(alkylsulfonyl)oxy]imino]- (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a photographic chemical. Based on EcoSAR analysis of test data on analogous vinyl/allyl nitriles, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, 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 concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300): and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10597.

PMN Numbers P-11-270, P-11-271, P-11-272, P-11-273, and P-11-274

Chemical names: (P-11-270) Lead strontium titanium zirconium oxide; (P-11-271) Calcium cobalt lead titanium tungsten oxide; (P-11-272) Calcium cobalt lead strontium titanium tungsten oxide; (P-11-273) Lanthanum lead titanium zirconium oxide; and (P-11-274) Lead niobium titanium zirconium oxide.

CAS numbers: (P-11-270) 61461-40-3; (P-11-271) 1262279-31-1; (P-11-272) 1262279-30-0; (P-11-273) 1227908-26-0; and (P-11-274) 56572-83-9.

Basis for action: The PMNs state that the substances will be used as piezoelectric ceramics for active and passive underwater acoustic systems. Based on test data on lead and SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for neurobehavioral and other neurological effects, cerebrovascular disease, high blood pressure, renal effects, cardiac effects, lung effects, neurological effects, hematological effects, reproductive toxicity, and immunotoxicity. In addition, based on EcoSAR analysis of test data on analogous inorganic lead compounds, EPA expects toxicity to aquatic organisms to occur at concentrations that exceed an aggregate of 8 ppb of the PMN substances in surface waters. For the uses described in the PMNs, worker inhalation exposures are expected to be minimal due to use of a NIOSH-certified respirator with an APF of at least 50, and releases of the PMN substances are not expected to result in an aggregate surface water concentration that exceeds 8 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances without the use of a NIOSH-certified respirator with an APF of at least 50, where there is a potential for inhalation exposures; any use of the substances other than as piezoelectric ceramics for active and passive underwater acoustic systems; or any use of the substances resulting in an aggregate surface water concentration exceeding 8 ppb may cause serious health effects and significant adverse environmental effects. Based on this information the PMN substances meet the concern criteria at § 721.170 (b)(3)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket under docket ID number EPA-HQ-OPPT-2012-0277) would help characterize the human health effects of the PMN substances.

CFR citations: 40 CFR 721.10598 (P-11-270); 40 CFR 721.10599 (P-11-271); 40 CFR 721.10600 (P-11-272); 40 CFR 721.10601 (P-11-273); and 40 CFR 721.10602 (P-11-274).

PMN Number P-11-280

Chemical name: Epoxy modified alkyd resin, partially neutralized (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a coating resin. Based on EcoSAR analysis of test data on analogous phosphates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, 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 concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of an algal toxicity test (OCSPP Test Guideline 850.4500) without adding phosphate would help characterize the environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation: 40 CFR 721.10603.

PMN Number P-11-447

Chemical name: Polyetherdiamine (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a gas treatment chemical for the removal of hydrogen sulfide from natural gas. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb of the PMN substance in surface waters. As described in the PMN, 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 concentrations exceeding 4 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10604.

PMN Numbers P-11-485, P-11-486, P-11-488, and P-11-489

Chemical names: (P-11-485) Polyoxyalkylene ether, polymer with aliphatic diisocyanate, homopolymer, alkanol-blocked (generic); (P-11-486) Alkyl substituted alkanediol polymer with aliphatic and alicyclic diisocyanates (generic); (P-11-488) Aliphatic diisocyanate, homopolymer, alkanol-blocked (generic); and (P-11-489) Aliphatic diisocyanate polymer with alkanediol and alkylglycol (generic).

CAS numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as hardeners for industrial coatings. Based on test data on analogous diisocyanates (including TSCA section 8(e) data on polymeric MDI), EPA identified concerns for oncogenicity. Also, based on test data on the PMN substances, the Agency identified concerns for lung and mucous membranes irritation as well as sensitization to workers from exposures to the PMN substances. For the uses and at the production volumes stated in the PMN, worker inhalation exposures will be minimal due to use of a NIOSH-certified respirator with an APF of at least 10, and there are no consumer exposures.

Therefore, EPA has not determined that the proposed manufacturing, processing, or use of these substances may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified respirator with an APF of at least 10, where there is a potential for inhalation exposures; any substantial increase of the annual manufacturing and importation volume of 10,000 kgs; or any use of the substances in consumer products may cause serious health effects. Based on this information, the PMN substances meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) on PMNs P-11-485, P-11-486, and either P-11-488 or P-1l-489, would help characterize the human health effects of the PMN substances.

CFR citations: 40 CFR 721.10605 (P-11-485); 40 CFR 721.10606 (P-11-486); 40 CFR 721.10607 (P-11-488); and 40 CFR 721.105608 (P-11-489).

PMN Number P-11-548

Chemical name: Imidodicarbonic diamide, N,N'-dibutyl-N',2-bis[4-[(4-isocyanatophenyl)methyl]phenyl]-.

CAS number: 1254743-03-7.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a polymer crosslinking agent. Based on SAR analysis of test data on analogous diisocyanates, EPA identified concerns for oncogenicity, sensitization, lung irritation, and mucous membrane irritation from exposure to the PMN substance. For the non-consumer use described in the PMN, inhalation exposures are not expected as the substance is not applied by a method that generates a vapor, mist, or aerosol. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance in consumer products; or any use of the substance involving an application method that generates a vapor, mist, or aerosol may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C) and (b)(3)(ii).

