Toxic substances: Significant new uses— Halogenated benzyl ester acrylate, etc.,

[Federal Register: January 5, 2000 (Volume 65, Number 3)]

[Rules and Regulations]

[Page 354-374]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr05ja00-9]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50635; FRL-6055-2]

RIN 2070-AB27

Significant New Uses of Certain Chemical Substances

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 SNUR 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 March 6, 2000 without further notice, unless EPA receives adverse comment or notice of intent to submit adverse comment before February 4, 2000. This rule shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on January 19, 2000.

If EPA receives adverse comment or notice before February 4, 2000 that someone wishes to submit adverse or critical comments on EPA's action in establishing a 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.C. of the ``SUPPLEMENTARY INFORMATION'' section. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-50635 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: For general information contact: Joe Carra, Deputy Director, Office of Pollution Prevention and Toxics (7401), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460, telephone numbers: (202) 554-1404 and TDD: (202) 554-0551; 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, Rm. E-435, 401 M St., SW., Washington, DC 20460, telephone number: (202) 260-1857; e-mail address: alwood.jim@epa.gov.

SUPPLEMENTARY INFORMATION:

  1. General Information

    1. 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:

      Examples of Categories

      NAICS

      Potentially Affected Entities

      Chemical manufacturers

      325

      Manufacturers, importers, processors, and users of chemicals

      Petroleum and coal product

      324

      Manufacturers, industries

      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 40 CFR 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed in the ``FOR FURTHER INFORMATION CONTACT.''

    2. 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 835 (63 FR 4259, January 28, l998) (FRL-5761-7), 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'' and then 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/OPPTS-Harmonized/.

      2. In person. The Agency has established an official record for this action under docket control number OPPTS-50635. 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

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      holidays. The telephone number for the Center is (202) 260-7099.

    3. 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-50635 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, 401 M St., SW., 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-50635. Electronic comments may also be filedonline at many Federal Depository Libraries.

    4. 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 identified in the ``FOR FURTHER INFORMATION CONTACT.''

    5. 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.

  2. Background

    1. 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.

    2. 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.

    3. 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 5 (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.

  3. 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

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    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. of this preamble.

    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. of this preamble, 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-97-991, P-97-342/343/344, P- 97-727/728/730/731/732/904, P-98-123, P-98-325, P-98-359, P-98-700/701, and P-98-796, 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. 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 notice of commencement (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-90-1527

    Chemical name: (generic) Halogenated benzyl ester acrylate. CAS number: Not available. Effective date of section 5(e) consent order: July 20, l998. 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 and the environment. Toxicity concern: The PMN substance has been shown to cause kidney and blood effects in test animals. Also, similar chemicals have been shown to form dibenzodioxins and dibenzofurans when incinerated under combustion conditions of municipal incinerators. Recommended testing: A 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline) is required to help characterize systemic effects observed in shorter term testing. An incineration simulation study is required to help characterize the potential for the formation of dibenzodioxins or dibenzofurans when plastics or resins containing the PMN substance are incinerated. The consent order contains two production volume limits. The PMN submitter has agreed not to exceed the first production volume limit without performing the 90-day subchronic oral study. The PMN submitter has also agreed not to exceed the second higher production volume limit without performing an incineration simulation test. CFR citation: 40 CFR 721.329.

    PMN Numbers P-94-697 through P-94-895

    Chemical name: (generic) Fatty acids C12-18, C18 unsaturated, C12-18alkyl esters. CAS number: Not available. Effective date of section 5(e) consent order: October 6, 1994. 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)(II) of TSCA based on a finding that these substances are expected to be produced in substantial quantities, there may be significant or substantial human exposure to the substances, and the substances may enter the environment in substantial quantities. 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): 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 one species (40 CFR 798.4900 or OPPTS 870.3700 test guideline) would help to characterize the health effects of the substances. EPA has determined that a ``modified Semicontinuous Activated Sludge (SCAS) test'' (OPPTS 835.3210 test guideline) and a ready biodegradation study (OPPTS 835.3110 test guideline) would help to characterize the environmental effects of the substances. The PMN submitter has agreed not to exceed the production volume limit without performing the toxicity studies using P-94-697 and the biodegradation studies using P-94-697. CFR citation: 40 CFR 721.3025.

    PMN Number P-95-169

    Chemical name: Morpholine, 4-(1-oxo-2-propenyl)-. CAS number: 5117-12-4.

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    Effective date of section 5(e) consent order: November 27, 1998. Basis for section 5(e) consent order: The order was issued under section 5(e)(1)(A)(i) and section 5(e)(l)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to health and the environment. Toxicity concern: Structurally similar chemicals have been shown to cause heritable mutagenicity, carcinogenicity, neurotoxicity, reproductive toxicity, developmental toxicity, and systemic toxicity in test animals and chronic aquatic toxicity in aquatic organisms. Recommended testing: The consent order contains four production volume limits. The PMN submitter has agreed not to exceed the first production volume limit without performing an OECD guideline no. 422 study extended to 90 days with observations for motor activity and neuropathology (NTIS: PB91-154617) within 1 year from the commencement of commercial manufacture or import to address the systemic, developmental, and neurotoxic effects. The PMN submitter has also agreed not to exceed the second higher production volume limit without performing a rodent dominant lethal assay (40 CFR 798.5450 or OPPTS 870.5450 test guideline) 14 weeks before manufacturing or importing 1,300,000 kilograms of the PMN substance. If the rodent dominant lethal assay is positive, the PMN submitter has also agreed not to exceed the third higher production volume limit without performing a rodent heritable translocation test (40 CFR 798.5460 or OPPTS 870.5460 test guideline) which would be the appropriate follow-up test and it must be submitted to EPA 14 weeks before manufacturing or importing 1,600,000 kilograms of the PMN substance or 1 year after the submission of the rodent dominant lethal assay to EPA, whichever comes later to help characterize the heritable mutagenic effects. The PMN submitter has also agreed not to exceed the fourth higher production volume limit without performing a 2-year, two-species oral carcinogenicity test (40 CFR 798.3300 or OPPTS 870.4200 test guideline) in rats and mice 14 weeks before manufacturing or importing an additional 4,000,000 kilograms of the PMN substance (a total of 5,500,000 kilograms) or 5 years after the commencement of commercial manufacture, whichever comes later to help characterize the carcinogenic effects.

    The following additional information would be required to evaluate the environmental effects which may be caused by the PMN substance: daphnid chronic toxicity study (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft)), a fish early life stage toxicity (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft)), and a semi- continuous activated sludge study (OPPTS 835.3210 test guideline). The order does not require submission of the above information at any specified time or production volume. However, the order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.5185.

