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Rule

Significant New Uses of Certain Chemical Substances

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 40 chemical substances which were the subject of premanufacture notices (PMNs) and subject to TSCA section 5(e) consent orders issued by EPA. Today's action requires persons who intend to manufacture, import, or process these substances for a significant new use to notify EPA at least 90 days before commencing the manufacturing or processing of the substance for a use designated by this rule as a significant new use. The required notice will provide EPA with the opportunity to evaluate the intended use, and if necessary, to prohibit or limit that activity before it occurs to prevent any unreasonable risk of injury to human health or the environment. EPA is promulgating this SNUR using direct final procedures.

DATES:

The effective date of this rule is February 26, 2001 without further notice, unless EPA receives adverse comment or notice of intent to submit adverse comment before January 25, 2001. This rule shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on January 9, 2001.

If EPA receives adverse comment or notice before January 25, 2001 that someone wishes to submit adverse or critical comments on EPA's action in establishing a significant new use rule (SNUR) for one or more of the chemical substances subject to this rule, EPA will withdraw the SNUR before the effective date for the substance for which the comment or notice of intent to comment is received and will issue a proposed SNUR providing a 30-day period for public comment.

ADDRESSES:

Comments or notice of intent to submit adverse or critical comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-50638 in the subject line on the first page of your response.

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FOR FURTHER INFORMATION CONTACT:

For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.

For technical information contact: James Alwood , Chemical Control Division (7405), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 260-1857; e-mail address: alwood.jim@epa.gov.

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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 categories and entities may include, but are not limited to:

CategoriesNAICS codesExamples of potentially affected entities
Chemical manufacturers325Manufacturers, importers, processors, and users of chemicals
Petroleum and coal product industries324Manufacturers, importers, processors, and users of chemicals

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 the table 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 or not this action applies to certain entities. To determine whether you or your business is affected by this action, you should carefully examine the applicability provisions in title 40 of the Code of Federal Regulations (CFR) at 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.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. You may also obtain copies of the notice of availability documents for the 850 (62 FR 16486, April 15, l996) (FRL-5363-1) and 870 (63 FR 41845, August 5, l998) (FRL-5740-1) series OPPTS harmonized test guidelines at this same site. To access these documents, on the Home Page, select “Laws and Regulations,” “Regulations and Proposed Rules,” and Start Printed Page 81387then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​. The OPPTS harmonized test guidelines referenced in this document are available on EPA's Internet Home Page at http://www.epa.gov/​opptsfrs/​home/​guidelin.htm.

2. In person. The Agency has established an official record for this action under docket control number OPPTS-50638. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260-7099.

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-50638 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: OPPT Document Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 260-7093.

3. Electronically. You may submit your comments electronically by e-mail to: oppt.ncic@epa.gov, or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments will also be accepted on standard disks in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-50638. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

We invite you to provide your views on the various options we propose, new approaches we haven't considered, the potential impacts of the various options (including possible unintended consequences), and any data or information that you would like the Agency to consider during the development of the final action. You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the rule.

7. Make sure to submit your comments by the deadline in this document.

8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Background

A. What Action is the Agency Taking?

This SNUR will require persons to notify EPA at least 90 days before commencing manufacturing, importing, or processing a substance for any activity designated by this SNUR as a significant new use. The supporting 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 the rules 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 section 5(a)(2) of TSCA. Once EPA determines that a use of a chemical substance is a significant new use, section 5(a)(1)(B) of TSCA requires persons to submit a notice to EPA at least 90 days before they manufacture, import, or process the substance for that use. The mechanism for reporting under this requirement is established under 40 CFR 721.5.

C. Applicability of General Provisions

General provisions for SNURs appear under subpart A of 40 CFR part 721. 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. Persons subject to this SNUR must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under section 5(a)(1)(A) of TSCA. In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section Start Printed Page 813885 (h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUR notice, 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 SNUR notice. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

Persons who intend to export a 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. Persons who intend to import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, which are codified at 19 CFR 12.118 through 12.127 and 127.28. Such persons must certify that they are in compliance with SNUR requirements. The EPA policy in support of the import certification appears at 40 CFR part 707.

III. Substances Subject to this Rule

EPA is establishing significant new use and recordkeeping requirements for the following chemical substances under 40 CFR part 721, subpart E. In this unit, EPA provides a brief description for each substance, including its 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 action taken by EPA in the TSCA section 5(e) consent order or as a non-section 5(e) SNUR for the substance (including the statutory citation and specific finding), toxicity concern, and the CFR citation assigned in the regulatory text section of this rule. The specific uses which are designated as significant new uses are cited in the regulatory text section of this document by reference to 40 CFR part 721, subpart E where the significant new uses are described in detail. 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.

Where the underlying TSCA section 5(e) consent order prohibits the PMN submitter from exceeding a specified production limit without performing specific tests to determine the health or environmental effects of a substance, the tests are described in this unit. As explained further in Unit VI., the SNUR for such substances contains the same production limit, and exceeding the production limit is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a significant new use notice (SNUN) at least 90 days in advance. In addition, this unit describes tests that are recommended by EPA to provide sufficient information to evaluate the substance, but for which no production limit has been established in the TSCA section 5(e) consent order. Descriptions of recommended tests are provided for informational purposes.

Data on potential exposures or releases of the substances, testing other than that specified in the TSCA section 5(e) consent order for the substances, or studies on analogous substances, which may demonstrate that the significant new uses being reported do not present an unreasonable risk, may be included with significant new use notification. Persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs, as stated in 40 CFR 721.1(c), including submission of test data on health and environmental effects as described in 40 CFR 720.50.

