2012-23235. 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 107 chemical substances which were the subject of premanufacture notices (PMNs). Eight 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 107 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 November 20, 2012. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on October 5, 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 October 22, 2012 (see Unit VI. of the SUPPLEMENTARY INFORMATION).

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

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2011-0941, 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-2011-0941. 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 [phone]. 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-2011-0941. 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 [phone], and the telephone number for the OPPT Docket is [phone]. 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: [phone]; email address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave. Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

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 under FOR 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. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see §  721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

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

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

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

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

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

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

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

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

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

II. Background

A. What action is the agency taking?

EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these rules are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376) (April 24, 1990 SNUR). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.

B. What is the agency's authority for taking this action?

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use. Persons who must report are described in § 721.5.

C. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to §  721.1(c), persons subject to these SNURs must comply with the same 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 sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

III. Significant New Use Determination

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 107 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 107 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 8 PMN substances (P-00-346, P-01-470, P-02-120, P-02-285, P-04-834, P-10-58, P-10-59, and P-10-60) 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 section 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.

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

This rule also includes SNURs on 99 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.

PMN Number P-96-308

Chemical name: Aminoalkanol (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 structure-activity relationship (SAR) analysis of the potential reaction of the PMN substance with nitrosating agents, and by analogy to monoethanolamine, diethanolamine and dimethylisopropylamine, EPA identified concerns for skin, eye, liver, kidney, lung, bone marrow, brain, testes, heart, and blood toxicity from exposure to the PMN substance via inhalation and dermal exposures, and the gastrointestinal (GI) tract. In addition, based on ecological structure-activity relationship (EcoSAR) analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 600 ppb of the PMN substance in surface waters. For the use described in the PMN, EPA does not expect dermal or inhalation exposures to manufacturing or processing workers or other targeted populations, nor does it expect releases 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 described in the PMN, or any use of the substance resulting in surface water concentrations exceeding 600 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 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a functional observational battery and histopathology; a prenatal developmental toxicity test (OPPTS Test Guideline 870.3700); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity test mitigated by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help to characterize the human health and environmental effect of the PMN substance.

CFR citation: 40 CFR 721.10427.

PMN Numbers P-96-1021 and P-96-1022

Chemical names: (P-96-1021) Fatty acids, C₁₈-unsatd., dimers, reaction products with 1-piperazineethanamine and (P-96-1022) Fatty acids, C₁₈-unsatd., dimers, reaction products with 1-piperazineethanamine and tall-oil fatty acids.

CAS numbers: (P-96-1021) 206565-90-4 and (P-96-1022) 206565-89-1.

Basis for action: The consolidated PMN states that the substances will be used as water based epoxy curing agents. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters. As described in the PMN, the substances are not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN 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 modified semi-continuous activated sludge (SCAS) test (OPPTS Test Guideline 835.3210); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) on PMN P-96-1022 would help characterize the environmental effects of the PMN substances.

CFR citations: 40 CFR 721.10428 (P-96-1021) and 40 CFR 721.10429 (P-96-1022).

PMN Number P-97-823

Chemical name: Tetra alkyl ammonium salt (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a curing agent for coatings. Based on test data submitted on the PMN substance at varying concentrations, EPA identified concerns for ocular lethality for occupational exposures to the PMN substance at concentrations greater than 25 percent. For the use described in the PMN, significant worker exposures are not expected as the PMN substance is used at concentrations no greater than 25 percent, and the material safety data sheet (MSDS) provides the ocular lethality results from the submitted eye irritation studies. 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 including the hazard communication warnings concerning the eye irritation test results in the MSDS, or any use of the substance in concentrations greater than 25 percent 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 an acute eye irritation test (OPPTS Test Guideline 870.2400) on the PMN substance at concentrations greater than 25 percent would help characterize human health effects of the PMN substance.

CFR citation: 40 CFR 721.10430.

PMN Numbers P-98-141 and P-98-142

Chemical name: Phosphoric acid esters (generic).

CAS number: Not available.

Basis for action: The consolidated PMN states that the generic (non-confidential) use of the substances will be as metal extractants. Based on EcoSAR analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 100 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 100 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10431.

PMN Number P-98-1028

Chemical name: 1,2,4,5,7,8-Hexoxonane, 3,6,9-triethyl-3,6,9-trimethyl-.

CAS number: 24748-23-0.

Basis for action: The PMN states that the substance will be used as a viscosity modifier in the manufacture of polypropylene, manufactured and supplied as a solution in at least 40 percent mineral spirits. Based on EcoSAR analysis of test data on analogous peroxides, 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 use described in the PMN, where the PMN substance is supplied as a solution of at least 40 percent mineral spirits, significant environmental releases 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 use of the substance other than as a viscosity modifier, manufactured and supplied as a solution in at least 40 percent mineral spirits, in the manufacture of polypropylene 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); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10432.

PMN Number P-99-184

Chemical name: Cyclopentene, 1,2,3,3,4,4,5,5-octafluoro-.

CAS number: 559-40-0.

Basis for action: The PMN states that the substance will be used as a dry etching agent and a chemical vapor deposition (CVD) agent for the production of semiconductors. Based on test data on the PMN substance, EPA identified concerns for acute toxicity, systemic toxicity, developmental toxicity, cardiac sensitization, and mutagenicity from inhalation exposures. As described in the PMN, the substance will be imported and not manufactured in the United States. As described in the PMN, EPA does not expect significant worker exposures during processing and use activities for the uses described in the PMN nor does it expect general population exposures for the uses described in the PMN. Therefore, EPA has not determined that the proposed processing or use may present an unreasonable risk. EPA has determined, however, that domestic manufacture, or any use of the substance other than as a dry etching agent and a CVD agent for the production of semiconductors 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 inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket under docket ID number EPA-HQ-OPPT-2011-0941), would help characterize the human health effects of the PMN substance.

CFR citations: 40 CFR 721.10433.

PMN Number P-99-214

Chemical name: Cyclopentane, 1,1,2,2,3,3,4-heptafluoro-.

CAS number: 15290-77-4.

Basis for action: The PMN states that the substance will be used as a solvent and a cleaning and drying agent. Based on test data on the PMN substance, EPA identified concerns for acute, systemic, and developmental toxicity, cardiac sensitization, and mutagenicity from inhalation exposures. As described in the PMN, the substance will be imported and not manufactured in the United States. As described in the PMN, EPA does not expect significant worker exposures during processing and use activities for the uses described in the PMN nor does it expect general population or consumer exposures for the uses described in the PMN. Therefore, EPA has not determined that the proposed processing or use may present an unreasonable risk. EPA has determined, however, that any domestic manufacture of the substance, use of the substance other than as a solvent or a cleaning and drying agent, or use in a consumer product 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 inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket under docket ID number EPA-HQ-OPPT-2011-0941), would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10434.

PMN Number P-99-1179

Chemical name: Phenol, 2-(1-methyl-1-phenylethyl)-4-(1,1,3,3-tetramethylbutyl)-.

CAS number: 73936-80-8.

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

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10435.

PMN Numbers P-99-1217 and P-99-1218

Chemical name: Amine neutralized phosphated polyesters (generic).

CAS number: Not available.

Basis for action: The consolidated PMN states that the generic (non-confidential) use of the substances will be as pigment dispersants. Based on EcoSAR analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur as a result of releases of the PMN substances in quantities greater than the combined 50,000 kilograms (kgs) per year production volume stated in the PMN. At the annual production volume of 50,000 kgs stated in the consolidated PMN, there were no significant environmental releases. 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 exceeding an annual aggregate manufacturing and importation volume of 50,000 kgs 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 characterize the environmental effects of the PMN substances.

CFR citation: 40 CFR 721.10436.

PMN Numbers P-99-1280, P-99-1281, and P-99-1282

Chemical name: Sulfonic acid, linear xylene alkylate, mono, sodium salts (generic).

CAS number: Not available.

Basis for action: The consolidated PMN states that the substances will be used as enhanced oil recovery surfactants. Based on EcoSAR analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the substances in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substances to surface water, from uses other than as described in the PMNs, exceed releases from the use described in the PMNs. For the use described in the PMNs, environmental releases did not exceed 2 ppb more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substances may present an unreasonable risk. EPA has determined, however, that any use of the substances other than as enhanced oil recovery surfactants may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10437.

PMN Number P-00-346

Chemical name: Dialkyl hydroxybenzenealkanoic acid ester (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: August 16, 2001.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a petroleum additive. Based on test data on the PMN substance and SAR analysis of structurally similar substances, EPA identified concerns for liver and thyroid toxicity from dermal exposures. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that this substance may present an unreasonable risk of injury to human health, the substance may be produced in substantial quantities, and there may be significant (or substantial) human exposure to the substance. To protect against these risks, the consent order requires:

1. Use of personal protective equipment including impervious gloves (when there is potential dermal exposure).

2. Establishment and use of a hazard communication program.

3. Submission of certain human health testing prior to exceeding the confidential production volume limit specified in the consent order.

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

Recommended testing: EPA has determined that the results of a 28-day dermal toxicity test (The Organisation for Economic Co-operation and Development (OECD) Test Guideline 410) with emphasis on the thyroid (per OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. The PMN submitter has agreed not to exceed the confidential production volume limit specified in the consent order without performing this test.

CFR citation: 40 CFR 721.10438.

PMN Number P-00-635

Chemical name: 1,3-Dioxolan-2-one, 4-ethenyl.

CAS number: 4427-96-7.

Basis for action: The PMN states that the generic (non-confidential) uses of the substance will be as a chemical intermediate and an industrial chemical additive. Based on test data on the PMN substance and SAR analysis of test data on analogous vinylene carbonate, EPA predicts acute toxicity, liver toxicity, kidney toxicity, developmental toxicity, immunotoxicity, and oncogenicity. For the uses described in the PMN, significant dermal exposures are not expected due to the use of impervious gloves. 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 exposures, or any use other than as described in the PMN may cause serious human health effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).

Recommended testing: EPA has determined that no additional testing is recommended at this time as the health effects have been adequately characterized by the testing submitted on the PMN substance.

CFR citation: 40 CFR 721.10439.

PMN Number P-00-1165

Chemical name: Diphosphoric acid, polymers with ethoxylated reduced Me esters of reduced polymd, oxidized tetrafluoroethylene.

CAS number: 200013-65-6.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a surface active agent. Based on analogous high molecular weight polymers, EPA identified concerns from inhalation exposures. For the industrial uses described in the PMN, worker inhalation exposures are not expected as the substance is not applied by a method that generates a vapor, mist, or spray. Therefore, EPA has not determined that the proposed manufacturing, processing, or use may present an unreasonable risk. EPA has determined, however, that any use of the substance in consumer products, or any use involving an application method that generates a vapor, mist, or spray may cause serious health effects. Based on the information, the PMN substance meets the criteria at 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of an acute inhalation toxicity test (OPPTS Test Guideline 870.1300) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10440.