    PMN Numbers P-95-1400 and P-95-1410

    Chemical names: (generic) (P-95-1400) Perfluorinatedalkyl polyhydroxysilane; and (P-95-1410) Perfluorinatedalkyl polyalkoxysilane. CAS number: Not available. Effective date of section 5(e) consent order: May 15, l998. Basis for section 5(e) consent order: The order was issued under section 5(e)(1)(A)(i) and section 5(e)(l)(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 submitted acute inhalation toxicity data with 10 percent formulations of PMN P-95-1400 containing hexadecyltrimethyl ammonium chloride, and sodium dodecylbenzene sulfonate as emulsifiers, P-95-1400 has been shown to cause death in test animals at concentrations as low as 61 milligrams per cubic meter. Recommended testing: EPA has determined that a 90-day subchronic inhalation study in rats (40 CFR 799.9346 or OPPTS 870.3465 test guideline) would help to characterize a lethality risk to consumers exposed via inhalation during use of these PMN substances. CFR citations: 40 CFR 721.9508 (P-95-1400); 40 CFR 721.9509 (P-95- 1410).

    PMN Number P-97-482

    Chemical name: Fatty acids, C10-13- branched, vinyl esters. CAS number: 184785-38-4. Effective date of section 5(e) consent order: July 31, 1998. 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 and the environment. Toxicity concern: Structurally similar chemicals have been shown to cause developmental and reproductive toxicity, neurotoxicity and cancer in test animals, and chronic toxicity to aquatic organisms. Recommended testing: A metabolic hydrolysis test on both the PMN substance and the structural analogue vinyl acetate, as well as a 90- day oral subchronic neurotoxicity testing in rats (OPPTS 870.3150 test guideline), with certain adjuncts to address reproductive toxicity concerns, will help the Agency to characterize the human health effects of the PMN substance. The PMN submitter has agreed not to exceed the production volume limit without performing these studies. The PMN submitter has submitted testing on the PMN substance to characterize environmental toxicity concerns. CFR citation: 40 CFR 721.9965.

    PMN Number P-97-635

    Chemical name: Boric acid (H3BO3), mixed esters with polyethylene glycol mono-Bu ether and polyethylene glycol mono Me ether. CAS number: 183290-62-2. Basis for action: This PMN substance will be used as a component of a brake fluid formulation. EPA has identified health concerns for reproductive and blood toxicity based on data on structurally similar borons. Since significant worker exposure is unlikely when workers wear impervious gloves, as described in the PMN, EPA has not determined that the proposed processing and use of the substance may present an unreasonable risk. EPA has determined, however, that manufacture, process, or use of the substance without dermal protection may result in serious chronic and developmental effects. Also, based on analogy to boron, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 300 parts per billion (ppb) of the PMN substance in surface waters. Since environmental releases are not expected to exceed 300 ppb as described in the PMN, EPA has not determined that the proposed processing and use of the substance may present an unreasonable risk. EPA has determined, however, that any release of the PMN substance to surface water above 300 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that the OECD reproductive toxicity screen in rats (OECD guideline

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    no. 421) with special attention to hematology would help to characterize the human health effects. If this screen is positive for reproductive toxicity, a reproductive fertility study in rats (40 CFR 799.9380) is recommended. In addition, the following acute aquatic toxicity tests: algal (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)); daphnid (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public)); and fish (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)) would help to characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.1729.

    PMN Number P-97-636

    Chemical name: Poly(oxy-1,2-ethanediyl), -butyl-- hydroxy, ester with boric acid (H3BO3). CAS number: 106008-93-9. Basis for action: This PMN substance will be used as a component of a brake fluid formulation. EPA has identified health concerns for reproductive and blood toxicity based on data on structurally similar borons. Since significant worker exposure is unlikely when workers wear impervious gloves, as described in the PMN, EPA has not determined that the proposed processing and use of the substance may present an unreasonable risk. EPA has determined, however, that manufacture, process, or use of the substance without dermal protection may result in serious chronic and developmental effects. Also, based on analogy to boron, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 300 ppb of the PMN substance in surface waters. Since environmental releases are not expected to exceed 300 ppb as described in the PMN, EPA has not determined that the proposed processing and use of the substance may present an unreasonable risk. EPA has determined, however, that any release of the PMN substance to surface water above 300 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that the OECD reproductive toxicity screen in rats (OECD guideline no. 421) with special attention to hematology would help to characterize the human health effects. If this screen is positive for reproductive toxicity, a reproductive fertility study in rats (40 CFR 799.9380) is recommended. In addition, the following acute aquatic toxicity tests would help to characterize the environmental effects: algal (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)); daphnid (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)); and fish (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)). CFR citation: 40 CFR 721.1730.

    PMN Number P-97-637

    Chemical name: Poly(oxy-1,2-ethanediyl), -methyl-- hydroxy, ester with boric acid (H3BO3). CAS number: 106008-94-0. Basis for action: This PMN substance will be used as a component of a brake fluid formulation. EPA has identified health concerns for reproductive and blood toxicity based on data on structurally similar borons. Since significant worker exposure is unlikely when workers wear impervious gloves, as described in the PMN, EPA has not determined that the proposed processing and use of the substance may present an unreasonable risk. EPA has determined, however, that manufacture, process, or use of the substance without dermal protection may result in serious chronic and developmental effects. Also, based on analogy to boron, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 300 ppb of the PMN substance in surface waters. Since environmental releases are not expected to exceed 300 ppb as described in the PMN, EPA has not determined that the proposed processing and use of the substance may present an unreasonable risk. EPA has determined, however, that any release of the PMN substance to surface water above 300 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that the OECD reproductive toxicity screen in rats (OECD guideline no. 421) with special attention to hematology would help to characterize the human health effects. If this screen is positive for reproductive toxicity, a reproductive fertility study in rats (40 CFR 799.9380) is recommended. In addition, the following acute aquatic toxicity tests would help to characterize the environmental effects: algal (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)); daphnid (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)); and fish (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)). CFR citation: 40 CFR 721.1731.

    PMN Number P-97-648

    Chemical name: Benzeneamine, 3,5-Difluoro-. CAS number: 372-39-4. Effective date of section 5(e) consent order: May 15, l998. 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, and that there may be significant or substantial human exposure to the PMN substance. Toxicity concern: Based on test data submitted with the PMN and data on structurally analogous chemicals (primarily aniline), the substance may cause neurotoxicity, mutagenicity, carcinogenicity, maternal and developmental toxicity, and blood effects to workers via both inhalation and dermal exposure. The substance has been shown to be acutely toxic and neurotoxic in test animals. Recommended testing: EPA has determined that a combined repeated dose 90-day study via oral route in rats with histopathology (OECD Testing Protocol guideline no. 422), an in vitro mouse lymphoma test (40 CFR 799.9530), and an in vivo micronucleus test (40 CFR 799.9539) would help to characterize the human health effects of the PMN substance. The PMN submitter has agreed not to exceed the production volume limit in the consent order without performing these tests. A 2-year oral carcinogenicity study in rats (40 CFR 799.9420) would also 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: algal (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)); fish (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)); and daphnid (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)). CFR citation: 40 CFR 721.1055.

    PMN Number P-97-649

    Chemical name: Hydrazinecarboxamide, N-(3,5-difluorophenyl-). CAS number: 167412-23-9. Effective date of section 5(e) consent order: May 15, l998. 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 test data submitted with the PMN and data on structurally analogous chemicals (primarily aniline), the substance may cause neurotoxicity, mutagenicity, carcinogenicity, maternal and

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    developmental toxicity, and blood effects to workers via inhalation exposure and via dermal exposure when in a solvent. Recommended testing: EPA has determined that a combined repeated dose 90-day study via oral route in rats with histopathology (OECD Testing Protocol guideline no. 422) and an in vivo micronucleus test (40 CFR 799.9539) would help to characterize the human health effects of the PMN substance. The PMN submitter has agreed not to exceed the production volume limit in the consent order without performing these tests. CFR citation: 40 CFR 721.4265.