EPA is not publishing SNURs for PMNs P-98-487, P-98-496, P-98-1033/1034/1035, P-99-31/32/33/34, P-99-531, P-99-519/522/593/594, P-99-544/545/546/547/548/583/584/585/ 586/587/588, P-99-703, and P-99-1131/1132/1133/1134/1135/1138, which are subject to a final TSCA section 5(e) consent order. The TSCA section 5(e) consent orders for these substances are derived from an exposure finding based solely on substantial production volume and significant or substantial human exposure and/or release to the environment of substantial quantities. For these cases there were limited or no toxicity data available for the PMN substances. In such cases, EPA regulates the new chemical substances under TSCA section 5(e) by requiring certain toxicity tests. For instance, chemical substances with potentially substantial releases to surface waters would be subject to toxicity testing of aquatic organisms and chemicals with potentially substantial human exposures would be subject to health effects testing for mutagenicity, acute effects, and subchronic effects. However, for these substances, the short-term toxicity testing required by the TSCA section 5(e) consent order is usually completed within 1 to 2 years of notice of commencement (NOC). EPA's experience with exposure-based SNURs requiring short-term testing is that the SNUR is often revoked within 1 to 2 years when the test results are received. Rather than issue and revoke SNURs in such a short span of time, EPA will defer publication of exposure-based SNURs until either a NOC or data demonstrating risk are received unless the toxicity testing required is long-term. EPA is issuing this explanation and notification as required in 40 CFR 721.160(a)(2) as it has determined that SNURs are not needed at this time for these substances which are subject to a final section 5(e) consent order under TSCA.

PMN Number P-97-0766

Chemical name: (generic) Tetrahydrohetero polycycle.

CAS number: Not available.

Effective date of section 5(e) consent order: January 29, 1999.

Basis for section 5(e) consent order: The order was issued under section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health.

Toxicity concern: Based on data on structural analogues, the substance may cause mutagenicity and carcinogenicity to workers who are exposed by either inhalation or dermal route.

Recommended testing: EPA has determined that a Mitogenicity Assay for rats via gavage based on the consent order guidelines and a 2-year, two-species oral carcinogenicity study (40 CFR 798.3300 or OPPTS 870.4200 test guideline) would help to characterize the human health effects of the PMN substance. The PMN submitter has agreed not to exceed the production volume limit without performing the Mitogenicity Assay.

CFR citation: 40 CFR 721.6479.

PMN Number P-97-0916

Chemical name: (generic) 4,4'-(1-methylethylidene)bisphenol, polymer with (chloromethyl)oxirane and a diamine.

CAS number: Not available. Effective date of section 5(e) consent order: March 30, 1999.

Basis for section 5(e) consent order: The order was issued under section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to the environment.

Toxicity concern: Based on test data submitted on the PMN substance, the concentration of concern for the PMN substance is 2 parts per billion (ppb) for daphnids and 8 ppb for fish.

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

Tier I: A daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1330 test guideline (public draft)). If test chemical shows no effects at saturation, Start Printed Page 81389then no further testing is required. If the test chemical shows chronic toxicity toward daphnids, then proceed to next tier.

Tier II: A chronic fish early life stage toxicity test in rainbow trout (40 CFR CFR 797.1600 or OPPTS 850.1400 test guideline (public draft)).

CFR citation: 40 CFR 721.5585.

PMN Number P-98-0002

Chemical name: (generic) Mixed metal oxides.

CAS number: Not available.

Effective date of section 5(e) consent order: April 29, l999.

Basis for action: The order was issued under section 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health.

Toxicity concern: Based on test data on structural analogues, the PMN substance may pose a risk of lung toxicity or fibrosis, developmental toxicity, or carcinogenicity through inhalation or ingestion of the PMN substance.

Recommended testing: EPA has determined that a 90-day subchronic inhalation study in rats (40 CFR 798.2450 or OPPTS 870.3465 test guideline) and a 2-year, two-species oral carcinogenicity test (40 CFR 798.3300 or OPPTS 870.4200 test guideline) would help to characterize the human health concerns. The consent order contains a production volume limit. The PMN submitter has agreed not to exceed the production volume limit without performing the 90-day oral subchronic toxicity test.

CFR citation: 40 CFR 721.4610.

PMN Number P-98-0903

Chemical name: (generic) Polyalkylene glycol polyamide ester phosphate.

CAS number: Not available.

Basis for action: The PMN substance will be used as a coating additive. Based on structural analogy to anionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 60 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and 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 study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)); a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.6180.

PMN Number P-98-1016

Chemical name: (generic) Polymer of polyalkylenepolyol and trisubstituted phenol.

CAS number: Not available.

Basis for action: The PMN substance will be used as an emulsifying component for adhesive resin. Based on structural analogy to alkyl ethoxylated nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 10 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the PMN substance is not released to surface water above 10 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and 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 above 10 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)); a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.6515.

PMN Numbers P-98-1274 and P-98-1275

Chemical names: (generic) (P-98-1274) Silicoaluminophosphates compd. with organic amine; (P-98-1275) Aluminosilicates, phospho-.

CAS numbers: Not available for (P-98-1274); for (P-98-1275) it is 201167-69-3.

Effective date of section 5(e) consent order: May 4, 1999.

Basis for section 5(e) consent order: The order was issued under section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a finding that these substances may present an unreasonable risk of injury to human health.

Toxicity concern: Structurally similar chemicals have been shown to cause lung effects and cancer in humans and test animals.

Recommended testing: EPA has determined that a 90-day subchronic inhalation toxicity study in rats (40 CFR 798.2450 or OPPTS 870.3465 test guideline) with special attention to lung tissues and histopathology of the lung tissues and a 2-year, two-species oral carcinogenicity study (40 CFR 798.3300 or OPPTS 870.4200 test guideline) would help to characterize the human health effects of the substances. The PMN submitter has agreed not to exceed the production volume limit without performing the 90 day inhalation toxicity test on P-98-1275.