PMN Numbers P-01-382 and P-01-383

Chemical names: (P-01-382) 1, 2-Benzenedicarboxylic acid, di-C_7-14-branched and linear alkyl esters and (P-01-383) 1,2-Benzenedicarboxylic acid, di-C_6-14-branched and linear alkyl esters.

CAS numbers: (P-01-382) 309934-68-7 and (P-01-383) 309934-69-8.

Basis for action: The consolidated PMN states that the substances will be used as plasticizers for flexible poly-vinyl chloride. Based on SAR analysis of the expected ester hydrolysis product of the PMNs, EPA identified concerns for liver, developmental, and reproductive toxicity; and oncogenicity. For the use described in the PMNs, neither significant worker exposures nor general population exposures are expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances in children's toys (e.g., pacifiers, rattles, and teethers) may cause serious health effects. Based on this information, the PMN substances meet the criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii).

Recommended testing: EPA has determined that the results of an acute oral toxicity test (OECD Test Guideline 401 or 420); an acute dermal toxicity test (OECD Test Guideline 402); an acute inhalation toxicity test (OECD Test Guideline 403); a repeated dose 28-day oral toxicity test in rodents (OECD Test Guideline 407); a 28-day dermal toxicity test (OECD Test Guideline 410); a 28-day subacute inhalation toxicity test (OECD Test Guideline 412); a prenatal developmental toxicity test (OECD Test Guideline 414); a 1-generation reproduction test (OECD Test Guideline 415); a reproduction and fertility effects test (OECD Test Guideline 416); a reproduction/development toxicity screening test (OECD Test Guideline 421); a combined repeated dose toxicity test with the reproduction/development toxicity screening test (OECD Test Guideline 422); a bacterial reverse mutation test (OECD Test Guideline 471); an in vitro mammalian chromosome aberration test (OECD Test Guideline 473); a mammalian erythrocyte micronucleus test (OECD Test Guideline 474); and a mammalian bone marrow chromosomal aberration test (OECD Test Guideline 475) would help characterize the human health effects of the PMN substances.

CFR citations: 40 CFR 721.10441 (P-01-382) and 40 CFR 721.10442 (P-01-383).

PMN Number P-01-470

Chemical name: Ethoxylated alkylphenol sulfate, ammonium salt (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: August 26, 2002.

Basis for TSCA section 5(e) consent order: The PMN states that the substance will be used as a dispersant for carbon black and organic pigments. Based on test data on the PMN substance, and EcoSAR analysis of test data on analogous ethoxylated anionic surfactants, EPA predicts environmental toxicity that varies depending on the average number of moles of ethoxylate. As the number of ethoxylate decreases, the aquatic toxicity of the substance increases. For this PMN substance, the average number of moles may vary. Based on submitted test data on the PMN—with an average number of 16.4 moles of ethoxylate—EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 200 ppb of the PMN substance in surface waters. When the average number of moles of ethoxylate is less than or equal to 10, EPA expects toxicity to aquatic organisms may occur at concentrations that exceed 60 ppb of the substance in surface waters. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that the substance may present an unreasonable risk of injury to the environment, may be produced in substantial quantities, and may be reasonably anticipated to enter the environment in substantial quantities. To protect against these risks, the consent order prohibits the company from manufacturing or importing the PMN substance unless either: The mean number of moles of the ethoxy group is greater than or equal to 10, or the average number molecular weight is greater than 950 daltons. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize environmental effects of the PMN substance. Testing should be conducted on the PMN substance with less than 10 moles of ethoxylate, or an average number molecular weight of less than 950 daltons. The consent order does not require the submission of the aforementioned 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 consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10443.

PMN Number P-01-499 and P-01-500

Chemical name: (P-01-499) Propanol, mercapto- and (P-01-500) 2-Propen-1-ol, reaction products with hydrogen sulfide, distn. residues.

CAS number: (P-01-499) 63947-56-8 and (P-01-500) 374078-75-8.

Basis for action: The PMNs state that the substances will be used as chemical intermediates. Based on SAR analysis of test data on structurally similar 3- mercaptopropanol, EPA identified concerns for developmental and maternal effects from dermal exposures to the PMN substances. In addition, based on test data on P-01-499 and EcoSAR analysis of analogous thiols, EPA predicts toxicity to aquatic organisms may occur at surface water concentrations that exceed 11 ppb for P-01-499 and 1 ppb for P-01-500. For the chemical intermediate use described in the PMNs, significant worker exposures are not expected due to the use of impervious dermal protection, and the substances are not released to surface water. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances without impervious dermal protection where there is a potential for dermal exposures, or any use of the substances resulting in surface water concentrations exceeding 11 ppb (P-01-499) or 1 ppb (P-01-500) may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii), (b)(4)(i), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010) on P-01-500 would help to characterize the environmental effects of the PMN substances.

CFR citation: 40 CFR 721.10444 (P-01-499) and 40 CFR 721.10445 (P-01-500).

PMN Number P-01-762

Chemical name: 1,9-Cyclohexadecadiene.

CAS number: 4277-06-9.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as open, non-dispersive use with limited employee exposure. Based on test data on the PMN substance, EPA identified concerns for dermal sensitization and irritation. In addition, based on test data on the PMN substance and EcoSAR analysis of test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, significant dermal exposures are not expected due to the use of impervious gloves, and releases of the substance to surface waters are not expected in concentrations that exceed 1 ppb. Therefore, EPA has not determined that manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without impervious protective equipment where there is a potential for dermal exposures, or any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria in § 721.170(b)(3)(i), (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); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10446.

PMN Number P-01-829

Chemical name: 17-Oxabicyclo[14.1.0]heptadec-8-ene.

CAS number: 34748-97-5.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as open, non-dispersive with limited employee exposure. Based on test data on the PMN substance, EPA identified concerns for dermal sensitization, respiratory sensitization, mutagenicity, developmental toxicity, male reproductive toxicity, liver toxicity, and kidney toxicity. In addition, based on test data on the PMN substance and EcoSAR analysis of test data on analogous epoxides, EPA predicts toxicity to aquatic organisms at concentrations that exceed 1 ppb of the substance in surface waters. As described in the PMN, significant exposures are not expected due to the use of protective dermal and respiratory equipment, and the substance is not released to surface waters in 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 impervious dermal and adequate respiratory protection where there is a potential for exposures, or any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause serious health effects and significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(3)(i), (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); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10447.

PMN Number P-02-120

Chemical name: Acetic acid, hydroxymethoxy-, methyl ester, reaction products with substituted alkylamine (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: September 12, 2003.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as an emulsifier. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur when the average number molecular weight is below 850 daltons. 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 reasonably be anticipated to enter the environment in substantial quantities and may present an unreasonable risk of injury to the environment. The consent order for this substance prohibits manufacturing or importing of the PMN substance unless the average number molecular weight is greater than or equal to 850 daltons. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500), on the PMN substance where the average number molecular weight is less than 850 daltons would help characterize possible environmental effects of the substance. The order does not require submission of the aforementioned information 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 substance will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10448.

PMN Number P-02-172

Chemical name: Aromatic polyester polyol (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 component. Based on EcoSAR analysis of test data on analogous esters, 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, EPA does not expect releases to surface waters to 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, however, determined that any use of the substance resulting in surface water concentrations exceeding 40 ppb may cause significant adverse environmental effects. Based on this information, the substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10449.

PMN Number P-02-285

Chemical name: Oxirane, 2-[[3-(trimethoxysilyl)propoxy]methyl]-, reaction products with wollastonite (Ca(SiO₃)).

CAS number: 100402-91-3.

Effective date of TSCA section 5(e) consent order: October 14, 2002.

Basis for TSCA section 5(e) consent order: The PMN states that the substance will be used as functional filler for polymer systems. Based on SAR analysis of analogous respirable, poorly soluble particulates, EPA identified concerns for lung toxicity based on lung overload, and concern for carcinogenicity based on test data on the starting raw material—wollastonite. The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this exposure and risk, the consent order requires the company to manufacture and process the PMN substance with an average aspect ratio of no greater than 5, and no more than 15 percent of the PMN substance shall have an aspect ratio greater than 10. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA had determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-day holding period and a carcinogenicity test (OPPTS Test Guideline 870.4200) would help characterize the human health effects of the PMN substance. These tests should be conducted on the PMN substance with an average aspect ratio of greater than 5, and more than 15 percent of the PMN substance with an aspect ratio of greater than 10. The order does not require submission of the aforementioned information 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 substance will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10450.

PMN Number P-02-436

Chemical name: Alkyd amide polyol (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an intermediate for polyurethane polymers. Based on EcoSAR analysis of test data on analogous nonionic surfactants, 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 (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10451.

PMN Number P-02-659

Chemical name: 9-Octadecenoic acid (9Z)-, 1,1′-(dimethylstannylene) ester.

CAS number: 3865-34-7.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a catalyst. Based on EcoSAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 ppb of the substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance 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 (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10452.

PMN Number P-02-796

Chemical name: Polyglycerin 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 lubricant additive. Based on test data on the PMN substance and EcoSAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb of the substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 3 ppb more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10453.

PMN Number P-02-828

Chemical name: Propoxylated ethoxylated alkylamine (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a concrete admixture. Based on EcoSAR analysis of analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 80 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters in concentrations that exceed 80 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 80 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); fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10454.

PMN Number P-03-61

Chemical name: Oxirane, 2,2′,2″-[ethylidynetris(4,1-phenyleneoxymethylene)]tris-.

CAS number: 87093-13-8.

Basis for action: The PMN states that the substance will be used as a high-density cross-linked polymer in resins, composites, and adhesives. Based on test data on the PMN substance and SAR analysis of test data on analogous epoxides, EPA identified concerns for cancer, reproductive toxicity in males, developmental toxicity, and sensitization to lungs from worker and consumer inhalation exposures. As described in the PMN, significant occupational and consumer inhalation exposures are not expected, as the substance is not spray applied. 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 involving an application method that generates a mist, vapor, or aerosol may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).

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

CFR citation: 40 CFR 721.10455.

PMN Number P-03-104

Chemical name: Tristyryl phenol alkoxylate salt (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an agricultural inert. Based on EcoSAR analysis of test data on analogous cationic and anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 2 ppb more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10456.

PMN Number P-03-154

Chemical name: 1,2-Benzenedicarboxylic acid, mixed esters with benzyl alc., cyclohexanol, 2-ethyl-1-hexanol, fumaric acid and propylene glycol.

CAS number: 464920-01-2.

Basis for action: The PMN states that the substance will be used as a monomer combined with styrene and unsaturated polyester resins. 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 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 to the environment. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10457.