    PMN Number P-97-661

    Chemical name: (generic) Alkyl substituted aromatic glycidyl ether. CAS number: Not available. Effective date of section 5(e) consent order: August 10, 1998. 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 and the environment. Toxicity concern: Based on data on structurally analogous epoxide chemicals, the substance may cause skin irritation, developmental toxicity, male reproductive toxicity, mutagenicity, carcinogenicity, liver and kidney toxicity and environmental toxicity. Recommended testing: EPA has determined that a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline) is required to help characterize the human health effects of the substance. The PMN submitter has agreed not to exceed the production volume limit in the consent order without performing this test. A 2- year, two-species oral carcinogencity study (40 CFR 799.4200 or OPPTS 870.4200 test guideline) is also recommended to help characterize the human health effects of the PMN substance. In addition, the following aquatic toxicity test would help to characterize the environmental effects: acute algal (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)); chronic fish (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft)); and chronic daphnid (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft)) would help to characterize the environmental effects of the substance. CFR citation: 40 CFR 721.3845.

    PMN Number P-98-105

    Chemical name: (generic) Cycloaliphatic epoxy resin. CAS number: Not available. Effective date of section 5(e) consent order: August 7, l998. Basis for section 5(e) consent order: The order was issued under section 5(e)(1)(A)(i) and section 5(e)(l)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. Toxicity concern: Structurally similar epoxides have been shown to cause mutagenicity, carcinogenicity, male reproductive toxicity, lung toxicity, and skin and lung sensitization in test animals. Recommended testing: EPA has determined that a 90-day subchronic oral toxicity test in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline) and a chronic/carcinogenicity oral study in rats (40 CFR 798.3320) would help to characterize the health effects of the PMN substance. The PMN submitter has agreed not to exceed the production volume limit without performing the 90-day test. CFR citation: 40 CFR 721.2755

    PMN Number P-98-150

    Chemical name: Poly[oxy(methyl-1,2-ethanediyl)],-(1-oxo-2- propenyl)--[(tetrahydro-2furanyl)methoxy]-. CAS number: 149303-87-7. Effective date of section 5(e) consent order: July 13, 1998. 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 structural analogy to acrylates/ methacrylates, EPA expects toxicity to aquatic organisms to occur at a concentration as low as 1 ppb when the average number of moles of the propoxy group is 12-14, as low as 20 ppb when the average number of moles of the propoxy group is 5, and as low as 40 ppb when the average number of moles of the propoxy group is equal to 2. Recommended testing: EPA has determined that the results of the following acute aquatic toxicity tests: algal (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)); daphnid (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)); and fish (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)) would help to characterize possible environmental effects of the substance when the average number of moles of the propoxy group is between 5 and 14. CFR citation: 40 CFR 721.3310.

    PMN Numbers P-98-315/316/317/318

    Chemical names: (P-98-315) Bicyclo[2.2.1]hept-2-ene, 5-butyl-; (P-98- 316) Bicyclo[2.2.1]hept-2-ene, 5-hexyl-; (P-98-317) Bicyclo[2.2.1]hept- 2-ene, 5-octyl-; (P-98-318) Bicyclo[2.2.1]hept-2-ene, 5-decyl-. CAS numbers: 22094-81-1, 22094-83-3, 22094-84-4, and 22094-85-5. Basis for action: The PMN substances will be used as monomers for specialty polymers. Based on structural analogy to neutral organics, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb. 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 releases to surface waters may cause significant adverse environmental effects. Based on this information the PMN substances meet the concern criteria at Sec. 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 citations: 40 CFR 721.4105 (P-98-315); 40 CFR 721.4106 (P-98-316); 40 CFR 721.4107 (P-98-317); 40 CFR 721.4108 (P-98-318).

    PMN Number P-98-400

    Chemical name: Amines, C12-14-tert-alkyl, sulfonates. CAS number: 197527-19-8. Basis for action: The PMN substance will be used as an extreme pressure lubricant additive in metalworking fluids. Based on structural analogy to aliphatic amines, 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 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

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    the concern criteria at Sec. 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 721.644.

    PMN Number P-98-475

    Chemical name: Benzenesulfonic acid, 2,2'-[(1E)-1,2- ethenediyl] bis[5-

    [[4-(methylamino)-6-[[4-[(methylamino)carbonyl] phenyl]amino]-1,3,5- triazin-2-yl]amino]-,disodium salt. CAS number: 180850-95-7. Effective date of section 5(e) consent order: June 27, 1998. 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), and section 5(e)(1)(A)(ii) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health, that the PMN substance will be produced in substantial quantities, and there may be significant or substantial human exposure to the substance. Toxicity concern: Test data on structurally similar chemicals have been shown to cause reproductive and developmental effects in test animals. Recommended testing: EPA has determined that an oral developmental toxicity test in rabbits (40 CFR 799.9370) would help to characterize the human health effects. The PMN submitter has agreed not to exceed the production volume limit without performing this test. CFR citation: 40 CFR 721.9785.

    PMN Number P-98-604

    Chemical name: (generic) Modified magnesium silicate polymer. CAS number: Not available. Basis for action: This PMN substance will be used as an additive in a polymer. EPA has identified health concerns for lung toxicity/fibrosis and cancer based on data on structurally similar compounds. Since significant inhalation exposure is unlikely because there is no inhalation exposures for the uses 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 in a powdered form may cause serious chronic effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(C) and (b)(3)(ii). Recommended testing: EPA has determined that a 90-day subchronic inhalation toxicity test (40 CFR 798.2450) and a 2-year, two-species inhalation carcinogenicity study (40 CFR 799.9420) would help to characterize the human health effects. CFR citation: 40 CFR 721.9513.

    PMN Number P-98-645

    Chemical name: (generic) Substituted perfluoroalkyl sulfonamide. CAS number: Not available. Basis for action: The PMN substance will be used as a polymer additive. 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, 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 Sec. 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 721.9573.

    PMN Number P-98-679

    Chemical name: (generic) Alkylbenzenesulfonic acid. CAS number: Not available. Basis for action: The PMN substance will be used as an extreme pressure lubricant additive in metalworking fluids. 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 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 releases to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at Sec. 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 721.1655.

    PMN Number P-98-716

    Chemical name: Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-

    [bis(2hydroxypropyl)amino] -6-[(3-sulfophenyl)amino]-1,3,5-triazin-2- yl]amino]-, disodium salt, compd. with 2,2',2''-nitrilotris[ethanol] (1:2); Benzenesulfonic acid, 5-[[4-[bis(2-hydroxyethyl)amino]-6-[(3- sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-[2-[4-[[4-[bis(2- hydroxypropyl)amino]-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2- yl]amino]-2-sulfophenyl]ethenyl]-disodium salt-, compd.with 2,2',2''- nitrilotris[ethanol] (1:2). CAS numbers: 198716-46-0 and 198716-48-2. Basis for action: The PMN substance will be used as a textile whitening agent. Based on toxicity data for structurally similar substances, EPA has identified health concerns for developmental toxicity. Since significant worker exposure is unlikely because it would not be manufactured, processed, or used as a powder or solid, 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 solid or powder may cause serious developmentally toxic effects. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(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) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.9790.

