Significant New Use Rules on Certain Chemical Substances

This Rule document was issued by the Environmental Protection Agency (EPA)

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2011-0577; FRL-9343-4]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

Agency

Environmental Protection Agency (EPA).

Action

Direct final rule.

Summary

EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 119 chemical substances which were the subject of premanufacture notices (PMNs). Four of these chemical substances are subject to TSCA consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 119 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.

Dates

This rule is effective on June 26, 2012. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on May 11, 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 May 29, 2012 (see Unit VI. of theSUPPLEMENTARY INFORMATION).

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

Addresses

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2011-0577, 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. Attention: Docket ID Number EPA-HQ-OPPT-2011-0577. 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-2011-0577. 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

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

I. General Information

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. Potentially affected entities may include, but are not limited to:

  • Manufacturers, importers, or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in § 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed underFOR FURTHER INFORMATION CONTACT.

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; see also 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importersof 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 Registerdate 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

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 theFederal Registerissue 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 notice requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), 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 theFederal Registerits reasons for not taking action.

III. Significant New Use Determination

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 119 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, taking into consideration the four bulleted TSCA section 5(a)(2) factors listed in this unit.

IV. Substances Subject to This Rule

EPA is establishing significant new use and recordkeeping requirements for 119 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

  • PMN number.
  • Chemical name (generic name, if the specific name is claimed as CBI).
  • Chemical Abstracts Service (CAS) number (if assigned for non-confidential chemical identities).
  • Basis for the 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 four PMN substances (P-10-470, P-10-471, P-10-472, and P-11-217) for which EPA determined, pursuant to TSCA section 5(e), that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal may present an unreasonable risk of injury to human health and the environment. Accordingly, these substances are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I). 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.

This rule also includes SNURs on 115 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-5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, “(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the SNUR 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, 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.

PMN Numbers P-00-2, P-00-5, and P-00-6

Chemical names: Polymeric MDI based polyurethanes (generic).

CAS numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as internal mold release. Based on ecological structure-activity relationship (EcoSAR) analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 part per billion (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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substances.

CFR citation: 40 CFR 721.10299.

PMN Number P-00-85

Chemical name: Benzeneacetic acid, .alpha.-chloro-.alpha.-phenyl-, ethyl ester.

CAS number: 52460-86-3.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a reaction aid in polymer synthesis. Based on EcoSAR analysis of test data on analogous benzyl halides, 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)(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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10300.

PMN Number P-00-317

Chemical name: Reaction products of fatty alcohols, (aminoethylaminopropyl)dialkoxymethylsilane, glycidol, and hydroxy-terminated polydimethylsiloxane (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a silicone textile treatment. Based on EcoSAR analysis of test data on analogous polycationic polymers, 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 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 exceeding40 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10301.

PMN Number P-00-442

Chemical name: Zinc ammonium phosphate (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a fertilizer. Based on EcoSAR analysis of test data on analogous zinc salts and inorganic phosphates, 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)(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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10302.

PMN Number P-00-833

Chemical name: Polyether modified polysiloxane, acrylated (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a non-dispersive additive. Based on test data on the PMN substance, and EcoSAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 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 4 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 4 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 fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10303.

PMN Number P-00-1099

Chemical name: Functionalized polymethine (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an infra red absorber. Based on EcoSAR analysis of test data on analogous cationic dyes, 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10304.

PMN Number P-00-1108

Chemical name: Modified cyclohexane esters (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a plasticizer. Based on EcoSAR analysis of test data on analogous epoxides, 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) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10305.

PMN Number P-01-114

Chemical name: Substituted phenylepoxide (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a destructive use (i.e., destroyed during process of manufacturing) electric devices. Based on test data on the PMN substance and EcoSAR analysis of test data on analogous epoxides, 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, 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 6 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 fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10306.

PMN Number P-01-343

Chemical name: Acrylate resin (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adhesive coating. Based on EcoSAR analysis of test data on analogous acrylates, 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)(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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10307.

PMN Numbers P-01-384, P-01-385, P-01-386, P-01-387, and P-01-388

Chemical names: (P-01-384) Ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, dialkylethanolamine salt (generic); (P-01-385) Ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate (generic); (P-01-386) Ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, ammonium salt (generic); (P-01-387) Ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, sodium salt (generic); and (P-01-388) Ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, ethanolamine salt (generic).

CAS numbers: Not available.

Basis for action: The consolidated PMN states that the generic (non-confidential) use of the substances will be as colorants for aqueous ink applications. Based on EcoSAR analysis of test data on analogous amphoteric dyes, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 70 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 70 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) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help to characterize the environmental effects of the PMN substances.

CFR citations: 40 CFR 721.10308 (P-01-384); 40 CFR 721.10309 (P-01-385); 40 CFR 721.10310 (P-01-386); 40 CFR 721.10311 (P-01-387); and 40 CFR 721.10312 (P-01-388).

PMN Number P-02-249

Chemical name: Fatty acids, C16-18 and C18-unsatd., Me esters, epoxidized.

CAS number: 158318-67-3.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a raw material for production of polyols. Based on EcoSAR analysis of test data on analogous polyepoxides, 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, 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 8 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10313.

PMN Numbers P-02-778, P-02-779, and P-02-780

Chemical names: Dialkyl dithiocarbamate esters (generic).

CAS numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be used as petroleum additives. EPA identified environmental concerns because the PMN substances may be persistent, bio-accumulative, and toxic (PBT) chemicals, based on physical/chemical properties of the PMN substances, as described in the New Chemicals Program's PBT category (64 FR 60194, November 4, 1999) (FRL-6097-7). EPA estimates that the PMN substances will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. Also, based on EcoSAR analysis of test data on analogous esters, 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 purposeful or predictable release containing the PMN substances into the waters of the United States may cause significant adverse environmental effects since the PMN substances have been characterized by EPA as PBTs. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii) and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT category would help characterize the PBT attributes of the PMN substances.

CFR citation: 40 CFR 721.10314.

PMN Number P-02-833

Chemical name: 1,5-Dioxa-9-azaspiro[5.5]undecane, 3,3,8,8,10,10-hexamethyl-9-[1-[4-(2-oxiranylmethoxy)phenyl]ethoxy]-.

CAS number: 434898-80-3.

Basis for action: The PMN states that the substance will be used as a polymerization initiator for thermoplastics and elastomers. EPA identified environmental concerns because the substance may be a PBT chemical, based on physical/chemical properties of the PMN substance, as described in the New ChemicalsProgram'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 1,000. Also, based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1ppb 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 purposeful or predictable release containing the PMN substance into the waters of the United States may cause significant adverse environmental effects since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(4)(ii) and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT category would help to characterize the PBT attributes of the PMN substance.

CFR citation: 40 CFR 721.10315.

PMN Number P-02-872

Chemical name: Dicyclopentadiene polymer with maleic anhydride and alkyl alcohols (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an open-dispersive use in molding operations. Based on EcoSAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb of the PMN substance in surface waters. As described in the PMN, 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 3 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a determination of the partition coefficient (n-octanol/water) by shake flask method (OPPTS Test Guideline 830.7550), generator column method (OPPTS Test Guideline 830.7560), or estimation by liquid chromatography (OPPTS Test Guideline 830.7570); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10316.

PMN Number P-02-1040

Chemical name: Alkyl phosphate derivative (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a processing aid. Based on EcoSAR analysis of test data on analogous soluble complexes of zinc, such as zinc-phosphate salts, 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, 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 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10317.

PMN Numbers P-02-1078 and P-02-1080

Chemical names: Mannich bases (generic).

CAS numbers: Not available.

Basis for action: The PMNs state that the substances will be used as curatives for epoxy resin to improve chemical resistance. Based on EcoSAR analysis of test data on analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 40 ppb of the PMN substances in surface waters. As described in the PMNs, the substances are not released to surface waters. Therefore, EPA had 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 40 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 porous pot test (OPPTS Test Guideline 835.3220); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substances.

CFR citation: 40 CFR 721.10318.

PMN Number P-03-42

Chemical name: Alkylamides, ethoxylated (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a surfactant. Based on EcoSAR analysis of test data on analogous nonionic 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); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10319.

PMN Number P-03-186

Chemical name: Fatty acid amide (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 test data on analogous nonionic surfactants and neutral organic chemicals, 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, 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 8 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10320.

PMN Number P-03-194

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, adhesive resins, encapsulant resins, and composite resins. EPA has identified environmental concerns because the substance may be a PBT chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemicals Program's PBT category. Also, 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 purposeful or predictable release containing the substance into the waters of the United States may cause significant adverse environmental effects since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii) and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT category would help characterize the PBT attributes of the PMN substance. 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10321.

PMN Number P-03-196

Chemical name: Metallic diol (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an additive for coatings, inks, adhesives, and composites. Based on EcoSAR analysis of test data on analogous zinc compounds, 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, the substance is not expected to be released to surface waters in concentrations that exceed 6 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 releases to surface waters exceeding 6 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10322.

PMN Number P-03-248

Chemical name: Glycerol fatty acid 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 plastic film additive. Based on EcoSAR analysis of test data on analogous nonionic surfactants, 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, the substance is not released to surface waters. 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 6 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 study (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity study (OPPTS Test Guideline 850.1300); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10323.

PMN Number P-03-362

Chemical name: Thionocarbamate derivative (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a sulfide mineral processing reagent. Based on test data on the PMN substance, 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, the substance is not expected to be released to surface waters in 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)(i).

Recommended testing: EPA has determined that the results of a porous pot test (OPPTS Test Guideline 835.3220) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10324.

PMN Number P-03-442

Chemical name: Cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me,Me hydrogen silazanes, reaction products with 3-(triethoxysilyl)-1-propanamine.

CAS number: 475645-84-2.

Basis for action: The PMN states that the substance will be used as a coating material. Based on EcoSAR analysis of test data on analogous polycationic polymers, 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, 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 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10325.

PMN Number P-03-458

Chemical name: 2-Propenoic acid, 2-methyl-, methyl ester, polymer with butyl 2-propenoate, ethyl 2-propenoate, zinc 2-methyl-2-propenoate (1:2) and zinc 2-propenoate (1:2), 2,2′-(1,2-diazenediyl)bis[2-methylbutanenitrile]- and 2,2′-(1,2-diazenediyl)bis[2-methylpropanenitrile]-initiated.

CAS number: 460739-39-3.

Basis for action: The PMN states that the substance will be used as a binder polymer in paints. Based on EcoSAR analysis of test data on analogous soluble complexes of zinc, 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, the substance is not released to surface water. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10326.

PMN Numbers P-03-529, P-03-530, and P-03-531

Chemical names: (P-03-529) Salt of mixed fatty amidoamines and polyethylenepolyamines (generic); (P-03-530) Salt of polyalkylenepolyamine derivative (generic); and (P-03-531) Salt of mixed fatty amidoamines (generic).

CAS numbers: Not available.