PMN Number P-03-238

Chemical name: Acrylate of hydroxyimide (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be in adhesives. Based on test data on the PMN substance and SAR analysis of test data on analogous acrylates, EPA identified concerns for developmental toxicity and sensitization from inhalation exposure to the PMN substance. In addition, based on EcoSAR analysis of test data on analogous acrylates, EPA expects toxicity to aquatic organisms may occur at concentrations that exceed 20 ppb of the PMN substance in surface waters. As described in the PMN, significant worker exposures are not expected as the substance is used in the liquid form, 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 manufacturing, processing, or use of the substance in a solid form, or any use resulting in surface water concentrations exceeding 20 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 prenatal developmental toxicity test (OPPTS Test Guideline 870.3700) in rats; a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help to characterize the human health and environmental effects of the substance.

CFR citation: 40 CFR 721.10458.

PMN Number P-03-282

Chemical name: Amino-substituted carbopolycycle (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 test data on the PMN substance and SAR analysis of test data on analogous alpha-naphthylamine, aniline, aromatic amine, and naphthalene, EPA identified concerns for mutagenicity, oncogenicity, sensitization, developmental toxicity, blood effects, neurotoxicity, liver effects, and cancer to workers exposed to the PMN substance. As described in the PMN, significant worker exposures are not expected due to the use of adequate personal protective equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without the use of impervious gloves where there is potential for dermal exposure, use of the substance without the use of a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 50 where there is potential inhalation exposure, domestic manufacture, or use of the substance other than as described in the PMN may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).

Recommended testing: EPA has determined that inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket under docket ID number EPA-HQ-OPPT-2011-0941), would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10459.

PMN Number P-03-307

Chemical name: Azo nickel 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 colorant. EPA identified concerns for oncogenicity, pulmonary sensitization, immunotoxicity, developmental toxicity, and neurotoxicity for released nickel. In addition, test data for nickel sulfate hexahydrate has shown effects on the brain, kidney, liver, testes, thymus, and spleen. For the use described in the PMN, worker inhalation exposures from the liquid form of the PMN are not expected. 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 other than as described in the PMN, or any use of the substance as a powder, 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); a reproduction and fertility effects test (OPPTS Test Guideline 870.3800); and a carcinogenicity study (OPPTS Test Guideline 870.4200) would help to characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10460.

PMN Number P-03-325

Chemical name: Oxazolidine, 3,3′-methylenebis[5-methyl-.

CAS number: 66204-44-2.

Basis for action: The PMN states that the substance will be used as a metalworking fluid. Based on test data on the PMN substance, EPA identified concerns for systemic toxicity and severe skin and eye irritation. In addition, based on test data on the PMN substance and EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at surface water concentrations that exceed 40 ppb of the substance in saltwater, and 100 ppb of the substance in freshwater. For the use described in the PMN, worker exposures are not expected as the substance is used in an enclosed system, and 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 use of the substance other than as a metalworking fluid, or any use of the substance resulting in surface water concentrations exceeding the freshwater and saltwater concentrations of concern may cause serious health effects and significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(3)(i), (b)(4)(i), and (b)(4)(ii).

Recommended testing: EPA has determined that the no additional testing is recommended at this time as the human health and environmental effects have been adequately characterized by the testing submitted on the PMN substance.

CFR citation: 40 CFR 721.10461.

PMN Number P-03-354

Chemical name: 1-Penten-3-one, 1-(4-chlorophenyl)-4,4-dimethyl-.

CAS number: 1577-03-3.

Basis for action: The PMN states that the substance will be used as an intermediate. Based on EcoSAR analysis of test data on analogous vinyl ketones, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 30 ppb of the substance in surface waters. For the use described in the PMN, EPA does not expect releases of the substance to surface waters in 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. However, EPA has determined that any use of the substance other than as an intermediate, or any use of the substance resulting in surface water concentrations exceeding 30 ppb may cause significant adverse environmental effects. Based on this information, the 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 early life-stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10462.

PMN Number P-03-388

Chemical name: Fatty acid amides (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a paint and coating additive. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 1 ppb more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10463.

PMN Number P-03-461

Chemical name: Fatty acid, reaction products with alkanolamine (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a petroleum additive. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 ppb of the substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 6 ppb more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10464.

PMN Numbers P-03-561, P-03-563, P-03-564, P-03-565, and P-03-566

Chemical names: (P-03-561) 2-Propenoic acid, 2-methyl-, 3-hydroxytricyclo[3.3.1.13,7]dec-1-yl ester; (P-03-563) 2-Propenoic acid, 2-methyl-, 2-ethyltricyclo[3.3.1.13,7]dec-2-yl ester; (P-03-564) 2-Propenoic acid, 3-hydroxytricyclo [3.3.1.13,7] dec-1-yl ester; (P-03-565) 2-Propenoic acid, 2-methyltricyclo[3.3.1.13,7]dec-2-yl ester; and (P-03-566) 2-Propenoic acid, 2-ethyltricyclo[3.3.1.13,7]dec-2-yl ester.

CAS numbers: (P-03-561) 115372-36-6; (P-03-563) 209982-56-9; (P-03-564) 216581-76-9; (P-03-565) 249562-06-9; and (P-03-566) 303186-14-3.

Basis for action: The consolidated PMN states that the generic (non-confidential) use of the substances will be as monomers. Based on test data on the PMN substances and SAR analysis of test data on analogous acrylates and methacrylates, EPA identified concerns for systemic toxicity and pulmonary sensitization. In addition, 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 substances in surface waters. For the uses described in the PMN, significant worker exposures are not expected due to the use of impervious gloves, protective clothing, eye protection, and adequate warnings in the MSDS; and the substance is 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 substance without worker protection where there is a potential for dermal or inhalation exposure, or any use of the substance resulting in surface water concentrations exceeding 3 ppb may cause serious health effects and significant adverse environmental effects. Based on this information the PMN substances meet the concern criteria at § 721.170(b)(3)(i), (b)(3)(ii), 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); a fish acute toxicity test mitigated by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help to characterize the environmental effects of the PMN substances.

CFR citations: 40 CFR 721.10465 (P-03-561); 40 CFR 721.10466; (P-03-563); 40 CFR 721.10467 (P-03-564); 40 CFR 721.10468 (P-03-565); and 40 CFR 721.10469 (P-03-566).

PMN Number P-03-567

Chemical name: Phosphonium, tetrabutyl-, 1,1,2,2,3,3,4,4,4-nonafluoro-1-butanesulfonate (1:1).

CAS number: 220689-12-3.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a polymer additive. Based on test data on the PMN substance, EPA identified concerns for systemic toxicity and neurotoxicity from inhalation exposures. In addition, EPA identified concern for potential degradation products, byproducts, unreacted material, and low molecular weight species. The PMN substance is a derivative of perfluorobutanesulfonate (PFBS) and may degrade to form PFBS. Further, concerns for the substance are based on analogous perfluorooctanesulfonate (PFOS). For the use described in the PMN, significant exposures and environmental releases are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as described in the PMN 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)(iii).

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); a 2 generation reproduction and fertility effects test (OPPTS Test Guideline 870.3200); a porous pot test (OPPTS Test Guideline 835.3220); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10470.

PMN Number P-03-622

Chemical name: 2-Propenoic acid, 1,1′-(3-methyl-1,5-pentanediyl) ester.

CAS number: 64194-22-5.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a component of a UV coating agent. Based on SAR analysis of test data on analogous acrylates, EPA identified concerns for carcinogenicity and sensitization. In addition, based on EcoSAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface waters, from uses other than as described in the PMN, exceed releases from the use described in the PMN. As described in the PMN, the substance will be imported and not manufactured in the United States. For the use described in the PMN, significant worker exposures are not expected during processing and use activities for the uses described in the PMN, and significant environmental releases 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 described in the PMN 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 carcinogenicity test (OPPTS Test Guideline 870.4200); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help to characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10471.

PMN Number P-03-645

Chemical name: 1,3-Benzenedimethanamine, polymers with epichlorohydrin-polyethylene glycol reaction products.

CAS number: 652968-34-8.

Basis for action: The PMN states that the substance will be used as a water retention aid for ornamental plants. Based on analogous swellable, high molecular weight polymers, EPA identified concerns for lung toxicity and cancer. As described in the PMN, the substance will be imported and not manufactured in the United States. For the use described in the PMN, significant worker exposures are not expected during processing and use activities for the uses described in the PMN. Therefore, EPA has not determined that the proposed processing or use of the substance may present an unreasonable risk. EPA has determined, however, that any domestic manufacture of the PMN substance 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) with a 60-day holding period, and a teabag test for water retention capacity (see http://www.epa.gov/​oppt/​newchems/​pubs/​teabag.pdf) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10472.

PMN Number P-03-865

Chemical name: 1-Propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl derivs., inner salts.

CAS number: 499781-63-4.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a non-corrosive foamer in the oil and gas industry. Based on test data on the PMN substance, and EcoSAR analysis of test data on analogous amphoteric and cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 85 ppb of the PMN substance in surface waters. As described in the PMN, EPA does not expect releases of the substance to surface waters in concentrations that exceed 85 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 85 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) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10473.

PMN Number P-04-107

Chemical name: Substituted amino ethane sulfonic acid salt (generic).

CAS number: Not available.

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

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

CFR citation: 40 CFR 721.10474.

PMN Number P-04-118

Chemical name: Hexanedioic acid, compd. with N1-(6-aminohexyl)-N1-methyl-1,6-hexanediamine (1:1).

CAS number: 659733-29-6.

Basis for action: The PMN states that the substance will be used as an intermediate for polymer manufacture. Based on SAR analysis of test data on analogous hexamethyl diamine, EPA identified concerns for immunotoxicity, systemic toxicity, developmental toxicity, and reproductive toxicity. In addition, 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, EPA does not expect significant worker exposures or releases of the substance to surface waters in concentrations that exceed 20 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as intermediate for polymer manufacture, or any use of the substance resulting in surface water concentrations exceeding 20 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 prenatal developmental toxicity test (OPPTS Test Guideline 870.3700); a reproduction and fertility effects test (OPPTS Test Guideline 870.3800); an immunotoxicity test (OPPTS Test Guideline 870.7800); a fish early life-stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10475.

PMN Number P-04-275

Chemical name: Oxetane, 3-(bromomethyl)-3-methyl-.

CAS number: 78385-26-9.

Basis for action: The PMN substance will be used as a chemical intermediate. Based on SAR analysis of test data on analogous chemical substances EPA identified concerns for cancer for the PMN material from dermal exposures. For the use described in the PMN, significant worker exposures are unlikely due to the use of impervious clothing. Therefore, EPA has not determined that manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, any use of the substance without impervious clothing where there is a potential for dermal exposures, or any use of the substance other than as an intermediate for the pharmaceutical, photographic, and other fine chemical industries may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C).

Recommended testing: EPA has determined that an in vivo micronucleus assay in erythrocytes (OPPTS Test Guideline 870.5395 or OECD Test Guideline 474), with exposure by the intraperitoneal route, would help to characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10476.

PMN Number P-04-290

Chemical name: Acrylate ester (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a monomer in radiation cured inks and coatings. Based on EcoSAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 1 ppb more than 20 days per year. Therefore, EPA had 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 may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10477.