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    PMN Number P-98-718

    Chemical name: (generic) Mixed alkyl phenolic novolak resin. CAS number: Not available. Basis for action: The PMN substance will be used as a raw material in the manufacture of photoresist. Based on structural analogy to polyphenols, 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, 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 Sec. 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 721.5380.

    PMN Number P-98-725

    Chemical name: Amides, tall-oil fatty, N-[2-[2- hydroxyethyl)amino]ethyl], reaction products with sulfur dioxide; Fatty acids, tall-oil, reaction products with 1-piperazineethanamine and sulfur dioxide; and Fatty acids, tall-oil reaction products with sulfur dioxide and triethylenetetramine. CAS numbers: 202483-48-5, 203809-20-5, and 204401-83-2. Basis for action: The PMN substance will be used as a corrosion inhibitor for oil and gas production and pipelines. Based on structural analogy to amphoteric 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, 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 Sec. 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 721.9672.

    PMN Number P-98-774

    Chemical name: (generic) Benzenesulfonic acid, 2,2'-(1,2- ethenediyl)bis[(4,6-dichloro-1,3,5-triazin-2-yl)amino]-, disodium salt; substituted with dialkyl amines. CAS number: Not available. Basis for action: The PMN substance will be used as a chemical intermediate. Based on toxicity data on structurally similar substances, EPA has identified health concerns for developmental toxicity. 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 developmentally toxic effects. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(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) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.9795.

    PMN Number P-98-807

    Chemical name: (generic) Alkoxylated acrylate polymer. CAS number: Not available. Basis for action: The PMN substance will be used as a formulation component for Ultra Violet (UV) curable photo polymer, a formulation component for UV curable coatings and a chemical intermediate. Based on an analogy to acrylates, 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 unlikely as the substance is not released to surface waters resulting in concentrations greater than 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 releases to surface waters greater than 10 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at Sec. 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 721.324.

    PMN Numbers P-98-843 and P-86-65

    Chemical name: (generic) Phenyl, alkyl, hydroxyalkyl substituted imidazole. CAS number: Not available. Basis for action: The PMN substance will be used as a curing agent in the manufacture of liquid epoxy adhesive. EPA has a concern for neurotoxicity based on structural analogy to methylimidiazoles and a concern for irritation to mucous membranes and eyes based on structural analogy to imidazole. Since significant worker exposure is unlikely when workers wear respiratory equipment, 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 without respiratory protection could result in exposures that may cause serious chronic effects. Additionally, based on analogy to aliphatic amines, EPA is also concerned that toxicity to aquatic organisms may occur at a concentration as low as 9 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 releases to surface waters may cause significant adverse environmental effects. Based on this

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    information the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that an acute oral study in rats (OPPTS 870.1100 test guideline) and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline) would help to characterize the health effects of the PMN substance. The PMN submitter has agreed not to exceed the production volume limit in the consent order without conducting these tests. EPA has also 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 721.4472.

    PMN Number P-98-1036

    Chemical name: Hydrofluoric acid, reaction products with heptane. CAS number: 207409-71-0. Basis for action: The PMN substance will be used as a chemical intermediate. Based on toxicity data on structurally similar substances, EPA has identified health concerns for developmental toxicity, cardiosensitization, reproductive toxicity in males, neurotoxicity, and liver toxicity. Since significant worker exposure is unlikely when the substance is used as an intermediate, 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 an intermediate could result in exposures which may cause serious chronic effects. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(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) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.4385.

    PMN Number P-98-1043

    Chemical name: (generic) Substituted amino alkyl triazinyl benzenesulfonic acid derivative. CAS number: Not available. Basis for action: This PMN substance will be used as an additive in a polymer. EPA has identified health concerns for lung toxicity/fibrosis and cancer based on data on structurally similar compounds. Since significant worker exposure is unlikely when the substance is processed and 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 manfacture of the substance could result in exposures which may cause serious chronic effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(1)(i)(C). Recommended testing: EPA has determined that a 90-day subchronic inhalation toxicity test (40 CFR 798.2450 or OPPTS 870.3465 test guideline) and a 2-year, two-species inhalation carcinogenicity study (40 CFR 798.3300 or OPPTS 870.4200 test guideline) would help to characterize the human health effects. CFR citation: 40 CFR 721.9810.

    PMN Numbers P-98-1046/1047

    Chemical name: (generic) Fluoroalkyl diester. CAS number: Not available. Basis for action: These PMN substances will be used as site limited intermediates in the production of a fluorinated compound. Based on structural analogy to esters, 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. 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 releases to surface waters may cause significant adverse environmental effects. Based on this information the PMN substances meets the concern criteria at Sec. 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 721.2385.

    PMN Number P-98-1048

    Chemical name: 3-furancarboxaldehyde, tetrahydro-. CAS number: 79710-86-4. Basis for action: The PMN substance will be used as a chemical intermediate. Based on toxicity data on structurally similar substances, EPA has identified health concerns for immunotoxicity, carcinogenicity, neurotoxicity, male reproductive toxicity, and corrosion to eyes, lung, and mucous membranes. Since significant worker exposure is unlikely when the substance is manufactured, processed, and used as an intermediate 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 intermediate could result in exposures which may cause serious chronic effects. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(ii) and (b)(1)(i)(C). Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in two-species (40 CFR 798.4900 or OPPTS 870.3700 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.2087.

    PMN Number P-98-1162

    Chemical name: 1,3-Benzenedicarboxylic acid, bis[[4-

    [(ethenyloxy)methyl] cyclohexyl] methyl] ester. CAS number: 119581-93-0. Basis for action: The PMN substance will be used as a radiation curable coating, ink, and adhesives. Based on structural analogy to 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 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 releases to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at Sec. 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

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    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 721.1576.

    PMN Number P-98-1163

    Chemical name: 1,4-Benzenedicarboxylic acid, bis[4-(ethenyloxy) butyl] ester. CAS number: 117397-31-6. Basis for action: The PMN substance will be used as a radiation curable coating, ink, and adhesives. Based on structural analogy to esters, 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 releases to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at Sec. 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 721.1577.

    PMN Number P-98-1164

    Chemical name: 1,4-Benzenedicarboxylic acid, bis[[4-

    [(ethenyloxy)methyl] cyclohexyl] methyl] ester. CAS number: 209072-72-0. Basis for action: The PMN substance will be used as a radiation curable coating, ink, and adhesives. Based on structural analogy to 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 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 releases to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at Sec. 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 721.1578.

    PMN Number P-98-1165

    Chemical name: 1,2,4-Benzenetricarboxylic acid, tris [4-(ethenyloxy) butyl] ester. CAS number: 196109-17-8. Basis for action: The PMN substance will be used as a radiation curable coating, ink, and adhesives. Based on structural analogy to esters, EPA is concerned that toxicity to aquatic organisms 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, 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 Sec. 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 721.1579.