Recommended testing: EPA has determined that the results of skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10609.

PMN Numbers P-11-635 and P-11-636

Chemical names: Toluene diisocyanate, polymers with polyalkylene glycol (generic).

CAS numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as reactants for the production of polyurethane elastomers. Based on SAR analysis of test data on analogous diisocyanates, EPA identified concerns for oncogenicity, irritation to lungs and mucous membranes, and sensitization to workers from exposure to the PMN substances. For the uses described in the PMNs significant worker exposure is unlikely because there are no applications generating a vapor, mist or aerosol, and there are no consumer exposures. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of these substances may present an unreasonable risk. EPA has determined, however, that use of any of the substances in consumer products; or any use of the substance involving an application method that generates a vapor, mist, or aerosol may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170 (b)(1)(i)(C) and (b)(3)(ii).

Recommended testing: EPA has determined that the results of a dermal sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substances.

CFR citation: 40 CFR 721.10610.

V. Rationale and Objectives of the Rule Back to Top

A. Rationale

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 7 of the 78 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160 (see Unit II.).

In the other 71 cases, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.

B. Objectives

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

  • EPA will receive notice of any person's intent to manufacture, 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.
  • EPA will ensure that all manufacturers, importers, and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at 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 December 4, 2012 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before November 5, 2012.

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 November 5, 2012, 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 78 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 Rule to Uses Occurring Before Effective Date of the Rule Back to Top

Significant new use designations for a chemical substance are legally established as of the date of publication of this direct final rule, October 5, 2012.

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. TSCA section 5(e) consent orders have been issued for 7 chemical substances and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which EPA is designating as significant new uses. 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 other person may commence such activities without first submitting a PMN. For chemical substances for which an NOC has not been submitted at this time, EPA concludes that the uses are not ongoing. However, EPA recognizes that prior to the effective date of the rule, when chemical substances identified in this SNUR are added to the TSCA Inventory, other persons may engage in a significant new use as defined in this rule before the effective date of the rule. However, 40 of the 78 chemical substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN bona fide submissions (per §§ 720.25 and 721.11), 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.

As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of this direct final rule rather than as of the effective date of the rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notification requirements because a person could defeat the SNUR by initiating the significant new use before the rule became effective, and then argue that the use was ongoing before the effective date of the rule. Thus, persons who begin commercial manufacture, import, or processing of the chemical substances regulated through this SNUR will have to cease any such activity before the effective date of this rule. To resume their activities, these persons would have to comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions expires.

EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person meets the conditions of advance compliance under § 721.45(h), the person is considered exempt from the requirements of the SNUR.

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 § 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-section 5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” or for guidelines that are not currently available on the Web site, EPA has placed a copy of that guideline in the public docket. The OECD test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or Source OECD at http://www.sourceoecd.org.

In the TSCA section 5(e) consent orders for 7 of the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each test at least 14 weeks (earlier TSCA section 5(e) consent orders required submissions at least 12 weeks) before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture, import, or processing.

The recommended tests specified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

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

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

IX. Procedural Determinations 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 § 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 §§ 721.25 and 720.40. 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-2012-0277.

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 and, in some cases, TSCA section 5(e) consent orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

According to PRA (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.

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)

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

J. Executive Order 12898

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

XIV. Congressional Review Act 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: September 24, 2012.

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 entries 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  
*****  
721.10426 2070-0012
721.10537 2070-0012
721.10538 2070-0012
721.10539 2070-0012
721.10540 2070-0012
721.10541 2070-0012
721.10542 2070-0012
721.10543 2070-0012
721.10544 2070-0012
721.10545 2070-0012
721.10546 2070-0012
721.10547 2070-0012
721.10548 2070-0012
721.10549 2070-0012
721.10550 2070-0012
721.10551 2070-0012
721.10552 2070-0012
721.10553 2070-0012
721.10554 2070-0012
721.10555 2070-0012
721.10556 2070-0012
721.10557 2070-0012
721.10558 2070-0012
721.10559 2070-0012
721.10560 2070-0012
721.10561 2070-0012
721.10562 2070-0012
721.10563 2070-0012
721.10564 2070-0012
721.10565 2070-0012
721.10566 2070-0012
721.10567 2070-0012
721.10568 2070-0012
721.10569 2070-0012
721.10570 2070-0012
721.10571 2070-0012
721.10572 2070-0012
721.10573 2070-0012
721.10574 2070-0012
721.10575 2070-0012
721.10576 2070-0012
721.10577 2070-0012
721.10578 2070-0012
721.10579 2070-0012
721.10580 2070-0012
721.10581 2070-0012
721.10582 2070-0012
721.10583 2070-0012
721.10584 2070-0012
721.10585 2070-0012
721.10586 2070-0012
721.10587 2070-0012
721.10588 2070-0012
721.10589 2070-0012
721.10590 2070-0012
721.10591 2070-0012
721.10592 2070-0012
721.10593 2070-0012
721.10594 2070-0012
721.10595 2070-0012
721.10596 2070-0012
721.10597 2070-0012
721.10598 2070-0012
721.10599 2070-0012
721.10600 2070-0012
721.10601 2070-0012
721.10602 2070-0012
721.10603 2070-0012
721.10604 2070-0012
721.10605 2070-0012
721.10606 2070-0012
721.10607 2070-0012
721.10608 2070-0012
721.10609 2070-0012
721.10610 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 § 721.10426 to subpart E to read as follows:

§ 721.10426 1-Octadecanol, manuf. of, distn. lights, fractionation heavies, distn. lights.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-octadecanol, manuf. of, distn. lights, fractionation heavies, distn. lights (PMN P-00-535; CAS No. 243640-46-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(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.