PMN Number P-04-318

Chemical name: Polyether polyol (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an intermediate for urethane polymers. Based on SAR analysis of test data on similar molecular structure chemicals, EPA identified concerns for developmental kidney and liver toxicity. In addition, based on EcoSAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 30 ppb of the substance in surface waters. For the use described in the PMN, significant worker exposures are not expected and the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as an intermediate for urethane polymers, or any use of the substance resulting in surface water concentrations exceeding 30 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)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of an acute oral toxicity test (OPPTS Test Guideline 870.1100 or OECD Test Guideline 425); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a mammalian erythrocyte micronucleus test (intraperitoneal route) (OPPTS Test Guideline 870.5395); a repeated dose 28-day oral toxicity in rodents (OPPTS Test Guideline 870.3050 or OECD Test Guideline 407), which should include, for all test doses, a neurotoxicity functional observational battery, as described in neurotoxicity screening battery test (OPPTS Test Guideline 870.6200); a prenatal developmental toxicity test (one species, oral route) (OPPTS Test Guideline 870.3700); a Zahn-Wellens/EMPA test (OPPTS Test Guideline 835.3200); an aerobic aquatic biodegredation 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 (OCSPP Test Guideline 850.4500) would help characterize the human health, environmental and fate effects for PMN substance.

CFR citation: 40 CFR 721.10478.

PMN Number P-04-335

Chemical name: Quaternary ammonium compounds, tris(hydrogenated tallow alkyl)methyl, chlorides.

CAS number: 308074-73-9.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a rheology additive. Based on EcoSAR analysis of test data on analogous dialkyl cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 1 ppb more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10479.

PMN Number P-04-384

Chemical name: Trimethylolpropane polyol, aminated (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 curing agent. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 9 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 and processing of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 9 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 ready biodegradability test (OPPTS Test Guideline 835.3110); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity test mitigated by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10480.

PMN Numbers P-04-429, P-04-430, P-04-431, and P-04-432

Chemical names: (P-04-429) Siloxanes and Silicones, Me vinyl, hydroxy-terminated, reaction products with silica; (P-04-430) Siloxanes and Silicones, di-Me, Me vinyl, hydroxy-terminated, reaction products with silica; (P-04-431) Siloxanes and Silicones, di-Me, Me vinyl, hydroxy-terminated, reaction products with [(ethenyldimethylsilyl)oxy]-modified silica; and (P-04-432) Siloxanes and Silicones, Me vinyl, hydroxy-terminated, reaction products with [(ethenyldimethylsilyl)oxy]-modified silica.

CAS numbers: (P-04-429) 630106-01-3; (P-04-430) 630106-00-2; (P-01-431) 630106-04-6; and (P-04-432) 630106-02-4.

Basis for action: The consolidated PMN states that the substances will be used as chemical fillers. Based on high molecular weight polymers, EPA identified concerns for lung overload. Further, based on analogy to respirable, poorly soluble particulates, under the subcategory of crystalline silica, EPA identified concerns for lung toxicity and cancer. For the use described in the PMN, significant worker inhalation exposures are not expected as the substance is used in a liquid form. Therefore, EPA has not determined that the proposed manufacturing, processing, and use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances in a powder form may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii).

Recommended testing: EPA has determined that a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats with special attention to histopathology (inflammation and cell proliferation) of the lung tissues and to various parameters of the bronchoalveolar lavage fluid (BALF) with a recovery period of 60 days; and a carcinogenicity test (OPPTS Test Guideline 870.4200) in rats would help characterize the human health effects of the PMN substance.

CFR citations: 40 CFR 721.10481 (P-04-429); 40 CFR 721.10482 (P-04-430); 40 CFR 721.10483 (P-01-431); and 40 CFR 721.10484 (P-04-432).

PMN Number P-04-479

Chemical name: Reaction products of alcohols, alkyl alcohols, amino alcohols and methanol sodium salts (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a cleaning agent. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 30 ppb of the substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 30 ppb more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN 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 721.10485.

PMN Number P-04-591

Chemical name: Alkyl substituted amino-benzamide (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an acetaldehyde scavenger for plastic bottle production. 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 waters, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the 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 use of the substance other than as an acetaldehyde scavenger for plastic bottle production could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria as § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10486.

PMN Numbers P-04-599, P-04-600, P-04-605, and P-04-606

Chemical name: Alkylbenzenes sulfonic acids, metal salts (generic).

CAS number: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as metalworking detergents. Based on EcoSAR analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 60 ppb of the substances in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substances to surface water, from uses other than as described in the PMNs, exceed releases from the use described in the PMNs. For the use described in the PMNs, environmental releases did not exceed 60 ppb more than 20 days per year. 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 use of the substances other than as described in the PMNs may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria as § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10487.

PMN Number P-04-636

Chemical name: Cuprate, [[[[[[[(sulfonaphthalenyl)]azo]-(substitutedphenyl)]azo]-(substitutedsulfonaphthalenyl)]azo]-substituted phenyl-substituted heteromonocycle], sodium salts (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an ink jet dye. Based on SAR analysis of test data on structurally similar substances, EPA identified concerns for oncogenicity. As described in the PMN, inhalation exposures are not expected for the use specified due to the use of a NIOSH-certified respirator with an APF of at least 5. 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 uses of the substance without respiratory protection where there is a potential for inhalation exposure 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 an unscheduled deoxyribonucleic acid (DNA) synthesis in mammalian cells in culture (OPPTS Test Guideline 870.5550), and if warranted by the results of the first test, a carcinogenicity test (OPPTS Test Guideline 870.4200) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10488.

PMN Number P-04-718

Chemical name: Substituted aryl sulfonium polyfluorophosphate salts (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a catalyst. Based on SAR analysis of test data on structurally similar substances, EPA identified concerns for corrosion and ocular lethality. In addition, based on EcoSAR analysis of test data on analogous cationic 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, significant worker exposures are not expected as the PMN is used in the form of a liquid and releases of the substance to surface waters are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use may present an unreasonable risk. EPA has determined, however, that any use of the substance in the form of a powder or solid, or any use of the substance resulting in surface water concentrations exceeding 6 ppb may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of an acute eye irritation test (OPPTS Test Guideline 870.2400); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10489.

PMN Number P-04-834

Chemical name: HDI biuret, hydroxyethyl methacrylate prepolymer (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: March 20, 2006.

Basis for TSCA section 5(e) consent order: The PMN states that the substance will be used as an ingredient in 2-component polyurethane coatings. Based on test data on analogous diisocyanates, EPA identified concerns for dermal and respiratory sensitization, pulmonary toxicity, and carcinogenicity from dermal and inhalation exposures. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based on a finding that this substance may present an unreasonable risk of injury to human health, the substance may be produced in substantial quantities, and there may be significant (or substantial) human exposure to the substance. To protect against this exposure and risk, the consent order requires:

1. Use of personal protective equipment including impervious gloves (when there is potential dermal exposure) and either a NIOSH-certified respirator with an APF of at least 25, or compliance with a NCEL of 0.05 mg/m³ as an 8-hour time-weighted average (when there is potential inhalation exposure).

2. Establishment and use of a hazard communication program.

3. Submission of certain human health testing prior to exceeding two confidential production volume limits specified in the consent order.

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

Recommended testing: EPA has determined that the results of a dermal sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. The PMN submitter has agreed not to exceed the first confidential production volume limit specified in the consent order without performing the dermal sensitization test, and has agreed not to exceed the second confidential production volume limit without performing the 90-day toxicity test. The order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10490.

PMN Number P-05-55

Chemical name: Benzenepropanal,.alpha.-methyl-.

CAS number: 5445-77-2.

Basis for action: The PMN states that the substance will be used as a site-limited intermediate. Based on SAR analysis of test data on structurally similar substances, EPA has identified concerns for developmental toxicity. For the use described in the PMN, significant dermal and inhalation exposures are not expected. Therefore, EPA has not determined that proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance other than as a site-limited intermediate may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of a prenatal developmental toxicity test (OPPTS Test Guideline 870.3700), by the dermal route in mice, would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10491.

PMN Number P-05-301

Chemical name: Trisphenol (generic).

CAS number: Not available.

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

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

CFR citation: 40 CFR 721.10492.

PMN Number P-05-417

Chemical name: Tris-alkyl-alkoxy melamine polymer (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a crosslinking resin. Based on test data on the PMN substance, 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 PMN 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).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), and an algal toxicity test (OCSPP Test Guideline 850.4500) on the hydrolysis products of the PMN substance would help to characterize the environmental effects of the PMN substance and its hydrolysis products.

CFR citation: 40 CFR 721.10493.

PMN Number P-05-501

Chemical name: Reaction product of trimethylolpropane triacrylate and alkylene imine (generic).

CAS number: Not available.

Basis for action: The PMN substance will be used as an amine synergist for coatings and inks. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 5 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation: 40 CFR 721.10494.

PMN Number P-05-634

Chemical name: Metal silicate (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 use restricted to enclosed toner cartridges. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung effects for the PMN substance. Based on physical properties, EPA identified concerns for potential systemic effects from dermal exposure to the PMN substance. As described in the PMN, the substance will be imported and not manufactured in the United States. For the use described in the PMN, worker dermal and inhalation exposures are not expected during processing and use activities. 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 described in the PMN may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats with special attention to histopathology (inflammation and cell proliferation) of the lung tissues and to various parameters of the BALF with a recovery period of 60 days would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10495.

PMN Number P-06-9

Chemical name: Amino alkoxy polydimethylsiloxane, hydroxy-terminated (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a textile additive. 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 (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10496.

PMN Numbers P-06-276, P-06-277, P-06-278, P-06-279, P-06-280, and P-06-281

Chemical names: (P-06-276 and P-06-279) Substituted alkyl ester, hydrolysis products with silica and substituted silane (generic); (P-06-277 and P-06-280) Substituted alkyl ester, hydrolysis products with silica (generic); and (P-06-278 and P-06-281) Substituted silane, hydrolysis products with silica (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 clearcoat. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified potential lung and systemic effects from inhalation and dermal exposures to the PMN substances. For the use described in the consolidated PMN, EPA does not expect significant worker exposures to the substances due to the use of appropriate impervious gloves and clothing; use of an appropriate NIOSH-certified respirator with an APF of at least 5; and no manufacturing, processing, or use in the form of a powder. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances without impervious gloves and clothing where there is a potential for dermal exposures; any use of the substances without a NIOSH-certified respirator with an APF of at least 5 where there is a potential for inhalation exposures; use of the substances other than as described in the PMN; or manufacturing, processing, or use of the substances in the form of a powder may cause serious adverse health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii).

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

CFR citations: 40 CFR 721.10497 (P-06-276 and P-06-279); 40 CFR 721.10498 (P-06-277 and P-06-280); and 40 CFR 721.10499 (P-06-278 and P-06-281).