    PMN Number P-98-1172

    Chemical name: (generic) Amine salt of organic acid. CAS number: Not available. Basis for action: This PMN substance will be used as a stabilizer for polymerization. Based on structural analogy to esters, EPA is concerned that toxicity to aquatic organisms 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, 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 Sec. 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 721.5465.

    PMN Number P-98-1222

    Chemical name: (generic) Benzenesulfonic acid, 2,2'-(1,2- ethanediyl)bis[5-[[4-substituted-6-substituted-1,3,5-triazin-2- yl]amino]-, sodium salt. CAS number: Not available. Basis for action: The PMN substance will be used as a fluorescent brightener in cellulosic paper applications. Based on submitted test data and analogy to structurally similar substances, EPA has identified health concerns for kidney effects and developmental toxicity. Since significant worker exposure is unlikely as the substance is not manufactured, processed, or used as a powder or a solid, as described in the PMN, EPA has not determined that the proposed manufacture, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance as a powder or solid could result in inhalation exposures that may cause serious chronic and developmentally toxic effects. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(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)

    [[Page 364]]

    would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.9798.

  4. 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 11 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. of this preamble. 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 29 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.

  5. 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 March 6, 2000, unless EPA receives a written notice before February 4, 2000 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 withdraw 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.

  6. 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. of this preamble 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. of this preamble. 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.

  7. 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 Sec. 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 Sec. 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 Sec. 721.1725(b)(1) with that under Sec. 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

    [[Page 365]]

    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 Sec. 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 Sec. 721.1725(b)(1).

  8. 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 12 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, 18 of the 41 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 (55 FR 17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant new use as of the date of publication 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 until the notice review period, including all extensions, expires.

    EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under Sec. 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.

  9. 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-50635).

  10. 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 SNURs are not a ``significant regulatory action'' subject to review by OMB, because SNURs do not meet the criteria in section 3(f) of the Executive Order.

    Based on EPA's experience with past 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 affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

    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 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 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 involve special considerations of environmental justice related issues as required 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), Pub. L. 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 has determined that the promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities. The Agency's generic certification for the

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    promulgation of new SNURs appears on June 2, l997 (62 FR 29684) (FRL- 5597-1) and 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 any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, OP Regulatory Information Division, Environmental Protection Agency (Mail Code 2137), 401 M St., SW., Washington, DC 20460. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

  11. 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 rule may take effect, the Agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 721

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

    Dated: December 20, 1999.

    Charles M. Auer,

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

    Therefore, 40 CFR part 721 is amended as follows:

    PART 721--[AMENDED]

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

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

    2. By adding new Sec. 721.324 to subpart E to read as follows:

      Sec. 721.324 Alkoxylated acrylate polymer (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkoxylated acrylate polymer (PMN P-98-807) is subject to 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 Sec. 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 Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of these substances.

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

    3. By adding new Sec. 721.329 to subpart E to read as follows:

      Sec. 721.329 Halogenated benzyl ester acrylate (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halogenated benzyl ester acrylate (PMN P-90-1527) is subject to 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 Sec. 721.63 (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iv), (a)(5)(v), (a)(6)(i), (b), and (c) (concentration set at 1.0 percent). The reporting requirement for Sec. 721.63(a)(5)(i) applies only during manufacture. The reporting requirement for Sec. 721.63 (a)(5)(ii), (a)(5)(iv), and (a)(5)(v) applies only during processing.

      (ii) Hazard communication program. Requirements as specified in Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g), (g)(1)(iv), (g)(2)(ii), (g)(2)(iv), and (g)(5). The following statement shall appear on each label as specified in Sec. 721.72(b) and the Material Safety Data Sheet (MSDS) as specified in Sec. 721.72 (c): The substance may cause internal organ effects (kidney and blood). The requirements of this section do not apply when the PMN substance is bound or embedded into a plastic, resin matrix, or pellet.

      (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 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 Sec. 721.125 (a), (b), (c), (d), (f), (g), (h), and (i).

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

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

    4. By adding new Sec. 721.644 to subpart E to read as follows:

      Sec. 721.644 Amines, C12-14-tert-alkyl, sulfonates.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as amines, C12-14-tert-alkyl, sulfonates (PMN P-98-400; CAS No. 197527- 19-8) 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) Release to water. Requirements as specified in Sec. 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 Sec. 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

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      provisions of Sec. 721.185 apply to this section.

    5. By adding new Sec. 721.1055 to subpart E to read as follows:

      Sec. 721.1055 Benzeneamine, 3,5-difluoro-.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzeneamine, 3,5- difluoro- (PMN P-97-648; CAS No. 372-39-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Protection in the workplace. Requirements as specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(v), (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 new chemical exposure limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. This NCEL is set at 0.4 mg/ m3.

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

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

      (iv) Release to water. Requirements as specified in Sec. 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. The following recordkeeping requirements are applicable to manufacturers, importers, and processors of this substance, as specified in Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i) and (k).

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

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

    6. By adding new Sec. 721.1576 to subpart E to read as follows:

      Sec. 721.1576 1,3-Benzenedicarboxylic acid, bis[[4-

      [(ethenyloxy)methyl] cyclohexyl] methyl] ester.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3- benzenedicarboxylic acid, bis[[4-[(ethenyloxy)methyl] cyclohexyl] methyl] ester (PMN P-98-1162; CAS No. 119581-93-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Release to water. Requirements as specified in Sec. 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 Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of these substances.

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

    7. By adding new Sec. 721.1577 to subpart E to read as follows:

      Sec. 721.1577 1,4-Benzenedicarboxylic acid, bis [4-(ethenyloxy) butyl] ester.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,4- benzenedicarboxylic acid, bis[4-(ethenyloxy) butyl] ester (PMN P-98- 1163; CAS No. 117397-31-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Release to water. Requirements as specified in Sec. 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 Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of these substances.

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

    8. By adding new Sec. 721.1578 to subpart E to read as follows:

      Sec. 721.1578 1,4-Benzenedicarboxylic acid, bis[[4-

      [(ethenyloxy)methyl] cyclohexyl] methyl] ester.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,4- benzenedicarboxylic acid, bis[[4-[(ethenyloxy)methyl] cyclohexyl] methyl] ester (PMN P-98-1164; CAS No. 209072-72-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Release to water. Requirements as specified in Sec. 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 Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of these substances.

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

    9. By adding new Sec. 721.1579 to subpart E to read as follows:

      Sec. 721.1579 1,2,4-Benzenetricarboxylic acid, tris [4-(ethenyloxy) butyl] ester.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2,4- benzenetricarboxylic acid, tris [4-(ethenyloxy) butyl] ester (PMN P-98- 1165; CAS No. 196109-17-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Release to water. Requirements as specified in Sec. 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 Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of these substances.

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

    10. By adding new Sec. 721.1655 to subpart E to read as follows:

      Sec. 721.1655 Alkylbenzenesulfonic acid (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylbenzenesulfonic acid (PMN P-98-679) 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 Sec. 721.90 (a)(1), (b)(1), and (c)(1).

      (ii) [Reserved]

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

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      apply to this section except as modified by this paragraph.

