E7-5797. Significant New Use Rules on Certain Chemical Substances and Notification on Certain Substances for Which Significant New Use Rules are Not Being Issued

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Direct final rule.

SUMMARY:

EPA is promulgating significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 65 chemical substances which were the subject of premanufacture notices (PMNs). Thirteen of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 65 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. This direct final rule also provides notification on two substances for which EPA has decided not to issue significant new use rules at this time.

DATES:

The effective date of this rule is May 29, 2007 without further notice, unless EPA receives adverse or critical comments, or notice of intent to submit adverse or critical comments before April 30, 2007. This rule shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on April 12, 2007.

If EPA receives adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before April 30, 2007, 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.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2003-0063, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID number EPA-HQ-OPPT-2003-0063. 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-2003-0063. EPA's policy is that all comments received will be included in the public docket without change and may be made available on-line 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 e-mail. The regulations.gov website 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 e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/​epahome/​dockets.htm.

Docket: All documents in the docket are listed in the docket's 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 Federal 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 general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

For technical information contact: Karen Chu, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail 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 40 CFR 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. Persons who import any chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after April 30, 2007 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 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 e-mail. 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. Additional rationale and background to this rule are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register of April 24, 1990 (55 FR 17376). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.

B. What is the Agency's Authority for Taking this Action?

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). 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. The mechanism for reporting under this requirement is established under 40 CFR part 721.5.

C. Applicability of General Provisions

General provisions for SNURs appear under 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 final rule. Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5 (h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities on which it has received the SNUN. If EPA does not take action, the Agency is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

Persons who export or intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, codified at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Such persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy on import certification appears at 40 CFR part 707, subpart B.

III. Substances Subject to this Rule

EPA is establishing significant new use and recordkeeping requirements for 65 chemical substances under 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).
• CAS number (if assigned for non-confidential chemical identities).
• Basis for the section 5(e) consent order, or, for non-5(e) SNURs, the basis for the SNUR.
• Toxicity concerns.
• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VI. for more information).
• CFR citation assigned in the regulatory text section of this rule.

The specific activities designated as significant new uses are listed in the regulatory text section of 40 CFR part 721, subpart E. Certain new uses, including production limits and other uses designated in the rule are claimed as CBI. The procedure for obtaining confidential information is set out in Unit VII.

This rule includes SNURs on 13 PMN substances that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) wherein EPA determined that activities associated with the PMN substances may present unreasonable risk to health or the environment. The consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNURs” on these substances are promulgated pursuant to 40 CFR 721.160, and are based on and consistent with the provisions in the underlying consent orders. The SNURs designate as a “significant new use” the absence of the protective measures required in the consent order.

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

This rule also includes SNURs on 52 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under section 5(e) of TSCA. EPA, however, 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 40 CFR 721.170. EPA has determined that every activity designated as a “significant new use” in all non-5(e) SNURs issued under 40 CFR 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-97-415

Chemical name: 2-Thiazolidinone.

CAS number: 2682-49-7.

Effective date of section 5(e) consent order: April 20, 2000.

Basis for section 5(e) consent order: The PMN states that the substance will be used as an intermediate. The order was issued under section 5(e)(1)(A)(i) and (ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to health and the environment. To protect against this risk, the consent order requires worker protection and hazard communication and restricts disposal, water releases, and aggregate manufacture/importation volume of the PMN substance. It also prohibits use of the PMN substance other than as an intermediate and prohibits domestic manufacturing, processing, or use of the PMN substance as a powder. The SNUR designates as a ‘significant new use’ the absence of these protective measures.

Toxicity concern: EPA has identified health concerns for high acute toxicity and signs of neurotoxic effects based on test data for the PMN substance. EPA also has concerns for chronic effects and systemic, developmental, and maternal toxicity based on test data on a structurally similar substance. The NCEL is 0.7 mg/m³ as an 8-hour time-weighted average. EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 300 parts per billion (ppb) of the PMN substance in surface waters based on test data on a structurally similar substance.

Recommended testing: EPA has determined that the following test would help characterize the human health effects of the PMN substance: A combined repeated dose toxicity with the reproductive/developmental toxicity screening test (oral route) (OPPTS 870.3650 test guideline) with a neurotoxicity functional observational battery (National Technical Information Service (NTIS) PB 91-154617) and a histopathologic examination extended to include the blood, liver, kidney, brain, and spinal cord on the PMN substance to help characterize neurotoxic, systemic, reproductive, and developmental effects. The PMN submitter has agreed not to exceed the production volume limit without performing this test. In addition, EPA has determined that a porous pot test (OPPTS 835.3220 test guideline), a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10002.

PMN Numbers P-98-625/626/627/628/629 and P-00-614/617

Chemical name: Manganese heterocyclic tetraamine complex (generic).

CAS number: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be in commercial research and development. EPA has identified health concerns for chronic organ effects based on data on a structurally similar substance. Since significant worker exposure is unlikely at the production volume identified in the PMNs, EPA has not determined that the proposed manufacture, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that a manufacture or importation volume greater than 10,000 kilograms/year of any one of the PMN substances may result in serious chronic effects. Based on this information, each of 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 oral toxicity study (OPPTS 870.3100 test guideline) would help characterize the human health effects of the PMN substances.

CFR citation: 40 CFR 721.10003.

PMN Number P-98-1181

Chemical name: 2-Butenoic acid, 4,4′-[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2′Z)-, di-C_8-10-isoalkyl esters, C₉-rich.

CAS number: 247041-56-1.

Basis for action: The PMN states that the substance will be used as a polyvinyl chloride stabilizer. EPA has identified concerns for corrosion to skin, eyes, and mucuous membranes, neurotoxicity, blood toxicity, liver toxicity, immunosupression, reproductive toxicity, and adrenal effects based on analogy to organotins. As described in the PMN, significant worker exposure is unlikely. 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 in a solid form, involving an application method that generates a vapor, mist, or aerosol, or where there is potential dermal exposure without the use of impervious gloves, 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 oral toxicity study (OPPTS 870.3100 test guideline) and a neurotoxicity screening test (OPPTS 870.6200 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10004.

PMN Number P-98-1182

Chemical name: 2-Butenoic acid, 4,4′-[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2′Z)-, di-C_9-11-isoalkyl esters, C₁₀-rich.

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a polyvinyl chloride stabilizer. EPA has identified concerns for corrosion to skin, eyes, and mucuous membranes, neurotoxicity, blood toxicity, liver toxicity, immunosupression, reproductive toxicity, and adrenal effects based on analogy to organotins. As described in the PMN, significant worker exposure is unlikely. 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 in a solid form, involving an application method that generates a vapor, mist, or aerosol, or where there is potential dermal exposure without the use of impervious gloves, 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 oral toxicity study (OPPTS 870.3100 test guideline) and a neurotoxicity screening test (OPPTS 870.6200 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10005.

PMN Number P-99-511

Chemical name: Mixed metal oxide (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an additive for coatings. Based on data for a similar substance, EPA has identified concerns for cancer, immunotoxicity, and lung toxicity. As described in the PMN, significant inhalation exposure is unlikely. 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 a manufacture/importation volume greater than 60,000 kilograms/year 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 a bacterial reverse mutation test (OPPTS 870.5100 test guideline) and a mammalian erythrocyte micronucleus test (intraperitoneal route) (OPPTS 870.5395 test guideline) with special attention to histopathology of the lung tissues and organs of the immune systems (spleen, thymus, bone marrow) would help characterize the human health effects of the PMN substance. If the results of the recommended tests indicate that the PMN substance has carcinogenic potential, a carcinogenicity study (OPPTS 870.4200 test guideline) would help further characterize the health effects.

CFR citation: 40 CFR 721.10006.

PMN Number P-00-11

Chemical name: Alcohols, C_12-14 - secondary, ethoxylated propoxylated.

CAS number: 103331-86-8.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a household cleaning agent additive. Based on analogy to nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at concentrations above 50 ppb in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations above 50 ppb. Thus, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in surface water concentrations above 50 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10007.

PMN Numbers P-00-1121/1122/1123/1124/1125/1126

Chemical names: (P-00-1121) Manganese strontium oxide (MnSrO₃); (P-00-1122) Manganese yttrium oxide (MnYO₃); (P-00-1123) Barium manganese oxide (BaMnO₃); (P-00-1124) Barium calcium manganese strontium oxide; (P-00-1125) Manganate (MnO₂^1-), calcium (2:1); and (P-00-1126) Manganese yttrium oxide (Mn₂ YO₅).