PMN Number P-06-341

Chemical name: Acrylated mixed metal oxides (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a film coating additive. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for potential lung effects from inhalation exposures and potential systemic effects from dermal exposures. For the use described in the PMN, inhalation and dermal exposures are not expected due to use of the substance as a liquid and with impervious dermal protection for exposed workers. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without the use of impervious dermal protection where there is potential for dermal exposures; any manufacture, processing, or use of the substance in the form of a powder; or any use of the substance other than as described in the PMN may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

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

CFR citation: 40 CFR 721.10500.

PMN Number P-06-542

Chemical name: Tridecyl phthalate (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 SAR analysis of test data on analogous phthalates, EPA identified concerns for developmental toxicity. For the use stated in the PMN, significant worker or consumer exposures are unlikely. 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 other use of the substance other than as described in the PMN may cause serious adverse human health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of an oral reproduction and fertility effects test (OPPTS Test Guideline 870.3800) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10501.

PMN Number P-06-616

Chemical name: Modified triethylene glycol dithiol (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a reactive diluent/binder in aerospace sealants. Based on EcoSAR analysis of test data on analogous thiols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the substance in surface waters. As described in the PMN, the substance is not expected to 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 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 ready biodegradability test (OPPTS Test Guideline 835.3110); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10502.

PMN Number P-06-622

Chemical name: 1,2-Ethanediol, 1-carbamate.

CAS number: 5395-01-7.

Basis for action: The PMN states that the substance will be used as an intermediate monomer for polymer synthesis. Based on test data on the PMN substance, and SAR analysis of test data on analogous urethanes and carbamates, EPA identified concerns for liver toxicity, developmental toxicity, and oncogenicity. For the use described in the PMN, EPA expects no significant dermal exposures due to the use of impervious gloves. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without impervious gloves where there is a potential for dermal exposures may cause serious adverse health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C),(b)(3)(i), and (b)(3)(ii).

Recommended testing: EPA has determined that the results of a prenatal developmental toxicity test (OPPTS Test Guideline 870.3700) and a carcinogenicity test (OPPTS Test Guideline 870.4200) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10503.

PMN Number P-06-682

Chemical name: Surface modified magnesium hydroxide (generic).

CAS number: Not available.

Basis for action: The PMN states the substance will be used as a compatibilizer for flame retardant for plastics. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung toxicity due to lung overload from inhalation exposure to the PMN substance. At the production volume of 100,000 kgs per year and for the specific use as a compatibilizer for flame retardant for plastics, significant worker exposures are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as a compatibilizer for flame retardant for plastics, or any use of the substance in quantities greater than 100,000 kgs per year may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

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

CFR citation: 40 CFR 721.10504.

PMN Number P-06-694

Chemical name: Phosphoric acid, mixed mono- and diesters with 2-ethyl-1-hexanol and polyethylene glycol mono-C_12-16-alkyl ethers.

CAS number: 882693-50-7.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a hydraulic fluid. Based on test data on the PMN substance and EcoSAR analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur as a result of releases of the PMN substance to surface waters from manufacture or import in quantities greater than 75,000 kgs per year, or from uses other than as stated in the PMN. At the annual production volume of 75,000 kgs per year, and for the use stated in the PMN, no significant environmental releases are expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as stated in the PMN, or exceeding an annual manufacturing and importation volume of 75,000 kgs 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 721.10505.

PMN Numbers P-07-11 and P-08-29

Chemical name: Alkylated phenols (generic).

CAS number: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substance will be as an antioxidant (P-07-11) and an intermediate (P-08-29). Based on test data on P-07-11 and SAR analysis of test data on analogous molecular structure chemicals, EPA identified concerns for liver effects, thyroid effects, and neurotoxicity. As described in the PMNs, worker dermal exposure to the PMN substances will be minimal due to impervious gloves. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without the use of impervious gloves where there is potential for dermal exposure may cause serious adverse health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i) and (b)(3)(ii).

Recommended testing: EPA has determined that a repeated dose 90-day oral toxicity test in rodents (OPPTS Test Guideline 870.3100) and a developmental neurotoxicity test (OPPTS Test Guideline 870.6300) would help characterize the health effects of the PMN substances.

CFR citation: 40 CFR 721.10506.

PMN Number P-07-107

Chemical name: Biphenyl substituted benzopyran (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 additive. 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, releases of the PMN substance are not expected to result in surface water concentrations that exceed 2 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 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 (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10507.

PMN Number P-07-161

Chemical name: Alkene substituted Bis phenol (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a hardener for epoxy resins. EPA identified human health and environmental concerns because the PMN substance may be a persistent, bio-accumulative, and toxic (PBT) chemical, based on the physical/chemical properties of the PMN substance, as described in the New Chemicals Program's PBT category (64 FR 60194, November 4, 1999) (FRL-6097-7). EPA estimates that the substance will persist in the environment for more than 2 months and estimates a bioaccumulation factor of greater than or equal to 5,000. Also, based on SAR analysis of test data on analogous safrole, methyleugenal and bisphenol A, EPA identified concerns for carcinogenicity and mutagenicity, systemic effects, and endocrine disruption. Further, 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 substance in surface waters. As described in the PMN, significant worker exposures are not expected due to the use of impervious dermal protective equipment, 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 without impervious dermal protection where there is a potential for dermal exposures, or any purposeful or predictable release of the substance to surface waters may cause serious health effects and significant adverse environmental risks. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a fish bioconcentration test (OPPTS Test Guideline 850.1730); an oral combined chronic toxicity/carcinogenicity study (OPPTS Test Guideline 870.4300); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.5400) would help to characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10508.

PMN Number P-07-204

Chemical name: Pentane, 1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)-.

CAS number: 870778-34-0.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a heat transfer fluid. Based on test data on the PMN substance and SAR analysis of test data on analogous perfluorinated substances, EPA identified concerns for neurotoxicity, liver effects, and cardiac sensitization from exposures to the PMN substance. For the use described in the PMN, EPA does not expect significant worker exposures due to the use of impervious gloves. 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 without impervious gloves where there is a potential for dermal exposures, or any use of the substance other than as described in the PMN may cause serious adverse health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i) and (b)(3)(ii).

Recommended testing: EPA has determined that the results of a 28-day dermal toxicity test (OPPTS Test Guideline 870.3200) in rats; a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465), and a test using the “Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact” (ASTM International standard F739) as reported in the “Standard Guide for Documenting the Results of Chemical Permeation Testing of Materials Used in Protective Clothing” (ASTM International standard F1194) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10509.

PMN Number P-07-319

Chemical name: Alkylaminoalcohol (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 for a polymer paint additive. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the 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 (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10510.

PMN Numbers P-07-320, P-07-321, P-07-322, P-07-323, and P-07-324

Chemical name: Quaternary ammonium salts (generic).

CAS number: Not available.

Basis for action: The consolidated PMN states that the generic (non-confidential) use of the substances will be as inhibitors for oil field applications. Based on EcoSAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 20 ppb of the substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 20 ppb more than 20 days per year. 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 use of the substances 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); a fish acute toxicity test mitigated by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances.

CFR citations: 40 CFR 721.10511.

PMN Numbers P-07-563 and P-07-564

Chemical name: Fatty acid maleic acid amides (generic).

CAS number: Not available.

Basis for action: The consolidated PMN states that the substances will be used as emulsifiers for oil well drilling fluids. 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 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 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 fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity test mitigated by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances.

CFR citation: 40 CFR 721.10512.

PMN Number P-07-599

Chemical name: Aromatic acrylate monomer (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be in the production of polymers. Based on EcoSAR analysis of test data on analogous acrylates, 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 expected to 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 fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10513.

PMN Number P-07-679

Chemical name: [1,1′-Biphenyl]-2,2′-disulfonic acid, 4-[2-(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)diazenyl]-4′-[2-(2-hydroxy-1-naphthalenyl)diazenyl]-, sodium salt (1:2).

CAS number: 6470-20-8.

Basis for action: The PMN states that substance will be used as a dye for stationery ink. Based on SAR analysis of test data on analogs of an azo reduction product (pyrazole and methyl pyrazole), EPA identified concerns for liver, blood, and developmental toxicity; neurotoxicity; mutagenicity; and oncogenicity. As described in the PMN, inhalation exposures to workers and consumers are not expected as the PMN substance will be imported in rollerball pens and refills for rollerball pens. 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 any processing or use of the substance in the form of a solid may cause serious adverse 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 bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) via the intraperitoneal route; a repeated dose 28-day oral toxicity test (OPPTS Test Guideline 870.3050) in rodents; and an acute oral toxicity test (OPPTS Test Guideline 870.1100) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10514.

PMN Numbers P-10-58, P-10-59, and P-10-60

Chemical name: Partially fluorinated alcohol substituted glycols (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: October 8, 2010.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) uses of the PMN substances will be as an intermediate (P-10-58 and P-10-59) and a surface active agent (P-10-60). EPA has concerns for potential incineration or other decomposition products of the PMN substances. These perfluorinated decomposition 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 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, including the presumed environmental degradant. 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 exposures and risks, the consent order requires submission of testing on the PMN substance P-10-60 at five identified aggregate manufacture and importation volumes; requires analysis of raw materials; and restricts the use of P-10-58 and P-10-59 to use as intermediates to manufacture P-10-60. 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 section 5(e) consent order would help characterize possible effects of the substances and their degradation products. The consent order contains five production volume limits. The PMN submitter has agreed not to exceed the confidential production volume limits without performing the specified testing on the PMN substance P-10-60. Additional testing is included in the preamble to the consent order, but this testing is not required 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 721.10515.

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 8 of the 107 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 99 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 November 20, 2012 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before October 22, 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 October 22, 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 (September 21, 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 eight 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, 67 of the 108 chemical substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN bona fide submissions (per §§ 720.25 and 721.11), the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of this direct final rule rather than as of the effective date of the rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR 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 about 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” or for guidelines that are not currently available on the Web site EPA has placed a copy of that guideline in the public docket. The 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. The ASTM International standards are available at http://www.astm.org/​Standard/​index.shtml.

In the TSCA section 5(e) consent orders for eight 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 § 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-2011-0941.

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 the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment.

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

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

C. Regulatory Flexibility Act

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.

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:

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

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

D. Unfunded Mandates Reform Act

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 the Federal 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: September 13, 2012.

Maria J. Doa,

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

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

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. In § 14;9.1, add the following sections in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:

§  9.1

OMB approvals under the Paperwork Reduction Act.