      (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 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 Sec. 721.185 apply to this section.

    11. By adding new Sec. 721.1729 to subpart E to read as follows:

      Sec. 721.1729 Boric acid (H3BO3), mixed esters with polyethylene glycol mono-Bu ether and polyethylene glycol mono Me ether.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as boric acid (H3BO3), mixed esters with polyethylene glycol mono-Bu ether and polyethylene glycol mono Me ether (PMN P-97-635; CAS No. 183290-62-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

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

      (ii) Release to water. Requirements as specified in Sec. 721.90 (a)(4), (b)(4), and (c)(4) (N=300).

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

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

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

    12. By adding new Sec. 721.1730 to subpart E to read as follows:

      Sec. 721.1730 Poly(oxy-1,2-ethanediyl), -butyl-- hydroxy, ester with boric acid (H3BO3).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,2- ethanediyl), -butyl--hydroxy, ester with boric acid (H3BO3) (PMN P-97-636; CAS No. 106008-93-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

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

      (ii) Release to water. Requirements as specified in Sec. 721.90 (a)(4), (b)(4), and (c)(4) (N=300).

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

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

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

    13. By adding new Sec. 721.1731 to subpart E to read as follows:

      Sec. 721.1731 Poly(oxy-1,2-ethanediyl), -methyl-- hydroxy, ester with boric acid (H3BO3).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,2- ethanediyl), -methyl--hydroxy, ester with boric acid (H3BO3) (PMN P-97-637; CAS No. 106008-94-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

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

      (ii) Release to water. Requirements as specified in Sec. 721.90 (a)(4), (b)(4), and (c)(4) (N=300).

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

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

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

    14. By adding new Sec. 721.2087 to subpart E to read as follows:

      Sec. 721.2087 3-furancarboxaldehyde, tetrahydro-.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a 3- furancarboxaldehyde, tetrahydro- (PMN P-98-1048; CAS No. 79710-86-4) 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 Sec. 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 Sec. 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 Sec. 721.185 apply to this section.

    15. By adding new Sec. 721.2385 to subpart E to read as follows:

      Sec. 721.2385 Fluoroalkyl diester (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fluoroalkyl diester (PMNs P-98-1046 and P-98-1047) is subject to 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 Sec. 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 Sec. 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 Sec. 721.185 apply to this section.

    16. By adding new Sec. 721.2755 to subpart E to read as follows:

      Sec. 721.2755 Cycloaliphatic epoxy resin (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cycloaliphatic epoxy resin (PMN P-98-105) is subject to 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 Sec. 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(6)(ii), (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 section 5(e) consent order for this substance. The NCEL is 0.3 mg/m3.

      (ii) Hazard communication program. Requirements as specified in Sec. 721.72 (a), (b), (c), (d), (e) (concentration set 0.1 percent), (f), (g)(1)(vi), (g)(1)(vii),

      [[Page 369]]

      (g)(2)(i), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5).

      (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 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 Sec. 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 Sec. 721.185 apply to this section.

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

    17. By adding new Sec. 721.3025 to subpart E to read as follows:

      Sec. 721.3025 Fatty acids C12-18, C18 unsaturated, C12-18alkyl esters (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids C12-18, C18unsaturated, C12-18 alkyl esters (PMNs P-94-697 through P-94-895) is subject to 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 Sec. 721.80(p) (750,000 kilograms).

      (ii) Hazard communication program. A significant new use of these substances is any manner or method of manufacture, import, or processing associated with any use of these substances without providing risk notification as follows:

      (A) If as a result of the test data required under the TSCA section 5(e) consent order for these substances, the employer becomes aware that these substances may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in Sec. 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substances are reintroduced into the workplace.

      (B) The employer must ensure that persons who will receive or who have received the substances from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A), are provided an MSDS as described in Sec. 721.72(c) containing the information required under paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes aware of the new information.

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

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

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

    18. By adding new Sec. 721.3310 to subpart E to read as follows:

      Sec. 721.3310 Poly[oxy(methyl-1,2-ethanediyl)],-(1-oxo-2- propenyl)--[(tetrahydro-2-furanyl)methoxy]-.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly[oxy(methyl- 1,2-ethanediyl)],-(1-oxo-2-propenyl)--[(tetrahydro- 2-furanyl)methoxy]- (PMN P-98-150; CAS No.149303-87-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. Manufacture of the PMN substance with an average number of moles of propoxy group between 5 and 14.

      (ii) [Reserved]

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

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

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

    19. By adding new Sec. 721.3845 to subpart E to read as follows:

      Sec. 721.3845 Alkyl substituted aromatic glycidyl ether (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl substituted aromatic glycidyl ether (PMN P-97-661) 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 Sec. 721.63 (a)(1) and (a)(3).

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

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

      (iv) Release to water. Requirements as specified in Sec. 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 Sec. 721.125 (a), (b), (c),(d),(e), (f), (g), (h),(i), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

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

    20. By adding new Sec. 721.4105 to subpart E to read as follows:

      Sec. 721.4105 Bicyclo[2.2.1]hept-2-ene, 5-butyl-.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Bicyclo[2.2.1]hept- 2-ene, 5-butyl- (PMN P-98-315; CAS No. 22094-81-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Release to water. Requirements as specified in Sec. 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 Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of these substances.

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

    21. By adding new Sec. 721.4106 to subpart E to read as follows:

      [[Page 370]]

      Sec. 721.4106 Bicyclo[2.2.1]hept-2-ene, 5-hexyl-.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Bicyclo[2.2.1]hept- 2-ene, 5-hexyl- (PMN P-98-316; CAS No. 22094-83-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Release to water. Requirements as specified in Sec. 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 Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of these substances.

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

    22. By adding new Sec. 721.4107 to subpart E to read as follows:

      Sec. 721.4107 Bicyclo[2.2.1]hept-2-ene, 5-octyl-.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Bicyclo[2.2.1]hept- 2-ene, 5-octyl- (PMN P-98-317; CAS No. 22094-84-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Release to water. Requirements as specified in Sec. 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 Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of these substances.

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

    23. By adding new Sec. 721.4108 to subpart E to read as follows:

      Sec. 721.4108 Bicyclo[2.2.1]hept-2-ene, 5-decyl-.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified Bicyclo[2.2.1]hept-2- ene, 5-decyl- (PMN P-98-318; CAS No. 22094-85-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Release to water. Requirements as specified in Sec. 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 Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of these substances.

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

    24. By adding new Sec. 721.4265 to subpart E to read as follows:

      Sec. 721.4265 Hydrazinecarboxamide, N-(3,5-difluorophenyl-).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as hydrazinecarboxamide, N-(3,5-difluorophenyl-) (PMN P-97-649; CAS No. 167412-23-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Protection in the workplace. Requirements as specified in Sec. 721.63 (a)(1) (applies only when the substance is in a solution), (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(v), (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 section 5(e) consent order for this substance. The NCEL is set at 0.4 mg/m3.

      (ii) Hazard communication program. Requirements as specified in Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(i), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), (g)(1)(vii), (g)(1)(ix), (g)(2)(i) (applies only when the substance is in a solvent), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v) (applies only when the substance is in a solvent), and (g)(5).