CAS numbers: (P-00-1121) 12163-45-0, (P-00-1122) 12032-75-6, (P-00-1123) 12230-80-7, (P-00-1124) 359427-90-0, (P-00-1125) 12049-47-7, and (P-00-1126) 12438-71-0.

Effective date of section 5(e) consent order: March 23, 2001.

Basis for section 5(e) consent order: The PMNs state that the generic (non-confidential) use of the substances will be as pigments. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that these substances may present an unreasonable risk of injury to human health and the environment. To protect against this risk, the consent order requires hazard communication and restricts aggregate manufacture/importation volume, particle size and water releases of the PMN substances. The SNUR designates as a ‘significant new use’ the absence of these protective measures.

Toxicity concern: EPA has health concerns for neurotoxicity and mutagenicity for the PMN substances based on exposure to manganese; concerns for lung toxicity, fibrosis, and possible cancer of the lungs due to potential exposure to the particulate form of the substances; and concern for lung effects through lung overload if respirable particles are inhaled. Based on test data on structurally similar substances, EPA is concerned that toxicity to aquatic organisms for each of these PMN substances may occur at concentrations as low as 100 ppb in surface waters. Further, the Agency has determined that the PMN substances may be persistant, bioaccumulative, and toxic based on physical/chemical properties of the substances, consistent with the New Chemical Program's Persistant, Bioaccumulative, and Toxic (PBT) Category (64 FR 60194, November 4, 1999) (FRL-6097-7). Because of the potential PBT nature of the PMN substances, bioaccumulation and the potential for eventual exposure to humans and wildlife could result from exposure to concentrations below 100 ppb. Therefore, to adequately mitigate this concern, EPA has decided to limit surface water concentrations resulting from manufacturing, processing, or use to 1 ppb or less for each of the PMN substances.

Recommended testing: EPA has determined that a fish bioconcentration factor (BCF) test (OPPTS 850.1730 test guideline (public draft)) would help characterize the environmental effects of the substances. The PMN submitter has agreed not to exceed the production volume limit without performing the fish BCF test on P-00-1122 or P-00-1126. EPA has determined that a 90-day inhalation toxicity study in rats with a 60-day holding period with special attention to the histopathology of the lungs (OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substances. Based on the results of the 90-day study, a 2-year inhalation carcinogenicity test (OPPTS 870.4200 test guideline) may be warranted.

CFR citations: 40 CFR 721.10008 (P-00-1121); 40 CFR 721.10009 (P-00-1122); 40 CFR 721.10010 (P-00-1123); 40 CFR 721.10011 (P-00-1124); 40 CFR 721.10012 (P-00-1125); and 40 CFR 721.10013 (P-00-1126).

PMN Number P-01-109

Chemical name: Halogenated naphthalic anhydride (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a dye intermediate. Based on toxicity data on structurally similar chemicals, EPA expects toxicity to aquatic organisms to occur at concentrations as low as 20 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed processing or use of the substance may present an unreasonable risk. EPA has determined, however, that releases to surface waters 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 the following testing would help characterize the PMN substance: An algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)).

CFR citation: 40 CFR 721.10014.

PMN Number P-01-110

Chemical name: Halogenated benzimidazole (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a dye intermediate. Based on Structure Activity Relationships (SAR) analysis, EPA expects toxicity to aquatic organisms to occur at concentrations as low as 1 ppb of the PMN substance in surface waters. In addition, EPA has identified environmental concerns because the PMN substance may be persistent, bioaccumulative, and toxic based on physical/chemical properties of the PMN substance, consistent with the New Chemical Program's PBT Category (64 FR 60194, November 4, 1999). 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 other uses of the substance resulting in release of the PMN substance to surface waters may cause significant adverse environmental effects, since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of the following tiered testing would help characterize the PMN substance: Tier 1 - Melting point/melting range test (OPPTS 830.7200 test guideline) and an octanol water partition coefficient/K_ow test (OPPTS 830.7550 test guideline); Tier 2 - Activated sludge sorption isotherm (OPPTS 835.1110 test guideline) or modified coagulation-flocculation jar test of water (D2034-80); Tier 3 - An algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)) and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)); Tier 4 - tiered testing as described in the New Chemicals Program's PBT Category (excluding the octanol water partition coefficient/K_ow test already recommended in Tier 1).

CFR citation: 40 CFR 721.10015.

PMN Number P-01-111

Chemical name: Dibenzimidazothianaphthalene

(generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a fluorescent dye. Based on toxicity data on structurally similar chemicals, EPA expects chronic toxicity to aquatic organisms to occur at concentrations as low as 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 processing or use of the substance may present an unreasonable risk. EPA has determined, however, that releases to surface waters 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 the following tiered testing would help characterize the PMN substance: Tier 1 - Activated sludge sorption isotherm test (OPPTS 835.1110 test guideline) or modified coagulation-flocculation jar test of water (D2034-80); Tier 2 - An algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)); and Tier 3 - A daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) and a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)).

CFR citation: 40 CFR 721.10016.

PMN Numbers P-01-257/258/259 and P-01-261

Chemical name: Amine terminated bisphenol A diglycidyl ether polymer

(generic).

CAS number: Not available.

Basis for action: The PMNs state that the substances will be used as epoxy resin curing agents. Based on analogy to structurally similar polycationic polymers, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 40 ppb in surface waters. As described in the PMNs, the substances are not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that other uses of the substances resulting in release to surface waters 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 an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), and a fish acute toxicity test mitigated by humic acid (OPPTS 850.1085 test guideline (public draft)) would help characterize the environmental effects of the PMN substances.

CFR citation: 40 CFR 721.10017.

PMN Number P-01-442

Chemical name: Calcium hydroxide oxide silicate (Ca₆ (OH)₂ O₂ (Si₂ O₅)₃).

CAS number: 13169-90-9.

Basis for action: The PMN states that the substance will be used as a filler to reinforce resins, an additive for resins, and a filter medium. Based on test data on this chemical and structurally similar compounds, EPA has identified human health concerns for cancer and toxicity to the respiratory tract, lungs, respiratory system, and liver to workers exposed via inhalation. As described in the PMN, significant worker exposure is unlikely. Therefore, EPA has not determined that the proposed import, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture, uses other than as described in the PMN, or processing or use as a powder resulting in significant worker inhalation exposure may cause significant adverse 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 a 90-day inhalation toxicity study (OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10018.

PMN Number P-01-563

Chemical name: Benzoic acid, 2-chloro-5-nitro-, 1,1-dimethyl-2-oxo-2-(2-propenyloxy) ethyl ester.

CAS number: 174489-76-0.

Basis for action: The PMN states that the substance will be used as a chemical intermediate. Based on submitted test data and on structural analogy to esters, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 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 other uses of the substance resulting in release to surface waters 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 a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), and an aerobic aquatic biodegradation test with an analytical methodology to identify the isononyl phenol degradation product (OPPTS 835.3100 test guideline) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10019.

PMN Number P-01-564

Chemical name: Benzoic acid, 5-amino-2-chloro-, 1,1-dimethyl-2-oxo-2-(2-propenyloxy) ethyl ester.

CAS number: 174489-43-1.

Basis for action: The PMN states that the substance will be used as a chemical intermediate. Based on structural analogy to anilines, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 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 other uses of the substance resulting in release to surface waters 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 a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), and an aerobic aquatic biodegradation test with an analytical methodology to identify the isononyl phenol degradation product (OPPTS 835.3100 test guideline) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10020.

PMN Number P-01-764

Chemical name: Magnesium potassium titanium oxide.

CAS number: 39290-90-9.

Effective date of section 5(e) consent order: July 29, 2002.

Basis for section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a physical characteristics modifier for industrial use in certain solid composite articles. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order requires worker protection and hazard communication and restricts the aggregate manufacture/importation volume of the PMN substance. The SNUR designates as a ‘significant new use’ the absence of these protective measures.

Toxicity concern: Based on test data on titanium dioxide, EPA has health concerns for lung toxicity, including lung overload and oncogenicity, with inhalation exposure. The NCEL is 5 mg/m³ as an 8-hour time-weighted average.

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity study with a 60-day holding period (OPPTS 870.3465 test guideline) and possibly a 2-year carcinogenicity study (OPPTS 870.4200 test guideline) would help characterize the human health effects of the PMN substance. The consent order contains two production volume limits. The PMN submitter agreed not to exceed the first production volume limit without performing the 90-day inhalation toxicity study and not to exceed the second production volume limit without performing the 2-year carcinogenicity study if warranted based on the results of the first study.

CFR citation: 40 CFR 721.10021.