CFR citations: 40 CFR 721.632 (P-98-1274) and 40 CFR 721.633 (P-98-1275).

PMN Number P-99-0026

Chemical name: Cerium, hydroxy oleate propionate complexes.

CAS number: Not available.

Basis for action: The PMN substance will be used as a fuel oil/diesel additive. Based on structural analogy to lanthanides or rare earth metals, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 7 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the substance is not released to surface waters above 7 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and 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 above 7 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)); a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.8657.

PMN Number P-99-0052

Chemical name: (generic) Hydrofluoric acid, reaction products with octane.

CAS number: Not available.

Basis for action: The PMN substance will be used as a chemical intermediate. Based on structural analogy to neutral Start Printed Page 81390organics, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 400 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and 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 study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.4461.

PMN Number P-99-0093

Chemical name: 1,4-Dioxa-7,9-dithia-8-stannacycloundecane-5,11-dione, 8,8- dioctyl-.

CAS number: 56875-68-4.

Basis for action: The PMN substance will be used as an additive for plastic. EPA has identified health concerns for neurotoxicity and immunotoxicity based on organotin compounds. Since significant worker exposure is unlikely when used, as described in the PMN, EPA has not determined that proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance could result in exposures that may cause serious health effects. Also, based on organotin data, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 6 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and 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)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance. EPA has determined that a 90-day oral subchronic study in rodents (40 CFR 798.2650 or OPPTS 870.3100 test guideline) would help to characterize the human health effects.

CFR citation: 40 CFR 721.9535.

PMN Number P-99-0114

Chemical name: Chromate (5-), bis[4-hydroxy-7-[(2-hydroxy-1- naphthalenyl)azo]-3-[(2-hydroxy-3-nitro-5-sulfophenyl)azo]-2- naphthalenesulfonato(4-)]-, pentasodium.

CAS number: 159574-72-8.

Basis for action: The PMN substance will be used as an acid dye for dyeing leather. EPA has identified health concerns for skin sensitization and blood toxicity based on submitted test data; and concerns for developmental toxicity, reproductive toxicity and carcinogenicity based on data for structurally similar substances. Since significant worker exposure is unlikely because it would not be manufactured, processed, or used as a powder, EPA has not determined that manufacturing, processing, or use of the substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that manufacturing, processing, or use of the substance as a powder may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(B), (b)(3)(i), and (b)(3)(ii) .

Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in two-species (40 CFR 799.9370) and a 2-year, two-species oral carcinogenicity study (40 CFR 798.3300) or 870.4200 test guideline)) would help to characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.5284.

PMN Number P-99-0115

Chemical name: (generic) Aminoester of polyalkenylated alkyldicarboxylic acid.

CAS number: Not available.

Basis for action: The PMN substance will be used as an emulsifier. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 30 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and 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 study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.480.

PMN Numbers P-99-0143/0144/0145/0146

Chemical names: (generic) (P-99-0143) Dimer acid/rosin amidoamine reaction product; (generic) (P-99-0144) Dimer acid/polymerized rosin amidoamine reaction product; (generic) (P-99-0145) Rosin amidoamine, and (generic) (P-99-0146) Polymerized rosin amidoamine.

CAS numbers: Not available.

Basis for action: The PMN substances will be used as described in the PMN. Based on structural analogy to aliphatic amines, EPA is concerned that effects to the aquatic environment may occur at a concentration as low as 40 ppb of the PMN substances in surface waters. Since significant environmental exposure is unlikely, as the substances are not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and 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 a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public Start Printed Page 81391draft)) would help to characterize the environmental effects of the PMN substances.

CFR citations: 40 CFR 721.9484 (P-99-0143), 40 CFR 721.9485 (P-99-0144), 40 CFR 721.9486 (P-99-0145), and 40 CFR 721.9487 (P-99-0146).

PMN Number P-99-0157

Chemical name: (generic) Ethyl silicate, reaction products with modified alkoxysilane salt.

CAS number: Not available.

Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to aliphatic amines and inorganic phosphoric acid, EPA is concerned that toxicity to aquatic organisms may occur at a concentration of 30 ppb in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and 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 study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substances.

CFR citation: 40 CFR 721.9514.

PMN Number P-99-0198

Chemical name: (generic) Tetraaryltin.

CAS number: Not available.

Basis for action: The PMN substance will be used as a coating system intermediate. EPA has identified health concerns for reproductive toxicity in males, immunotoxicity, and allergic reaction based on analogy to organotin compounds; and concern for mutagenicity based on data for triphenyltin hydroxide. Since significant worker exposure is unlikely when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing and use of the substance may present an unreasonable health risk. EPA has determined, however, that other uses of the substance other than as an intermediate may result in serious health effects. Also, based on data on organotins, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since environmental releases are not expected above 1 ppb as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable environmental risk. EPA has determined, however, that any release of the PMN substance to surface waters above 1 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that a prenatal development toxicity study by the oral route in two-species (40 CFR 799.9370) would help to characterize the human health effects of the PMN substance. In addition, the following acute aquatic toxicity tests would help to characterize the environmental effects: A fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public)).

CFR citation: 40 CFR 721.9670.

PMN Number P-99-0199

Chemical name: (generic) Triaryltin.

CAS number: Not available.