      (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80 (g) and (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 Sec. 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 Sec. 721.185 apply to this section.

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

    25. By adding new Sec. 721.4385 to subpart E to read as follows:

      Sec. 721.4385 Hydrofluoric acid, reaction products with heptane.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a hydrofluoric acid, reaction products with heptane (PMN P-98-1036; CAS No. 207409-71- 0) 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 Sec. 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 Sec. 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 Sec. 721.185 apply to this section.

    26. By adding new Sec. 721.4472 to subpart E to read as follows:

      Sec. 721.4472 Phenyl, alkyl, hydroxyalkyl substituted imidazole (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenyl, alkyl, hydroxyalkyl substituted imidazole (PMNs P-98-843 and P-86-65) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Protection in the workplace. Requirements as specified in Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (b) (concentration set at 1.0 percent), and (c).

      (ii) Hazard communication program. Requirements as specified in Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), and (g)(1)(iii).

      (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(r) (56,000 kg) (acute oral study (OPPTS 870.1100 test

      [[Page 371]]

      guideline) followed by a (90-day subchronic inhalation study in rats (40 CFR 799.9346). A person may not manufacture or import the substance beyond the aggregate production volume limit, unless that person conducts this study on the substance and submits all final reports and underlying data in accordance with the procedures and criteria specified in paragraphs (a)(2)(iii)(A), (a)(2)(iii)(B), (a)(2)(iii)(C), and (a)(2)(iii)(D) of this section.

      (A) Each study required to be performed pursuant to this section must be scientifically valid. Scientifically valid means that the study was conducted according to:

      (1) The test guidelines specified in paragraph (a)(2)(iii) of this section.

      (2) An EPA-approved protocol.

      (3) TSCA Good Laboratory Practice Standards at 40 CFR part 792.

      (4) Using methodologies generally accepted at the time the study is initiated.

      (5) Any deviation from these requirements must be approved in writing by EPA.

      (B) Before starting to conduct any of the studies in paragraph (a)(2)(iii) of this section, the person must obtain approval of test protocols from EPA by submitting written protocols. EPA will respond to the person within 4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (a)(2)(iii) of this section (e.g., 40 CFR part 797 or part 798) provide general guidance for development of test protocols, but are not themselves acceptable protocols.

      (C) The person shall:

      (1) Conduct each study in good faith with due care.

      (2) Promptly furnish to EPA the results of any interim phase of each study.

      (3) Submit, in triplicate (with an additional sanitized copy, if confidential business information is involved), the final report of each study and all underlying data (``the report and data'') to EPA no later than 14 weeks prior to exceeding the applicable production volume limit. The final report shall contain the contents specified in 40 CFR 792.185.

      (D)(1) Except as described in paragraph (a)(2)(iii)(D)(2), if, within 6 weeks of EPA's receipt of a test report and data, the person receives written notice that EPA finds that the data generated by a study are scientifically invalid, the person is prohibited from further manufacture and import of the PMN substance beyond the applicable production volume limit.

      (2) The person may continue to manufacture and import the PMN substance beyond the applicable production limit only if so notified, in writing, by EPA in response to the person's compliance with either of the following paragraphs (a)(2)(iii)(D)(2)(i) or (a)(2)(iii)(D)(2)(ii) of this section.

      (i) The person may reconduct the study. If there is sufficient time to reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by paragraph (a)(2)(iii)(C)(3) of this section, the person shall comply with paragraph (a)(2)(iii)(C)(3) of this section. If there is insufficient time for the person to comply with paragraph (a)(2)(iii)(C)(3) of this section, the person may exceed the production limit and shall submit the report and data in triplicate to EPA within a reasonable period of time, all as specified by EPA in the notice described in paragraph (a)(2)(iii)(D)(1) of this section. EPA will respond to the person in writing, within 6 weeks of receiving the person's report and data.

      (ii) The person may, within 4 weeks of receiving from EPA the notice described in paragraph (a)(2)(iii)(D)(1) of this section, submit to EPA a written report refuting EPA's finding. EPA will respond to the person in writing, within 4 weeks of receiving the person's report.

      (E) The person is not required to conduct a study specified in paragraph (a)(2)(iii) of this section if notified in writing by EPA that it is unnecessary to conduct that study.

      (iv) Release to water. Requirements as specified in Sec. 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 Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

    27. By adding new Sec. 721.5185 to read as follows:

      Sec. 721.5185 Morpholine, 4-(1-oxo-2-propenyl)-.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as morpholine, 4-(1- oxo-2-propenyl)- (PMN P-95-169; CAS No. 5117-12-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Protection in the workplace. Requirements as specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iv), (a)(3)(i), (a)(3)(ii), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), (a)(5)(xv), (a)(6)(v), (b) (concentration set at 0. 1 percent), and (c). The following material has been tested in accordance with the American Society for Testing Materials (ASTM) F739 method and found by EPA to satisfy the consent order's and Sec. 721.63(a)(2)(i) requirements for dermal protection to 100 percent PMN substance. The following gloves have been tested in accordance with the ASTM F739 and found to satisfy the requirement for use by EPA: Safety 4/4H EVOH/PE laniinate, Ansell Edmont Neoprene number 865, and Solvex Nitrile Rubber number 275. Gloves and other dermal protection 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. For additional dermal protection materials, a company must submit all test data to the Agency and must receive written Agency approval for each type of material tested prior to use of that material as worker dermal protection. However, for the purposes of determining the imperviousness of gloves, up to 1 year after the commencement of commercial manufacture or import, the employer may use the method described in Sec. 721.63 (a)(3)(ii), thereafter, they must use the method described in Sec. 721.63 (a)(3)(i).

      (ii) [Reserved]

      (iii) Hazard communication program. Requirements as specified in Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0. 1 percent), (f), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), (g)(4)(iii), and (g)(5).

      (iv) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80 (a), (c), (f), (p): First trigger (1 year), second (1,500,000), and third (2,000,000) or 1 year whichever is greater then 7,750,000 or 5 years after the commencement of commercial manufacture, whichever comes later and Sec. 721.80(y)(1).

      (v) Disposal. Requirements as specified in Sec. 721.85 (a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). Disposal by landfill must go to a RCRA hazardous waste landfill.

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

      [[Page 372]]

      (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 Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), (j), and (k).

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

    28. By adding new Sec. 721.5380 to subpart E to read as follows:

      Sec. 721.5380 Mixed alkyl phenolic novolak resin (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed alkyl phenolic novolak resin (PMN P-98-718) 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 Sec. 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 Sec. 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 Sec. 721.185 apply to this section.

    29. By adding new Sec. 721.5465 to subpart E to read as follows:

      Sec. 721.5465 Amine salt of organic acid (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as amine salt of organic acid (PMN P-98-1172) is subject to 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 Sec. 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 Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of these substances.

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

    30. By adding new Sec. 721.9508 to subpart E to read as follows:

      Sec. 721.9508 Perfluorinatedalkyl polyhydroxysilane (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluorinatedalkyl polyhydroxysilane (PMN P-95-1400) is subject to 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 Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(v), (g)(5). The following statement shall appear on each label as specified in Sec. 721.72(b) and the MSDS as specified in Sec. 721.72(c): This substance may cause death if inhaled.