PMN Numbers P-01-769/770/771/772

Chemical names: (P-01-769) Benzenamine, N-phenyl-, ar-(C₉-rich C_8-10-branched alkyl) derivs; (P-01-770) Benzenamine, N-phenyl-, ar, ar′-(C₉-rich C_8-10-branched alkyl) derivs; (P-01-771) 10H-Phenothiazine, ar-(C₉-rich C_8-10-branched alkyl) derivs; and (P-01-772) 10H-Phenothiazine, ar, ar′-(C₉-rich C_8-10-branched alkyl) derivs.

CAS numbers: (P-01-769) 333955-69-4, (P-01-770) 333955-70-7, (P-01-771) 333955-79-6, and (P-01-772) 333955-80-9.

Basis for action: The PMNs state that the substances will be used as antioxidants for lubricating oils. EPA has identified human health and environmental concerns because the PMN substances may be persistent, bioaccumulative, and toxic, based on submitted test data and physical/chemical properties of the PMN substances, consistent with the New Chemical Program's PBT Category (64 FR 60194, November 4, 1999). As described in the PMNs, significant worker exposure is unlikely and 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 use of the PMN substances other than as described in the PMNs resulting in release to water may cause serious chronic human health effects and significant environmental effects, since the PMN substances have been characterized by EPA as a PBT. Based on this information, the PMN substances meet the concern criteria at § 721.170 (b)(3)(i), (b)(4)(ii), and (b)(4)(iii).

Recommended testing: EPA has determined that the results of testing Tiers 2 and 3 as described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substances.

CFR citations: 40 CFR 721.10022 (P-01-769); 40 CFR 721.10023 (P-01-770); 40 CFR 721.10024 (P-01-771); and 40 CFR 721.10025 (P-01-772).

PMN Number P-01-856

Chemical name: Cashew, nutshell liq., ethoxylated.

CAS number: 350820-95-0.

Effective date of section 5(e) consent order: July 5, 2002.

Basis for section 5(e) consent order: The PMN states that the substance will be used as a pigment dispersant. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to the environment. To protect against this risk, the consent order restricts molecular weight and composition of the PMN substance. The SNUR designates as a ‘significant new use’ the absence of these protective measures.

Toxicity concern: Based on test data on structurally similar nonionic surfactants, particularly alkyl ethoxylate, EPA has concerns that the environmental toxicity of the PMN substance varies depending on the average number of moles of the ethoxy. As the number of moles of ethoxy decreases, the aquatic toxicity of the substance increases. For this PMN substance, the average number of moles may vary. When the average number of moles of the ethoxy group is 80, EPA expects toxicity to aquatic organisms to occur at concentrations as low as 1,000 ppb.

Recommended testing: The Agency has determined that the results of a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize possible environmental effects of the substance. The tests should be conducted on the PMN substance with less than 55 moles of the ethoxy group or with an average molecular weight less than 2,700 daltons.

CFR citation: 40 CFR 721.10026.

PMN Number P-01-862

Chemical name: Ethoxylated alkylsulfate, substituted alkylamine 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 processing aid. Based on analogy to cationic surfactants and similar substances, EPA is concerned that chronic toxicity to aquatic organisms may occur at concentrations as low as 4 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters in significant quantities. 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 other uses of the substance resulting in significant release to surface waters 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 a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)), a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)), and a ready biodegradability test (OPPTS 835.3110 test guideline) would help characterize the chronic environmental effects and the fate in the environment of the PMN substance. After this testing is completed, if the results of the testing and projected environmental risk warrant it, a porous pot test (OPPTS 835.3220 test guideline) or modified semi-continuous activated sludge (SCAS) test (OPPTS 835.3210 test guideline) would further characterize the environmental fate of this substance.

CFR citation: 40 CFR 721.10027.

PMN Numbers P-01-901 and P-01-902

Chemical name: Disubstituted benzene metal salt (generic).

CAS number: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as a polymer additive. Based on test data and analogy to phenols and hydroquinones/quinones, EPA has concerns for dermal corrosivity, acute toxicity, kidney and liver effects, mutagenicity, carcinogenicity, neurotoxicity, developmental toxicity, depigmentation of skin, thyroid effects, and sensitization. Also, based on analogy to phenols and hydroquinones/quinones, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 1 ppb in surface waters. As described in the PMNs, significant worker exposure is not expected as workers wear impervious personal protective equipment and significant environmental exposure is not expected as the substances are not released to surface waters in significant quantities. 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 without workers wearing impervious gloves or uses other than as described in the PMNs could result in serious health effects or significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)) would help characterize the environmental effects of the PMN substances. EPA has also determined that a 90-day inhalation toxicity study with a 60-day holding period (OPPTS 870.3465 test guideline) would help characterize the human health effects.

CFR citation: 40 CFR 721.10028.

PMN Number P-01-918

Chemical name: Isocyanate compound, modified with methoxysilane (generic).

CAS number: Not available.

Effective date of section 5(e) consent order: May 30, 2002.

Basis for section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a sealant. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order requires worker protection and hazard communication and restricts the aggregate manufacture/importation volume of the PMN substance. The SNUR designates as a ‘significant new use’ the absence of these protective measures.

Toxicity concern: Based on test data on diisocyanates, the Agency has concern for dermal and respiratory sensitization and pulmonary toxicity. The NCEL is 0.05 mg/m³ or 0.005 ppm as an 8-hour time-weighted average.

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

CFR citation: 40 CFR 721.10029.

PMN Number P-01-919

Chemical name: Pyrimido[5,4-g]pteridine-2,4,6,8-tetramine, 4-methylbenzenesulfonate, base-hydrolyzed.

CAS number: 346709-25-9.

Basis for action: The PMN states that the substance will be used as a pigment for thermoplastic polymers. Based on analogy to structurally similar N-heterocyclic chemicals, EPA has concerns for potential developmental toxicity from exposure to the PMN material. Significant worker exposure is unlikely when the substance is used as described in the PMN. In addition, based on test data on the PMN substance, EPA is concerned that chronic toxicity to aquatic organisms may occur at concentrations as low as 10 ppb in surface waters. As described in the PMN, the substance is not released to surface waters in significant quantities. 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 domestic manufacture of the substance 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)(i).

Recommended testing: EPA has determined that a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OPPTS 870.3650 test guideline), a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)), and a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)) would help characterize the human health and environmental effects of the substance.

CFR citation: 40 CFR 721.10030.

PMN Number P-02-214

Chemical name: Lithium potassium titanium oxide.

CAS number: 39318-30-4.

Effective date of section 5(e) consent order: June 17, 2002.

Basis for section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a physical characteristics modifier for industrial use in certain solid composite articles. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order requires worker protection and hazard communication and restricts the aggregate manufacture/importation volume of the PMN substance. The SNUR designates as a ‘significant new use’ the absence of these protective measures.

Toxicity concern: Based on test data on titanium dioxide, the Agency has concerns for lung toxicity (including oncogenicity) if the PMN substance is inhaled. The NCEL is 5 mg/m³ as an 8-hour time-weighted average.

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity study with a 60-day holding period (OPPTS 870.3465 test guideline) and possibly a 2-year carcinogenicity study (OPPTS 870.4200 test guideline) would help characterize the human health effects of the PMN substance. The consent order contains two production volume limits. The PMN submitter agreed not to exceed the first production volume limit without performing the 90-day inhalation toxicity study and not to exceed the second production volume limit without performing the 2-year carcinogenicity study if warranted based on the results of the first study.

CFR citation: 40 CFR 721.10031.

PMN Number P-02-269

Chemical name: Acrylic acid, polymer with substituted acrylamides (generic).

CAS number: Not available.

Effective date of section 5(e) consent order: October 22, 2002.

Basis for section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a thermo-sensitive water absorbing/desorbing polymer to soil. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order restricts the particle size of the PMN substance. The SNUR designates as a ‘significant new use’ the absence of this protective measure.

Toxicity concern: Based on test data on swellable high molecular weight polymers (see 60 FR 16319-16320, March 29, 1995) (FRl-4921-9), the Agency has concerns for lung toxicity and oncogenicity if the PMN substance is inhaled.

Recommended testing: The Agency has determined that a 90-day inhalation toxicity study (OPPTS 870.3465 test guideline) and a carcinogenicity study (OPPTS 870.4200 test guideline) would help characterize possible human health effects of the substance.

CFR citation: 40 CFR 721.10032.

PMN Number P-02-322

Chemical name: Zinc, [ethanedioato(2-)-. kappa. O¹, . kappa. O²]-.