5.Add § 721.10537 to subpart E to read as follows:

§ 721.10537 Acrylate ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acrylate ester (PMN P-01-579) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=50).

(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.

6.Add § 721.10538 to subpart E to read as follows:

§ 721.10538 Phosphonium, tetrakis(hydroxymethyl)-, chloride (1:1), reaction products with 1-tetradecanamine and urea.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphonium, tetrakis(hydroxymethyl)-, chloride (1:1), reaction products with 1-tetradecanamine and urea (PMN P-02-161; CAS No. 359406-89-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 2).

(ii) [Reserved]

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

(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.

7.Add § 721.10539 to subpart E to read as follows:

§ 721.10539 Bis[phenyl-2H-1,3-benzoxazine]derivative (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as bis[phenyl-2H-1,3-benzoxazine]derivative (PMN P-02-653) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(ii) [Reserved]

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 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 § 721.10540 to subpart E to read as follows:

§ 721.10540 1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3-benzenedimethanamine, N-(2-phenylethyl) derivs. (PMN P-02-984; CAS No. 404362-22-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=5).

(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.

9.Add § 721.10541 to subpart E to read as follows:

§ 721.10541 5,2,6-(Iminomethenimino)-1H-imidazo[4,5-b]pyrazine, octahydro-1,3,4,7,8,10-hexanitro-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 5,2,6-(iminomethenimino)-1H-imidazo[4,5-b]pyrazine, octahydro-1,3,4,7,8,10-hexanitro- (PMN P-03-481; CAS No. 135285-90-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (b)(concentration set at 0.1 percent), and (c). The following respirator meets the requirements of § 721.63(a)(4): a National Institute for Occupational Safety and Health (NIOSH)-certified air purifying respirator with a particulate P100 vapor cartridge or canister.

(ii) Release to water. Requirements as specified in § 721.90 (a)(2)(v), (b)(2)(v), and (c)(2)(v).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), and (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.

10.Add § 721.10542 to subpart E to read as follows:

§ 721.10542 Dodecanedioic acid, 1,12-dimethyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as dodecanedioic acid, 1,12-dimethyl ester (PMN P-03-624; CAS No. 1731-79-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=30).

(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.

11.Add § 721.10543 to subpart E to read as follows:

§ 721.10543 Oxetane, 3-methyl-3-[(2,2,3,3,3-pentafluoropropoxy)methyl]-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxetane, 3-methyl-3-[(2,2,3,3,3-pentafluoropropoxy)methyl]- (PMN P-04-79; CAS No. 449177-94-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b)(concentration set at 0.1 percent), and (c).

(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) through (e) 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.

12.Add § 721.10544 to subpart E to read as follows:

§ 721.10544 Oxetane, 3-methyl-3-[[(3,3,4,4,5,5,6,6,6-nonafluorohexyl)oxy]methyl]-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxetane, 3-methyl-3-[[(3,3,4,4,5,5,6,6,6-nonafluorohexyl)oxy]methyl]- (PMN P-04-80; CAS No. 475678-78-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN after it has been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (b)(concentration set at 0.1 percent), and (c).

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e)(concentration set at 0.1 percent), (f), (g)(1)(vi), (g)(1)(viii), (g)(2)(i), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(ii), and (g)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q).

(iv) 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), (e), (f), (g), (h), (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 (a)(2)(iii) of this section.

13.Add § 721.10545 to subpart E to read as follows:

§ 721.10545 Aminotriazine modified cresol novolec resin (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aminotriazine modified cresol novolec resin (PMN P-04-313) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 10).

(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.

14.Add § 721.10546 to subpart E to read as follows:

§ 721.10546 Pentenylated polyethylene glycol sulfate salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as pentenylated polyethylene glycol sulfate salt (PMN P-04-340) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(ii) [Reserved]

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

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

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

15.Add § 721.10547 to subpart E to read as follows:

§ 721.10547 Dialkyl dimethyl ammonium methylcarbonate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dialkyl dimethyl ammonium methylcarbonate (PMN P-04-587) 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(g).

(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.

16.Add § 721.10548 to subpart E to read as follows:

§ 721.10548 Mixed alkyl phosphate esters alkoxylated (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed alkyl phosphate esters alkoxylated (PMN P-04-624) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 40).

(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.