* * * * *

40 CFR citation	OMB Control No.
*    *    *    *    *
Significant New Uses of Chemical Substances
*    *    *    *    *
721.10427	2070-0012
721.10428	2070-0012
721.10429	2070-0012
721.10430	2070-0012
721.10431	2070-0012
721.10432	2070-0012
721.10433	2070-0012
721.10434	2070-0012
721.10435	2070-0012
721.10436	2070-0012
721.10437	2070-0012
721.10438	2070-0012
721.10439	2070-0012
721.10440	2070-0012
721.10441	2070-0012
721.10442	2070-0012
721.10443	2070-0012
721.10444	2070-0012
721.10445	2070-0012
721.10446	2070-0012
721.10447	2070-0012
721.10448	2070-0012
721.10449	2070-0012
721.10450	2070-0012
721.10451	2070-0012
721.10452	2070-0012
721.10453	2070-0012
721.10454	2070-0012
721.10455	2070-0012
721.10456	2070-0012
721.10457	2070-0012
721.10458	2070-0012
721.10459	2070-0012
721.10460	2070-0012
721.10461	2070-0012
721.10462	2070-0012
721.10463	2070-0012
721.10464	2070-0012
721.10465	2070-0012
721.10466	2070-0012
721.10467	2070-0012
721.10468	2070-0012
721.10469	2070-0012
721.10470	2070-0012
721.10471	2070-0012
721.10472	2070-0012
721.10473	2070-0012
721.10474	2070-0012
721.10475	2070-0012
721.10476	2070-0012
721.10477	2070-0012
721.10478	2070-0012
721.10479	2070-0012
721.10480	2070-0012
721.10481	2070-0012
721.10482	2070-0012
721.10483	2070-0012
721.10484	2070-0012
721.10485	2070-0012
721.10486	2070-0012
721.10487	2070-0012
721.10488	2070-0012
721.10489	2070-0012
721.10490	2070-0012
721.10491	2070-0012
721.10492	2070-0012
721.10493	2070-0012
721.10494	2070-0012
721.10495	2070-0012
721.10496	2070-0012
721.10497	2070-0012
721.10498	2070-0012
721.10499	2070-0012
721.10500	2070-0012
721.10501	2070-0012
721.10502	2070-0012
721.10503	2070-0012
721.10504	2070-0012
721.10505	2070-0012
721.10506	2070-0012
721.10507	2070-0012
721.10508	2070-0012
721.10509	2070-0012
721.10510	2070-0012
721.10511	2070-0012
721.10512	2070-0012
721.10513	2070-0012
721.10514	2070-0012
721.10515	2070-0012
*    *    *    *

* * * * *

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 § 721.10427 to subpart E to read as follows:

§ 721.10427

Aminoalkanol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aminoalkanol (PMN P-96-308) 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=600).

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

5. Add § 721.10428 to subpart E to read as follows:

§ 721.10428

Fatty acids, C₁₈-unsatd., dimers, reaction products with 1-piperazineethanamine.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as fatty acids, C₁₈-unsatd., dimers, reaction products with 1-piperazineethanamine (PMN P-96-1021; CAS No. 206565-90-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) 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.

6. Add § 721.10429 to subpart E to read as follows:

§ 721.10429

Fatty acids, C₁₈-unsatd., dimers, reaction products with 1-piperazineethanamine and tall-oil fatty acids.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as fatty acids, C₁₈-unsatd., dimers, reaction products with 1-piperazineethanamine and tall-oil fatty acids (PMN P-96-1022; CAS No. 206565-89-1) 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=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.

7. Add § 721.10430 to subpart E to read as follows:

§  721.10430

Tetra alkyl ammonium salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tetra alkyl ammonium salt (PMN P-97-823) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Hazard communication program. Requirements as specified in § 721.72(a) and (c)(2) (the following statement must be included in the material safety data sheet (MSDS): “The results of an eye irritation test in rabbits resulted in deaths at levels of the PMN substance greater than 25 percent concentration”).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (use of the substance as described in the PMN at concentrations less than or equal to 25 percent).

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

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

8. Add § 721.10431 to subpart E to read as follows:

§ 721.10431

Phosphoric acid esters (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as phosphoric acid esters (PMNs P-98-141 and P-98-142) 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=100).

(ii) [Reserved]

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

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

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

9. Add §  721.10432 to subpart E to read as follows:

§  721.10432

1,2,4,5,7,8-Hexoxonane, 3,6,9-triethyl-3,6,9-trimethyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2,4,5,7,8-hexoxonane, 3,6,9-triethyl-3,6,9-trimethyl-. (PMN P-98-1028; CAS No. 24748-23-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (viscosity modifier in the manufacture of polypropylene manufactured and supplied as a solution in at least 40 percent mineral spirits).

(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.

10. Add §  721.10433 to subpart E to read as follows:

§  721.10433

Cyclopentene, 1,2,3,3,4,4,5,5-octafluoro-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cyclopentene, 1,2,3,3,4,4,5,5-octafluoro- (PMN P-99-184; CAS No. 559-40-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (j) (dry etching agent and chemical vapor deposition agent for the production of semiconductors).

(ii) [Reserved]

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

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

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

11. Add §  721.10434 to subpart E to read as follows:

§  721.10434

Cyclopentane, 1,1,2,2,3,3,4-heptafluoro-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cyclopentane, 1,1,2,2,3,3,4-heptafluoro- (PMN P-99-214; CAS No. 15290-77-4) 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(f), (j) (solvent and a cleaning and drying agent), and (o).

(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.

12. Add §  721.10435 to subpart E to read as follows:

§  721.10435

Phenol, 2-(1-methyl-1-phenylethyl)-4-(1,1,3,3-tetramethylbutyl)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phenol, 2-(1-methyl-1-phenylethyl)-4-(1,1,3,3-tetramethylbutyl)- (PMN P-99-1179; CAS No. 73936-80-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

13. Add § 721.10436 to subpart E to read as follows:

§ 721.10436

Amine neutralized phosphated polyesters (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as amine neutralized phosphated polyesters (PMN P-99-1217 and P-99-1218) 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(s) (50,000 kilograms combined for the substances identified in PMNs P-99-1217 and P-99-1218).

(ii) [Reserved]

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

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

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

14. Add § 721.10437 to subpart E to read as follows:

§ 721.10437

Sulfonic acid, linear xylene alkylate, mono, sodium salts (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as sulfonic acid, linear xylene alkylate, mono, sodium salts (PMNs P-99-1280, P-99-1281, and P-99-1282) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

15. Add § 721.10438 to subpart E to read as follows:

§ 721.10438

Dialkyl hydroxybenzenealkanoic acid ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dialkyl hydroxybenzenealkanoic acid ester (PMN P-00-346) 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)(3), (b) (concentration set at 1.0 percent), and (c).

(ii) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(iv), (g)(2)(i), (g)(2)(v), and (g)(5).

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

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (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 paragraph (a)(2)(iii) of this section.

16. Add § 721.10439 to subpart E to read as follows:

§ 721.10439

1,3-Dioxolan-2-one, 4-ethenyl.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3-dioxolan-2-one, 4-ethenyl (PMN P-00-635; CAS No. 4427-96-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

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

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e), 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 paragraph (a)(2)(ii) of this section.

17. Add § 721.10440 to subpart E to read as follows:

§ 721.10440

Diphosphoric acid, polymers with ethoxylated reduced Me esters of reduced polymd. oxidized tetrafluoroethylene.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as diphosphoric acid, polymers with ethoxylated reduced Me esters of reduced polymd. oxidized tetrafluoroethylene (PMN P-00-1165; CAS No. 200013-65-6) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o) and (y)(1).

(ii) [Reserved]

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

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

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

18. Add § 721.10441 to subpart E to read as follows:

§ 721.10441

1,2-Benzenedicarboxylic acid, di-C_7-14-branched and linear alkyl esters.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2-benzenedicarboxylic acid, di-C_7-14-branched and linear alkyl esters (PMN P-01-382; CAS No. 309934-68-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o) (use as plasticizers for flexible polyvinyl chloride not to include children's toys (e.g., pacifiers, rattles, and teethers)).

(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.

19. Add § 721.10442 to subpart E to read as follows:

§ 721.10442

1,2-Benzenedicarboxylic acid, di-C_6-14-branched and linear alkyl esters.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2-benzenedicarboxylic acid, di-C_6-14-branched and linear alkyl esters (PMN P-01-383; CAS No. 309934-69-8) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o) (use as plasticizers for flexible polyvinyl chloride not to include children's toys (e.g., pacifiers, rattles, and teethers)).

(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.

20. Add § 721.10443 to subpart E to read as follows:

§ 721.10443

Ethoxylated alkylphenol sulfate, ammonium salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ethoxylated alkylphenol sulfate, ammonium salt (PMN P-01-470) 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) (manufacture and import of the PMN substance according to the chemical composition section of the consent order where the substance must have either a mean number of moles of ethoxy groups greater than or equal to 10, or the average number molecular weight is greater than 950 daltons).

(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.

21. Add § 721.10444 to subpart E to read as follows:

§ 721.10444

Propanol, mercapto-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propanol, mercapto- (PMN P-01-499; CAS No. 63947-56-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), (b) (concentration set at 1.0 percent), and (c).

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

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (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.

22. Add § 721.10445 to subpart E to read as follows:

§ 721.10445

2-Propen-1-ol, reaction products with hydrogen sulfide, distn. residues.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propen-1-ol, reaction products with hydrogen sulfide, distn. residues (PMN P-01-500; CAS No. 374078-75-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), (b) (concentration set at 1.0 percent), and (c).

(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) through (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.

23. Add § 721.10446 to subpart E to read as follows:

§ 721.10446

1, 9-Cyclohexadecadiene.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,9-cyclohexadecadiene (PMN P-01-762; CAS No. 4277-06-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), (b) (concentration set at 1.0 percent), and (c).

(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) through (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.

24. Add § 721.10447 to subpart E to read as follows:

§ 721.10447

17-Oxabicyclo[14.1.0]heptadec-8-ene.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 17-oxabicyclo[14.1.0]heptadec-8-ene (PMN P-01-829; CAS No. 34748-97-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), (a)(4) (National Institute for Occupational Safety and Health (NIOSH)-certified air purifying respirator equipped with a high efficiency particulate filter including disposable cartridge), (a)(5)(vii), (b) (concentration set at 1.0 percent), and (c).

(ii) Release to water. Requirement 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) through (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.

25. Add § 721.10448 to subpart E to read as follows:

§ 721.10448

Acetic acid, hydroxy- methoxy-, methyl  ester, reaction products with substituted alkylamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acetic acid, hydroxymethoxy-, methyl ester, reaction products with substituted alkylamine (PMN P-02-120) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (manufacture and import of the PMN substance according to the average number molecular weight section of the consent order where the average molecular weight is greater than or equal to 850 daltons).

(ii) [Reserved]

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

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

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

26. Add § 721.10449 to subpart E to read as follows:

§ 721.10449

Aromatic polyester polyol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic polyester polyol (PMN P-02-172) 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.

27. Add § 721.10450 to subpart E to read as follows:

§  721.10450

Oxirane, 2-[[3-(trimethoxysilyl)propoxy]methyl]-, reaction products with wollastonite (Ca(SiO₃)).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2-[[3-(trimethoxysilyl)propoxy]methyl]-, reaction products with wollastonite (Ca(SiO₃)) (PMN P-02-285; CAS No. 100402-91-3) 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(k) (manufacture and process the PMN substance with an average number aspect ratio no greater than 5, and no more than 15 percent of the PMN substance shall have an aspect ratio greater than 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 (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.