CAS number: 547-68-2.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate. Based on analogy to similar zinc compounds, EPA is concerned that toxicity to aquatic organisms may occur at concentrations above 1 ppb in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations above 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substance may cause significant adverse effects. EPA has determined, however, that other uses of the PMN substance resulting in surface water concentrations above 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)), and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10033.

PMN Number P-02-359

Chemical name: Substituted pyridine coupled with diazotized substituted nitrobenzonitrile, diazotized substituted benzenamine and substituted pyridinecarbonitrile (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 dye. Based on structural analogy to neutral organics, EPA is concerned that chronic toxicity to aquatic organisms may occur at concentrations above 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters in significant quantities. 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 other uses of the substance resulting in release to surface waters in concentrations above 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 a fish early-life toxicity test (OPPTS 850.1400 test guideline (public draft)), a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10034.

PMN Number P-02-382

Chemical name: Alkylbenzene sulfonate (generic).

CAS number: Not available.

Effective date of section 5(e) consent order: December 17, 2002.

Basis for section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a petroleum lubricant additive. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to the environment. To protect against this risk, the consent order restricts the formulation of the PMN substance. The SNUR designates as a ‘significant new use’ the absence of this protective measure. In addition, the order was issued under section 5(e)(1)(A)(ii)(II) of TSCA based on a finding that this substance will be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities.

Toxicity concern: Based on analogy to structurally similar anionic surfactants, EPA expects toxicity to aquatic organisms to occur at concentrations as low as 500 ppb in surface waters. However, when the PMN substance is manufactured, processed, and used in mineral oil as described in the PMN, EPA does not expect releases of this PMN substance to pose a risk to the environment. The oil diluent serves to minimize dispersion and bioavailability of the PMN substance in surface waters. EPA has determined that other uses of the substance when not diluted in mineral oil may result in significant release to surface waters and may cause significant adverse environmental effects.

Recommended testing: EPA has determined that an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)) would help characterize the environmental effects of the PMN substance when not used in mineral oil.

CFR citation: 40 CFR 721.10035.

PMN Number P-02-406

Chemical name: Acetaldehyde based 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 corrosion inhibitor. EPA has identified health and environmental concerns for this substance. EPA has identified health concerns for carcinogenicity and dermal sensitization based on analogy to structurally similar chemicals. Based on structural analogy to aldehydes, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 1 ppb of the PMN substance in surface waters. In addition, the PMN substance may be persistent, bioaccumulative, and potentially toxic based on physical/chemical properties of the PMN substance as described in the New Chemical Program's PBT Category (64 FR 60194, November 4, 1999). As described in the PMN, significant worker exposure is unlikely and 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 other domestic manufacturing or other uses that result in predictable or purposeful releases to surface water could result in exposures which may cause serious chronic human health effects and significant environmental effects since the substance has been characterized by EPA as a PBT. 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 the tiered testing as described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substance.

CFR citation: 40 CFR 721.10036.

PMN Number P-02-423

Chemical name: Complex halogenated salt of tris(ethylated aminocarbocyclic)methane (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a colorant for inks. Based on structurally similar compounds, EPA has identified human health concerns for carcinogenicity, mutagenicity, reproductive effects, and developmental effects from inhalation exposure to the PMN substance. In addition, based on structurally similar compounds, EPA expects toxicity to aquatic organisms at surface water concentrations above 1 ppb. As described in the PMN, significant worker and environmental exposure are unlikely. 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 other uses of the substance resulting in surface water concentrations above 1 ppb or any processing or use beyond the site of manufacture or import could result in worker and environmental exposures which may cause carcinogenic and serious chronic effects in humans and significant 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 a prenatal developmental toxicity study by the oral route (OPPTS 870.3700 test guideline), a reproductive and fertility effects study (OPPTS 870.3800 test guideline), a Salmonella typhimurium reverse mutation assay (40 CFR 798.5265), and a mammalian erythrocyte micronucleus study by the intraperitoneal route (OPPTS 870.5395 test guideline) would help characterize the human health effects of the PMN substance. Positive results in the mutagencity studies would trigger a carcinogenicity study (OPPTS 870.4200 test guideline). In addition, EPA has determined that a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10037.

PMN Number P-02-434

Chemical name: Trimellitic anhydride, polymer with substituted glycol, alkyl phenols and ethoxylated nonylphenol (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as curing resin for industrial can coatings. Based on structural analogy to esters, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 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 other uses of the substance resulting in release to surface waters 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 an aerobic biodegradation test with an analytical methodology to identify the branched-nonyl phenol degradation product (OPPTS 835.3100 test guideline) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10038.

PMN Number P-02-514

Chemical name: Diethoxybenzenamine derivative, diazotized, coupled with aminonaphthalenesulfonic acid derivative, 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 dyestuff in printing ink. Based on structural analogy, EPA has identified concerns for carcinogenicity, mutagenicity, and developmental toxicity for the substituted beta-naphthylamine azo reduction product, blood and developmental toxicity for the aniline-acid-based azo reduction product, and carcinogenicity, developmental, liver toxicity and sensitization for the para-phenylenediamine-based azo reduction product. There is concern for chronic effects based on the submitted 28-day subchronic study with a No Observed Adverse Effect Level (NOAEL) of 15 mg/kg. As described in the PMN, worker inhalation 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 domestic manufacture or processing or use of the substance as a solid 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), (b)(3)(ii), and (b)(3)(iii).

Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in two species (40 CFR 799.9370), an Ames assay with the Prival modification with a concurrent positive control (OPPTS 870.5100 test guideline), and a 90-day inhalation toxicity study in rats (OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10039.

PMN Number P-02-522

Chemical name: Substituted acridine naphtha substituted benzamide (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be in exhaust dyeing of polyester fibers. Based on analogy to neutral organics, EPA is concerned that toxicity to aquatic organisms may occur at concentrations above 2 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 above 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 other uses of the substance resulting in release to surface waters in concentrations above 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 an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a fish chronic toxicity test (OPPTS 850.1400 test guideline (public draft)), and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10040.

PMN Number P-02-530

Chemical name: 1-Butanone, 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(4-morpholinyl)phenyl]-.

CAS number: 119344-86-4.

Basis for action: The PMN states that the substance will be used as a photo initiator for coatings and inks. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 2 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters in significant quantities. 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 domestic manufacture of the PMN substance may result in 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 a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10041.

PMN Number P-02-585

Chemical name: 2-Propanol, 1-[bis(2-hydroxyethyl)amino]-.

CAS number: 6712-98-7.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a grinding aid and intermediate. EPA has identified health concerns for lung sensitization and carcinogenicity based on analogy to triethanolamine. There is concern for developmental toxicity, eye irritation, liver toxicity, kidney toxicity, and blood toxicity based on submitted test data. As described in the PMN, significant inhalation exposure is unlikely. 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 other uses of the substance other than as described in the PMN may result in significant human exposure. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).

Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in rats (OPPTS 870.3700 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10042.

PMN Number P-02-697

Chemical name: Dineopentyl-4-substituted 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 catalyst component. EPA has identified health and environmental concerns because the PMN substance may be persistent, bioaccumulative, and toxic based on physical/chemical properties of the PMN substance as described in the New Chemical Program's PBT Category (64 FR 60194, November 4, 1999). EPA has identified health concerns for developmental toxicity based on analogy to other phthalates and concerns for liver, kidney, and neurotoxicity based on analogy to haloaromatic compounds. As described in the PMN, significant worker exposure is unlikely and 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 other uses of the PMN substance which may result in predictable or purposeful release of the PMN substance into waters of the United States or any use of the PMN substance other than as described in the PMN could result in exposures which may cause serious chronic human health effects and significant environmental effects since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(ii) and (b)(4)(ii).

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

CFR citation: 40 CFR 721.10043.

PMN Number P-02-698

Chemical name: Metal oxide, modified with alkyl and vinyl terminated polysiloxanes (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an adhesive. EPA has identified health concerns for lung toxicity based on analogy to poorly soluble respirable particulates. As described in the PMN, significant worker exposure is unlikely. 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 manufacturing, processing, or use of the substance as a powder could result in exposures which 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 study in rodents with a 60-day holding period (OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10044.

PMN Number P-02-737

Chemical name: Diazotized substituted heteromonocycle coupled with naphthalene sulfonic acid derivative, nickel complex, alkaline 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 colorant for coating compositions. EPA has identified concerns for carcinogenicity, pulmonary sensitization, immunotoxicity, developmental toxicity, and neurotoxicity from analogous compounds, and carcinogenicity, mutagenicity, and developmental toxicity for the azo reduction products. As described in the PMN, worker inhalation exposure is not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture or processing or use of the substance as a solid may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(1)(i)(D), (b)(3)(ii), and (b)(3)(iii).