17.Add § 721.10549 to subpart E to read as follows:

§ 721.10549 Ethane, 1,1,2,2-tetrafluoro-1-(2,2,2-trifluoroethoxy)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as ethane, 1,1,2,2-tetrafluoro-1-(2,2,2-trifluoroethoxy)- (PMN P-04-635; CAS No. 406-78-0) 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 (f), (j)(cleaning electronic components; precision cleaning; dewatering of electronic components and other parts following aqueous cleaning; and carrier/lubricant coating for hard disk drives and other precision parts), and (l).

(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.

18.Add § 721.10550 to subpart E to read as follows:

§ 721.10550 Rare earth salt of a carboxylic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as rare earth salt of a carboxylic acid (PMN P-05-324) 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 = 5).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (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 (a)(2)(i) of this section.

19.Add § 721.10551 to subpart E to read as follows:

§ 721.10551 Bisphenol S mono ether (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as bisphenol S mono ether (PMN P-05-613) 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 (f) and (j).

(ii) Release to water. Requirements as specified in § 721.90 (b)(4) and (c)(4) (N=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), (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 (a)(2)(i) of this section.

20.Add § 721.10552 to subpart E to read as follows:

§ 721.10552 Oxirane, 2-(1-chlorocyclopropyl)-2-[(2-chlorophenyl)methyl]-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2-(1-chlorocyclopropyl)-2-[(2-chlorophenyl)methyl]- (PMN P-05-774; CAS No. 134818-68-1) 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) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b)(concentration set at 0.1 percent), and (c).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(h).

(iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=2).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), (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.

21.Add § 721.10553 to subpart E to read as follows:

§ 721.10553 Potassium titanium oxide.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as potassium titanium oxide (PMN P-06-149; CAS No. 12673-69-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance that have been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4) and (a)(6)(i). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose- fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(1) As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.5 mg/m [3] . Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under 40 CFR 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order.

(2) [Reserved]

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv)(use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 1.5 mg/m [3] ), and (a)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (k)(manufacture of the substance with a particle size of at least 100 nanometers).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (f), (g), (h), 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.

22.Add § 721.10554 to subpart E to read as follows:

§ 721.10554 Iso-tridecanol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as iso-tridecanol (PMN P-06-153) 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(k) (manufacture of the PMN substance with no greater than an average of three branches per alkyl unit, and routine analysis of representative samples for compliance with the chemical composition section of the consent order).

(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.

23.Add § 721.10555 to subpart E to read as follows:

§ 721.10555 Benzoic acid nonyl ester, branched and linear.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzoic acid nonyl ester, branched and linear (PMN P-06-370; CAS No. 670241-72-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b)(concentration set at 0.1 percent), and (c).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f).

(iii) Release to water. Requirements as specified in § 721.90 (b)(4) and (c)(4) (N=6).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), (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.

24.Add § 721.10556 to subpart E to read as follows:

§ 721.10556 Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 12-15-alkyl ethers (PMN P-06-450; CAS No. 675869-02-0) 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(s)(45,000 kilograms cumulative production volume of: Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 12-15-alkyl ethers (PMN P-06-450; CAS No. 675869-02-00); Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 10-16-alkyl ethers (PMN P-06-451; CAS No. 620610-66-4); and Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 12-16-alkyl ethers (PMN P-06-452; CAS No. 675869-05-3)).

(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.

25.Add § 721.10557 to subpart E to read as follows:

§ 721.10557 Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 10-16-alkyl ethers (PMN P-06-451; CAS No. 620610-66-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(s)(45,000 kilograms cumulative production volume of: Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 12-15-alkyl ethers (PMN P-06-450; CAS No. 675869-02-00); Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 10-16-alkyl ethers (PMN P-06-451; CAS No. 620610-66-4); and Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 12-16-alkyl ethers (PMN P-06-452; CAS No. 675869-05-3)).

(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.

26.Add § 721.10558 to subpart E to read as follows:

§ 721.10558 Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 12-16-alkyl ethers (PMN P-06-452; CAS No. 675869-05-3) 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(s)(45,000 kilograms cumulative production volume of: Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 12-15-alkyl ethers (PMN P-06-450; CAS No. 675869-02-00); Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 10-16-alkyl ethers (PMN P-06-451; CAS No. 620610-66-4); and Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C 12-16-alkyl ethers (PMN P-06-452; CAS No. 675869-05-3)).

(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.

27.Add § 721.10559 to subpart E to read as follows:

§ 721.10559 Morpholine, 4-C

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as morpholine, 4-C 6-12 acyl derivs. (PMN P-06-793; CAS No. 887947-29-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b)(concentration set at 0.1 percent), and (c).

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e)(concentration set at 0.1 percent), (f), (g)(1)(systemic effects), (g)(2)(i), and (g)(2)(v).

(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) through (h) 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.

28.Add § 721.10560 to subpart E to read as follows:

§ 721.10560 Alkanoldioic dialkyl esters (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as alkanoldioic dialkyl esters (PMNs P-07-143 and P-07-144) 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) 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 these substances.

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

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to (a)(2)(i) of this section.

29.Add § 721.10561 to subpart E to read as follows:

§ 721.10561 Substituted phenol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted phenol (PMN P-07-327) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Hazard communication program. Requirements as specified as § 721.72 (a), (b), (c), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).

(ii) Industrial, commercial, and consumer activities. Requirements as specified as § 721.80(q).