28. Add § 721.10451 to subpart E to read as follows:

§ 721.10451

Alkyd amide polyol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyd amide polyol (PMN P-02-436) 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=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.

29. Add § 721.10452 to subpart E to read as follows:

§ 721.10452

9-Octadecenoic acid (9Z)-, 1,1′-(dimethylstannylene) ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 9-octadecenoic acid (9Z)-, 1,1′-(dimethylstannylene) ester (PMN P-02-659; CAS No. 3865-34-7) 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) 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 § 721.10453 to subpart E to read as follows:

§ 721.10453

Polyglycerin alkyl ether (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyglycerin alkyl ether (PMN P-02-796) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved].

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

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

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

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

31. Add § 721.10454 to subpart E to read as follows:

§ 721.10454

Propoxylated ethoxylated alkylamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as propoxylated ethoxylated alkylamine (PMN P-02-828) 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=80).

(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 § 721.10455 to subpart E to read as follows:

§ 721.10455

Oxirane, 2,2′,2″-[ethylidynetris(4,1-phenyleneoxymethylene)]tris-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2,2′,2″-[ethylidynetris(4,1-phenyleneoxymethylene)]tris- (PMN P-03-61; CAS No. 87093-13-8) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(y)(1).

(ii) [Reserved].

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

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

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

33. Add § 721.10456 to subpart E to read as follows:

§ 721.10456

Tristyryl phenol alkoxylate salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tristyryl phenol alkoxylate salt (PMN P-03-104) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved].

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

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

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

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

34. Add § 721.10457 to subpart E to read as follows:

§ 721.10457

1,2-Benzenedicarboxylic acid, mixed esters with benzyl alc., cyclohexanol, 2-ethyl-1-hexanol, fumaric acid and propylene glycol.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2-benzenedicarboxylic acid, mixed esters with benzyl alc., cyclohexanol, 2-ethyl-1-hexanol, fumaric acid and propylene glycol (PMN P-03-154; CAS No. 464920-01-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved].

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

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

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

35. Add § 721.10458 to subpart E to read as follows:

§ 721.10458

Acrylate of hydroxyimide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acrylate of hydroxyimide (PMN P-03-238) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(v)(2), (w)(2), and (x)(2).

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

(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.

36. Add § 721.10459 to subpart E to read as follows:

§ 721.10459

Amino-substituted carbopolycycle (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as amino-substituted carbopolycycle (PMN P-03-282) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 50), (a)(6), (b) (concentration set at 0.1 percent), and (c). Best's Viton model 878, Best's Butyl model 878, Barrier Laminated Film, and PVA Supported Polyvinyl Alcohol have been demonstrated to satisfy the requirements of § 721.63(a)(3)(i). Other demonstrated impervious gloves that satisfy § 721.63(a)(3)(i) are permissible. The following respirators meet the minimum requirements of § 721.63(a)(4): NIOSH-certified air-purifying, tight-fitting, half-face respirator equipment with N100 (if oil aerosols absent), R100, or P100 filters; NIOSH-certified air-purifying, tight-fitting full-face respirator with N100 (if oil aerosols absent), R100, or P100 filters; NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters; NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters; or NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

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

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

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (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 paragraph (a)(2)(iii) of this section.

37. Add § 721.10460 to subpart E to read as follows:

§ 721.10460

Azo nickel complex (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as azo nickel complex (PMN P-03-307) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [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 paragraph (a)(2)(i) of this section.

38. Add § 721.10461 to subpart E to read as follows:

§ 721.10461

Oxazolidine, 3,3′-methylenebis[5-methyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxazolidine, 3,3′-methylenebis[5-methyl- (PMN P-03-325; CAS No. 66204-44-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=40 (saltwater) and N=100 (freshwater)).

(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.

39. Add § 721.10462 to subpart E to read as follows:

§ 721.10462

1-Penten-3-one, 1-(4-chlorophenyl)-4,4-dimethyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-penten-3-one, 1-(4-chlorophenyl)-4,4-dimethyl- (PMN P-03-354; CAS No. 1577-03-3) 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(g).

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

(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.

40. Add § 721.10463 to subpart E to read as follows:

§ 721.10463

Fatty acid amides (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acid amides (PMN P-03-388) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j).

(ii) [Reserved].

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

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

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

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

41. Add § 721.10464 to subpart E to read as follows:

§ 721.10464

Fatty acid, reaction products with alkanolamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acid, reaction products with alkanolamine (PMN P-03-461) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved].

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

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

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

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

42. Add § 721.10465 to subpart E to read as follows:

§ 721.10465

2-Propenoic acid, 2-methyl-, 3-hydroxytricyclo[3.3.1.13,7]dec-1-yl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propenoic acid, 2-methyl-, 3-hydroxytricyclo[3.3.1.13,7]dec-1-yl ester (PMN P-03-561; CAS No. 115372-36-6) 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), (a)(2)(iii), (a)(3), (a)(4) (National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b) (concentration set at 1.0 percent), and (c).

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=3).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e) and (k) and 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 § 721.10466 to subpart E to read as follows:

§ 721.10466

2-Propenoic acid, 2-methyl-, 2-ethyltricyclo[3.3.1.13,7]dec-2-yl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propenoic acid, 2-methyl-, 2-ethyltricyclo[3.3.1.13,7]dec-2-yl ester (PMN P-03-563; CAS No. 209982-56-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4) (National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b) (concentration set at 1.0 percent), and (c).

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=3).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e) and (k) and 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 § 721.10467 to subpart E to read as follows:

§  721.10467

2-Propenoic acid, 3-hydroxytricyclo[3.3.1.13,7]dec-1-yl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propenoic acid, 3-hydroxytricyclo[3.3.1.13,7]dec-1-yl ester (PMN P-03-564; CAS No. 216581-76-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4) (National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b) (concentration set at 1.0 percent), and (c).

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=3).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e) and (k) and 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 § 721.10468 to subpart E to read as follows:

§  721.10468

2-Propenoic acid, 2-methyltricyclo[3.3.1.13,7]dec-2-yl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propenoic acid, 2-methyltricyclo[3.3.1.13,7]dec-2-yl ester (PMN P-03-565; CAS No. 249562-06-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4) (National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b) (concentration set at 1.0 percent), and (c).

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=3).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e) and (k) and 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 §  721.10469 to subpart E to read as follows:

§ 721.10469

2-Propenoic acid, 2-ethyltricyclo[3.3.1.13,7]dec-2-yl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propenoic acid, 2-ethyltricyclo[3.3.1.13,7]dec-2-yl ester (PMN P-03-566; CAS No. 303186-14-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4) (National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b) (concentration set at 1.0 percent), and (c).

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=3).

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e) and (k) and 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 §  721.10470 to subpart E to read as follows:

§  721.10470

Phosphonium, tetrabutyl-, 1,1,2,2,3,3,4,4,4-nonafluoro-1-butanesulfonate (1:1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphonium, tetrabutyl-, 1,1,2,2,3,3,4,4,4-nonafluoro-1-butanesulfonate (1:1) (PMN P-03-567; CAS No. 220689-12-3) 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(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 paragraph (a)(2)(i) of this section.

48. Add § 721.10471 to subpart E to read as follows:

§ 721.10471

2-Propenoic acid, 1,1′-(3-methyl-1,5-pentanediyl) ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propenoic acid, 1,1′-(3-methyl-1,5-pentanediyl) ester (PMN P-03-622; CAS No. 64194-22-5) 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 (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 paragraph (a)(2)(i) of this section.

49. Add § 721.10472 to subpart E to read as follows:

§ 721.10472

1,3-Benzenedimethanamine, polymers with epichlorohydrin-polyethylene glycol reaction products.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3-benzenedimethanamine, polymers with epichlorohydrin-polyethylene glycol reaction products (PMN P-03-645; CAS No. 652968-34-8) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f).

(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.

50. Add § 721.10473 to subpart E to read as follows:

§ 721.10473

1-Propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl derivs., inner salts.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl derivs., inner salts (PMN P-03-865; CAS No. 499781-63-4) 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=85).

(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 § 721.10474 to subpart E to read as follows:

§ 721.10474

Substituted amino ethane sulfonic acid salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted amino ethane sulfonic acid salt (PMN P-04-107) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved].

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

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

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

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

52. Add § 721.10475 to subpart E to read as follows:

§ 721.10475

Hexanedioic acid, compd. with N1-(6-aminohexyl)-N1-methyl-1,6-hexanediamine (1:1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as hexanedioic acid, compd. with N1-(6-aminohexyl)-N1-methyl-1,6-hexanediamine (1:1) (PMN P-04-118; CAS No. 659733-29-6) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (intermediate for polymer manufacture).

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

(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 this section.

53. Add § 721.10476 to subpart E to read as follows:

§ 721.10476

Oxetane, 3-(bromomethyl)-3-methyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxetane, 3-(bromomethyl)-3-methyl- (PMN P-04-275; CAS No. 78385-26-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), (b) (concentration set at 1.0 percent), and (c).

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

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e) 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.

54. Add § 721.10477 to subpart E to read as follows:

§ 721.10477

Acrylate ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acrylate ester (PMN P-04-290) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j).

(ii) [Reserved].

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

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

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

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

55. Add § 721.10478 to subpart E to read as follows:

§ 721.10478

Polyether polyol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyether polyol (PMN P-04-318) 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) (intermediate for making urethane polymer).

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

(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.

56. Add § 721.10479 to subpart E to read as follows:

§ 721.10479

Quaternary ammonium compounds, tris(hydrogenated tallow alkyl)methyl, chlorides.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as quaternary ammonium compounds, tris(hydrogenated tallow alkyl)methyl, chlorides (PMN P-04-335; CAS No. 308074-73-9) 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).

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

57. Add § 721.10480 to subpart E to read as follows:

§ 721.10480

Trimethylolpropane polyol, aminated (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as trimethylolpropane polyol, aminated (PMN P-04-384) 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=9).

(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 § 721.10481 to subpart E to read as follows:

§ 721.10481

Siloxanes and Silicones, Me vinyl, hydroxy-terminated, reaction products with silica.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Siloxanes and Silicones, Me vinyl, hydroxy-terminated, reaction products with silica (PMN P-04-429; CAS No. 630106-01-3) 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(v)(1), (w)(1), and (x)(1).

(ii) [Reserved]

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

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

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

59. Add § 721.10482 to subpart E to read as follows:

§ 721.10482

Siloxanes and Silicones, di-Me, Me vinyl, hydroxy-terminated, reaction products with silica.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Siloxanes and Silicones, di-Me, Me vinyl, hydroxy-terminated, reaction products with silica (PMN P-04-430; CAS No. 630106-00-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

60. Add § 721.10483 to subpart E to read as follows:

§ 721.10483

Siloxanes and Silicones, di-Me, Me vinyl, hydroxy-terminated, reaction products with [(ethenyldimethylsilyl)oxy]-modified silica.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Siloxanes and Silicones, di-Me, Me vinyl, hydroxy-terminated, reaction products with [(ethenyldimethylsilyl)oxy]-modified silica (PMN P-04-431; CAS No. 630106-04-6) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (v)(1), (w)(1), and (x)(1).