Recommended testing: EPA has determined that a 90-day oral toxicity test in rodents (OPPTS 870.3100 test guideline), a bacterial reverse mutation test with Prival modification (OPPTS 870.5100 test guideline), and an unscheduled DNA synthesis test in rat hepatocytes (OPPTS 870.5550 test guideline) would help characterize the human health effects of the PMN substance. If warranted by the results of any of the three above studies, a carcinogenicity test (OPPTS 870.4200 test guideline) is recommended.

CFR citation: 40 CFR 721.10045.

PMN Number P-02-747

Chemical name: Polyaromatic amine phosphate (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a film additive. Based on structural analogy to soluble nonionic dyes and inorganic phosphates, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 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 other uses of the substance resulting in release to surface waters 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 a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10046.

PMN Number P-02-766

Chemical name: Polyphosphoric acids, compds. with piperazine.

CAS number: 383905-85-9.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a flame retardant. Based on analogy to aliphatic amines and inorganic phosphates, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 10 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters in significant quantities. Therefore, EPA has not determined that the proposed manufacturing or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10047.

PMN Number P-02-869

Chemical name: Substituted anthraquinone (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a site limited intermediate. Based on structural analogy to phenols, EPA is concerned that chronic toxicity to aquatic organisms may occur at concentrations above 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 above 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 a manufacture/importation volume greater than 4,500 kilograms/year may result in 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 a fish early life stage test (OPPTS 850.1400 test guideline (public draft)), a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10048.

PMN Number P-02-912

Chemical name: Phenol, 4,4′-cyclohexylidenebis[2-methyl-.

CAS number: 2362-14-3.

Basis for action: The PMN states that the substance will be used as a raw material. Based on structural analogy to phenols, EPA is concerned that chronic toxicity to aquatic organisms may occur at concentrations as low as 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface water. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any release of the PMN substance to surface water 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 a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)) and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10049.

PMN Number P-02-929

Chemical name: Disubstituted-N′- hydroxy-benzenecarboximidamide (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an intermediate. EPA has concerns for chronic toxicity to blood, kidney, and liver based on a submitted 28-day study. As described in the PMN, significant worker exposure is unlikely. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA determined, however, that use of the substance other than as an intermediate may result in exposures which may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i).

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

CFR citation: 40 CFR 721.10050.

PMN Number P-02-961

Chemical name: Spiro naphthoxazine (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. Based on structural analogy to neutral organic chemicals, EPA expects chronic toxicity to aquatic organisms at concentrations as low as 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters in significant quantities. 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 domestic manufacture of the substance 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 a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)) and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10051.

PMN Number P-02-1088

Chemical name: Aminoalkyl substituted alkylphenol (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be in a destructive use. Based on structural analogy to phenols and aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 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 or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10052.

PMN Number P-03-41

Chemical name: Alkyl silane methacrylate (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 structural analogy to methacrylates and esters, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 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 other uses of the substance resulting in release to surface waters 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 (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10053.

PMN Number P-03-43

Chemical name: Phenol, polymer with formaldehyde, 3-[(2-aminocyclohexyl)amino]-2-hydroxypropyl ethers.

CAS number: 452082-53-0.

Basis for action:

The PMN states that the generic (non-confidential) use of the substance will be as a resin component. Based on structural analogy to polycationic polymers, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 20 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters 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 an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), and a fish acute toxicity test mitigated by humic acid (OPPTS 850.1085 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10054.

PMN Number P-03-46

Chemical name: 1-Propanaminium, 3-amino-N-(carboxymethyl)-N, N-dimethyl-, N-soya acyl derivs., inner salts.

CAS number: 136504-87-5.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an oilfield foamer. EPA has identified health concerns for developmental toxicity, neurotoxicity, irritation and corrosion to skin and eyes, and lung effects based on analogy to similar quaternary compounds. As described in the PMN, significant inhalation exposure is unlikely. 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 other uses of the substance other than as described in the PMN may result in significant human exposure. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in rats or rabbits (OPPTS 870.3700 test guideline) and a repeated dose 28-day oral toxicity study in rats (OPPTS 870.3050 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10055.

PMN Number P-03-47

Chemical name: Benzenemethanaminium, N-(3-aminopropyl)-N, N-dimethyl-, N-soya acyl derivs., chlorides.

CAS number: 90194-13-1.

Basis for action: The PMN states that the generic (non-confidential) use of substance will be as an oilfield corrosion inhibitor. EPA has identified health concerns for developmental toxicity, neurotoxicity, lung effects, irritation to the lungs and mucous membranes, and severe eye irritation based on analogy to similar quaternary compounds. As described in the PMN, significant inhalation exposure is unlikely. 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 other uses of the substance other than as described in the PMN may result in significant human exposure. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in rats or rabbits (OPPTS 870.3700 test guideline) and a repeated dose 28-day oral toxicity study in rats (OPPTS 870.3050 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10056.

IV. Objectives and Rationale for this Rule

A. Rationale

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 13 of the 65 chemical substances, regulation was warranted under section 5(e) of TSCA, 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 III. 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 listed in this document are consistent with the provisions of the TSCA section 5(e) consent orders.

In the other 52 cases for which the proposed 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 40 CFR 721.170 were met, as discussed in Unit III.

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:

1. 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.

2. 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.

3. EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described significant new use of the chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7.

4. 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. Manufacturers, importers, and processors are responsible for ensuring that a new chemical substance subject to a final SNUR is listed on the TSCA Inventory.

V. Direct Final Procedures

EPA is issuing these SNURs as a direct final rule, as described in 40 CFR 721.160(c)(3) and 721.170(d)(4). In accordance with 40 CFR 721.160(c)(3)(ii) and 721.170(d)(4)(i), this rule will be effective May 29, 2007, unless EPA receives a written notice by April 30, 2007 of adverse or critical comments, or notice of intent to submit adverse or critical comments, on EPA's action. If EPA receives such a notice, EPA will publish a document to withdraw the direct final SNUR for the specific chemical substance to which the adverse or critical comments apply. EPA will then propose a SNUR for the specific chemical substance providing a 30-day comment period.

This action 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 a notice.

VI. Test Data and Other Information

EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. 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. 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 III. lists those tests. Unit III. also lists recommended testing for non-5(e) SNURs. Descriptions of recommended tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Many test guidelines are now available on the Internet at http://www.epa.gov/​opptsfrs/​home/​guidelin.htm.

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

The recommended tests may not be the only means of addressing the potential risks of the chemical substance. However, SNUNs submitted for significant new uses 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 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:

1. Human exposure and environmental release that may result from the significant new use of the chemical substances.

2. Potential benefits of the chemical substances.

3. Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

VII. Procedural Determinations

EPA is establishing through this rule certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2. EPA is required to keep this information confidential to protect the CBI of the original PMN submitter. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI. This procedure appears in 40 CFR 721.1725(b)(1) and is similar to that in § 721.11 for situations where the chemical identity of the chemical substance subject to a SNUR is CBI. This procedure is cross-referenced in each of the SNURs that include specific significant new uses that are CBI.

A manufacturer or importer may request EPA to determine whether a proposed use would be a significant new use under this rule. Under the procedure in § 721.1725(b)(1), a manufacturer or importer must show that it has a bona fide intent to manufacture or import the chemical substance and must identify the specific use for which it intends to manufacture or import the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or import 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 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 a manufacturer or importer is told that the production volume identified in the bona fide submission would not be a significant new use, i.e., it is below the level that would be a significant new use, that person can manufacture or import the chemical substance as long as the aggregate amount does not exceed that identified in the bona fide submission to EPA. 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. EPA is considering whether to adopt a special procedure for use when CBI production volume is designated as a significant new use. Under such a procedure, a person showing a bona fide intent to manufacture or import the chemical substance, under the procedure described in § 721.11, would automatically be informed of the production volume that would be a significant new use. Thus, the person would not have to make multiple bona fide submissions to EPA for the same chemical substance to remain in compliance with the SNUR, as could be the case under the procedures in § 721.1725(b)(1).

VIII. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule

To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have recently undergone premanufacture review. TSCA section 5(e) consent orders have been issued for 13 chemical substances and notice 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 has concluded that the uses are not ongoing. However, EPA recognizes in cases when chemical substances identified in this SNUR are added to the TSCA Inventory prior to the effective date of the rule, the chemical substances may be manufactured, imported, or processed by other persons for a significant new use as defined in this rule before the effective date of the rule. However, 35 of the 65 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 40 CFR 720.25 and 721.11), the Agency believes that it is highly unlikely that any of the significant new uses described in the following regulatory text are ongoing. EPA solicits comments on whether any of the uses described as significant new uses are ongoing.