Basis for action: The consolidated PMN states that the generic (non-confidential) use of the substances will be as processing aids. Based on EcoSAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 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 10 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 porous pot test (OPPTS Test Guideline 835.3220) would help to characterize the environmental fate of the PMN substances.

CFR citations: 40 CFR 721.10327 (P-03-529); 40 CFR 721.10328 (P-03-530); and 40 CFR 721.10329 (P-03-531).

PMN Number P-03-722

Chemical name: Pyrazolone derivative (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a dye for use in thermal transfer printing systems. EPA has identified environmental concerns because the substance may be a PBT chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemicals Program's PBT category. Also, based on test data on the PMN substance and EcoSAR analysis of test data on analogous hydrazines, EPA predicts toxicity to aquatic organisms at surface water 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 release to surface waters may cause significant adverse environmental effects since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(4)(i), (b)(4)(ii), and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT category would help characterize the PBT attributes of the PMN substance. 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10330.

PMN Number P-03-767

Chemical name: Aromatic isocyanate methacrylate blocked (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a component in composite formulations. Based on EcoSAR analysis of test data on analogous methacrylates and esters, 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 chronictoxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10331.

PMN Number P-03-824

Chemical name: Lithium metal phosphate (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an electrode material. 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10332.

PMN Number P-03-840

Chemical name: Substituted benzamine thio-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 raw material. Based on EcoSAR analysis of test data on analogous anilines, 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 PMN 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10333.

PMN Number P-03-861

Chemical name: Ethanol, 2,2′-[(3-[(2-ethylhexyl)oxy]pentyl]imino]bis-.

CAS number: 284477-82-3.

Basis for action: The PMN states that the substance will be used as an intermediate, emulsifier for industrial textile softening, and an industrial dye additive. Based on EcoSAR analysis of test data on analogous aliphatic amines, 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, 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 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10334.

PMN Number P-03-862

Chemical name: 1-Pentanamine, 3-[(2-ethylhexyl)oxy]-.

CAS number: 174615-16-8.

Basis for action: The PMN states that the substance will be used as a surfactant intermediate. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 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 7 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 7 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10335.

PMN Number P-04-1

Chemical name: Poly(oxy-1,2-ethanediyl), .alpha.-(1-oxo-2-propen-1-yl)-.omega.-([1,1′-biphenyl]-2-yloxy)-.

CAS number: 72009-86-0.

Basis for action: The PMN states that the substance will be used as an ultra violet (UV)-curable additive for optical lens. Based on EcoSAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb of the PMN substance in surface waters. As described in the PMN, 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 3 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a 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, tiers I and II (OPPTS Test Guideline 850.5400) wouldhelp to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10336.

PMN Number P-04-6

Chemical name: Copper, iodotris(triphenylphosphine)-, (T-4)-.

CAS number: 15709-82-7.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an additive. EPA has identified environmental concerns because the substance may be a PBT chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemicals Program's PBT category. EPA estimates that the PMN substance will persist in the environment for more than six months and estimates a bioaccumulation factor of greater than or equal to 1,000. In addition, based on test data on the PMN substance and EcoSAR analysis of analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 60 ppb of the PMN substance in surface water. 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 PMN substance may present an unreasonable risk. EPA has determined, however, that any purposeful or predictable release containing the PMN substance into the waters of the United States may cause serious significant adverse environmental effects since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(4)(i), (b)(4)(ii), and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT category would help characterize the PBT attributes of the PMN substance.

CFR citation: 40 CFR 721.10337.

PMN Number P-04-53

Chemical name: 2-Propenoic acid, 1,1′-(1,9-nonanediyl) ester.

CAS number: 107481-28-7.

Basis for action: The PMN states that the substance will be used as a UV-curable monomer for optical lens. Based on EcoSAR analysis of test data on analogous acrylates, 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)(ii).

Recommended testing: EPA has determined that the results a fish acute toxicity study (OPPTS Test Guideline 850.1075); a daphnid acute toxicity study (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10338.

PMN Number P-04-113

Chemical name: Adipic acid, substituted propane, alkyldiol, acrylate (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an open non-dispersive acrylate resin. Based on EcoSAR analysis of test data on analogous acrylates and esters, 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10339.

PMN Number P-04-146

Chemical name: Potassium zinc fluoride (KZnF 3).

CAS number: 13827-02-6.

Basis for action: The PMN states that the substance will be used as a flux for brazing aluminum. Based on EcoSAR analysis of test data on analogous zinc compounds, 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)(ii).

Recommended testing: EPA has determined that 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10340.

PMN Number P-04-338

Chemical name: Amino alkyl organoborane (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 catalyst/initiator for thermosetting acrylic adhesive. Based on EcoSAR analysis of test data on analogous aminoborane, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 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 7 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10341.

PMN Number P-04-516

Chemical name: Quaternary ammonium compounds, fatty alkyl dialkyl hydroxide (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a fuel additive. Based on EcoSAR analysis of test data on analogous 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); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10342.

PMN Number P-04-563

Chemical name: Alkylated aryloxyaniline thiourea (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a pesticide intermediate. EPA identified environmental concerns because the PMN substance may be a PBTchemical based on physical/chemical properties of the PMN substance as described in the New Chemicals Program's PBT category. EPA estimates that the PMN substance will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 5,000. Also, based on EcoSAR analysis of test data on analogous neutral organics and isocyanates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the substance in surface waters. According to the scenario 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 purposeful or predictable release containing the substance into the waters of the United States may cause significant environmental effects since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(4)(ii) and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT category would help characterize the PBT attributes of the PMN substance.

CFR citation: 40 CFR 721.10343.

PMN Number P-04-810

Chemical name: Alkylated aromatic isothiocyanate (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an insecticide intermediate. EPA identified environmental concerns because the PMN substance may be a PBT chemical based on physical/chemical properties of the PMN substance, as described in the New Chemicals Program's PBT category. EPA estimates that the PMN substance will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 5,000. Also, based on EcoSAR analysis of test data on analogous neutral organics and isocyanates, EPA predicts toxicity to aquatic organisms at concentrations that exceed 1,000 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 purposeful or predictable release containing the substance into the waters of the United States may cause significant environmental effects since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(4)(ii) and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT category would help characterize the PBT attributes of the PMN substance.

CFR citation: 40 CFR 721.10344.

PMN Number P-05-110

Chemical name: 1,2-Benzenedicarboxylic acid, 1,2-bis(methylcyclohexyl) ester.

CAS number: 27987-25-3.

Basis for action: The PMN states that the substance will be used as a plastic softener. Based on EcoSAR analysis of test data on analogous esters, EPA predicts that 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10345.

PMN Number P-05-599

Chemical name: 3H-Indolium, 2-[2-[2-chloro-3-[2-(1,3-dihydro-3,3-dimethyl-1-propyl-2H-indol-2-ylidene)ethylidene]-1-cyclohexen-1-yl]ethenyl]-3,3-dimethyl-1-propyl-, iodide (1:1).

CAS number: 207399-07-3.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an additive for coating compositions. Based on EcoSAR analysis of test data on analogous cationic dyes, 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 will 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 had determined that the results of a Zahn-Wellens/EMPA test (OPPTS Test Guideline 835.3200); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10346.

PMN Number P-06-268

Chemical name: Bicyclo[2.2.1]heptanedimethanamine, N,N′-bis(1,2-dimethylpropylidene)-.

CAS number: 664980-30-7.

Basis for action: The PMN states that the substance will be used as a curing agent for epoxides and urethanes. Based on EcoSAR analysis of test data on analogous aliphatic amines, 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, 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 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 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.

CFR citation: 40 CFR 721.10347.

PMN Numbers P-06-623 and P-06-624

Chemical names: Aspartic acid, N,N′-(iminodi-alkanediyl)bis, tetraalkane esters (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 industrial coatings. Based on EcoSAR analysis of test data on analogous aliphatic amines and esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 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 3 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 ready biodegradation test (OPPTS Test Guideline 835.3100); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substances.

CFR citation: 40 CFR 721.10348.

PMN Number P-06-731

Chemical name: 1,4-Benzenediamine, N′-(alkyl)-N-[4-[(alkyl)amino]phenyl]-N-phenyl- (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be used as an open, non-dispersive resin. Based on EcoSAR analysis of test data on analogous cationic dyes, 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, 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10349.

PMN Number P-06-742

Chemical name: Amines, C11-14-branched and linear alkyl.

CAS number: 863766-30-7.

Basis for action: The PMN states that the substance will be used as a raw material. EPA identified environmental concerns because the PMN substance may be a PBT chemical based on physical/chemical properties of the PMN substance as described in the New Chemicals Program's PBT category. EPA estimates that the PMN substance will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. Also, 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 purposeful or predictable release containing the PMN substance into the waters of the United States may cause significant adverse environmental effects since the PMN substance has been characterized by EPA has a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(4)(ii) and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT category would help characterize the PBT attributes of the PMN substance.

CFR citation: 40 CFR 721.10350.

PMN Number P-07-351

Chemical name: Carbomonocycle, bis[(4-methylphenoxy)methyl]- (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a component of a manufactured consumer article. 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 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 1 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meetsthe 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10351.

PMN Number P-08-93

Chemical name: Dimethyl terephthalate, polymer with alkyl diol and substituted benzoates (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a binder in foundry applications. Based on EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 60 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 60 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 60 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 (Organisation for Economic Co-operation and Development (OECD) Test Guideline 303A); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10352.

PMN Number P-08-510

Chemical name: Organosulfide (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a co-stabilizer for plastics. Based on EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10353.

PMN Number P-08-623

Chemical name: 1,1′-Biphenyl, 3,3′,4,4′-tetramethyl-.

CAS number: 4920-95-0.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a raw material for production of biphenyl dianhydride. 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, 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10354.

PMN Number P-08-722

Chemical name: Poly(oxy-1,2-ethanediyl), .alpha.-(1-oxododecyl)-.omega.-[3-triethoxysilyl)propoxy]-.

CAS number: 1041420-54-5.

Basis for action: The PMN states that the substance will be used as a pigment treatment and surface treatment agent. Based on EcoSAR analysis of test data on analogous esters, 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 will not be 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 hydrolysis test (OPPTS Test Guideline 835.2120); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10355.

PMN Number P-09-98

Chemical name: Zinc, bis[3-(acetyl-.kappa.O)-6-methyl-2H-pyran-2,4(3H)-dionato-.kappa.O4]diaqua-.

CAS number: 171884-15-4.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a polymer additive. Based on EcoSAR analysis of test data on analogous zinc compounds and allyl/vinyl esters, with molecular weight adjustments, 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 ready biodegradability test (OPPTS Test Guideline 835.3110); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); anaquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10356.

PMN Number P-09-382

Chemical name: Iron, citrate phosphate potassium complexes.

CAS number: 120579-31-9.