Basis for action: The PMN substance will be used as a coating system intermediate. EPA has identified health concerns for reproductive toxicity in males, carcinogenicity, immunotoxicity, and allergic reaction based on analogy to organotin compounds; and concern for mutagenicity based on data for triphenyltin hydroxide. Since significant worker exposure is unlikely when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable health risk. EPA has determined, however, that other uses of the substance other than as an intermediate may result in serious health effects. Also, based on data on organotins, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since environmental releases are not expected above 1 ppb as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable environmental risk. EPA has determined, however, that any release of the PMN substance to surface waters above 1 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that a prenatal development toxicity study by the oral route in two-species (40 CFR 799.9370) would help to characterize the human health effects of the PMN substance. In addition, the following acute aquatic toxicity tests would help to characterize the environmental effects: A fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)).

CFR citation: 40 CFR 721.9671.

PMN Numbers P-99-0207 and P-99-0208

Chemical names: (P-99-0207) L-Glutamic acid, N-(1-oxododecyl)-, disodium salt; and (P-99-0208) L-Glutamic acid, N-(1-oxododecyl)-.

CAS numbers: 50622-20-3 and 3397-65-7.

Basis for action: The PMN substances will be used as isolated intermediates. Based on structural analogy to anionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 200 ppb of the PMN substances in surface waters as a soluble salt at pH7. Since significant environmental exposure is unlikely, as the substances are not released to surface waters in significant amounts, as described in the PMNs, EPA has not determined that the proposed manufacturing, processing, and 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 a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substances. The sodium salt at pH7 should be tested for P-99-0208. Start Printed Page 81392

CFR citations: 40 CFR 721.3820 (P-99-0207) and 40 CFR 721.3821 (P-99-0208).

PMN Number P-99-0313

Chemical name: (generic) Substituted ethoxylated hydrocarbon.

CAS number: Not available.

Basis for action: The PMN substance will be used as an intermediate. Based on structural analogy to ethoxylated nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters above 100 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and 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 study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.4365.

PMN Number P-99-0365

Chemical name: (generic) Substituted acetate.

CAS number: Not available. donna

Basis for action: The PMN substance will be used as a chemical intermediate. EPA has identified health concerns for developmental toxicity, reproductive toxicity, and immunotoxicity based on data from the carboxylic acid based ester hydrolysis product, and concern for neurotoxicity based on solvent properties. Since significant worker exposure is unlikely when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and 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 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 28-day oral toxicity study in rats (Organization for Economic Cooperation and Development (OECD) guideline no. 407) that includes a neurotoxicity functional observational battery (National Technical Information Service (NTIS) (NTIS: PB 91-154617)) for all test doses with the highest dose set at 1,000 milligram/kilogram (mg/kg), and for the highest test dose group only, histopathologic examination shall be extended to include testes/ovaries and lungs, and an oral developmental toxicity study in two-species (40 CFR 798.4900 or OPPTS 870.3700 test guideline) would help to characterize the health effects of the substance.

CFR citation: 40 CFR 721.303.

PMN Numbers P-99-0368 and P-99-0369

Chemical name: (generic) Dimethyl alkylamine salt.

CAS number: Not available.

Basis for action: The PMN substances will be used as water clarifiers. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 2 ppb in surface waters for P-99-0368 and 6 ppb in surface waters for P-99-0369. Since significant environmental exposure is unlikely, as the substances are not released to surface waters in significant amounts, when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substances may present an unreasonable risk. EPA has determined, however, that use of the substances other than as described in the PMN 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 a freshwater fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an freshwater algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.333.

PMN Number P-99-0385

Chemical name: (generic) Fatty alkyl phosphate, alkali metal salt.

CAS number: Not available.

Basis for action: The PMN substance will be used as a lubricant. Based on structural analogy to phosphate-based anionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 8 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.5985.

PMN Number P-99-0423

Chemical name: (generic) Polyalkylene oxide dialkylamine.

CAS number: Not available.

Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 100 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.2265.

PMN Number P-99-0435 Start Printed Page 81393

Chemical name: (generic) Polyether modified fatty acids.

CAS number: Not available.

Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 4 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substances other than as described in the PMN may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.3710.

PMN Number P-99-0467

Chemical name: (generic) Acrylated (long-chainalkyl) glycidyl ether.

CAS number: Not available.

Basis for action: The PMN substance will be used as an intermediate. Based on structural analogy to acrylates, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 2 ppb of the PMN substance in surface waters. Since environmental exposure is unlikely, as the substance is not released to surface water above 2 ppb as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in 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 a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.3850.

PMN Number P-99-0472

Chemical name: (generic) Polyalkenylalkylphenol.

CAS number: Not available.

Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to phenols, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.545.

PMN Number P-99-0479

Chemical name: (generic) Polysubstituted bis phenylazonapthalene disulfonic acid.

CAS number: Not available.

Basis for action: The PMN substance will be used in leather dyeing as described in the PMN. Based on structural analogy to aminoaniline anionic dyes, EPA has identified health concerns for carcinogenicity, developmental toxicity, kidney toxicity, liver toxicity and neurotoxicity based on the potential azo reduction products. Since significant worker exposure is unlikely, when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacturing could result in exposures which may cause serious chronic and developmental 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 oral subchronic in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline) with neurotoxicity adjuncts (NTIS PB 91-154517), a prenatal development toxicity study by the oral route in two-species (40 CFR 799.9370), and a 2-year, two-species oral carcinogenicity study (40 CFR 798.3300 or OPPTS 870.4200 test guideline) would help to characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.5914.

PMN Number P-99-0531

Chemical name: (generic) Formaldehyde, reaction products with an alkylated phenol and an aliphatic amine.

CAS number: Not available.

Basis for action: The PMN substance will be used as a detergent additive for gasoline and diesel fuel. Based on structural analogy to aliphatic amines and phenols, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 3 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substances other than as described in the PMN may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance. The PMN substance should be tested as 100 percent active ingredients.