(iii) Release to water. Requirements as specified as § 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), (f), (g), (h), (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 (a)(2)(ii) of this section.

30.Add § 721.10562 to subpart E to read as follows:

§ 721.10562 Aluminum trihydrate and silane homopolymer (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aluminum trihydrate and silane homopolymer (PMN P-07-375) 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(s)(100,000 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.

31.Add § 721.10563 to subpart E to read as follows:

§ 721.10563 2-Oxiranemethanamine, N-[3-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-oxiranemethanamine, N-[3-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)- (PMN P-07-496; CAS No. 71604-74-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b)(concentration set at 0.1 percent), and (c).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j)(preparation of pre-impregnated cloth/fiber tapes for aerospace composite articles).

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

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

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

32.Add § 721.10564 to subpart E to read as follows:

§ 721.10564 Mixed amino diaryl sulfone isomers (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed amino diaryl sulfone isomers (PMN P-08-39) 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 (o), (v)(1), (w)(1), and (x)(1).

(ii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=8).

(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.

33.Add § 721.10565 to subpart E to read as follows:

§ 721.10565 Ethanol, 2,2′-[[3-[(2-hydroxyethyl)amino]propyl]imino]bis-, N-(hydrogenated tallow alkyl) derivs.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as ethanol, 2,2′-[[3-[(2-hydroxyethyl)amino]propyl]imino]bis-, N-(hydrogenated tallow alkyl) derivs. (PMN P-08-263; CAS No. 90367-25-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(ii) [Reserved]

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

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

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

34.Add § 721.10566 to subpart E to read as follows:

§ 721.10566 1-Propanamine, N-(1-methylethyl) -,3-(C

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-propanamine, N- (1-methylethyl)-,3- (C 12-15-alkyloxy) derivs (PMN P-08-292; CAS No. 944835-56-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(ii) [Reserved]

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

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

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

35.Add § 721.10567 to subpart E to read as follows:

§ 721.10567 Amidoamine salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as amidoamine salt (PMN P-08-300) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(ii) [Reserved]

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

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

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

36.Add § 721.10568 to subpart E to read as follows:

§ 721.10568 Diethanolamine salt of polymeric acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as diethanolamine salt of polymeric acid (PMN P-08-464) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(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.

37.Add § 721.10569 to subpart E to read as follows:

§ 721.10569 Tricyclic quaternary amine salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tricyclic quaternary amine salt (PMN P-08-471) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=100).

(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.

38.Add § 721.10570 to subpart E to read as follows:

§ 721.10570 Cyclic amine reaction product with acetophenone and formaldehyde acid salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cyclic amine reaction product with acetophenone and formaldehyde acid salt (PMN P-08-537) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=8).

(ii) [Reserved]

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), 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.

39.Add § 721.10571 to subpart E to read as follows:

§ 721.10571 1,3-Benzenediol, polymer with 1,1'-methylenebis[isocyanatobenzene].

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3-benzenediol, polymer with 1,1'-methylenebis[isocyanatobenzene] (PMN P-08-611; CAS No. 1008753-84-1) 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)(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=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), (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 (a)(2)(i) of this section.

40.Add § 721.10572 to subpart E to read as follows:

§ 721.10572 Benzamide, N-[[4-[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxy-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzamide, N-[[4-[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxy- (PMN P-08-680; CAS No. 221667-31-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(i), (b)(concentration set at 0.1 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e)(concentration set at 0.1 percent), (f), (g)(1)(iv), (g)(2)(iv), and (g)(2)(v).

(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) through (h) 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.

41.Add § 721.10573 to subpart E to read as follows:

§ 721.10573 Magnesium hydroxide surface treated with substituted alkoxysilanes (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as magnesium hydroxide surface treated with substituted alkoxysilanes (PMN P-08-737) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (b)(concentration set at 0.1 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Hazard communication program. Requirements as specified in § 72l.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent), (f), (g)(l)(ii), (g)(l)(viii), and (g)(2)(iv).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(s) (100,000 kilograms).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (f), (g), (h), 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.

42.Add § 721.10574 to subpart E to read as follows:

§ 721.10574 Alkylcarboxy polyester acrylate reaction products with mixed metal oxides (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylcarboxy polyester acrylate reaction products with mixed metal oxides (PMN P-09-48) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance after it has been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), and (a)(3).

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (f), (g)(1)(ii), (g)(1)(iv), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(v), (g)(4)(i), (g)(4)(iii), and (g)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified § 721.80 (a) (if used in the form of a powder), (b) (if manufactured in the form of a powder), (c) (if processed in the form of a powder), (k) (transport to processors using only reusable tote tanks cleaned not more than once per year), (y)(1), and (y)(2).

(iv) Disposal. Requirements as specified in § 721.85 (a)(1), (b)(1), (c)(1), and (d)(recycling of use waste stream via polymer reclamation as an alternative to incineration). (All incineration shall be via Resource Conservation and Recovery Act (RCRA) approved hazardous waste incineration).

(v) 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) through (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 (a)(2)(iii) of this section.