Basis for action: The PMN states that the substance will be used as a nutrient for agriculture, and as an intermediate used to manufacture agricultural soil amendments. Based on EcoSAR analysis of test data on analogous inorganic phosphates, EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the described use in the PMN, where the substance will only be transported in drums with a maximum capacity of 20 gallons, or in bottom-loading totes, significant environmental releases 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 use of the substance other than as described in the PMN could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10357.

PMN Number P-09-546

Chemical name: Formaldehyde reaction products with aryl amine (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate. Based on EcoSAR analysis of test data on analogous anilines, EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed the releases expected from the use described in the PMN. For the intermediate use described in the PMN, significant environmental releases 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 other than as an intermediate that has been manufactured using the process described in the premanufacture notice 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10358.

PMN Number P-09-613

Chemical name: Cardanol-based alkyl phosphate (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a site-limited polymer modifier for non-consumer products. Based on EcoSAR analysis of test data on analogous anionic surfactants and organic phosphates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 18 ppb of the PMN substance in surface waters. For the use described in the PMN, general population exposure is limited and the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 18 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). EPA has also determined, however, in accordance with TSCA section 5(a)(2)(A) and 5(a)(2)(C) and with § 721.170(a), that uses other than as described in the PMN may result in significant human exposures.

Recommended testing: EPA has determined that the results of an acute oral toxicity study (OPPTS Test Guideline 870.1100) or an acute oral toxicity up-and-down procedure (OECD Test Guideline 425); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a mammalian erythrocyte micronucleus test via the intraperitoneal route (OPPTS Test Guideline 870.5395); a repeated dose 28-day oral toxicity test in rodents (OPPTS Test Guideline 870.3050 or OECD Test Guideline 407) with a neurotoxicity functional observational screening battery (OPPTS Test Guideline 870.6200) for all test doses; 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10359.

PMN Number P-09-628

Chemical name: 1-Substituted propane, 3-(triethoxysilyl)-, reaction products with polyethylene glycol mono-(branched tridecyl) 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 cross-linking, coupling agent. Based on test data on the PMN substance, 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 will not be 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)(i).

Recommended testing: EPA has determined that the results of 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.

CFR citation: 40 CFR 721.10360.

PMN Number P-10-15

Chemical name: Anthraquinonedicarboximide, diamino-N-alkyl- (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a fuel additive.Based on EcoSAR analysis of test data on analogous imides and anilines, 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 fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) with sheepshead minnows; a mysid chronic toxicity test (OPPTS Test Guideline 850.1350); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) with diatom Skeletonema costatum would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10361.

PMN Number P-10-44

Chemical name: Oils, callitropsis nootkatensis.

CAS number: 1069136-34-0.

Basis for action: The PMN states that the substance will be used as a fragrance ingredient. Based on EcoSAR analysis of test data on analogous neutral organic compounds (hydrocarbons), 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10362.

PMN Number P-10-47

Chemical name: Alkenoic acid, 2-methyl-, 2-oxiranylmethyl ester, reaction products with 4,4′-methylenebis (cyclohexanamine) (generic).

CAS number: Not available.

Basis for action: The PMN states that the use of the substance is as a curing agent for epoxy resin in protective coatings. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 44 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 release of manufacturing or processing streams containing the PMN substance resulting in surface water concentrations exceeding 44 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10363.

PMN Number P-10-53

Chemical name: Halogenated aromatic amine (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a reactant for the manufacture of a pesticide. Based on EcoSAR analysis of test data on analogous aromatic amines, 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)(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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10364.

PMN Number P-10-56

Chemical name: Butanoic acid, 3-mercapto-2-methyl-, ethyl ester.

CAS number: 888021-82-7.

Basis for action: The PMN states that the substance will be used as an ingredient in fragrance compounds. Based on EcoSAR analysis of test data on analogous esters and thiols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 8 ppb of the PMN substance in surface waters. At the maximum annual manufacturing and importation production levels 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 may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 8 ppb, or exceedance of the annual maximum manufacturing and importation limit of 100 kilograms 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10365.

PMN Number P-10-76

Chemical name: Benzene, 4-bromo-1,2-dimethyl-.

CAS number: 583-71-1.

Basis for action: The PMN states that the substance will be used as a raw material used for production of 1,1-biphenyl,3,3′,4,4′-tetramethyl. Based on EcoSAR analysis of test data on analogous neutral organic chemicals, 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, 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 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 simulation test to assess the biodegradability of chemicals discharged in wastewater (OECD Test Guideline 314); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10366.

PMN Number P-10-83

Chemical name: Hydroxy-aryl, polymer with substituted benzene, cyanate (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a resin component. Based on EcoSAR analysis of test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 3 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 3 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a water solubility test (OECD Test Guideline 105); 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.

CFR citation: 40 CFR 721.10367.

PMN Number P-10-84

Chemical name: Triphenodioxazine derivatives (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a dispersion additive for printing ink. Based on EcoSAR analysis of test data on analogous aliphatic amines and diamines, 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10368.

PMN Number P-10-88

Chemical name: Carbonic acid, diphenyl ester, polymer with diphenyl P-methylphosphonate and 4,4′-(1-methylethylidene)bis[phenol].

CAS number: 77226-90-5.

Basis for action: The PMN states that the substance will be used as a flame retardant and flame retardant additive where the particle size is greater than 10 microns. Based on analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung overload from inhalation exposures of the PMN substance. For the uses described in the PMN, significant worker and general population exposure is unlikely, as exposure to respirable particles is not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as as a flame retardant and flame retardant additive where the particle size is greater than 10 microns, may result in significant human exposures to the respirable form of the PMN substance. 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 human health effects of the PMN substance.

CFR citation: 40 CFR 721.10369.

PMN Number P-10-99

Chemical name: Phosphonic acid, p-octyl-, lanthanum (3+) salt (2:1).

CAS number: 1186211-38-0.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a modifier for polymers. Based on EcoSAR analysis of test data on analogous lanthanum salts, 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 may present 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)(ii).

Recommended testing: EPA has determined that the results of a simulated biodegradability test (OECD Test Guideline 314); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10370.

PMN Number P-10-136

Chemical names: (P-10-136, Chemical A) Butanoic acid, 3-mercapto-,1,1′-[2,2-bis[(substituted-1-oxoalkoxy)methyl]-1,3-propanediyl] ester (generic) and (P-10-136, Chemical B) Butanoic acid, 3-mercapto-,1,1′-[2-(hydroxymethyl)-2-(substituted-1-oxoalkoxy)methyl)-1,3-propanediyl] ester (generic).

CAS numbers: Not available.

Basis for action: The PMN states that the substance will be used as a monomer for acryl-based UV-curing coatings, inks, and adhesives. Based on test data on the PMN substance, EPA identified concerns for systemic toxicity, mutagenic effects, dermal sensitization and neurotoxicity from dermal and inhalation exposures to the PMN substance. Further, based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. For the uses described in the PMN, significant worker exposure is unlikely, as dermal and inhalation exposures are low, and the substance is not released to surface waters. Therefore, EPA has not determined that the proposed processing or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture, use other than as described in the PMN, or any use of the substance resulting in surface water concentrations exceeding 2 ppb may cause serious health effects and significant 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 mammalian bone marrow chromosomal aberration test (OPPTS Test Guideline 870.5385) by the intraperitoneal route; a reproduction/developmental toxicity screening test (OECD Test Guideline 421); 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 citations: 40 CFR 721.10371 (P-10-136, Chemical A) and 40 CFR 721.10372 (P-10-136, Chemical B).

PMN Number P-10-153

Chemical name: 1H-Imidazole, 1-(1-methylethyl)-.

CAS number: 4532-96-1.

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, and EcoSAR analysis of test data on analogous imidazoles, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 70 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 other than as a chemical intermediate, or any use of the substance resulting in surface water concentrations exceeding 70 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—CO 2 in sealed vessels (OPPTS Test Guideline 835.3140 or OECD Test Guideline 310); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10373.

PMN Number P-10-163

Chemical name: Silane, (3-chloro-propoxy)dimethyl(l-methylethyl)-.

CAS number: 1191036-21-1.

Basis for action: The PMN states that the substance will be used as an isolated intermediate in the preparation of a lithium reagent. Based on the expected alkylating agent potential of the PMN substance, and analysis of test data on analogous substances, EPA identified concerns for oncogenicity, mutagenicity, developmental toxicity, liver toxicity, irritation, and possible corrosion to all tissues to workers exposed to the PMN substance. Further, based on EcoSAR analysis of test data on analogous neutral organic chemicals, 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, worker inhalation and dermal exposures are not expected due to the use of organic vapor respirators, impervious gloves and goggles, and environmental 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 the use of impervious gloves, goggles, and organic vapor respirators, where there is a potential of dermal or inhalation exposure; 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)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) via the intraperitoneal route; an acute dermal irritation test (OPPTS Test Guideline 870.2500); a skin sensitization test (OPPTS Test Guideline 870.2600); a repeated dose 28-day oral toxicity test (OPPTS Test Guideline 870.3050) in rodents; a fish acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10374.

PMN Number P-10-200

Chemical name: Hydroxypropyl methacrylate, reaction products with propylene oxide and ethylene oxide, copolymer with N-vinyl caprolactam (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an oilfield polymer. Based on test data on the PMN substance, and EcoSAR analysis of test data on analogous nonionic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 155 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 155 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 155 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meetsthe concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

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

CFR citation: 40 CFR 721.10375.

PMN Number P-10-222

Chemical name: Alkyltin halide (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an alkylating agent. Based on test data on a structurally similar substance, EPA identified concerns for immunotoxicity, asthma, and sensitization from exposure to the PMN substance via the inhalation and dermal route. Further, based on EcoSAR analysis of test data on analogous tin compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 22 ppb of the PMN substance in surface waters. For the use described in the PMN, worker inhalation and dermal exposures are expected to be minimal and releases of the PMN substance to surface waters are not expected to result in surface water concentrations that exceed 22 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as described in the PMN, or any release of the substance resulting in surface water concentrations exceeding 22 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 ready biodegradability test (OPPTS Test Guideline 835.3110); a fish acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10376.

PMN Number P-10-247

Chemical names: (P-10-247, Chemical A) 1,2-Cyclohexanedicarboxylic acid, benzyl C8-10-isoalkyl esters, C9-rich and (P-10-247, Chemical B) 1,2-Cyclohexanedicarboxylic acid, benzyl nonyl ester, branched and linear.

CAS numbers: (P-10-247, Chemical A) 1190265-49-6 and (P-10-247, Chemical B) 1190264-82-4.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an additive for polymers. Based on test data on the PMN substance, EPA identified concerns for skin and eye irritation via the dermal route. In addition, based on test data on a structurally similar compound, EPA identified concerns for systemic health effects. Further, based on EcoSAR analysis of test data on analogous esters, 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, worker exposure to the substance is expected to be minimal due to the use of impervious gloves, and 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 without the use of impervious gloves where there is a potential for dermal exposure, 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)(i), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a porous pot test (OPPTS Test Guideline 835.3220); a combined chronic toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substance.