CFR citation: 40 CFR 721.3830.

PMN Number P-99-0557

Chemical name: Benzenamine,4,4'-methylenebis[N-ethyl-N-methyl-.

CAS number: 76176-94-8.

Basis for action: The PMN substance will be used as an intermediate. EPA has identified health concerns for mutagenicity, developmental toxicity, and sensitization based on analogy to Start Printed Page 81394methylenedianiline (MDA). EPA also has concerns for carcinogenicity and male reproductive toxicity based on analogy to N,N,N',N'-tetramethyl methylenedianiline (tetramethyl MDA). Since significant worker exposure is unlikely when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance other than as described in the PMN 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 28-day oral toxicity study in rats (OECD guideline no. 407) where histopathologic examination shall be extended to include testes/ovaries and lungs, and an oral developmental toxicity study by oral route in two-species (40 CFR 798.4900 or OPPTS 870.3700 test guideline) would help to characterize the health effects of the substance.

CFR citation: 40 CFR 721.1085.

PMN Number P-99-0558

Chemical name: (generic) Formaldehyde, polymers with substituted phenols.

CAS number: Not available.

Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to polynonionic polymers and phenols, EPA has concern for toxicity to aquatic organisms, which may occur at a concentration as low as 5 ppb of the PMN substance with a number average-molecular weight below 600. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases to surface waters of lower molecular weight species 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 study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.3810.

PMN Number P-99-0610

Chemical name: (generic) Modified hydroxystyrene homopolymer.

CAS number: Not available.

Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to polynonionic polymers and phenols, EPA has concern for toxicity to aquatic organisms, which may occur at a concentration as low as 5 ppb of the PMN substance with a number average-molecular weight below 600. Since significant exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases to surface waters of lower molecular weight species 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 study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.4565.

PMN Number P-99-0618

Chemical name: (generic) Hydrochloride salt of a fatty polyalkylene polyamine.

CAS number: Not available.

Basis for action: The PMN substance will be used as a processing aid. Based on structural analogy to aliphatic amines, EPA is concerned that effects to the aquatic environment may occur at a concentration as low as 50 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in 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 a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.6196.

PMN Number P-99-0645

Chemical name: (generic) Amidoamine modified polyethylene glycol.

CAS number: Not available.

Basis for action: The PMN substance will be used as a surfactant. Based on structural analogy to aliphatic amines, EPA is concerned that effects to the aquatic environment may occur at a concentration as low as 20 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in 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 a fish chronic toxicity study (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft)), a daphnid chronic toxicity study (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.6493.

PMN Number P-99-0654

Chemical name: (generic) Thiosubstituted carbonate ester.

CAS number: Not available.

Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to thiocarbamates esters, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental Start Printed Page 81395exposure is unlikely, as the substance is not released to surface waters, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in 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 a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.2121.

PMN Number P-99-0723

Chemical name: (generic) Phenoxazin-5-ium, 3-dialkylamino-7-arylamino-, salt.

CAS number: Not available.

Basis for action: The PMN substance will be used as a basic dye for cationic dyeable polyester fibers. Based on structural analogy to cationic dyes with delocalized cationic charge, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture of the substance 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 study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.5912.

PMN Number P-99-0754

Chemical name: 9-Phosphabicyclo[3.3.1]nonane, 9,9'-(1,2-ethanediyl)bis- (9C1).

CAS number: 153280-11-6.

Basis for action: The PMN substance will be used as a catalyst. EPA has identified health concerns for neurotoxicity and internal organ effects based on analogy to structurally similar compounds. Since significant worker exposure is unlikely when the substance is used as a liquid. EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable health risk. EPA has determined, however, that manufacture, process, or use of the substance as a solid may result in serious health effects. Also, based on analogy to cationic dyes with delocalized charge, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely as the substance is not released to surface waters as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable environmental risk. EPA has determined, however, that other uses of the substance resulting in 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)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that a 28-day oral toxicity study in rats (OECD guideline no. 407) that includes a neurotoxicity functional observational battery (NTIS: PB 91-154617) for all test doses with the highest dose set at 1,000 mg/kg, and for the highest test dose group only, histopathologic examination shall be extended to include testes/ovaries and lungs, would help to characterize the human health effects of the PMN substance. In addition, the following chronic aquatic toxicity tests would help to characterize the environmental effects: A fish chronic toxicity study (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft)), a daphnid chronic toxicity study (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft)), and an algal toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)).

CFR citation: 40 CFR 721.5378.

IV. Objectives and Rationale of the Rule

During review of the PMNs submitted for the chemical substances that are subject to this SNUR, EPA concluded that for 5 of the 40 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 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 substances designated herein are consistent with the provisions of the TSCA section 5(e) consent orders.

In the other 35 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.

EPA is issuing this SNUR for specific chemical substances which have undergone premanufacture review to ensure that:

1. EPA will receive notice of any company's intent to manufacture, import, or process a listed chemical substance for a significant new use before that activity begins.

2. EPA will have an opportunity to review and evaluate data submitted in a SNUR notice before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for a significant new use.

3. When necessary, to prevent unreasonable risks, EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before a significant new use of that substance occurs.

4. All manufacturers, importers, and processors of the same chemical substance which 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 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), this rule will be effective February 26, 2001, unless EPA receives a written notice by January 25, 2001 that someone wishes to make adverse or critical comments on EPA's action. If EPA receives such a notice, EPA will publish a document to Start Printed Page 81396withdraw the direct final SNUR for the specific substance to which the adverse or critical comments apply. EPA will then propose a SNUR for the specific substance providing a 30-day comment period.