43.Add § 721.10575 to subpart E to read as follows:

§ 721.10575 1-Propanone, 1,1'-(oxydi-4,1-phenylene)bis[2-hydroxy-2-methyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-propanone, 1,1'-(oxydi-4,1-phenylene)bis[2-hydroxy-2-methyl- (PMN P-09-480; CAS No. 71868-15-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (b) (concentration set at 0.1 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 50 satisfy the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Hazard communication program. Requirements as specified in § 72l.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(vi), (g)(2)(ii), (g)(2)(iv), and (g)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f).

(iv) Release to water. Requirements as specified in § 721.90 (b)(4) and (c)(4) (N=14).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (f), (g), (h), (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.

44.Add § 721.10576 to subpart E to read as follows:

§ 721.10576 Polyalkenyl, N,N'-bistriazole (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyalkenyl, N,N'-bistriazole (PMN P-09-486) 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 (a)(2)(i) of this section.

45.Add § 721.10577 to subpart E to read as follows:

§ 721.10577 Benzenamine, 5-(1,1-dimethylethyl)-2-[(2-ethylhexyl)thio]-,4-methylbenzenesulfonate (1:1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzenamine, 5-(1,1-dimethylethyl)-2-[(2-ethylhexyl)thio]-,4-methylbenzenesulfonate (1:1) (PMN P-09-636; CAS No. 852360-51-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance after it has been completely reacted (cured).

(2) The significant new uses are:

(i) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (f), (g)(1)(ix), (g)(2)(ii), (g)(2)(iii), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (h) and (p)(15,000 kilograms, 170,000 kilograms, and 496,000 kilograms).

(iii) 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), (f), (g), (h), (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.

46.Add § 721.10578 to subpart E to read as follows:

§ 721.10578 Unsaturated polyester imide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as unsaturated polyester imide (PMN P-10-231) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 52).

(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.

47.Add § 721.10579 to subpart E to read as follows:

§ 721.10579 Carbon black derived from the pyrolysis of rubber tire shreds (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbon black derived from the pyrolysis of rubber tire shreds (PMN P-10-367) 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 (k)(Manufacture of the PMN substance using only the process described in PMN; manufacturing, processing, or use of the PMN substance in compliance with the Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (PEL) for carbon black of 3.5 mg/m [3] ; and manufacture of the PMN substance to meet the NIOSH recommended time weighted average (TWA) for polyaromatic hydrocarbons (PAH) in carbon black of 0.1 mg/m [3] ); and (q).

(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), (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 (a)(2)(i) of this section.

48.Add § 721.10580 to subpart E to read as follows:

§ 721.10580 Poly[oxy(methyl-1,2-ethanediyl)], alpha, alpha′-[1,4-cyclohexanediylbis(methylene)]bis[omega-(2-aminomethylethoxy)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly[oxy(methyl-1,2-ethanediyl)], alpha, alpha′-[1,4-cyclohexanediylbis(methylene)]bis[omega-(2-aminomethylethoxy)- (PMN P-10-452; CAS No. 1220986-58-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 98).

(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.

49.Add § 721.10581 to subpart E to read as follows:

§ 721.10581 Brominated polyurethane prepolymers of methylene diphenyl diisocyanate (MDI) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as brominated polyurethane prepolymers of methylene diphenyl diisocyanate (MDI) (PMNs P-10-524 and P-10-525) 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) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b)(concentration set at 0.1 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose- fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o).

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

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

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

50.Add § 721.10582 to subpart E to read as follows:

§ 721.10582 Quaternary ammonium compound (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as quaternary ammonium compound (PMN P-10-571) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 47).

(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.

51.Add § 721.10583 to subpart E to read as follows:

§ 721.10583 Benzenamine, 4,4′-[1,3-phenylenebis(1-methylethylidene)]bis-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzenamine, 4,4′-[1,3-phenylenebis(1-methylethylidene)]bis- (PMN P-10-588; CAS No. 2687-27-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b)(concentration set at 0.1 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 1,000 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 1).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), and (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.

52.Add § 721.10584 to subpart E to read as follows:

§ 721.10584 Cyclopentene, 1,3,3,4,4,5,5-heptafluoro-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cyclopentene, 1,3,3,4,4,5,5-heptafluoro- (PMN P-11-29; CAS No. 1892-03-1) 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 (f), (j)(dry etching agent for production of semiconductors), (o), and (s) (10,000 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.

53.Add § 721.10585 to subpart E to read as follows:

§ 721.10585 Disiloxane, 1-butyl-1,1,3,3-tetramethyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as disiloxane, 1-butyl-1,1,3,3-tetramethyl- (PMN P-11-43; CAS No. 121263-51-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 1).

(ii) [Reserved]

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

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

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

54.Add § 721.10586 to subpart E to read as follows:

§ 721.10586 Disiloxane, 1,3-dibutyl-1,1,3,3-tetramethyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as disiloxane, 1,3-dibutyl-1,1,3,3-tetramethyl- (PMN P-11-44; CAS No. 4619-08-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 1).

(ii) [Reserved]

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

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

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

55.Add § 721.10587 to subpart E to read as follows:

§ 721.10587 1H-Pyrazole, 3,4-dimethyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1H-pyrazole, 3,4-dimethyl- (PMN P-11-81; CAS No. 2820-37-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 19).