      (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(y)(1). Use in any formulation that contains alkylbenzenesulfonate emulsifiers.

      (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 Sec. 721.125 (a), (b), (c), (f), (g), (h), and (i).

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

    31. By adding new Sec. 721.9509 to subpart E to read as follows:

      Sec. 721.9509 Perfluorinatedalkyl polyalkoxysilane (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluorinatedalkyl polyalkoxysilane (PMN P-95-1410) is subject to 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 Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(v), (g)(5). The following statement shall appear on each label as specified in Sec. 721.72(b) and the MSDS as specified in Sec. 721.72(c): This substance may cause death if inhaled.

      (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(y)(1). Use in any formulation that contains alkylbenzenesulfonate emulsifiers.

      (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 Sec. 721.125 (a), (b), (c), (f), (g), (h), and (i).

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

    32. By adding new Sec. 721.9513 to subpart E to read as follows:

      Sec. 721.9513 Modified magnesium silicate polymer (generic). .

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified magnesium silicate polymer (PMN P-98-604) is subject to 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 Sec. 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 Sec. 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 Sec. 721.185 apply to this section.

    33. By adding new Sec. 721.9573 to subpart E to read as follows:

      Sec. 721.9573 Substituted perfluoroalkyl sulfonamide (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a substituted perfluoroalkyl sulfonamide (PMN P-98-645) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

      [[Page 373]]

      (2) The significant new uses are:

      (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 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 Sec. 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 Sec. 721.185 apply to this section.

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

    34. By adding new Sec. 721.9672 to subpart E to read as follows:

      Sec. 721.9672 Amides, tall-oil fatty, N-[2-[2- hydroxyethyl)amino]ethyl], reaction products with sulfur dioxide; fatty acids, tall-oil, reaction products with 1-piperazineethanamine and sulfur dioxide; fatty acids, tall-oil reaction products with sulfur dioxide and triethylenetetramine.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as amides, tall-oil fatty, N-[2-[2-hydroxyethyl)amino]ethyl], reaction products with sulfur dioxide; fatty acids, tall-oil, reaction products with 1- piperazineethanamine and sulfur dioxide; fatty acids, tall-oil reaction products with sulfur dioxide and triethylenetetramine (PMN P-98-725; CAS Nos. 202483-48-5, 203809-20-5, and 204401-83-2) 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 Sec. 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 Sec. 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 Sec. 721.185 apply to this section.

    35. By adding new Sec. 721.9785 to subpart E to read as follows:

      Sec. 721.9785 Benzenesulfonic acid, 2,2'-[(1E)-1,2- ethenediyl] bis[5-[[4-(methylamino)-6-[[4-[(methylamino)carbonyl]phenyl]amino]- 1,3,5-triazin-2-yl]amino]-,disodium salt.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzenesulfonic acid, 2,2'-[(1E)-1,2- ethenediyl] bis[5-[[4-(methylamino)-6-[[4-

      [(methylamino)carbonyl] phenyl]amino]-1,3,5-triazin-2-yl]amino]- ,disodium salt (PMN P-98-475; CAS No. 180850-95-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80 (f) and (q).

      (ii) [Reserved]

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

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

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

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

    36. By adding new Sec. 721.9790 to subpart E to read as follows:

      Sec. 721.9790 Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-

      [bis(2-hydroxypropyl) amino] - 6-[(3-sulfophenyl)amino]-1,3,5-triazin-2- yl]amino]-, disodium salt, compd. with 2,2',2''-nitrilo-tris[ethanol] (1:2); Benzenesulfonic acid, 5-[[4-[bis(2-hydroxyethyl)amino]-6-[(3- sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-[2-[4-[[4-[bis(2- hydroxypropyl)amino]-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2- yl]amino]-2-sulfophenyl]ethenyl]-, disodium salt, compd. with 2,2',2''- nitrilotris[ethanol] (1:2).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2hydroxypropyl)amino]-6-[(3- sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-, disodium salt, compd. with 2,2',2''-nitrilotris[ethanol] (1:2); Benzenesulfonic acid, 5-[[4-

      [bis(2-hydroxyethyl)amino] -6-[(3-sulfophenyl)amino]-1,3,5-triazin-2- yl]amino]-2-[2-[4-[[4-[bis(2-hydroxypropyl)amino]-6-[(3- sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl] ethenyl]-, disodium salt, compd. with 2,2',2''-nitrilotris[ethanol] (1:2) (PMN P- 98-716; CAS Nos. 198716-46-0 and 198716-48-2) 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 Sec. 721.80 (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), and (x)(2).

      (ii) [Reserved]

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

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

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

    37. By adding new Sec. 721.9795 to subpart E to read as follows:

      Sec. 721.9795 Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[(4,6- dichloro-1,3,5-triazin-2-yl) amino]-, disodium salt, substituted with dialkyl amines (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[(4,6-dichloro-1,3,5- triazin-2-yl)amino]-, disodium salt, substituted with dialkyl amines (PMN P-98-774) 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 Sec. 721.80 (v)(1), (w)(1), (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 Sec. 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 Sec. 721.185 apply to this section.

    38. By adding new Sec. 721.9798 to subpart E to read as follows:

      [[Page 374]]

      Sec. 721.9798 Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4- substituted-6-substituted-1,3,5-triazin-2-yl]amino]-, sodium salt (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-substituted-6- substituted-1,3,5-triazin-2-yl]amino]-, sodium salt (PMN P-98-1222) 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 Sec. 721.80 (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), and (x)(2).

      (ii) [Reserved]

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

      (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 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 Sec. 721.185 apply to this section.

    39. By adding new Sec. 721.9810 to subpart E to read as follows:

      Sec. 721. 9810 Substituted amino alkyl triazinyl benzenesulfonic acid derivative (generic).

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a substituted amino alkyl triazinyl benzenesulfonic acid derivative (PMN P-98-1043) 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 Sec. 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 Sec. 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 Sec. 721.185 apply to this section.

    40. By adding new Sec. 721.9965 to subpart E to read as follows:

      Sec. 721.9965 Fatty acids, C10-13- branched, vinyl esters.

      (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as fatty acids, C10-13- branched, vinyl esters (PMN P-97-482; CAS No. 184785-38-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      (2) The significant new uses are:

      (i) Protection in the workplace. Requirements as specified in Sec. 721.63 (a)(1), (a)(2), (a)(3), (a)(4), (a)(5)(ii) (if data on Cartridge Service Life Testing has been reviewed and approved in writing by EPA). The following respirators may be used as specified in Sec. 721.63 (a)(5)(xii), (a)(5)(xiii), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (a)(6)(v), (b) (concentration set at 1.0 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 section 5(e) consent order for this substance. The NCEL is 1 ppm.

      (ii) Hazard communication program. Requirements as specified in Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(i), (g)(1)(iii), (g)(1)(v), (g)(1)(vi), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), and (g)(5).

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

      (iv) Release to water. Requirements as specified in Sec. 721.90 (a)(4) and (b)(4) (N=6).

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

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

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

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

      [FR Doc. 00-179Filed1-4-00; 8:45 am]

      BILLING CODE 6560-50-F

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