As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA 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 final, and then argue that the use was ongoing as of the effective date of the final rule. Thus, persons who begin commercial manufacture, import, or processing of the chemical substances regulated through this SNUR will have to cease any such activity before the effective date of this rule. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires. EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under § 721.45(h), the person would be considered to have met the requirements of the final SNUR for those activities.

IX. SNUN Submissions

EPA recommends that submitters consult with the Agency prior to submitting a SNUN to discuss what data may be useful in evaluating a significant new use. Discussions with the Agency prior to submission can afford submitters ample time to conduct any tests that might be helpful in evaluating risks posed by the substance. According to 40 CFR 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 40 CFR 720.50.

SNUNs must be mailed to the Environmental Protection Agency, OPPT Document Control Office (7407M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Information must be submitted in the form and manner set forth in EPA Form No. 7710-25. This form is available from the Environmental Assistance Division (7408M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 (see 40 CFR 721.25 and 720.40). Forms and information are also available electronically at http://www.epa.gov/​opptintr/​newchems/​pubs/​pmnforms.htm.

X. Notification on Substances for Which Significant New Use Rules are Not Being Issued

As required in 40 CFR 721.160(a)(2), EPA is providing notification on the following two chemical substances that are subject to final TSCA section 5(e) consent orders but for which EPA has decided not to issue significant new use rules at this time. EPA is not publishing SNURs for PMNs P-02-193 and P-03-394 because they are subject to exposure-based consent orders. EPA's exposure-based policies for new chemical substances are based on TSCA section 5(e)(1)(A)(ii)(II) and are described on the New Chemicals website at http://www.epa.gov/​oppt/​newchems/​pubs/​expbased.htm. Exposure-based consent orders are based on two findings: 1) Insufficient information available on the health and environmental effects of the PMN substance, and 2) expected substantial production volume and significant or substantial human exposure and/or release to the environment. Exposure-based consent orders prohibit the submitter from exceeding a specific, aggregate production or import volume unless the submitter has conducted the fate, aquatic toxicity, and/or health effects testing specified in the order and submitted the results to EPA. The production or import volume limit is usually set so that it will occur within a few years. Therefore, instead of publishing and often revoking exposure-based SNURs within a short timespan, EPA generally defers publication of SNURs on substances subject to exposure-based consent orders until the test data are received. In many cases, data received through an exposure-based consent order confirm the Agency's prediction of low or no risk, so no further regulatory action is warranted.

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 public docket.

XII. Statutory and Executive Order Reviews

1. Executive Order 12866: Regulatory Planning and Review

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that a proposed or final SNUR is not a “significant regulatory action” subject to review by OMB, because it does not meet the criteria in section 3(f) of the Executive order.

2. 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 the 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.

The information collection requirements related to this action have already been approved by OMB pursuant to the 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.

3. Regulatory Flexibility Act

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is as follows. A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” By definition of the word “new,” and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activity. Since a SNUR only requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN, no economic impact will even occur until someone decides to engage in those activities. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of over 1,000 SNURs, the Agency receives on average only 10 notices per year. Of those SNUNs submitted, none appear to be from small entities in response to any SNUR. In addition, the estimated reporting cost for submission of a SNUN (see Unit IX.), is minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impact of complying with this SNUR is not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published on June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented it's general determination that proposed and final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

4. 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 reason to believe that any State, local, or Tribal government will be impacted by this rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

5. Executive Order 13132: Federalism

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).

6. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments

This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This does not significantly or 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 6, 2000), do not apply to this rule.

7. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks

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.

8. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use

This rule 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.

9. National Technology Transfer 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.

10. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations

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).

11. Executive Order 12630: Governmental Actions and Interference with Constitutionally Protected Property Rights (Takings)

EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive order.

12. Executive Order 12988: Civil Justice Reform

In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996).

13. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a final rule may take effect, the Agency promulgating the final rule must submit a final rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this final 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 this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

• Environmental protection
• Chemicals
• Hazardous substances
• Reporting and recordkeeping requirements

Dated: March 22, 2007.

Charles M. Auer,

Director, Office of Pollution Prevention and Toxics.

Therefore, 40 CFR part 721 is amended as follows:

PART 721—[AMENDED]

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

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

2. By adding new § 721.10002 to subpart E to read as follows:

§ 721.10002

2-Thiazolidinone.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-thiazolidinone (PMN P-97-415; CAS No. 2682-49-7) 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), (a)(4), (a)(6)(i), (b), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-approved respirators with an assigned protection factor (APF) of 10-25 meet the minimum requirements for § 721.63(a)(4): Air-purifying, tight-fitting respirator (either half- or full-face) equipped with N100 (if aerosols absent), R100, or P100 filters; powered air-purifying respirator equipped with a loose-fitting hood or helmet and High Efficiency Particulate Air (HEPA) filters; powered air-purifying respirator equipped with a tight-fitting facepiece (either half- or full-face) and HEPA filters; and supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight-fitting facepiece (either half- or full-face). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.7 mg/m³ as an 8-hour time-weighted average. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under 40 CFR 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order.

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv) (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.7 mg/m³), (g)(2)(v), (g)(3)(ii), (g)(4)(i), (g)(4)(ii), (g)(4)(iii), and (g)(5). The following statement shall appear on each label as specified in § 721.72(b) and the Material Safety Data Sheet (MSDS) as specified in § 721.72(c). The substance may cause severe eye irritation. The substance may cause internal organ effects (blood, liver, and kidney). The substance may cause developmental/maternal effects. When handling this substance as a powder, use respiratory protection.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (g), (p) (300,000 kilograms), (v)(1), (w)(1), and (x)(1).

(iv) Disposal. Requirements as specified in § 721.85 (a)(1), (a)(2), (a)(3), (b)(1), (b)(2), (b)(3), (c)(1), (c)(2), and (c)(3).

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

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), (j), 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. By adding new § 721.10003 to subpart E to read as follows:

§ 721.10003

Manganese heterocyclic tetraamine complex (generic).

(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as manganese heterocyclic tetraamine complex (PMNs P-98-625/626/627/628/629 and P-00-614/617) 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) (10,000 kilograms per chemical substance).

(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.

4. By adding new § 721.10004 to subpart E to read as follows:

§ 721.10004

2-Butenoic acid, 4,4′-[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2′Z)-, di-C_8-10-isoalkyl esters, C₉-rich.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-butenoic acid, 4,4′-[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2′Z)-, di-C_8-10-isoalkyl esters, C₉-rich (PMN P-98-1181; CAS No. 247041-56-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

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

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

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

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

5. By adding new § 721.10005 to subpart E to read as follows:

§ 721.10005

2-Butenoic acid, 4,4′-[(dibutylstannylene)bis(oxy)]bis [4-oxo-, (2Z,2′Z)-, di-C_9-11-isoalkyl esters, C₁₀-rich.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-butenoic acid, 4 ,4′-[(dibutylstannylene)bis(oxy)]bis [4-oxo-, (2Z,2′Z)-, di-C_9-11-isoalkyl esters, C₁₀-rich (PMN P-98-1182) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

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

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

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

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

6. By adding new § 721.10006 to subpart E to read as follows:

§ 721.10006

Mixed metal oxide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxide (PMN P-99-511) is subject to 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) (60,000 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.

7. By adding new § 721.10007 to subpart E to read as follows:

§ 721.10007

Alcohols, C_12-14- secondary, ethoxylated propoxylated.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alcohols, C_12-14- secondary, ethoxylated propoxylated (PMN P-00-11; CAS No. 103331-86-8) 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 = 50).

(ii) [Reserved]

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

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

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

8. By adding new § 721.10008 to subpart E to read as follows:

§ 721.10008

Manganese strontium oxide (MnSrO₃).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as manganese strontium oxide (MnSrO₃) (PMN P-00-1121; CAS No. 12163-45-0) 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) 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)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (k) (manufacture, processing, or use of the PMN substance if the particle size is less than 10 microns) and (q).

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

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

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

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

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

9. By adding new § 721.10009 to subpart E to read as follows:

§ 721.10009

Manganese yttrium oxide (MnYO₃).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as manganese yttrium oxide (MnYO₃) (PMN P-00-1122; CAS No. 12032-75-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) 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)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (k) (manufacture, processing, or use of the PMN substance if the particle size is less than 10 microns) and (q).

