98-1074. Significant New Uses of Certain Chemical Substances  

  • [Federal Register Volume 63, Number 14 (Thursday, January 22, 1998)]
    [Rules and Regulations]
    [Pages 3394-3441]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-1074]
    
    
    
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    Part II
    
    
    
    
    
    Environmental Protection Agency
    
    
    
    
    
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    40 CFR Part 721
    
    
    
    Significant New Uses of Certain Chemical Substances; Final Rule
    
    Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules 
    and Regulations
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 721
    
    [OPPTS-50628; FRL-5720-3]
    RIN 2070-AB27
    
    
    Significant New Uses of Certain Chemical Substances
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
    section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 163 
    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. EPA is promulgating this SNUR using direct final 
    procedures.
    
    DATES: The effective date of this rule is March 23, 1998. This rule 
    shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) 
    on February 5, 1998.
        If EPA receives notice before February 23, 1998 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 for the substance for which the notice of 
    intent to comment is received and will issue a proposed SNUR providing 
    a 30-day period for public comment.
    
    ADDRESSES: Each comment or notice of intent to submit adverse or 
    critical comment must bear the docket control number OPPTS-50628 and 
    the name(s) of the chemical substance(s) subject to the comment. All 
    comments should be sent in triplicate to: OPPT Document Control Officer 
    (7407), Office of Pollution Prevention and Toxics, Environmental 
    Protection Agency, 401 M Street, SW., Room G-099, East Tower, 
    Washington, DC 20460.
        Comments and data may also be submitted electronically to: 
    oppt.ncic@epamail.epa.gov. Follow the instructions under Unit X of this 
    document. No Confidential Business Information (CBI) should be 
    submitted through e-mail.
        All comments which contain information claimed as CBI must be 
    clearly marked as such. Three sanitized copies of any comments 
    containing information claimed as CBI must also be submitted and will 
    be placed in the public record for this rulemaking. Persons submitting 
    information on any portion of which they believe is entitled to 
    treatment as CBI by EPA must assert a business confidentiality claim in 
    accordance with 40 CFR 2.203(b) for each portion. This claim must be 
    made at the time that the information is submitted to EPA . If a 
    submitter does not assert a confidentiality claim at the time of 
    submission, EPA will consider this as a waiver of any confidentiality 
    claim and the information may be made available to the public by EPA 
    without further notice to the submitter.
    
    FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
    Environmental Assistance Division (7408), Office of Pollution 
    Prevention and Toxics, Environmental Protection Agency, Rm. E-543A, 401 
    M St., SW., Washington, DC 20460, telephone: (202) 554-1404, TDD: (202) 
    554-0551; e-mail: TSCA-Hotline@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION:
        Electronic Availability: Electronic copies of this document are 
    available from the EPA Home Page at the Federal Register-Environmental 
    Documents entry for this document under ``Laws and Regulations'' 
    (http://www.epa.gov/fedrgstr/).
        This SNUR will require persons to notify EPA at least 90 days 
    before commencing manufacturing 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 SNURs 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.
    
    I. Authority
    
        Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
    determine that a use of a chemical substance is a ``significant new 
    use.'' EPA must make this determination by rule after considering all 
    relevant factors, including those listed in TSCA section 5(a)(2). Once 
    EPA determines that a use of a chemical substance is a significant new 
    use, 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 721.10.
    
    II. Applicability of General Provisions
    
        General provisions for SNURs appear under 40 CFR part 721, subpart 
    A. These provisions describe persons subject to the rule, recordkeeping 
    requirements, exemptions to reporting requirements, and applicability 
    of the rule to uses occurring before the effective date of the final 
    rule. Provisions relating to user fees appear at 40 CFR part 700. 
    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 section 5 (h)(1), (2), (3), and 
    (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 section 12(b) appear at 
    40 CFR part 707. Persons who intend to import a chemical substance 
    identified in a final SNUR are subject to the TSCA section 13 import 
    certification requirements, which are codified at 19 CFR 12.118 through 
    12.127 and 127.28. Such persons must certify that they are in 
    compliance with SNUR requirements. The EPA policy in support of the 
    import certification appears at 40 CFR part 707.
    