CFR citations: 40 CFR 721.10377 (P-10-247, Chemical A) and 40 CFR 721.10378 (P-10-247, Chemical B).

PMN Number P-10-266

Chemical name: Propanoic acid, 3-(dodecylthio)-, 2-(1,1-dimethylethyl)-4-[[5-(1,1-dimethylethyl)-4-hydroxy-2-methylphenyl]thio]-5-methylphenyl ester.

CAS number: 69075-62-3.

Basis for action: The PMN states that the substance will be used as an antioxidant for plastic articles. Based on test data on the PMN substance, EPA identified health concerns to workers from exposure to the PMN substance via inhalation, which include long-term effects to the liver, heart, blood, and possible immunotoxicity. As described in the PMN, and at the production level stated in the PMN, worker inhalation exposure will be minimal. 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 if the production volume increases substantially, the potential for exposure could change correspondingly, and 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 the results of a reproductive/developmental toxicity screening test, via the oral route (OPPTS Test Guideline 870.3550 or OECD Test Guideline 421) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10379.

PMN Number P-10-285

Chemical name: Benzoic acid, 3-amino-2-mercapto-.

CAS number: 71807-60-8.

Basis for action: The PMN states that the substance will be used as an intermediate. Based on EcoSAR analysis of test data on analogous thiols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 33 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 33 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 TestGuideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10380.

PMN Number P-10-290

Chemical name: Cyclic carboxylic acid, polymer with dihydroxy dialkyl ether, hydroxy substituted alkane and carboxylic acid anhydride, methacrylate terminated polyester (generic).

CAS number: Not available.

Basis for action: The PMN states that the use of the substance is a base resin for gel coat compounds. Based on EcoSAR analysis of test data on analogous esters, 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, 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 8 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10381.

PMN Number P-10-313

Chemical name: Diphosphoric acid, calcium salt (1:1).

CAS number: 14866-19-4.

Basis for action: The PMN states that the substance will be used as an opacifying agent for ceramic whiteware. Based on test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung effects if respirable particles are inhaled. Further, based on EcoSAR analysis of test data on analogous inorganic phosphates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 60 ppb of the PMN substance in surface waters. For the use described in the PMN, no significant inhalation exposures are expected and the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as an opacifying pigment for ceramic whiteware, or any use resulting in releases to surface waters that produce surface water concentrations that exceed 60 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 water solubility test, shake flask method (OPPTS Test Guideline 830.7840) using mass spectrometry as the analytical method; 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effect of the PMN substance. Depending on the results of the water solubility test, a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-day holding period may be necessary.

CFR citation: 40 CFR 721.10382.

PMN Number P-10-324

Chemical name: Urea, N, N′-(methyl-1,3-phenylene)bis[N′, N′-bis[3-polyalkyleneamino]-, compd. with formaldehyde polymer with phenol (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a curing agent or accelerator for epoxy resin. Based on EcoSAR analysis of test data on analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 43 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 43 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10383.

PMN Number P-10-332

Chemical name: Substituted alkanolamine phenol (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a polyol for rigid foam. Based on EcoSAR analysis of test data on analogous aliphatic amines, phenols, and phenol-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 be 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 water solubility test: Column elution method; shake flask method (OPPTS Test Guideline 830.7840); either a simulation test—aerobic sewage treatment: Activated sludge units (OECD Test Guideline 303A) or an aerobic aquatic biodegradation test (OPPTS Test Guideline 835.3100); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10384.

PMN Number P-10-344

Chemical name: Phenoxy alkyl 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 plasticizing component of a two part coating containing a flexibilizer at a maximum concentration of 10 percent. Based on test data on the hydrolysis product of the PMN substance, EPA identified concerns for blood effects, developmental effects, and reproductiveeffects to workers exposed to the PMN substance. For the use described in the PMN, significant worker exposure is unlikely, as the substance is imported, and significant dermal and inhalation exposures 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 domestic manufacture, or use of the substance other than as a plasticizing component of a two part coating containing a flexibilizer at a maximum PMN concentration of 10 percent, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(iii).

Recommended testing: Based on the test data available to EPA on the hydrolysis product of the PMN substance, EPA does not recommend additional testing at this time.

CFR citation: 40 CFR 721.10385.

PMN Number P-10-361

Chemical name: Substituted phenol (generic).

CAS number: Not available.

Basis for action: The PMN states that the use of the substance will be as an organic intermediate in substituted bis-phenol manufacturing. 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10386.

PMN Number P-10-362

Chemical name: Substituted bis-phenol (generic).

CAS number: Not available.

Basis for action: The PMN states that the use of the substance will be as an organic intermediate in bis-phosphite synthesis. Based on EcoSAR analysis of test data on analogous polyphenols, 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10387.

PMN Number P-10-364

Chemical name: Bisphospite nickel cyanoalkyl complex (generic).

CAS number: Not available.

Basis for action: The PMN states that the use of the substance will be as a soluble metal catalyst for organic synthesis. Based on EcoSAR analysis of test data on analogous inorganic nickel compounds, 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, 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10388.

PMN Number P-10-401

Chemical name: Styrene, copolymer with acrylic acid, salt with alkoxylated alkenylamine (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a non-dispersive additive. Based on EcoSAR analysis of test data on analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 27 ppb of the PMN substance in surface waters. Based on the wastewater treatment processes described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 27 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 27 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10389.

PMN Number P-10-403

Chemical name: Acetoacetanilide reaction product with multifunctional acrylate (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a polymer composite. Based on EcoSAR analysis of test data on analogous acrylates, esters, and amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance isnot 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10390.

PMN Number P-10-424

Chemical name: Copper gallium indium selenide.

CAS number: 144972-86-1.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a copper indium metal selenide deposited on a substrate as a part of manufacturing copper indium metal selenide solar panel. Based on analysis of test data on analogous respirable, poorly soluble particulates (subcategory titanium dioxide), EPA identified concerns for lung effects and lung tumors to workers exposed to the PMN substance. As described in the PMN, worker exposure will be minimal due to the use of adequate respiratory protection and adequate hazard communication warnings in the Material Safety Data Sheet (MSDS). 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 National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an Assigned Protection Factor (APF) of at least 10, or the equivalent NCEL of 1.5 mg/m 3 as an 8-hour time weighted average, where there is a potential for inhalation exposure, may cause serious health effects. EPA has also determined that any use of the substance without adequate hazard communication 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 inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats would help characterize the human health effects of the PMN substance. Testing should include a 60-day recovery.

CFR citation: 40 CFR 721.10391.

PMN Number P-10-426

Chemical name: Halo substituted sulfamidylbenzyluracil (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate. Based on test data on structurally similar chemicals, EPA identified concerns for developmental toxicity via the inhalation route. Further, based on test data for a close structural analog of the PMN substance and EcoSAR analysis of test data on analogous neutral organics, 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, worker inhalation exposures are expected to be minimal due to manufacturing in an enclosed system and use as a chemical intermediate, and releases to surface waters are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substance may present an unreasonable risk. EPA has determined, however, that any manufacture of the substance in a non-enclosed system, use of the substance other than as a chemical intermediate, or 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), (b)(4)(i), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a prenatal developmental toxicity test (OPPTS Test Guideline 870.3700); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10392.

PMN Number P-10-433

Chemical name: Sodium bromide MDA complex (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 for manufacturing polyurethane rubber elastomer for tires, wheels, rolls, screens, belts, and other specialty urethane articles. Based on EcoSAR analysis of test data on analogous anilines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb of the PMN substance in surface waters. As described in the PMN, 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 3 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a dissociation constant in water test (OECD Test Guideline 112); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10393.

PMN Number P-10-436

Chemical name: Copolymer of anhydride, a diol and a disubstituted diol (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a resin additive. Based on EcoSAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 55 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 55 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 55 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 fishacute 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10394.

PMN Number P-10-458

Chemical name: Fatty acids, C14-18 and C16-18 unsatd., polymers with adipic acid and triethanolamine, di-Me sulfate-quaternized.

CAS number: 1211825-32-9.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adjuvant in the production of paper. Based on test data on the PMN substance and EcoSAR analysis of test data on analogous polycationic polymers, 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, 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 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)(i) and (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) and an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10395.

PMN Number P-10-470

Chemical name: Dimethyl siloxy-polyfluoro methyl siloxy-poly(oxyalkylenediyl) methyl siloxy copolymer (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: April 20, 2011.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the PMN substance will be as an open, non-dispersive carpet treatment. EPA has concerns for potential incineration or other decomposition products of the PMN substance. These perfluorinated products may be released to the environment from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers that suggests that, under some conditions, the PMN substance could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic to people, wild mammals, and birds. These concerns are based on data on analog chemicals, including perfluorooctanoic acid (PFOA) and other perfluorinated alkyls, which include the presumed environmental degradant of the PMN substance. There is pharmacokinetic and toxicological data in animals on PFOA, as well as epidemiological and blood monitoring data in humans. Toxicity studies on PFOA indicate developmental, reproductive, and systemic toxicity in various species, as well as cancer. These factors, taken together, raise concerns for potential adverse chronic effects from the presumed degradation product in humans and wildlife. The 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 the environment and human health, 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: No manufacture of the substance beyond an annual aggregate manufacture and importation volume; recording and reporting of certain fluorinated impurities in the starting raw material; and manufacture of the PMN substance not to exceed the maximum established impurity levels of certain fluorinated impurities. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of certain fate and physical/chemical property testing identified in the TSCA 5(e) consent order would help characterize possible effects of the substance and its degradation products. The order does not require submission of the testing at any specified time or production volume. However, the order's restrictions on manufacture, import, processing, distribution in commerce, use and disposal of the PMN 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 721.10396.

PMN Numbers P-10-471 and P-10-472

Chemical names: Alkyl acrylate-polyfluoro methacrylate-poly(oxyalkylenediyl)- methacrylates (generic).

CAS numbers: Not available.

Effective date of TSCA section 5(e) consent order: April 20, 2011.

Basis for TSCA section 5(e) consent order: The consolidated PMN states that the generic (non-confidential) use of the PMN substances will be as open, non-dispersive additives. EPA has concerns for potential incineration or other decomposition products of the PMN substances. These perfluorinated products may be released to the environment from incomplete incineration of the PMN substances at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers that suggests that, under some conditions, the PMN substances could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could be PBT chemicals, based on data on analog chemicals, including PFOA and other perfluorinated alkyls, which include the presumed environmental degradant of the PMN substances. There is pharmacokinetic and toxicological data in animals on PFOA, as well as epidemiological and blood monitoring data in humans. Toxicity studies on PFOA indicate developmental, reproductive, and systemic toxicity in various species, as well as cancer. These factors, taken together, raise concerns for potential adverse chronic effects from the presumed degradation product in humans and wildlife. The 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 these substances may present an unreasonable risk of injury to the environment and human health, the substances 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 substances and their potential degradation products. To protect against these risks, the consent order requires: No manufacture of the substances beyond an annual aggregate manufacture and importation volume; recording and reporting of certainfluorinated impurities in the starting raw materials; and manufacture of the PMN substances not to exceed the maximum established impurity levels of certain fluorinated impurities. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of certain fate and physical/chemical property testing identified in the TSCA 5(e) consent order would help characterize possible effects of the substances and their degradation products. The order does not require submission of the testing at any specified time or production volume. However, the order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMNs 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 721.10397.