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

VI. Test Data and Other Information

EPA recognizes that section 5 of TSCA 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. In cases where a TSCA section 5(e) consent order requires or recommends certain testing, Unit III. lists those recommended tests.

However, EPA has established production limits in the TSCA section 5(e) consent orders for several of the substances regulated under this rule, 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 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 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.

The recommended studies may not be the only means of addressing the potential risks of the 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:

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

2. Potential benefits of the substances.

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

VII. Procedural Determinations

EPA is establishing through this rule some 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 substance subject to a SNUR is CBI. This procedure is cross-referenced in each of these SNURs.

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 incorporated from § 721.1725(b)(1), a manufacturer or importer must show that it has a bona fide intent to manufacture or import the substance and must identify the specific use for which it intends to manufacture or import the substance. If EPA concludes that the person has shown a bona fide intent to manufacture or import the 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 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 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 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 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 5 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 an NOC and the substance has not been added to the Inventory, no other person may commence such activities without first submitting a PMN. For 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 Inventory prior to the effective date of the rule, the 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, 31 of the 40 substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN bona fide submissions, the Agency believes that it is highly unlikely that any of the significant new uses described in the following regulatory text are ongoing.

As discussed in the Federal Register of April 24, 1990, 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 rather than as of the effective date of the rule. Thus, persons who begin commercial manufacture, import, or processing of the 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 Start Printed Page 81397until 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. If persons who begin commercial manufacture, import, or processing of the substance between publication and the effective date of the SNUR do not meet the conditions of advance compliance, they must cease that activity before the effective date of the 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.

IX. Economic Analysis

EPA has evaluated the potential costs of establishing significant new use notice requirements for potential manufacturers, importers, and processors of the chemical substance subject to this rule. EPA's complete economic analysis is available in the official record for this rule (OPPTS-50638).

X. Regulatory Assessment Requirements

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 proposed or final SNURs are not a “significant regulatory action” subject to review by OMB, because they do not meet the criteria in section 3(f) of the Executive Order.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

Similarly, this action is not subject to the requirement for prior consultation with Indian tribal governments as specified in Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998). Nor will this action 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).

In issuing this final 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).

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 final 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.

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).

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.

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.

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 530 SNURs, the Agency has received fewer than 15 SNUNs. 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.), are minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impact of complying with this SNUR are 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 its 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.

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, after initial display in the preamble of the final rule and in addition to its display on any related collection instrument, are listed in 40 CFR part 9.

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 significant new use notice 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 significant new use notice.

Send any comments about the accuracy of the burden estimate, and Start Printed Page 81398any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, OP Regulatory Information Division (2137), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

XI. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a final rule may take effect, the Agency promulgating it must submit a final rule report, which includes a copy of the final rule, 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 the final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Start List of Subjects

List of Subjects in 40 CFR Part 721

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Dated: December 13, 2000.

Mary Ellen Weber,

Acting Office Director, Office of Pollution Prevention and Toxics.

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Therefore,

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PART 721—[AMENDED]

End Part Start Amendment Part

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

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

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2. By adding new § 721.303 to subpart E to read as follows:

End Amendment Part
Substituted acetate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a substituted acetate (PMN P-99-0365) is subject to reporting under this section for the significant new use 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.

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3. By adding new § 721.333 to subpart E to read as follows:

End Amendment Part
Dimethyl alkylamine salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as a Dimethyl alkylamine salt (PMNs P-99-0368 and P-99-0369) are subject to reporting under this section for the significant new use 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.

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4. By adding new § 721.480 to subpart E to read as follows:

End Amendment Part
Aminoester of polyalkenylated alkyldicarboxylic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Aminoester of polyalkenylated alkyldicarboxylic acid (PMN P-99-0115) is subject to 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.

Start Amendment Part

5. By adding new § 721.545 to subpart E to read as follows:

End Amendment Part
Polyalkenylalkylphenol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a Polyalkenylalkylphenol (PMN P-99-0472) is subject to reporting under this section for the significant new use 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.

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6. By adding new § 721.632 to subpart E to read as follows:

End Amendment Part
Silicoaluminophosphates, compd. with organic amine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as Silicoaluminophosphates, compd. with organic amine (PMN P-98-1274) is subject to 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)(5)(i), (b) and (c). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor Start Printed Page 81399may choose to follow the New Chemical Exposure Limit (NCEL) provisions listed in the section TSCA 5(e) consent order for these substances. The NCEL is 0.1 mg/m3 as an 8-hour time weighted average verified by actual monitoring data.

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

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7. By adding new § 721.633 to subpart E to read as follows:

End Amendment Part
Aluminosilicates, phospho-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Aluminosilicates, phospho- (PMN P-98-1275; CAS No. 201167-69-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(5)(i), (b), and (c). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the NCEL provisions listed in the TSCA section 5(e) consent order for these substances. The NCEL is 0.1 mg/m3 as an 8-hour time weighted average verified by actual monitoring data.

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

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8. By adding new § 721.1085 to subpart E to read as follows:

End Amendment Part
Benzenamine,4,4'-methylenebis[N-ethyl-N-methyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a Benzenamine,4,4'-methylenebis[N-ethyl-N-methyl- (PMN P-99-0557; CAS No. 76176-94-8) is subject to reporting under this section for the significant new use 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.

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9. By adding new § 721.2121 to subpart E to read as follows:

End Amendment Part
Thiosubstituted carbonate ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Thiosubstituted carbonate ester (PMN P-99-0654) is subject to reporting under this section for the significant new use 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.

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10. By adding new § 721.2265 to subpart E to read as follows:

End Amendment Part
Polyalkylene oxide dialkylamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Polyalkylene oxide dialkylamine (PMN P-99-0423) is subject to reporting under this section for the significant new use 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.