(ii) [Reserved]

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

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

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

61. Add § 721.10484 to subpart E to read as follows:

§ 721.10484

Siloxanes and Silicones, Me vinyl, hydroxy-terminated, reaction products with [(ethenyldimethylsilyl)oxy]-modified silica.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Siloxanes and Silicones, Me vinyl, hydroxy-terminated, reaction products with [(ethenyldimethylsilyl)oxy]-modified silica (PMN P-04-432; CAS No. 630106-02-4) 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 (v)(1), (w)(1), and (x)(1).

(ii) [Reserved]

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

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

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

62. Add § 721.10485 to subpart E to read as follows:

§ 721.10485

Reaction products of alcohols, alkyl alcohols, amino alcohols and methanol sodium salts (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as reaction products of alcohols, alkyl alcohols, amino alcohols and methanol sodium salts (PMN P-04-479) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

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

63. Add § 721.10486 to subpart E to read as follows:

§ 721.10486

Alkyl substituted amino-benzamide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl substituted amino-benzamide (PMN P-04-591) 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) (acetaldehyde scavenger for plastic bottle production).

(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 § 721.10487 to subpart E to read as follows:

§ 721.10487

Alkylbenzenes sulfonic acids, metal salts (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as alkylbenzenes sulfonic acids, metal salts (PMNs P-04-599, P-04-600, P-04-605, and P-04-606) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

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

65. Add § 721.10488 to subpart E to read as follows:

§ 721.10488

Cuprate, [[[[[[[(sulfonaphthalenyl)]azo]-(substitutedphenyl)]azo]-(substitutedsulfonaphthalenyl)]azo]-substituted phenyl-substituted heteromonocycle], sodium salts (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cuprate, [[[[[[[(sulfonaphthalenyl)]azo]-(substitutedphenyl)]azo]-(substitutedsulfonaphthalenyl)]azo]-substituted phenyl-substituted heteromonocycle], sodium salts (PMN P-04-636) 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)(4) (National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 5), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b) (concentration set at 0.1 percent), and (c).

(ii) [Reserved]

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

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

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

66. Add § 721.10489 to subpart E to read as follows:

§ 721.10489

Substituted aryl sulfonium polyfluorophosphate salts (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted aryl sulfonium polyfluorophosphate salts (PMN P-04-718) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), and (x)(2).

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

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

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

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

67. Add § 721.10490 to subpart E to read as follows:

§ 721.10490

HDI biuret, hydroxyethyl methacrylate prepolymer (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as HDI biuret, hydroxyethyl methacrylate prepolymer (PMN P-04-834) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance that have been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2), (a)(3), (a)(4), (b) (concentration set at 0.1 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 25 meet the minimum requirements for § 721.63(a)(4): NIOSH-certified air-purifying, tight-fitting half-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters; NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters; NIOSH-certified powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters; NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (either half-face or full-face) and HEPA filters; or 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).

(A) 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) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.05 mg/m³ as an 8-hour time-weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [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)(i), (g)(1)(ii), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5).

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

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (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 paragraph (a)(2)(iii) of this section.

68. Add § 721.10491 to subpart E to read as follows:

§ 721.10491

Benzenepropanal,.alpha.-methyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzenepropanal,.alpha.-methyl- (PMN P-05-55; CAS No. 5445-77-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(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.

69. Add § 721.10492 to subpart E to read as follows:

§ 721.10492

Trisphenol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as trisphenol (PMN P-05-301) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

70. Add § 721.10493 to subpart E to read as follows:

§ 721.10493

Tris-alkyl-alkoxy melamine polymer (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tris-alkyl-alkoxy melamine polymer (PMN P-05-417) 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.

71. Add § 721.10494 to subpart E to read as follows:

§ 721.10494

Reaction product of trimethylolpropane triacrylate and alkylene imine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as reaction product of trimethylolpropane triacrylate and alkylene imine (PMN P-05-501) 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 = 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.

72. Add § 721.10495 to subpart E to read as follows:

§ 721.10495

Metal silicate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as metal silicate (PMN P-05-634) 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 paragraph (a)(2)(i) of this section.

73. Add § 721.10496 to subpart E to read as follows:

§  721.10496

Amino alkoxy polydimethylsiloxane, hydroxy-terminated (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as amino alkoxy polydimethylsiloxane, hydroxy-terminated (PMN P-06-9) 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 = 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.

74. Add § 721.10497 to subpart E to read as follows:

§ 721.10497

Substituted alkyl ester, hydrolysis products with silica and substituted silane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as substituted alkyl ester, hydrolysis products with silica and substituted silane (PMNs P-06-276 and P-06-279) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), (a)(4), (b) (concentration set 1.0 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 5 meet the requirements of § 721.63(a)(4): NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters; NIOSH-certified air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters; NIOSH-certified powered air-purifying respirator equipped with a tightfitting facepiece (full-face) and HEPA filters; or NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (full-face).

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

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

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

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

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

75. Add § 721.10498 to subpart E to read as follows:

§ 721.10498

Substituted alkyl ester, hydrolysis products with silica (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as substituted alkyl ester, hydrolysis products with silica (PMNs P-06-277 and P-06-280) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), (a)(4), (b) (concentration set at 1.0 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 5 meet the requirements of § 721.63(a)(4): NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters; NIOSH-certified air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters; NIOSH-certified powered air-purifying respirator equipped with a tightfitting facepiece (full-face) and HEPA filters; or NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (full-face).

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

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

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

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

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

76. Add § 721.10499 to subpart E to read as follows:

§ 721.10499

Substituted silane, hydrolysis products with silica (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as substituted silane, hydrolysis products with silica (PMNs P-06-278 and P-06-281) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), (a)(4), (b) (concentration set at 1.0 percent), and (c). The following National Institute for Occupational Safety and Health NIOSH-certified respirators with an assigned protection factor (APF) of at least 5 meet the requirements of § 721.63(a)(4): NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters; NIOSH-certified air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate air (HEPA) filters; NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (full-face) and HEPA filters; or NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (full-face).

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

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

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

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

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

77. Add § 721.10500 to subpart E to read as follows:

§ 721.10500

Acrylated mixed metal oxides (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acrylated mixed metal oxides (PMN P-06-341) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1.0 percent), and (c).

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

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

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

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

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

78. Add § 721.10501 to subpart E to read as follows:

§ 721.10501

Tridecyl phthalate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tridecyl phthalate (PMN P-06-542) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

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

79. Add § 721.10502 to subpart E to read as follows:

§ 721.10502

Modified triethylene glycol dithiol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified triethylene glycol dithiol (PMN P-06-616) 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.

80. Add § 721.10503 to subpart E to read as follows:

§ 721.10503

1,2-Ethanediol, 1-carbamate.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2-ethanediol, 1-carbamate (PMN P-06-622; CAS No. 5395-01-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

81. Add § 721.10504 to subpart E to read as follows:

§ 721.10504

Surface modified magnesium hydroxide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as surface modified magnesium hydroxide (PMN P-06-682) 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) (compatibilizer for flame retardant for plastics) and (s) (100,000 kilograms).

(ii) [Reserved]

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

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

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

82. Add § 721.10505 to subpart E to read as follows:

§  721.10505

Phosphoric acid, mixed mono- and diesters with 2-ethyl-1-hexanol and polyethylene glycol mono-C_12-16-alkyl ethers.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphoric acid, mixed mono- and diesters with 2-ethyl-1-hexanol and polyethylene glycol mono-C_12-16-alkyl ethers (PMN P-06-694; CAS No. 882693-50-7) 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 (j) and (s) (75,000 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.

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

83. Add § 721.10506 to subpart E to read as follows:

§ 721.10506

Alkylated phenols (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as alkylated phenols (PMNs P-07-11 and P-08-29) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1.0 percent), and (c).

(ii) [Reserved]

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e) are applicable to manufacturers, importers, and processors of these substances.

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

84. Add § 721.10507 to subpart E to read as follows:

§ 721.10507

Biphenyl substituted benzopyran (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as biphenyl substituted benzopyran (PMN P-07-107) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

85. Add § 721.10508 to subpart E to read as follows:

§ 721.10508

Alkene substituted Bis phenol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkene substituted bis phenol (PMN P-07-161) 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)(3), (b) (concentration set at 0.1 percent), and (c).

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

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (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.

86. Add § 721.10509 to subpart E to read as follows:

§ 721.10509

Pentane, 1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as pentane, 1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)- (PMN P-07-204; CAS No. 870778-34-0) 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) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1.0 percent), and (c).

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

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e) 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 paragraph (a)(2)(ii) of this section.

87. Add § 721.10510 to subpart E to read as follows:

§ 721.10510

Alkylaminoalcohol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylaminoalcohol (PMN P-07-319) 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.

88. Add § 721.10511 to subpart E to read as follows:

§ 721.10511

Quaternary ammonium salts (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as quaternary ammonium salts (PMNs P-07-320, P-07-321, P-07-322, P-07-323, and P-07-324) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

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

89. Add §  721.10512 to subpart E to read as follows:

§  721.10512

Fatty acid maleic acid amides (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as fatty acid maleic acid amides (PMNs P-07-563 and P-07-564) 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=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 these substances.

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

90. Add §  721.10513 to subpart E to read as follows:

§  721.10513

Aromatic acrylate monomer (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic acrylate monomer (PMN P-07-599) 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.

91. Add §  721.10514 to subpart E to read as follows:

§  721.10514

[1,1'-Biphenyl]-2,2'-disulfonic acid, 4-[2-(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)diazenyl]-4'-[2-(2-hydroxy-1-naphthalenyl)diazenyl]-, sodium salt (1:2).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as [1,1'-Biphenyl]-2,2'-disulfonic acid, 4-[2-(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)diazenyl]-4'-[2-(2-hydroxy-1-naphthalenyl)diazenyl]-, sodium salt (1:2) (PMN P-07-679; CAS No. 6470-20-8) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (f), (v)(2), and (x)(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 (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.

92. Add §  721.10515 to subpart E to read as follows:

§  721.10515

Partially fluorinated alcohol substituted glycols (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as partially fluorinated alcohol substituted glycols (PMNs P-10-58, P-10-59, and P-10-60) 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) (manufacture and import of the PMN substances according to the chemical synthesis and composition section of the consent order, including analysis, reporting, and limitations of maximum impurity levels of certain fluorinated impurities; manufacture and import of P-10-58 and P-10-59 only as described in the manufacturing section of the consent order), (l) (compliance with the maximum established percentage of the PMN substances in a non-industrial product or distributed for use as a non-industrial product), (o) (use of P-10-60 in a consumer product that could be spray applied), and (q).

(ii) [Reserved]

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of these substances, except the recordkeeping requirements for § 721.125 (b) and (c) do not apply to importers or processors when any one of the substances are contained in a formulation at less than 3 weight percent.

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