PMN Number P-10-495

Chemical name: Poly(oxy-1,2-ethanediyl),.alpha., -monoalkyl ethers-.omega.-mono (hydrogen maleate)- (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 additive. Based on test data submitted with the PMN, EPA identified concerns for dermal sensitization to workers and consumers exposed to the PMN substance. For the industrial uses described in the PMN, significant worker exposures will be minimal due to the use of 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 use of the substance other than for industrial applications may result in consumer exposures which may cause 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 the results of a dermal sensitization test (OPPTS Test Guideline 870.2600) at varying concentrations or different formulations would help characterize human health effects of the PMN substance.

CFR citation: 40 CFR 721.10398.

PMN Number P-10-501

Chemical name: Benzoic acid azo-substituted pyridine (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as site-limited intermediate. 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 PMN 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10399.

PMN Numbers P-10-517 and P-10-518

Chemical names: (P-10-517) Oxirane, 2-ethyl-, polymer with oxirane, mono-C12-14-sec-alkyl ethers and (P-10-518) Oxirane, 2-ethyl-, polymer with oxirane, mono-C11-15-sec-alkyl ethers.

CAS numbers: (P-10-517) 1013910-41-2 and (P-10-518) 1022990-65-3.

Basis for action: The consolidated PMN states that the substances will be used as surfactants for architectural coatings and industrial metal cleaning solutions. Based on test data on the PMN substances, and EcoSAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 14 ppb of the PMN substance P-10-517, and 20 ppb of the PMN substance P-10-518, in surface waters. As described in the consolidated PMN notice, releases to surface waters are not expected to exceed 14 ppb or 20 ppb, respectively, due to pretreatment of wastes prior to release. 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 14 ppb of P-10-517, or 20 ppb of P-10-518, may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of an activated sludge simulation study (OECD Test Guideline 303A); 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 substances.

CFR citations: 40 CFR 721.10400 (P-10-517) and 40 CFR 721.10401 (P-10-518).

PMN Number: P-10-548

Chemical name: Vegetable oil, modified products (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 compounds, 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, 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 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citations: 40 CFR 721.10402.

PMN Number P-10-550

Chemical name: Vegetable oil, modified products, esters (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 esters, 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 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 may present an unreasonable risk. EPA has determined, however, that any use of any 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)(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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citations: 40 CFR 721.10403.

PMN Numbers P-10-551 and P-10-552

Chemical names: Olefins (generic) (P-10-551 and P-10-552).

CAS numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as chemical intermediates. Based on EcoSAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 ppb of the PMN substances in surface waters. As described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed 6 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 any of the substances resulting in surface water concentrations exceeding 6 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substances.

CFR citations: 40 CFR 721.10404.

PMN Number P-10-553

Chemical name: Olefins (generic) (P-10-553).

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 test data on analogous neutral organic compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. For the specific use and production limit 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 use of the substance other than as described in the PMN, any use of the substance resulting in surface water concentrations exceeding 1 ppb, or use beyond the annual aggregate production limit may result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10405.

PMN Number P-10-554

Chemical name: Fatty acid methyl esters (generic) (P-10-554).

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 esters, 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 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 may present an unreasonable risk. EPA has determined, however, that any use of any 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)(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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citations: 40 CFR 721.10406.

PMN Number: P-10-555

Chemical name: Fatty acid methyl esters (generic) (P-10-555).

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 esters, 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citations: 40 CFR 721.10407.

PMN Number P-10-556

Chemical name: Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethyl]-.omega.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethoxy]-.

CAS number: 613246-75-6.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a latent curingagent in polyurethane adhesives. 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10408.

PMN Number P-11-217

Chemical name: Poly(oxyalkylenediyl), .alpha.-[[[methyl-3-[[[(polyfluoroalkyl)oxy]carbonyl]amino]phenyl]amino]carbonyl]-.omega.-methoxy-(generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: June 24, 2011.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the PMN substance will be as an open, non-dispersive carpet treatment. EPA has concerns for potential incineration or other decomposition products of the PMN substance. These perfluorinated products may be released to the environment from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers that suggests that, under some conditions, the PMN substance could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could be PBT chemicals, based on data on analog chemicals, including PFOA and other perfluorinated alkyls, which include the presumed environmental degradant. There is pharmacokinetic and toxicological data in animals on PFOA, as well as epidemiological and blood monitoring data in humans. Toxicity studies on PFOA indicate developmental, reproductive, and systemic toxicity in various species, as well as cancer. These factors, taken together, raise concerns for potential adverse chronic effects from the presumed degradation product in humans and wildlife. The 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 the environment and human health, 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: No manufacture of the substance beyond an annual aggregate manufacture and importation volume; recording and reporting of certain fluorinated impurities in the starting raw material; and manufacture of the PMN substance not to exceed the maximum established impurity levels of certain fluorinated impurities. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of certain fate and physical/chemical property testing identified in the TSCA 5(e) consent order would help characterize possible effects of the substance and its degradation products. The order does not require submission of the testing at any specified time or production volume. However, the order's restrictions on manufacture, import, processing, distribution in commerce, use and disposal of the PMN 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 721.10409.

V. Rationale and Objectives of the Rule

A. Rationale

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for four of the 119 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.

In the other 117 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 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

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 June 26, 2012 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before May 29, 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 May 29, 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 a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment.

VII. Applicability of Rule to Uses Occurring Before Effective Date of the Rule

Significant new use designations for a chemical substance are legally established as of the date of publication of this direct final rule April 27, 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 four 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, 83 of the 119 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 April 24, 1990 SNUR, 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 notice 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. 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 notice 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

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. describes those tests. Unit IV. also lists recommended testing for non-5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection and test reporting. To access the harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.

In the TSCA section 5(e) consent orders for four of the chemical substances regulated under this rule, EPA has established restrictions 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 restrictions will not be removed until EPA determines that the unrestricted use will not present an unreasonable risk of injury, or result in significant or substantial exposure or environmental release. This determination is usually made based on the results of the required or recommended toxicity tests.

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

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 that EPA 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

According to § 721.1(c), persons submitting a SNUN must comply with the same notice 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

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-2011-0577.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

This rule establishes SNURs for several new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in theFederal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. 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

On February 18, 2012, EPA certified pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (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, and (2) the SNUN 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: (1) A significant number of SNUNs would not be submitted by small entities in response to the SNUR and (2) 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

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 sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

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

In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

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

XIII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and the Comptroller General of the United States. 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 theFederal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

Dated: April 12, 2012.
Ward Penberthy,
Acting Director, Chemical Control Division, Office of Pollution Prevention and Toxics.

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

Regulatory Text

Part 9 Amended

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. The table in § 9.1 is amended by adding the following sections in numerical order under the heading “Significant New Uses of Chemical Substances” to read as follows:

§ 9.1 OMB approvals under the Paperwork Reduction Act.

* * * * *

40 CFR citationOMB control No.
*****
Significant New Uses of Chemical Substances 
*****
721.102992070-0012
721.103002070-0012
721.103012070-0012
721.103022070-0012
721.103032070-0012
721.103042070-0012
721.103052070-0012
721.103062070-0012
721.103072070-0012
721.103082070-0012
721.103092070-0012
721.103102070-0012
721.103112070-0012
721.103122070-0012
721.103132070-0012
721.103142070-0012
721.103152070-0012
721.103162070-0012
721.103172070-0012
721.103182070-0012
721.103192070-0012
721.103202070-0012
721.103212070-0012
721.103222070-0012
721.103232070-0012
721.103242070-0012
721.103252070-0012
721.103262070-0012
721.103272070-0012
721.103282070-0012
721.103292070-0012
721.103302070-0012
721.103312070-0012
721.103322070-0012
721.103332070-0012
721.103342070-0012
721.103352070-0012
721.103362070-0012
721.103372070-0012
721.103382070-0012
721.103392070-0012
721.103402070-0012
721.103412070-0012
721.103422070-0012
721.103432070-0012
721.103442070-0012
721.103452070-0012
721.103462070-0012
721.103472070-0012
721.103482070-0012
721.103492070-0012
721.103502070-0012
721.103512070-0012
721.103522070-0012
721.103532070-0012
721.103542070-0012
721.103552070-0012
721.103562070-0012
721.103572070-0012
721.103582070-0012
721.103592070-0012
721.103602070-0012
721.103612070-0012
721.103622070-0012
721.103632070-0012
721.103642070-0012
721.103652070-0012
721.103662070-0012
721.103672070-0012
721.103682070-0012
721.103692070-0012
721.103702070-0012
721.103712070-0012
721.103722070-0012
721.103732070-0012
721.103742070-0012
721.103752070-0012
721.103762070-0012
721.103772070-0012
721.103782070-0012
721.103792070-0012
721.103802070-0012
721.103812070-0012
721.103822070-0012
721.103832070-0012
721.103842070-0012
721.103852070-0012
721.103862070-0012
721.103872070-0012
721.103882070-0012
721.103892070-0012
721.103902070-0012
721.103912070-0012
721.103922070-0012
721.103932070-0012
721.103942070-0012
721.103952070-0012
721.103962070-0012
721.103972070-0012
721.103982070-0012
721.103992070-0012
721.104002070-0012
721.104012070-0012
721.104022070-0012
721.104032070-0012
721.104042070-0012
721.104052070-0012
721.104062070-0012
721.104072070-0012
721.104082070-0012
721.104092070-0012
*****

* * * * *

Part 721 Amended

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

Authority:

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

4. Add § 721.10299 to subpart E to read as follows:

§ 721.10299 Polymeric MDI based polyurethanes (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as polymeric MDI based polyurethanes (PMNs P-00-2, P-00-5, and P-00-6) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

5. Add § 721.10300 to subpart E to read as follows:

§ 721.10300 Benzeneacetic acid, .alpha.-chloro-.alpha.-phenyl-, ethyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzeneacetic acid, .alpha.-chloro-.alpha.-phenyl-, ethyl ester (PMN P-00-85; CAS No. 52460-86-3) 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=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.

6. Add § 721.10301 to subpart E to read as follows:

§ 721.10301 Reaction products of fatty alcohols, (aminoethylaminopropyl) dialkoxymethylsilane, glycidol, and hydroxy-terminated polydimethylsiloxane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as reaction products of fatty alcohols, (aminoethylaminopropyl) dialkoxymethylsilane, glycidol, and hydroxy-terminated polydimethylsiloxane (PMN P-00-317) 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.