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11. By adding new § 721.3710 to subpart E to read as follows:

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Polyether modified fatty acids (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a Polyether modified fatty acids (PMN P-99-0435) is subject to reporting under this section for the significant new use 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.

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12. By adding new § 721.3810 to subpart E to read as follows:

End Amendment Part
Formaldehyde, polymers with substituted phenols (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Formaldehyde, polymers with substituted phenols (PMN P-99-0558) is subject to reporting under this section for the significant new use 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.

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13. By adding new § 721.3820 to subpart E to read as follows:

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L-Glutamic acid, N-(1-oxododecyl)-, disodium salt.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as L-Glutamic acid, N-(1-oxododecyl)-, disodium salt (PMN P-99-0207; CAS No. 50622-20-3) is subject to reporting under this section for the significant new use 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.

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14. By adding new § 721.3821 to subpart E to read as follows:

End Amendment Part
L-Glutamic acid, N-(1-oxododecyl)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as L-Glutamic acid, N-(1-oxododecyl)- (PMN P-99-0208; CAS No. 3397-65-7) is subject to reporting under this section for the significant new use 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.

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15. By adding new § 721.3830 to subpart E to read as follows:

End Amendment Part
Formaldehyde, reaction products with an alkylated phenol and an aliphatic amine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Formaldehyde, reaction products with an alkylated phenol and an aliphatic amine (PMN P-99-0531) is subject to reporting under this section for the significant new use 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.

Start Amendment Part

16. By adding new § 721.3850 to subpart E to read as follows:

End Amendment Part
Acrylated (long-chainalkyl) glycidyl ether (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a Acrylated (long-chainalkyl) glycidyl ether (PMN P-99-0467) is subject to reporting under this section for the significant new use 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 ppb).

(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.

Start Amendment Part

17. By adding new § 721.4365 to subpart E to read as follows:

End Amendment Part
Substituted ethoxylated hydrocarbon (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Substituted ethoxylated hydrocarbon (PMN P-99-0313) is subject to reporting under this section for the significant new use 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 ppb).

(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.

Start Amendment Part

18. By adding new § 721.4461 to subpart E to read as follows:

End Amendment Part
Hydrofluoric acid, reaction products with octane (generic).

(a) Chemical substance and significant new uses subject to reporting. Start Printed Page 81401(1) The chemical substance identified generically as a hydrofluoric acid, reaction products with octane (PMN P-99-0052) is subject to reporting under this section for the significant new use 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.

Start Amendment Part

19. By adding new § 721.4565 to subpart E to read as follows:

End Amendment Part
Modified hydroxystyrene homopolymer (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Modified hydroxystyrene homopolymer (PMN P-99-0610) is subject to reporting under this section for the significant new use 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.

Start Amendment Part

20. By adding new § 721.4610 to subpart E to read as follows:

End Amendment Part
Mixed metal oxides (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxides (PMN P-98-0002) is subject to reporting under this section for the significant new use 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)(5)(i), (a)(6)(i), (b) (concentration set at 0.1 percent), and (c). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the NCEL provisions listed in the TSCA 5(e) consent order for this substance. The NCEL is 0.05 mg/m3 as an 8-hour time weighted average verified by actual monitoring data.

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

(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. The following recordkeeping requirements are applicable to manufacturers, importers, and processors of this substance, as specified in § 721.125 (a), (b), (c), (d), (f), (g), (h), and (i).

(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.

Start Amendment Part

21. By adding new § 721.5284 to subpart E to read as follows:

End Amendment Part
Chromate (5-), bis[4-hydroxy-7-[(2-hydroxy-1-naphthalenyl)azo]- 3-[(2-hydroxy-3-nitro-5-sulfophenyl)azo]-2- naphthalenesulfonato(4-)]-, pentasodium.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a Chromate (5-), bis[4-hydroxy-7-[(2-hydroxy-1- naphthalenyl)azo]- 3-[(2-hydroxy-3-nitro-5-sulfophenyl)azo]-2- naphthalenesulfonato(4-)]-, pentasodium (PMN P-99-0114; CAS No. 159574-72-8) is subject to reporting under this section for the significant new use 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.

Start Amendment Part

22. By adding new § 721.5378 to subpart E to read as follows:

End Amendment Part
9-Phosphabicyclo[3.3.1]nonane,9,9'-(1,2-ethanediyl)bis- (9C1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 9-Phosphabicyclo[3.3.1]nonane,9,9'-(1,2-ethanediyl)bis- (9C1) (PMN P-99-0754; CAS No.153280-11-6) is subject to reporting under this section for the significant new use 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), (w)(2), and (y)(2).

(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.

Start Amendment Part

23. By adding new § 721.5585 to subpart E to read as follows:

End Amendment Part
4,4'-(1-methylethylidene)bisphenol, polymer with (chloromethyl)oxirane and a diamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 4,4'-(1-methylethylidene)bisphenol, polymer with (chloromethyl) oxirane and a diamine (PMN P-97-0916) is subject to 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), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).

(ii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=2 ppb). Start Printed Page 81402

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

Start Amendment Part

24. By adding new § 721.5912 to subpart E to read as follows:

End Amendment Part
Phenoxazin-5-ium, 3-dialkylamino-7-arylamino-, salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Phenoxazin-5-ium, 3-dialkylamino-7-arylamino-, salt (PMN P-99-0723) is subject to 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.

Start Amendment Part

25. By adding new § 721.5914 to subpart E to read as follows:

End Amendment Part
Polysubstituted bis phenylazonapthalene disulfonic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a Polysubstituted bis phenylazonapthalene disulfonic acid. (PMN P-99-0479) is subject to reporting under this section for the significant new use 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.