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

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

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

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

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

10. By adding new § 721.10010 to subpart E to read as follows:

§ 721.10010

Barium manganese oxide (BaMnO₃).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as barium manganese oxide (BaMnO₃) (PMN P-00-1123; CAS No. 12230-80-7) 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) 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)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (k) (manufacture, processing, or use of the PMN substance if the particle size is less than 10 microns) and (q).

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

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

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

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

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

11. By adding new § 721.10011 to subpart E to read as follows:

§ 721.10011

Barium calcium manganese strontium oxide.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as barium calcium manganese strontium oxide (PMN P-00-1124; CAS No. 359427-90-0) 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) 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)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (k) (manufacture, processing, or use of the PMN substance if the particle size is less than 10 microns) and (q).

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

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

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

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

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

12. By adding new § 721.10012 to subpart E to read as follows:

§ 721.10012

Manganate (MnO₂^1-), calcium (2:1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as manganate (MnO₂^1-), calcium (2:1) (PMN P-00-1125; CAS No. 12049-47-7) 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) 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)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (k) (manufacture, processing, or use of the PMN substance if the particle size is less than 10 microns) and (q).

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

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

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

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

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

13. By adding new § 721.10013 to subpart E to read as follows:

§ 721.10013

Manganese yttrium oxide (Mn₂ YO₅).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as manganese yttrium oxide (Mn₂ YO₅) (PMN P-00-1126; CAS No. 12438-71-0) 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) 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)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (k) (manufacture, processing, or use of the PMN substance if the particle size is less than 10 microns) and (q).

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

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

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

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

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

14. By adding new § 721.10014 to subpart E to read as follows:

§ 721.10014

Halogenated naphthalic anhydride (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halogenated naphthalic anhydride (PMN P-01-109) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

15. By adding new § 721.10015 to subpart E to read as follows:

§ 721.10015

Halogenated benzimidazole (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halogenated benzimidazole (PMN P-01-110) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

16. By adding new § 721.10016 to subpart E to read as follows:

§ 721.10016

Dibenzimidazothianaphthalene (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dibenzimidazothianaphthalene (PMN P-01-111) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

17. By adding new § 721.10017 to subpart E to read as follows:

§ 721.10017

Amine terminated bisphenol A diglycidyl ether polymer (generic).

(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as amine terminated bisphenol A diglycidyl ether polymer (PMNs P-01-257/258/259 and P-01-261) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

18. By adding new § 721.10018 to subpart E to read as follows:

§ 721.10018

Calcium hydroxide oxide silicate (Ca₆ (OH)₂ O₂ (Si₂ O₅)₃).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as calcium hydroxide oxide silicate (Ca₆ (OH)₂ O₂ (Si₂ O₅)₃) (PMN P-01-442; CAS No. 13169-90-9) 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 (f), (j) (use other than as filler to reinforce resins, additive for resins, and filter medium), (v)(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.

19. By adding new § 721.10019 to subpart E to read as follows:

§ 721.10019

Benzoic acid, 2-chloro-5-nitro-, 1,1-dimethyl-2-oxo-2-(2-propenyloxy) ethyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzoic acid, 2-chloro-5-nitro-, 1,1-dimethyl-2-oxo-2-(2-propenyloxy) ethyl ester (PMN P-01-563; CAS No. 174489-76-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

20. By adding new § 721.10020 to subpart E to read as follows:

§ 721.10020

Benzoic acid, 5-amino-2-chloro-, 1,1-dimethyl-2-oxo-2-(2-propenyloxy) ethyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzoic acid, 5-amino-2-chloro-, 1,1-dimethyl-2-oxo-2-(2-propenyloxy) ethyl ester (PMN P-01-564; CAS No. 174489-43-1) 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 § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

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

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

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

21. By adding new § 721.10021 to subpart E to read as follows:

§ 721.10021

Magnesium potassium titanium oxide.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as magnesium potassium titanium oxide (PMN P-01-764; CAS No. 39290-90-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (b) (concentration set at 0.1 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-approved respirators with an assigned protection factor (APF) of 10-25 meet the minimum requirements for § 721.63(a)(4): Air-purifying, tight-fitting respirator equipped with N100 (if aerosols absent), R100, or P100 filters (either half- or full-face); powered air-purifying respirator equipped with a loose-fitting hood or helmet and High Efficiency Particulate Air (HEPA) filters; powered air-purifying respirator equipped with a tight-fitting facepiece (either half- or full-face) and HEPA filters; and supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight-fitting facepiece (either half- or full-face). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 5 mg/m³ as an 8-hour time-weighted average. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under 40 CFR 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order.

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set 0.1 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 5 mg/m³) 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), (b), (c), (d), (f), (g), (h), and (i) are applicable to manufacturers, importers, and processors of this substance.

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

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

22. By adding new § 721.10022 to subpart E to read as follows:

§ 721.10022

Benzenamine, N-phenyl-, ar′-(C₉-rich C_8-10-branched alkyl) derivs.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzenamine, N-phenyl-, ar′-(C₉-rich C_8-10-branched alkyl) derivs (PMN P-01-769; CAS No. 333955-69-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

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

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

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

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

23. By adding new § 721.10023 to subpart E to read as follows:

§ 721.10023

Benzenamine, N-phenyl-, ar ar′-(C₉-rich C_8-10-branched alkyl) derivs.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzenamine, N-phenyl-, ar,ar′-(C₉-rich C_8-10-branched alkyl) derivs (PMN P-01-770; CAS No. 333955-70-7) 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) (antioxidant for lubricating oils).

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

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

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

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

24. By adding new § 721.10024 to subpart E to read as follows:

§ 721.10024

10H-Phenothiazine, ar-(C₉-rich C_8-10-branched alkyl) derivs.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 10H-phenothiazine, ar-(C₉-rich C_8-10-branched alkyl) derivs (PMN P-01-771; CAS No. 333955-79-6) 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) (antioxidant for lubricating oils).

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

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

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

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

25. By adding new § 721.10025 to subpart E to read as follows:

§ 721.10025

10H-Phenothiazine, ar, ar′-(C₉-rich C_8-10-branched alkyl) derivs.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified as 10H-phenothiazine, ar, ar′-(C₉-rich C_8-10-branched alkyl) derivs (PMN P-01-772; CAS No. 333955-80-9) 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) (antioxidant for lubricating oils).

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

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

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

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

26. By adding new § 721.10026 to subpart E to read as follows:

§ 721.10026

Cashew, nutshell liq., ethoxylated.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cashew, nutshell liq., ethoxylated (PMN P-01-856; CAS No. 350820-95-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (any manufacturing, processing, or use of the PMN substance with less than 55 moles of the ethoxy or with an average molecular weight less than 2,700 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.

27. By adding new § 721.10027 to subpart E to read as follows:

§ 721.10027

Ethoxylated alkylsulfate, substituted alkylamine salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ethoxylated alkylsulfate, substituted alkylamine salt (PMN P-01-862) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

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

28. By adding new § 721.10028 to subpart E to read as follows:

§ 721.10028

Disubstituted benzene metal salts (generic).

(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as disubstituted benzene metal salts (PMNs P-01-901 and P-01-902) 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) and (a)(3).

(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), (b), (c), (d), (e), and (i) are applicable to manufacturers, importers, and processors of this substance.

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

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

29. By adding new § 721.10029 to subpart E to read as follows:

§ 721.10029

Isocyanate compound, modified with methoxysilane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanate compound, modified with methoxysilane (PMN P-01-918) is subject to 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)(ii), (a)(2)(iii), (a)(2)(iv), (a)(3), (a)(4), and (a)(6). The following National Institute for Occupational Safety and Health (NIOSH)-approved respirators meet the minimum requirement for § 721.63(a)(4): Air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters; powered air-purifying respirator equipped with a tight-fitting full facepiece and High Efficiency Particulate Air (HEPA) filters; supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a tight-fitting full facepiece. As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.05 mg/m³ as an 8-hour time-weighted average. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under 40 CFR 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order.

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv) (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.05 mg/m³), (g)(2)(v), and (g)(5). The following statements shall appear on each label as specified in § 721.72(b) and the Material Safety Data Sheet (MSDS) as specified in § 721.72(c): This substance may cause skin irritation and sensitization.

(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), (b), (c), (d), (e), (f), (g), (h), and (i) are applicable to manufacturers, importers, and processors of this substance.

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

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

30. By adding new § 721.10030 to subpart E to read as follows:

§ 721.10030

Pyrimido[5,4-g]pteridine-2,4,6,8-tetramine, 4-methylbenzenesulfonate, base-hydrolyzed.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as pyrimido[5,4-g]pteridine-2,4,6,8-tetramine, 4-methylbenzenesulfonate, base-hydrolyzed (PMN P-01-919; CAS No. 346709-25-9) 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(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.