7. Add § 721.10302 to subpart E to read as follows:

§ 721.10302 Zinc ammonium phosphate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as zinc ammonium phosphate (PMN P-00-442) 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.

8. Add § 721.10303 to subpart E to read as follows:

§ 721.10303 Polyether modified polysiloxane, acrylated (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyether modified polysiloxane, acrylated (PMN P-00-833) 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.

9. Add § 721.10304 to subpart E to read as follows:

§ 721.10304 Functionalized polymethine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as functionalized polymethine (PMN P-00-1099) 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.

10. Add § 721.10305 to subpart E to read as follows:

§ 721.10305 Modified cyclohexane esters (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified cyclohexane esters (PMN P-00-1108) 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.

11. Add § 721.10306 to subpart E to read as follows:

§ 721.10306 Substituted phenylepoxide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted phenylepoxide (PMN P-01-114) 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=6).

(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.

12. Add § 721.10307 to subpart E to read as follows:

§ 721.10307 Acrylate resin (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acrylate resin (PMN P-01-343) 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.

13. Add § 721.10308 to subpart E to read as follows:

§ 721.10308 Ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, dialkylethanolamine salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, dialkylethanolamine salt (PMN P-01-384) 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=70).

(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 § 721.10309 to subpart E to read as follows:

§ 721.10309 Ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate (PMN P-01-385) 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=70).

(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 § 721.10310 to subpart E to read as follows:

§ 721.10310 Ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, ammonium salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, ammonium salt as (PMN P-01-386) 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=70).

(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.

16. Add § 721.10311 to subpart E to read as follows:

§ 721.10311 Ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, sodium salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, sodium salt (PMN P-01-387) 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=70).

(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 § 721.10312 to subpart E to read as follows:

§ 721.10312 Ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, ethanolamine salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, ethanolamine salt (PMN P-01-388) 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=70).

(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.

18. Add § 721.10313 to subpart E to read as follows:

§ 721.10313 Fatty acids, C16-18 and C18-unsatd., Me esters, epoxidized.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as fatty acids, C16-18 and C18-unsatd., Me esters, epoxidized (PMN P-02-249; CAS No. 158318-67-3) 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=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.

19. Add § 721.10314 to subpart E to read as follows:

§ 721.10314 Dialkyl dithiocarbamate esters (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as dialkyl dithiocarbamate esters (PMNs P-02-778, P-02-779, and P-02-780) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

20. Add § 721.10315 to subpart E to read as follows:

§ 721.10315 1,5-Dioxa-9-azaspiro[5.5]undecane, 3,3,8,8,10,10-hexamethyl-9-[1-[4-(2-oxiranylmethoxy)phenyl]ethoxy]-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,5-dioxa-9-azaspiro[5.5]undecane, 3,3,8,8,10,10-hexamethyl-9-[1-[4-(2-oxiranylmethoxy)phenyl]ethoxy]- (PMN P-02-833; CAS No. 434898-80-3) 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)(1), (b)(1), and (c)(1).

(ii) [Reserved]

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

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

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

21. Add § 721.10316 to subpart E to read as follows:

§ 721.10316 Dicyclopentadiene polymer with maleic anhydride and alkyl alcohols (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dicyclopentadiene polymer with maleic anhydride and alkyl alcohols (PMN P-02-872) 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=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 (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.

22. Add § 721.10317 to subpart E to read as follows:

§ 721.10317 Alkyl phosphate derivative (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl phosphate derivative (PMN P-02-1040) 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.

23. Add § 721.10318 to subpart E to read as follows:

§ 721.10318 Mannich bases (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as mannich bases (PMNs P-02-1078 and P-02-1080) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

24. Add § 721.10319 to subpart E to read as follows:

§ 721.10319 Alkylamides, ethoxylated (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylamides, ethoxylated (PMN P-03-42) 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.

25. Add § 721.10320 to subpart E to read as follows:

§ 721.10320 Fatty acid amide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acid amide (PMN P-03-186) 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.

26. Add § 721.10321 to subpart E to read as follows:

§ 721.10321 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-03-194) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

27. Add § 721.10322 to subpart E to read as follows:

§ 721.10322 Metallic diol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identifiedgenerically as metallic diol (PMN P-03-196) 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=6).

(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.

28. Add § 721.10323 to subpart E to read as follows:

§ 721.10323 Glycerol fatty acid ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as glycerol fatty acid ester (PMN P-03-248) 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=6).

(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.

29. Add § 721.10324 to subpart E to read as follows:

§ 721.10324 Thionocarbamate derivative (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as thionocarbamate derivative (PMN P-03-362) 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.

30. Add § 721.10325 to subpart E to read as follows:

§ 721.10325 Cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes, reaction products with 3-(triethoxysilyl)-1-propanamine.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes, reaction products with 3-(triethoxysilyl)-1-propanamine (PMN P-03-442; CAS No. 475645-84-2) 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=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.

31. Add § 721.10326 to subpart E to read as follows:

§ 721.10326 2-Propenoic acid, 2-methyl-, methyl ester, polymer with butyl 2-propenoate, ethyl 2-propenoate, zinc 2-methyl-2-propenoate (1:2) and zinc 2-propenoate (1:2), 2,2'-(1,2-diazenediyl)bis[2-methylbutanenitrile]- and 2,2'-(1,2-diazenediyl)bis[2-methylpropanenitrile]-initiated.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propenoic acid, 2-methyl-, methyl ester, polymer with butyl 2-propenoate, ethyl 2-propenoate, zinc 2-methyl-2-propenoate (1:2) and zinc 2-propenoate (1:2), 2,2′-(1,2-diazenediyl)bis[2-methylbutanenitrile]- and 2,2′-(1,2-diazenediyl)bis[2-methylpropanenitrile]-initiated (PMN P-03-458; CAS No. 460739-39-3) 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=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.

32. Add § 721.10327 to subpart E to read as follows:

§ 721.10327 Salt of mixed fatty amidoamines and polyethylenepolyamines (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as salt of mixed fatty amidoamines and polyethylenepolyamines (PMN P-03-529) 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.

33. Add § 721.10328 to subpart E to read as follows:

§ 721.10328 Salt of polyalkylenepolyamine derivative (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identifiedgenerically as salt of polyalkylenepolyamine derivative (PMN P-03-530) 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.

34. Add § 721.10329 to subpart E to read as follows:

§ 721.10329 Salt of mixed fatty amidoamines (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as salt of mixed fatty amidoamines (PMN P-03-531) 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.

35. Add § 721.10330 to subpart E to read as follows:

§ 721.10330 Pyrazolone derivative (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as pyrazolone derivative (PMN P-03-722) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

36. Add § 721.10331 to subpart E to read as follows:

§ 721.10331 Aromatic isocyanate methacrylate blocked (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic isocyanate methacrylate blocked (PMN P-03-767) 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.

37. Add § 721.10332 to subpart E to read as follows:

§ 721.10332 Lithium metal phosphate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as lithium metal phosphate (PMN P-03-824) 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.

38. Add § 721.10333 to subpart E to read as follows:

§ 721.10333 Substituted benzamine thio-ether (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted benzamine thio-ether (PMN P-03-840) 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.

39. Add § 721.10334 to subpart E to read as follows:

§ 721.10334 Ethanol, 2,2′-[(3-[(2-ethylhexyl)oxy]pentyl]imino]bis-].

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as ethanol, 2,2′-[(3-[(2-ethylhexyl)oxy]pentyl]imino]bis- (PMN P-03-861; CAS No. 284477-82-3) 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=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. Theprovisions of § 721.185 apply to this section.

40. Add § 721.10335 to subpart E to read as follows:

§ 721.10335 1-Pentanamine, 3-[(2-ethylhexyl)oxy]-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-pentanamine, 3-[(2-ethylhexyl)oxy]- (PMN P-03-862; CAS No. 174615-16-8) 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=7).

(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.

41. Add § 721.10336 to subpart E to read as follows:

§ 721.10336 Poly(oxy-1,2-ethanediyl), .alpha.-(1-oxo-2-propen-1-yl)-.omega.-([1,1′-biphenyl]-2-yloxy)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,2-ethanediyl), .alpha.-(1-oxo-2-propen-1-yl)-.omega.-([1,1′-biphenyl]-2-yloxy)- (PMN P-04-1; CAS No. 72009-86-0) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=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 (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.

42. Add § 721.10337 to subpart E to read as follows:

§ 721.10337 Copper, iodotris(triphenylphosphine)-, (T-4)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as copper, iodotris(triphenylphosphine)-, (T-4)- (PMN P-04-6; CAS No. 15709-82-7) 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)(1), (b)(1), and (c)(1).

(ii) [Reserved]

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

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

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

43. Add § 721.10338 to subpart E to read as follows:

§ 721.10338 2-Propenoic acid, 1,1′-(1,9-nonanediyl) ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propenoic acid, 1,1′-(1,9-nonanediyl) ester (PMN P-04-53; CAS No. 107481-28-7) 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=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.

44. Add § 721.10339 to subpart E to read as follows:

§ 721.10339 Adipic acid, substituted propane, alkyldiol, acrylate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as adipic acid, substituted propane, alkyldiol, acrylate (PMN P-04-113) 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.

45. Add § 721.10340 to subpart E to read as follows:

§ 721.10340 Potassium zinc fluoride (KZnF3).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as potassium zinc fluoride (KZnF 3) (PMN P-04-146; CAS No. 13827-02-6) 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.

46. Add § 721.10341 to subpart E to read as follows:

§ 721.10341 Amino alkyl organoborane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as amino alkyl organoborane (PMN P-04-338) 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=7).

(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 § 721.10342 to subpart E to read as follows:

§ 721.10342 Quaternary ammonium compounds, fatty alkyl dialkyl hydroxide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as quaternary ammonium compounds, fatty alkyl dialkyl hydroxide (PMN P-04-516) 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.

48. Add § 721.10343 to subpart E to read as follows:

§ 721.10343 Alkylated aryloxyaniline thiourea (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylated aryloxyaniline thiourea (PMN P-04-563) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

49. Add § 721.10344 to subpart E to read as follows:

§ 721.10344 Alkylated aromatic isothiocyanate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylated aromatic isothiocyanate (PMN P-04-810) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

50. Add § 721.10345 to subpart E to read as follows:

§ 721.10345 1,2-Benzenedicarboxylic acid, 1,2-bis(methylcyclohexyl) ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2-benzenedicarboxylic acid, 1,2-bis(methylcyclohexyl) ester (PMN P-05-110; CAS No. 27987-25-3) 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.