(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.

56.Add § 721.10588 to subpart E to read as follows:

§ 721.10588 Phenol, 2-[1-[[3-(1H-imidazol-1-yl)propyl]imino]ethyl]-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phenol, 2-[1-[[3-(1H-imidazol-1-yl)propyl]imino]ethyl]- (PMN P-11-98; CAS No. 1253404-90-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

57.Add § 721.10589 to subpart E to read as follows:

§ 721.10589 Unsaturated fatty acids, amides with polyethylenepolyamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as unsaturated fatty acids, amides with polyethylenepolyamine (PMN P-11-106) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(ii) [Reserved]

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

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

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

58.Add § 721.10590 to subpart E to read as follows:

§ 721.10590 Fatty acids, amides with triethylentetramine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, amides with triethylentetramine (PMN P-11-107) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(ii) [Reserved]

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

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

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

59.Add § 721.10591 to subpart E to read as follows:

§ 721.10591 Tertiary ammonium compound (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tertiary ammonium compound (PMN P-11-110) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(ii) [Reserved]

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

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

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

60.Add § 721.10592 to subpart E to read as follows:

§ 721.10592 1-Butanol, 4-amino-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-butanol, 4-amino- (PMN P-11-130; CAS No. 13325-10-5) 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(g).

(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.

61.Add § 721.10593 to subpart E to read as follows:

§ 721.10593 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 5-isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester (PMN P-11-162; CAS No. 70293-55-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=20).

(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.

62.Add § 721.10594 to subpart E to read as follows:

§ 721.10594 Hexanedioic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,6-hexanediol, hydrazine, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and 1,1′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis[2-propanol], iso-Bu alc.-blocked, compds. with triethylamine.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as hexanedioic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,6-hexanediol, hydrazine, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and 1,1′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis[2-propanol], iso-Bu alc.-blocked, compds. with triethylamine (PMN P-11-173; CAS No. 1138156-39-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=150) (Where primary, secondary, and tertiary waste treatment will occur, or treatment in a lined, self-contained solar evaporation pond where ultraviolet light will degrade the substance, the number of kilograms per day per site is calculated after wastewater treatment).

(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.

63.Add § 721.10595 to subpart E to read as follows:

§ 721.10595 Octadecen-1-aminium, N-ethyl-N,N-dimethy-, ethyl sulfate (1:1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as octadecen-1-aminium, N-ethyl-N,N-dimethy-, ethyl sulfate (1:1) (PMN P-11-230; CAS No. 1256282-88-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(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.

64.Add § 721.10596 to subpart E to read as follows:

§ 721.10596 Oligomeric phenolic ether (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as oligomeric phenolic ether (PMN P-11-234) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(ii) [Reserved]

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

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

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

65.Add § 721.10597 to subpart E to read as follows:

§ 721.10597 Benzeneacetonitrile, alkoxy-[[(alkylsulfonyl)oxy]imino]- (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as benzeneacetonitrile, alkoxy-[[(alkylsulfonyl)oxy]imino]- (PMN P-11-252) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(ii) [Reserved]

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

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

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

66.Add § 721.10598 to subpart E to read as follows:

§ 721.10598 Lead strontium titanium zirconium oxide.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as lead strontium titanium zirconium oxide (PMN P-11-270; CAS No. 61461-40-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 50 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (piezoelectric ceramics for active and passive underwater acoustic systems).

(iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (Where N=8, and 8 is an aggregate of releases for the following substances: Lead strontium titanium zirconium oxide (PMN P-11-270; CAS No. 61461-40-3); Calcium cobalt lead titanium tungsten oxide (PMN P-11-271; CAS No. 1262279-31-1); Calcium cobalt lead strontium titanium tungsten oxide (PMN P-11-272; CAS No. 1262279-30-0); Lanthanum lead titanium zirconium oxide (PMN P-11-273; CAS No. 1227908-26-0); and Lead niobium titanium zirconium oxide (PMN P-11-274; CAS No. 56572-83-9)).

(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.

67.Add § 721.10599 to subpart E to read as follows:

§ 721.10599 Calcium cobalt lead titanium tungsten oxide.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as calcium cobalt lead titanium tungsten oxide (PMN P-11-271; CAS No. 1262279-31-1) 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) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 50 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (piezoelectric ceramics for active and passive underwater acoustic systems).

(iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (Where N=8, and 8 is an aggregate of releases for the following substances: Lead strontium titanium zirconium oxide (PMN P-11-270; CAS No. 61461-40-3); Calcium cobalt lead titanium tungsten oxide (PMN P-11-271; CAS No. 1262279-31-1); Calcium cobalt lead strontium titanium tungsten oxide (PMN P-11-272; CAS No. 1262279-30-0); Lanthanum lead titanium zirconium oxide (PMN P-11-273; CAS No. 1227908-26-0); and Lead niobium titanium zirconium oxide (PMN P-11-274; CAS No. 56572-83-9)).

(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.

68.Add § 721.10600 to subpart E to read as follows:

§ 721.10600 Calcium cobalt lead strontium titanium tungsten oxide.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as calcium cobalt lead strontium titanium tungsten oxide (PMN P-11-272; CAS No. 1262279-30-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 50 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (piezoelectric ceramics for active and passive underwater acoustic systems).

(iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (Where N=8, and 8 is an aggregate of releases for the following substances: Lead strontium titanium zirconium oxide (PMN P-11-270; CAS No. 61461-40-3); Calcium cobalt lead titanium tungsten oxide (PMN P-11-271; CAS No. 1262279-31-1); Calcium cobalt lead strontium titanium tungsten oxide (PMN P-11-272; CAS No. 1262279-30-0); Lanthanum lead titanium zirconium oxide (PMN P-11-273; CAS No. 1227908-26-0); and Lead niobium titanium zirconium oxide (PMN P-11-274; CAS No. 56572-83-9)).

(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.

69.Add § 721.10601 to subpart E to read as follows:

§ 721.10601 Lanthanum lead titanium zirconium oxide.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as lanthanum lead titanium zirconium oxide (PMN P-11-273; CAS No. 1227908-26-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 50 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (piezoelectric ceramics for active and passive underwater acoustic systems).

(iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (Where N=8, and 8 is an aggregate of releases for the following substances: Lead strontium titanium zirconium oxide (PMN P-11-270; CAS No. 61461-40-3); Calcium cobalt lead titanium tungsten oxide (PMN P-11-271; CAS No. 1262279-31-1); Calcium cobalt lead strontium titanium tungsten oxide (PMN P-11-272; CAS No. 1262279-30-0); Lanthanum lead titanium zirconium oxide (PMN P-11-273; CAS No. 1227908-26-0); and Lead niobium titanium zirconium oxide (PMN P-11-274; CAS No. 56572-83-9)).

(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.

70.Add § 721.10602 to subpart E to read as follows:

§ 721.10602 Lead niobium titanium zirconium oxide.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as lead niobium titanium zirconium oxide (PMN P-11-274; CAS No. 56572-83-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 50 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (piezoelectric ceramics for active and passive underwater acoustic systems).

(iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (Where N=8, and 8 is an aggregate of releases for the following substances: Lead strontium titanium zirconium oxide (PMN P-11-270; CAS No. 61461-40-3); Calcium cobalt lead titanium tungsten oxide (PMN P-11-271; CAS No. 1262279-31-1); Calcium cobalt lead strontium titanium tungsten oxide (PMN P-11-272; CAS No. 1262279-30-0); Lanthanum lead titanium zirconium oxide (PMN P-11-273; CAS No. 1227908-26-0); and Lead niobium titanium zirconium oxide (PMN P-11-274; CAS No. 56572-83-9)).

(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.

71.Add § 721.10603 to subpart E to read as follows:

§ 721.10603 Epoxy modified alkyd resin, partially neutralized (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as epoxy modified alkyd resin, partially neutralized (PMN P-11-280) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(ii) [Reserved]

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

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

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

72.Add § 721.10604 to subpart E to read as follows:

§ 721.10604 Polyetherdiamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyetherdiamine (PMN P-11-447) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(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.

73.Add § 721.10605 to subpart E to read as follows:

§ 721.10605 Polyoxyalkylene ether, polymer with aliphatic diisocyanate, homopolymer, alkanol-blocked (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyoxyalkylene ether, polymer with aliphatic diisocyanate, homopolymer, alkanol-blocked (PMN P-11-485) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (o) and (s) (10,000 kilograms).

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

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

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

74.Add § 721.10606 to subpart E to read as follows:

§ 721.10606 Alkyl substituted alkanediol polymer with aliphatic and alicyclic diisocyanates (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl substituted alkanediol polymer with aliphatic and alicyclic diisocyanates (PMN P-11-486) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (o) and (s) (10,000 kilograms).

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

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

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

75.Add § 721.10607 to subpart E to read as follows:

§ 721.10607 Aliphatic diisocyanate, homopolymer, alkanol-blocked (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aliphatic diisocyanate, homopolymer, alkanol-blocked (PMN P-11-488) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o) and (s) (10,000 kilograms).

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

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

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

76.Add § 721.10608 to subpart E to read as follows:

§ 721.10608 Aliphatic diisocyanate polymer with alkanediol and alkylglycol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aliphatic diisocyanate polymer with alkanediol and alkylglycol (PMN P-11-489) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(C) NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters.

(D) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters.

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (o) and (s) (10,000 kilograms).

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

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

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

77.Add § 721.10609 to subpart E to read as follows:

§ 721.10609 Imidodicarbonic diamide, N,N′-dibutyl-N′,2-bis[4-[(4-isocyanatophenyl)methyl]phenyl]-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as imidodicarbonic diamide, N,N′-dibutyl-N′,2-bis[4-[(4-isocyanatophenyl)methyl]phenyl]-(PMN P-11-548; CAS No. 1254743-03-7) 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 (o) and (y)(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.

78.Add § 721.10610 to subpart E to read as follows:

§ 721.10610 Toluene diisocyanate, polymers with polyalkylene glycol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as toluene diisocyanate, polymers with polyalkylene glycol (PMNs P-11-635 and P-11-636) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (o) and (y)(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 these substances.

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

end regulatory text

[FR Doc. 2012-23993 Filed 10-4-12; 8:45 am]

BILLING CODE P

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