31. By adding new § 721.10031 to subpart E to read as follows:

§ 721.10031

Lithium potassium titanium oxide.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as lithium potassium titanium oxide (PMN P-02-214; CAS No. 39318-30-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (b) (concentration set at 0.1 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-approved respirators with an APF of 10-25 meet the minimum requirements for § 721.63(a)(4): Air-purifying, tight-fitting respirator (either half- or full-face) equipped with N100 (if aerosols absent), R100, or P100 filters; powered air-purifying, respirator equipped with a loose-fitting hood or helmet or tight-fitting facepiece (either half- or full-face) and High Efficiency Particulate Air (HEPA) filters; and supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight-fitting facepiece (either half- or full-face). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 5 mg/m³ as an 8-hour time-weighted average. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under 40 CFR 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order.

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set 0.1 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 5 mg/m³), 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), (b), (c), (d), (f), (g), (h), and (i) are applicable to manufacturers, importers, and processors of this substance.

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

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

32. By adding new § 721.10032 to subpart E to read as follows:

§ 721.10032

Acrylic acid, polymer with substituted acrylamides (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acrylic acid, polymer with substituted acrylamides (PMN P-02-269) is subject to 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) (any manufacturing, processing, or use of the PMN substance with an aerodynamic diameter less than 10 microns).

(ii) [Reserved]

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

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

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

33. By adding new § 721.10033 to subpart E to read as follows:

§ 721.10033

Zinc, [ethanedioato(2-)-. kappa. O¹, . kappa. O²]-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as zinc, [ethanedioato(2-)-. kappa. O¹, . kappa. O²]- (PMN P-02-322; CAS No. 547-68-2) 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 § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(ii) [Reserved]

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

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

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

34. By adding new § 721.10034 to subpart E to read as follows:

§ 721.10034

Substituted pyridine coupled with diazotized substituted nitrobenzonitrile, diazotized substituted benzenamine and substituted pyridinecarbonitrile (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted pyridine coupled with diazotized substituted nitrobenzonitrile, diazotized substituted benzenamine and substituted pyridinecarbonitrile (PMN P-02-359) is subject to 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 § 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. By adding new § 721.10035 to subpart E to read as follows:

§ 721.10035

Alkylbenzene sulfonate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylbenzene sulfonate (PMN-02-382) is subject to 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, import, or processing of the chemical without 19 percent or more mineral oil as a diluent).

(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.

36. By adding new § 721.10036 to subpart E to read as follows:

§ 721.10036

Acetaldehyde based polymer (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acetaldehyde based polymer (PMN P-02-406) is subject to 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) Release to water. Requirements as specified § 721.90 (b)(1) and (c)(1).

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

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

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

37. By adding new § 721.10037 to subpart E to read as follows:

§ 721.10037

Complex halogenated salt of tris(ethylatedaminocarbocyclic)methane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as complex halogenated salt of tris(ethylatedaminocarbocyclic)methane (PMN P-02-423) is subject to 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 (d) and (e).

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

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

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

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

38. By adding new § 721.10038 to subpart E to read as follows:

§ 721.10038

Trimellitic anhydride, polymer with substituted glycol, alkyl phenols and ethoxylated nonylphenol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as trimellitic anhydride, polymer with substituted glycol, alkyl phenols and ethoxylated nonylphenol (PMN P-02-434) is subject to 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 § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

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

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

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

39. By adding new § 721.10039 to subpart E to read as follows:

§ 721.10039

Diethoxybenzenamine derivative, diazotized, coupled with aminonaphthalenesulfonic acid derivative, ammonium salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a diethoxybenzenamine derivative, diazotized, coupled with aminonaphthalenesulfonic acid derivative, ammonium salt (PMN P-02-514) is subject to 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.

40. By adding new § 721.10040 to subpart E to read as follows:

§ 721.10040

Substituted acridine naphtha substituted benzamide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a substituted acridine naphtha substituted benzamide (PMN P-02-522) is subject to 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 § 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.

41. By adding new § 721.10041 to subpart E to read as follows:

§ 721.10041

1-Butanone, 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(4-morpholinyl)phenyl]-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-butanone, 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(4-morpholinyl)phenyl]-(PMN P-02-530; CAS No. 119344-86-4) 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).

(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.

42. By adding new § 721.10042 to subpart E to read as follows:

§ 721.10042

2-Propanol, 1-[bis(2-hydroxyethyl)amino]-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propanol, 1-[bis(2-hydroxyethyl)amino]- (PMN P-02-585; CAS No. 6712-98-7) 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).

(ii) [Reserved]

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

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

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

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

43. By adding new § 721.10043 to subpart E to read as follows:

§ 721.10043

Dineopentyl-4-substituted phthalate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dineopentyl-4-substituted phthalate (PMN P-02-697) is subject to 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 § 721.90 (a)(1), (b)(1), and (c)(1).

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

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

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

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

44. By adding new § 721.10044 to subpart E to read as follows:

§ 721.10044

Metal oxide, modified with alkyl and vinyl terminated polysiloxanes (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as metal oxide, modified with alkyl and vinyl terminated polysiloxanes (PMN P-02-698) is subject to 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.

45. By adding new § 721.10045 to subpart E to read as follows:

§ 721.10045

Diazotized substituted heteromonocycle coupled with naphthalene sulfonic acid derivative, nickel complex, alkaline salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a diazotized substituted heteromonocycle coupled with naphthalene sulfonic acid derivative, nickel complex, alkaline salt (PMN P-02-737) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) 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.

46. By adding new § 721.10046 to subpart E to read as follows:

§ 721.10046

Polyaromatic amine phosphate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyaromatic amine phosphate (PMN P-02-747) is subject to 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 § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

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

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

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

47. By adding new § 721.10047 to subpart E to read as follows:

§ 721.10047

Polyphosphoric acids, compds. with piperazine.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a polyphosphoric acids, compds. with piperazine (PMN P-02-766; CAS No. 383905-85-9) 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 this section.

48. By adding new § 721.10048 to subpart E to read as follows:

§ 721.10048

Substituted anthraquinone (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted anthraquinone (PMN P-02-869) is subject to 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) (4,500 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.

49. By adding new § 721.10049 to subpart E to read as follows:

§ 721.10049

Phenol, 4,4′- cyclohexylidene bis[2-methyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a phenol, 4,4′- cyclohexylidene bis[2-methyl- (PMN P-02-912; CAS No. 2362-14-3) 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) Release to water. Requirements as specified § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

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

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

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

50. By adding new § 721.10050 to subpart E to read as follows:

§ 721.10050

Disubstituted-N′- hydroxy-benzenecarboximidamide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as disubstituted-N′- hydroxy-benzenecarboximidamide (PMN P-02-929) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

51. By adding new § 721.10051 to subpart E to read as follows:

§ 721.10051

Spiro naphthoxazine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as spiro naphthoxazine (PMN P-02-961) is subject to 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.

52. By adding new § 721.10052 to subpart E to read as follows:

§ 721.10052

Aminoalkyl substituted alkylphenol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aminoalkyl substituted alkylphenol (PMN P-02-1088) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

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

53. By adding new § 721.10053 to subpart E to read as follows:

§ 721.10053

Alkyl silane methacrylate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl silane methacrylate (PMN P-03-41) is subject to 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 § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

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

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

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

54. By adding new § 721.10054 to subpart E to read as follows:

§ 721.10054

Phenol, polymer with formaldehyde, 3-[(2-aminocyclohexyl)amino]-2-hydroxypropyl ethers.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a phenol, polymer with formaldehyde, 3-[(2-aminocyclohexyl)amino]-2-hydroxypropyl ethers (PMN P-03-43; CAS No. 452082-53-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

55. By adding new § 721.10055 to subpart E to read as follows:

§ 721.10055

1-Propanaminium, 3-amino-N-(carboxymethyl)-N, N-dimethyl-, N-soya 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-(carboxymethyl)-N, N-dimethyl-, N-soya acyl derivs., inner salts (PMN P-03-46; CAS No. 136504-87-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

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

56. By adding new § 721.10056 to subpart E to read as follows:

§ 721.10056

Benzenemethanaminium, N-(3-aminopropyl)-N, N-dimethyl-, N-soya acyl derivs., chlorides.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzenemethanaminium, N-(3-aminopropyl)-N, N-dimethyl-, N-soya acyl derivs., chlorides (PMN P-03-47; CAS No. 90194-13-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

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

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

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

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