51. Add § 721.10346 to subpart E to read as follows:

§ 721.10346 3H-Indolium, 2-[2-[2-chloro-3-[2-(1,3-dihydro-3,3-dimethyl-1-propyl-2H-indol-2-ylidene)ethylidene]-1-cyclohexen-1-yl]ethenyl]-3,3-dimethyl-1-propyl-, iodide (1:1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 3H-indolium, 2-[2-[2-chloro-3-[2-(1,3-dihydro-3,3-dimethyl-1-propyl-2H-indol-2-ylidene)ethylidene]-1-cyclohexen-1-yl]ethenyl]-3,3-dimethyl-1-propyl-, iodide (1:1) (PMN P-05-599; CAS No. 207399-07-3) 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.

52. Add § 721.10347 to subpart E to read as follows:

§ 721.10347 Bicyclo[2.2.1] heptanedimethanamine, N,N′-bis(1,2-dimethylpropylidene)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as bicyclo[2.2.1]heptanedimethanamine, N,N′-bis(1,2-dimethylpropylidene)- (PMN P-06-268; CAS No. 664980-30-7) 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=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) areapplicable 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 § 721.10348 to subpart E to read as follows:

§ 721.10348 Aspartic acid, N,N′-(iminodi-alkanediyl)bis, tetraalkane esters (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as aspartic acid, N,N′-(iminodi-alkanediyl)bis, tetraalkane esters (PMNs P-06-623 and P-06-624) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=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 (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 § 721.10349 to subpart E to read as follows:

§ 721.10349 1,4-Benzenediamine, N′-(alkyl)-N-[4-[(alkyl)amino]phenyl]-N-phenyl- (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 1,4-benzenediamine, N′-(alkyl)-N-[4-[(alkyl)amino]phenyl]-N-phenyl- (PMN P-06-731) 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 § 721.10350 to subpart E to read as follows:

§ 721.10350 Amines, C11-14-branched and linear alkyl.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as amines, C11-14-branched and linear alkyl (PMN P-06-742; CAS No. 863766-30-7) 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)(1), (b)(1), and (c)(1).

(ii) [Reserved]

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

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

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

56. Add § 721.10351 to subpart E to read as follows:

§ 721.10351 Carbomonocycle, bis[(4-methylphenoxy)methyl]- (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbomonocycle, bis[(4-methylphenoxy)methyl]- (PMN P-07-351) 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 § 721.10352 to subpart E to read as follows:

§ 721.10352 Dimethyl terephthalate, polymer with alkyl diol and substituted benzoates (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dimethyl terephthalate, polymer with alkyl diol and substituted benzoates (PMN P-08-93) 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=60).

(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 § 721.10353 to subpart E to read as follows:

§ 721.10353 Organosulfide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as organosulfide (PMN P-08-510) 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 § 721.10354 to subpart E to read as follows:

§ 721.10354 1,1′-Biphenyl, 3,3′,4,4′-tetramethyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,1′-biphenyl, 3,3′,4,4′-tetramethyl-(PMN P-08-623; CAS No. 4920-95-0) 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) 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 § 721.10355 to subpart E to read as follows:

§ 721.10355 Poly[oxy-1,2-ethanediyl), .alpha.-(1-oxododecyl)-.omega.-[3-triethoxysilyl)propoxy]-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly[oxy-1,2-ethanediyl), .alpha.-(1-oxododecyl)-.omega.-[3-triethoxysilyl)propoxy]- (PMN P-08-722; CAS No. 1041420-54-5) 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) 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.

61. Add § 721.10356 to subpart E to read as follows:

§ 721.10356 Zinc, bis[3-(acetyl-.kappa.O)-6-methyl-2H-pyran-2,4(3H)-dionato-.kappa.O4]diaqua-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as zinc, bis[3-(acetyl-.kappa.O)-6-methyl-2H-pyran-2,4(3H)-dionato-.kappa.O4]diaqua- (PMN P-09-98; CAS No. 171884-15-4) 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=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.

62. Add § 721.10357 to subpart E to read as follows:

§ 721.10357 Iron, citrate phosphate potassium complexes.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as iron, citrate phosphate potassium complexes (PMN P-09-382; CAS No. 120579-31-9) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (micronutrient in fertilizer or soil amendment which will only be transported in containers with a maximum capacity of 20 gallons or in bottom-loading totes).

(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.

63. Add § 721.10358 to subpart E to read as follows:

§ 721.10358 Formaldehyde reaction products with aryl amine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as formaldehyde reaction products with aryl amine (PMN P-09-546) 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) and (j) (use other than as an intermediate that has been manufactured using the process described in the premanufacture notice).

(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.

64. Add § 721.10359 to subpart E to read as follows:

§ 721.10359 Cardanol-based alkyl phosphate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cardanol-based alkyl phosphate (PMN P-09-613) 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(j) (site-limited polymer modifier in non-consumer products).

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=18).

(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.

65. Add § 721.10360 to subpart E to read as follows:

§ 721.10360 1-Substituted propane, 3-(triethoxysilyl)-, reaction products with polyethylene glycol mono-(branched tridecyl) ether (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 1-substituted propane, 3-(triethoxysilyl)-, reaction products with polyethylene glycol mono-(branched tridecyl) ether (PMN P-09-628) 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.

66. Add § 721.10361 to subpart E to read as follows:

§ 721.10361 Anthraquinonedicarboximide, diamino-N-alkyl- (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as anthraquinonedicarboximide, diamino-N-alkyl- (PMN P-10-15) 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.

67. Add § 721.10362 to subpart E to read as follows:

§ 721.10362 Oils, callitropsis nootkatensis.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oils, callitropsis nootkatensis (PMN P-10-44; CAS No. 1069136-34-0) 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) 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.

68. Add § 721.10363 to subpart E to read as follows:

§ 721.10363 Alkenoic acid, 2-methyl-, 2-oxiranylmethyl ester, reaction products with 4,4′ -methylenebis (cyclohexanamine) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkenoic acid, 2-methyl-, 2-oxiranylmethyl ester, reaction products with 4,4′ -methylenebis (cyclohexanamine) (PMN P-10-47) 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) and (b)(4) (N=44).

(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.

69. Add § 721.10364 to subpart E to read as follows:

§ 21.10364 Halogenated aromatic amine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halogenated aromatic amine (PMN P-10-53) 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.

70. Add § 721.10365 to subpart E to read as follows:

§ 721.10365 Butanoic acid, 3-mercapto-2-methyl-, ethyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as butanoic acid, 3-mercapto-2-methyl-, ethyl ester (PMN P-10-56; CAS No. 888021-82-7) 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(s) (100 kilograms).

(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.

71. Add § 721.10366 to subpart E to read as follows:

§ 721.10366 Benzene, 4-bromo-1,2-dimethyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzene, 4-bromo-1,2-dimethyl-(PMN P-10-76; CAS No. 583-71-1) 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) 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.

72. Add § 721.10367 to subpart E to read as follows:

§ 721.10367 Hydroxy-aryl, polymer with substituted benzene, cyanate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydroxy-aryl, polymer with substituted benzene, cyanate (PMN P-10-83) 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=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 (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 § 721.10368 to subpart E to read as follows:

§ 721.10368 Triphenodioxazine derivatives (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as triphenodioxazine derivatives (PMN P-10-84) 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.

74. Add § 721.10369 to subpart E to read as follows:

§ 721.10369 Carbonic acid, diphenyl ester, polymer with diphenyl P-methylphosphonate and 4,4′-(1-methylethylidene) bis[phenol].

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as carbonic acid, diphenyl ester, polymer with diphenyl P-methylphosphonate and 4,4′-(1-methylethylidene) bis[phenol] (PMN P-10-88; CAS No. 77226-90-5) 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(j) (flame retardant and flame retardant additive, where the particle size is greater than 10 microns).

(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.

75. Add § 721.10370 to subpart E to read as follows:

§ 721.10370 Phosphonic acid, p-octyl-, lanthanum (3+) salt (2:1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphinic acid, p-octyl-, lanthanum (3+) salt (2:1) (PMN P-10-99; CAS No. 1186211-38-0) 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) 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.

76. Add § 721.10371 to subpart E to read as follows:

§ 721.10371 Butanoic acid, 3-mercapto-,1,1′-[2-(hydroxymethyl)-2-(substituted-1-oxoalkoxy)methyl)-1,3-propanediyl] ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as butanoic acid, 3-mercapto-,1,1′-[2-(hydroxymethyl)-2-(substituted-1-oxoalkoxy)methyl)-1,3-propanediyl] ester (PMN P-10-136, Chemical A) 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) (monomer for acryl-based ultra-violet (UV)-curing coatings, inks, and adhesives).

(ii) Release to water. Requirements as specified in § 721.90(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), (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.

77. Add § 721.10372 to subpart E to read as follows:

§ 721.10372 Butanoic acid, 3-mercapto-,1,1′-[2,2-bis[(substituted-1-oxoalkoxy)methyl]-1,3-propanediyl] ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as butanoic acid, 3-mercapto-,1,1′-[2,2-bis[(substituted-1-oxoalkoxy)methyl]-1,3-propanediyl] ester (PMN P-10-136, Chemical B) 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) (monomer for acryl-based UV-curing coatings, inks, and adhesives).

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

(b) Specific requirements. The provisions of subpart A of this partapply 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.

78. Add § 721.10373 to subpart E to read as follows:

§ 721.10373 1H-Imidazole, 1-(1-methylethyl)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1H-imidazole, 1-(1-methylethyl)- (PMN P-10-153; CAS No. 4532-96-1) 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(g).

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=70).

(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.

79. Add § 721.10374 to subpart E to read as follows:

§ 721.10374 Silane, (3-chloropropoxy)dimethyl(1-methylethyl)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as silane, (3-chloropropoxy)dimethyl(1-methylethyl)-(PMN P-10-163; CAS No. 1191036-21-1) 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)(2)(iii) (gloves and goggles), (a)(3), (a)(4). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10 meets the minimum requirements for § 721.63(a)(4): NIOSH-certified organic vapor respirator.

(ii) 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), 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.

80. Add § 721.10375 to subpart E to read as follows:

§ 721.10375 Hydroxypropyl methacrylate, reaction products with propylene oxide and ethylene oxide, copolymer with N-vinyl caprolactam (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydroxypropyl methacrylate, reaction products with propylene oxide and ethylene oxide, copolymer with N-vinyl caprolactam (PMN P-10-200) 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=155).

(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.

81. Add § 721.10376 to subpart E to read as follows:

§ 721.10376 Alkyltin halide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyltin halide (PMN P-10-222) 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=22).

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

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

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

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

82. Add § 721.10377 to subpart E to read as follows:

§ 721.10377 1,2-Cyclohexanedicarboxylic acid, benzyl C8-10-isoalkyl esters, C9-rich.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2-cyclohexanedicarboxylic acid, benzyl C8-10-isoalkyl esters, C9-rich (PMN P-10-247, Chemical A; CAS No. 1190265-49-6) 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)(1), (a)(2)(i), and (a)(3).

(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), (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.