    III. Substances Subject to This Rule
    
        EPA is establishing significant new use and recordkeeping 
    requirements for the following chemical substances under 40 CFR part 
    721, subpart E. In this unit, EPA provides a brief description for each 
    substance, including its PMN number, chemical name (generic name if the 
    specific name is claimed as CBI), CAS number (if assigned and and the 
    specific chemical identity is not claimed as CBI), basis for the action 
    taken by EPA in the TSCA section 5(e) consent order or as a non-
    
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     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 B 
    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) 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) 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) 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-95-266, 95-615/616, P-95-
    941, P-95-973, P-95-1046, P-95-1115, P-95-1827, P-95-1854, P-95-2075, 
    P-96-262, P-96-291, P-96-317, P-96-576 through P-96-581, P-96-726 
    through P-96-744, P-96-803/804, P-96-1277/78, P-96-1482/1483, P-96-
    1708, P-96-1509/1519, P-96-1548 through P-96-1551, P-97-205 through P-
    97-208, and P-97-276/277 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) order is 
    usually completed within 1 to 2 years of notice of commencement (NOC). 
    EPA's experience with exposure-based SNURs requiring short-term testing 
    is that the SNUR is often revoked within 1 to 2 years when the test 
    results are received. Rather than issue and revoke SNURs in such a 
    short span of time, EPA will defer publication of exposure-based SNURs 
    until either a NOC or data demonstrating risk are received unless the 
    toxicity testing required is long-term. EPA is issuing this explanation 
    and notification as required in 40 CFR 721.160(a)(2) as it has 
    determined that SNURs are not needed at this time for these substances 
    which are subject to a final TSCA section 5(e) consent order under 
    TSCA.
    
    PMN Number P-87-323
    
    Chemical name: (generic) Poly(oxy-1,2-ethanediyl), alpha substituted-
    omega-hydroxy-, C16-20 alkyl ethers.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on submitted fish, daphnia, and algae tests on the PMN substance, 
    EPA expects toxicity to aquatic organisms at surface water 
    concentrations as low as 20 parts per billion (ppb). EPA determined 
    that use of the substance as described in the PMN did not present an 
    unreasonable risk because the substance did not exceed a concentration 
    of 20 ppb when released to surface waters. EPA has determined that 
    other uses may result in releases to surface waters above 20 ppb. Based 
    on this information the PMN substance meets the concern criteria at 
    Sec. 721.170(b)(4)(i).
    Recommended testing: EPA has determined that a chronic 60-day fish 
    early life stage toxicity test in rainbow trout (40 CFR 797.1600 or 
    OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 
    797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, 
    April 15, 1996) (FRL-5363-1)) would help characterize the environmental 
    effects of the PMN substance.
    CFR citation: 40 CFR 721.3488.
    
    PMN Number P-88-1108
    
    Chemical name: (generic) Alcohols, C6-12, ethoxylated, 
    reaction product with maleic anhydride.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a plastics 
    additive. Based on analogy to anionic surfactants, 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. EPA determined that 
    use of the substance as described in the PMN did not present an 
    unreasonable risk because the substance would not be released to 
    surface waters in significant quantities. EPA has determined that other 
    uses of the substance may result in releases to surface waters which 
    exceed the concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.524.
    
    PMN Number P-90-581
    
    Chemical name: (generic) Brominated phthalate ester.
    CAS number: Not available.
    Effective date of section 5(e) consent order: March 21, 1996.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to 
    health and the environment.
    Toxicity concern: Similar chemicals have been shown to form 
    dibenzodioxins and dibenzofurans when incinerated under combustion 
    conditions of municipal incinerators.
    
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    Recommended 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 PMN submitter has agreed not to exceed the production 
    volume limit without performing this study.
    CFR citation: 40 CFR 721.3085.
    
    PMN Numbers P-91-1131 and P-90-564
    
    Chemical name: (generic) Imidazolethione.
    CAS number: Not available.
    Effective date of section 5(e) consent order: October 25, 1995.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to human 
    health.
    Toxicity concern: Based on the submitted 90-day subchronic study, the 
    PMN substance causes thyroid and other systemic effects in test 
    animals. Based on the submitted developmental toxicity study, the PMN 
    substance causes developmental toxicity in test animals. Based on 
    analogy to structurally similar substances the PMN substance may cause 
    thyroid cancer.
    Recommended testing: A 2-year, two-species oral bioassay in rats (40 
    CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) is 
    recommended to help characterize the human health effects of the PMN 
    substance.
    CFR citation: 40 CFR 721.4469.
    
    PMN Number P-92-314
    
    Chemical name: (generic) Aryloxyarene.
    CAS number: Not available.
    Effective date of section 5(e) consent order: March 11, 1996.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to the 
    environment.
    Toxicity concern: Based on test data on this substance, there is 
    concern for toxicity to aquatic organisms, particularly effects on 
    daphnid reproduction, at concentrations as low as 1 ppb in surface 
    waters.
    Recommended testing: A 28-day chironomid sediment toxicity study (OPPTS 
    850.1790 test guideline (public draft; 61 FR 16486, April 15, 1996)) 
    (FRL-5363-1) is recommended to help characterize the toxicity of the 
    PMN substance to benthic organisms.
    CFR citation: 40 CFR 721.977.
    