Start Amendment Part

26. By adding new § 721.5985 to subpart E to read as follows:

End Amendment Part
Fatty alkyl phosphate, alkali metal salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a fatty alkyl phosphate, alkali metal salt (PMN P-99-0385) is subject to reporting under this section for the significant new use 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.

Start Amendment Part

27. By adding new § 721.6180 to subpart E to read as follows:

End Amendment Part
Polyalkylene glycol polyamide ester phosphate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyalkylene glycol polyamide ester phosphate (PMN P-98-0903) is subject to 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.

Start Amendment Part

28. By adding new § 721.6196 to subpart E to read as follows:

End Amendment Part
Hydrochloride salt of a fatty polyalkkylene polyamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Hydrochloride salt of a fatty polyalkkylene polyamine (PMN P-99-0618) is subject to reporting under this section for the significant new use 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.

Start Amendment Part

29. By adding new § 721.6479 to subpart E to read as follows:

End Amendment Part
Tetrahydroheteropolycycle (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Tetrahydroheteropolycycle (PMN P-97-0766) is subject to reporting under this section for the significant new use 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)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) (if no data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xii) (if data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xiii), (a)(5)(xiv), (a)(6)(i), (a)(6)(ii) (a)(6)(iii), (a)(6)(iv), (a)(6)(v), and (a)(6)(vi), (b) (concentration set at 1.0 percent), and (c). The imperviousness of each item pursuant to paragraph (a)(2)(i) must be demonstrated by actual testing under paragraph (a)(3) and not by manufacturer specifications. Permeation Start Printed Page 81403testing shall be conducted according to the American Society for Testing Materials (ASTM) F739 “Standard Test Method for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases.” Results shall be recorded as a cumulative permeation rate as a function of time, and shall be documented in accordance with ASTM F739 using the format specified in ASTM 1194-89 “Guide for Documenting the Results of Chemical Permeation Testing on Protective Clothing Materials.” Gloves may not be used for a time period longer than they are actually tested and must be replaced at the end of each work shift. The manufacturer, importer, or processor must submit all test data to the Agency and must receive written Agency approval for each type of glove tested prior to use of such gloves. The following gloves have been tested in accordance with the ASTM F739 method and found to satisfy the requirements for use by EPA: Latex (at least 14 mils thick), Nitrile (at least 16 mils thick), and Silvershield (at least 3 mils thick). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the NCEL provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 ug/m3 as an 8-hour time weighted average verified by actual monitoring data.

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

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(p) (12,300 kilograms).

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

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

Start Amendment Part

30. By adding new § 721.6493 to subpart E to read as follows:

End Amendment Part
Amidoamine modified polyethylene glycol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a amidoamine modified polyethylene glycol (PMN P-99-0645) is subject to reporting under this section for the significant new use 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.

Start Amendment Part

31. By adding new § 721.6515 to subpart E to read as follows:

End Amendment Part
Polymerof polyalkylenepolyol and trisubstituted phenol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polymer of polyalkylenepolyol and trisubstituted phenol (PMN P-98-1016) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(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.

Start Amendment Part

32. By adding new § 721.8657 to subpart E to read as follows:

End Amendment Part
Cerium, hydroxy oleate propionate complexes.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Cerium, hydroxy oleate propionate complexes (PMN P-99-0026) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=7 ppb).

(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.

Start Amendment Part

33. By adding new § 721.9484 to subpart E to read as follows:

End Amendment Part
Dimer acid/rosin amidoamine reaction product (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Dimer acid/rosin amidoamine reaction product (PMN P-99-0143) is subject to reporting under this section for the significant new use 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.

Start Amendment Part

34. By adding new § 721.9485 to subpart E to read as follows:

End Amendment Part
Dimer acid/polymerized rosin amidoamine reaction product (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Dimer acid/polymerized rosin amidoamine reaction product (PMN P-99-0144) is subject to reporting under this section for the significant new use 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 Start Printed Page 81404apply 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.

Start Amendment Part

35. By adding new § 721.9486 to subpart E to read as follows:

End Amendment Part
Rosin amidoamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Rosin amidoamine (PMN P-99-0145) is subject to reporting under this section for the significant new use 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.

Start Amendment Part

36. By adding new § 721.9487 to subpart E to read as follows:

End Amendment Part
Polymerized rosin amidoamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Polymerized rosin amidoamine (PMN P-99-0146) is subject to reporting under this section for the significant new use 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.

Start Amendment Part

37. By adding new § 721.9514 to subpart E to read as follows:

End Amendment Part
Ethyl silicate, reaction products with modified alkoxysilane salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Ethyl silicate, reaction products with modified alkoxysilane salt (PMN P-99-0157) is subject to 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.

Start Amendment Part

38. By adding new § 721.9535 to subpart E to read as follows:

End Amendment Part
1,4-Dioxa-7,9-dithia-8-stannacycloundecane-5,11-dione, 8,8-dioctyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a 1,4-Dioxa-7,9-dithia-8-stannacycloundecane-5,11-dione, 8,8-dioctyl- (PMN P-99-0093; CAS No. 56875-68-4) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

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

Start Amendment Part

39. By adding new § 721.9670 to subpart E to read as follows:

End Amendment Part
Tetraaryltin (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a Tetraaryltin (PMN P-99-0198) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

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

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

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40. By adding new § 721.9671 to subpart E to read as follows:

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Triaryltin (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a Triaryltin (PMN P-99-0199) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

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

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

End Supplemental Information

[FR Doc. 00-32766 Filed 12-22-00; 8:45 am]

BILLING CODE 6560-50-S