83. Add § 721.10378 to subpart E to read as follows:

§ 721.10378 1,2-Cyclohexanedicarboxylic acid, benzyl nonyl ester, branched and linear.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2-cyclohexanedicarboxylic acid, benzyl nonyl ester, branched and linear (PMN P-10-247, Chemical B; CAS No. 1190264-82-4) 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), and (a)(3).

(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), (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.

84. Add § 721.10379 to subpart E to read as follows:

§ 721.10379 Propanoic acid, 3-(dodecylthio)-, 2-(1,1-dimethylethyl)-4-[[5-(1,1-dimethylethyl)-4-hydroxy-2-methylphenyl]thio]-5-methylphenyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propanoic acid, 3-(dodecylthio)-, 2-(1,1-dimethylethyl)-4-[[5-(1,1-dimethylethyl)-4-hydroxy-2-methylphenyl]thio]-5-methylphenyl ester (PMN P-10-266; CAS No. 69075-62-3) 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) (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.

85. Add § 721.10380 to subpart E to read as follows:

§ 721.10380 Benzoic acid, 3-amino-2-mercapto-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzoic acid, 3-amino-2-mercapto- (PMN P-10-285; CAS No. 71807-60-8) 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=33).

(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.

86. Add § 721.10381 to subpart E to read as follows:

§ 721.10381 Cyclic carboxylic acid, polymer with dihydroxy dialkyl ether, hydroxy substituted alkane and carboxylic acid anhydride, methacrylate terminated polyester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cyclic carboxylic acid, polymer with dihydroxy dialkyl ether, hydroxy substituted alkane and carboxylic acid anhydride, methacrylate terminated polyester (PMN P-10-290) 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.

87. Add § 721.10382 to subpart E to read as follows:

§ 721.10382 Diphosphoric acid, calcium salt (1:1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as diphosphoric acid, calcium salt (1:1) (PMN P-10-313; CAS No. 14866-19-4) 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(j) (opacifying agent for ceramic whiteware).

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=60).

(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.

88. Add § 721.10383 to subpart E to read as follows:

§ 721.10383 Urea, N,N′-(methyl-1,3-phenylene)bis[N′,N′-bis[3-polyalkyleneamino]-, compd. with formaldehyde polymer with phenol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as urea, N,N′-(methyl-1,3-phenylene)bis[N′,N′-bis[3-polyalkyleneamino]-, compd. with formaldehyde polymer with phenol (PMN P-10-324) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=43).

(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.

89. Add § 721.10384 to subpart E to read as follows:

§ 721.10384 Substituted alkanolamine phenol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted alkanolamine phenol (PMN P-10-332) is subject to reporting under this section for thesignificant 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.

90. Add § 721.10385 to subpart E to read as follows:

§ 721.10385 Phenoxy alkyl ether (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenoxy alkyl ether (PMN P-10-344) 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) [Reserved]

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

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

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

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

91. Add § 721.10386 to subpart E to read as follows:

§ 721.10386 Substituted phenol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted phenol (PMN P-10-361) 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.

92. Add § 721.10387 to subpart E to read as follows:

§ 721.10387 Substituted bis-phenol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted bis-phenol (PMN P-10-362) 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.

93. Add § 721.10388 to subpart E to read as follows:

§ 721.10388 Bisphospite nickel cyanoalkyl complex (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as bisphospite nickel cyanoalkyl complex (PMN P-10-364) 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.

94. Add § 721.10389 to subpart E to read as follows:

§ 721.10389 Styrene, copolymer with acrylic acid, salt with alkoxylated alkenylamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as styrene, copolymer with acrylic acid, salt with alkoxylated alkenylamine (PMN P-10-401) 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=27). Where primary, secondary, and tertiary waste treatment will occur, or treatment in a lined self-contained solar evaporation pond where UV 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.

95. Add § 721.10390 to subpart E to read as follows:

§ 721.10390 Acetoacetanilide reaction product with multifunctional acrylate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acetoacetanilide reaction product with multifunctional acrylate (PMN P-10-403) 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.

96. Add § 721.10391 to subpart E to read as follows:

§ 721.10391 Copper gallium indium selenide.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as copper gallium indium selenide (PMN P-10-424; CAS No. 144972-86-1) 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), (b) (concentration set at 0.1 percent), and (c). The following NIOSH-certified respirators with an assigned protection factor (APF) of at least 10 meet the minimum requirements for § 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; or

(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 in paragraph (a)(2)(i), a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) of 1.5 mg/m 3 as an 8-hour time-weighted-average. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30.

(2) [Reserved]

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

97. Add § 721.10392 to subpart E to read as follows:

§ 721.10392 Halo substituted sulfamidylbenzyluracil (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halo substituted sulfamidylbenzyluracil (PMN P-10-426) 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(b) and (g).

(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.

98. Add § 721.10393 to subpart E to read as follows:

§ 721.10393 Sodium bromide MDA complex (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sodium bromide MDA complex (PMN P-10-433) 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=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 (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.

99. Add § 721.10394 to subpart E to read as follows:

§ 721.10394 Copolymer of anhydride, a diol and a disubstituted diol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as copolymer of anhydride, a diol and a disubstituted diol (PMN P-10-436) 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=55).

(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.

100. Add § 721.10395 to subpart E to read as follows:

§ 721.10395 Fatty acids, C14-18 and C16-18 unsatd., polymers with adipic acid and triethanolamine, di-Me sulfate-quaternized.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as fatty acids, C14-18 and C16-18 unsat., polymers with adipic acid and triethanolamine, di-Me sulfate-quaternized (PMN P-10-458; CAS No. 1211825-32-9) 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=5).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this partapply 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.

101. Add § 721.10396 to subpart E to read as follows:

§ 721.10396 Dimethyl siloxy-polyfluoro methyl siloxy-poly(oxyalkylenediyl) methyl siloxy copolymer (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dimethyl siloxy-polyfluoro methyl siloxy-poly(oxyalkylenediyl) methyl siloxy copolymer (PMN P-10-470) 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) (recording and reporting of certain fluorinated impurities in the starting raw material, and manufacture of the PMN substance not to exceed the maximum established impurity levels of certain fluorinated impurities) and (t).

(ii) [Reserved]

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

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

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

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

102. Add § 721.10397 to subpart E to read as follows:

§ 721.10397 Alkyl acrylate-polyfluoro methacrylate-poly(oxyalkylenediyl)-methacrylates (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as alkyl acrylate-polyfluoro methacrylate-poly(oxyalkylenediyl)- methacrylates (PMNs P-10-471 and P-10-472) 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(k) (recording and reporting of certain fluorinated impurities in the starting raw material, and manufacture of the PMN substances not to exceed the maximum established impurity levels of certain fluorinated impurities) and (t).

(ii) [Reserved]

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

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

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

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

103. Add § 721.10398 to subpart E to read as follows:

§ 721.10398 Poly(oxy-1,2-ethanediyl),. alpha., -monoalkyl ethers-.omega.-mono (hydrogen maleate)- (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as poly(oxy-1,2-ethanediyl), .alpha., -monoalkyl ethers-.omega.-mono (hydrogen maleate)- (PMN P-10-495) 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(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.

104. Add § 721.10399 to subpart E to read as follows:

§ 721.10399 Benzoic acid azo-substituted pyridine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as benzoic acid azo-substituted pyridine (PMN P-10-501) 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.

105. Add § 721.10400 to subpart E to read as follows:

§ 721.10400 Oxirane, 2-ethyl-, polymer with oxirane, mono-C12-14-sec-alkyl ethers.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2-ethyl-, polymer with oxirane, mono-C12-14-sec-alkyl ethers (PMN P-10-517; CAS No. 1013910-41-2) 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=14), where the amount of substance reasonably likely to be removed during waste pretreatment prior to release may be subtracted in calculating the number of kilograms released.

(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.

106. Add § 721.10401 to subpart E to read as follows:

§ 721.10401 Oxirane, 2-ethyl-, polymer with oxirane, mono-C11-15-sec-alkyl ethers.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2-ethyl-, polymer with oxirane,mono C11-15-sec-alkyl ethers (PMN P-10-518; CAS No. 1022990-65-3) 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=20), where the amount of substance reasonably likely to be removed during waste pretreatment prior to release may be subtracted in calculating the number of kilograms released.

(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.

107. Add § 721.10402 to subpart E to read as follows:

§ 721.10402 Vegetable oil, modified products (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as vegetable oil, modified products (PMN P-10-548) 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.

108. Add § 721.10403 to subpart E to read as follows:

§ 721.10403 Vegetable oil, modified products, esters (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as vegetable oil, modified products, esters (PMN P-10-550) 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.

109. Add § 721.10404 to subpart E to read as follows:

§ 721.10404 Olefins (generic) (P-10-551 and P-10-552).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as olefins (PMNs P-10-551 and P-10-552) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(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.

110. Add § 721.10405 to subpart E to read as follows:

§ 721.10405 Olefins (generic) (P-10-553).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as olefins (PMN P-10-553) 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) and (s).

(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 this section.

111. Add § 721.10406 to subpart E to read as follows:

§ 721.10406 Fatty acid methyl esters (generic) (P-10-554).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acid methyl esters (PMN P-10-554) 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.

112. Add § 721.10407 to subpart E to read as follows:

§ 721.10407 Fatty acid methyl esters (generic) (P-10-555).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acid methyl esters (PMN P-10-555) 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.

113. Add § 721.10408 to subpart E to read as follows:

§ 721.10408 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[[2,2-dimethyl-3-[(1-oxododecyl) oxy]propylidene] amino] methylethyl]-.omega.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene] amino]methylethoxy]-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene] amino] methylethyl]-.omega.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino] methylethoxy]- (PMN P-10-556; CAS No. 613246-75-6) 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=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.

114. Add § 721.10409 to subpart E to read as follows:

§ 721.10409 Poly(oxyalkylenediyl), .alpha.-[[[methyl-3-[[[(polyfluoroalkyl)oxy]carbonyl]amino]phenyl]amino]carbonyl]-.omega.-methoxy-(generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as poly(oxyalkylenediyl), .alpha.-[[[methyl-3-[[[(polyfluoroalkyl) oxy]carbonyl]amino]phenyl]amino] carbonyl]-.omega.-methoxy- (PMN P-11-217) 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) (recording and reporting of certain fluorinated impurities in the starting raw material, and manufacture of the PMN substance not to exceed the maximum established impurity levels of certain fluorinated impurities) and (t).

(ii) [Reserved]

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

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

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

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

[FR Doc. 2012-9800 Filed 4-26-12; 8:45 am]
BILLING CODE 6560-50-P
 
 
Comment Period Closed
May 29 2012, at 11:59 PM ET
ID: EPA-HQ-OPPT-2011-0577-0001
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Date Posted: Apr 27, 2012
RIN: 2070-AB27
CFR: 40 CFR Parts 9 and 721
Federal Register Number: 2012-09800
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Comments Received*
Comment submitted by Lynn L. Bergeson, Bergeson & Campbell, P.C. (B&C) (see attached)

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