    PMN Numbers P-93-204 and P-94-1870 through P-94-1874
    
    Chemical name: (generic) Phenyl substituted triazolinones.
    CAS numbers: Not available.
    Effective date of section 5(e) consent order: July 23, 1996.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that these substances may present an unreasonable risk of injury to 
    human health and the environment.
    Toxicity concern: Data on several of the PMN substances and a chemical 
    similar to P-94-1870 have shown developmental and reproductive effects, 
    blood and liver effects, and neurotoxicity in test animals.
    Recommended testing: An oral developmental toxicity study in rats (40 
    CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) and a 90-day 
    subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test 
    guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) 
    would help characterize the human health effects. A semi-continuous 
    activated sludge (SCAS) study (OPPTS 835.3210 test guideline (public 
    draft; 61 FR 16486, April 15, 1996)) (FRL-5363-1), a ready 
    biodegradability study (OPPTS 835.3110 test guideline (public draft; 61 
    FR 16486, April 15, 1996)) (FRL-5363-1), and a soil sediment adsorption 
    isotherm (40 CFR 796.2750 or OPPTS 835.1220 test guideline (public 
    draft; 61 FR 16486, April 15, 1996) (FRL-5363-1) would help 
    characterize the environmental effects of the substance.
    CFR citation: 40 CFR 721.9825.
    
    PMN Number P-93-568
    
    Chemical name: (generic) Polysubstituted piperidine.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on submitted test data, 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. EPA determined that use of the substance 
    as described in the PMN did not present an unreasonable risk because 
    the substance would not be released to surface waters above a level of 
    30 ppb. EPA has determined that other uses of the substance may result 
    in releases to surface waters which exceed the concern concentration. 
    Based on this information the PMN substance meets the concern criteria 
    at Sec. 721.170(b)(4)(i).
    Recommended testing: EPA has determined that a chronic 60-day fish 
    early life stage toxicity test in rainbow trout (40 CFR 797.1600 or 
    OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 
    797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, 
    April 15, 1996) (FRL-5363-1)) would help characterize the environmental 
    effects of the PMN substance.
    CFR citation: 40 CFR 721.6165.
    
    PMN Number P-93-761
    
    Chemical name: 2-Pyrrolidinone, 1,1'-(2-methyl-1,5-pentanediyl)bis-.
    CAS number: 146453-62-5.
    Effective date of section 5(e) consent order: September 6, 1995.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to human 
    health.
    Toxicity concern: Test data on the PMN substance and similar chemicals 
    have shown that these types of chemicals cause systemic toxicity and 
    neurotoxicity in test animals.
    Recommended testing: A 90-day oral subchronic study in rats (40 CFR 
    798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, 
    June 20, 1996) (FRL-5367-7)) with additional neurotoxicity endpoints 
    following NTIS-PB91-154617 (functional observation battery, 
    neurohistopathology and motor activity) would help to characterize the 
    systemic and neurotoxicity effects. The PMN submitter has agreed not to 
    exceed the production volume limit without performing this test.
    CFR citation: 40 CFR 721.9005.
    
    PMN Number P-93-1369
    
    Chemical name: (generic) N,N'-di(alkyl heteromonocycle)amino 
    chlorotriazine.
    CAS number: Not available.
    Effective date of section 5(e) consent order: June 13, 1995.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to 
    health and the environment.
    Toxicity concern: Similar chemicals have been shown to cause systemic 
    toxicity, developmental toxicity, and cancer in test animals. In 
    addition, similar chemicals have been shown to be toxic to aquatic 
    organisms.
    Recommended testing: EPA has determined that a 90-day subchronic 
    toxicity test in rats via gavage (40 CFR 798.2650 or OPPTS 870.3100 
    test guideline (public draft; 61 FR 31522,
    
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    June 20, 1996) (FRL-5367-7)), a two-species developmental study (rodent 
    and non-rodent) (40 CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-
    5719-5) and a 2-year, one-species bioassay (rats) (40 CFR 799.9420) (62 
    FR 43838, August 15, 1997) (FRL-5719-5) would help characterize the 
    human health effects of the PMN substance. The 90-day subchronic 
    toxicity test should include special emphasis on hematology; weight of 
    the spleen and thymus; cellularity of the bone marrow, thymus, and 
    spleen; and histopathology of the liver, kidney, heart, and all 
    endocrine glands for which weight changes are observed. In addition 
    natural killer cell activity should be evaluated on the same population 
    of test animals, and IgM antibody plaque-forming cells should be 
    enumerated in two satellite groups of animals (10 in the high-dose 
    group and 10 in the control group). EPA has determined that a fish 
    acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline 
    (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid 
    acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance. 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 toxicity test. The PMN submitter has also agreed not to 
    exceed the second higher production volume limit without performing the 
    two-species developmental study and the 2-year, one-species bioassay if 
    the results of the 90-day test indicate biological activity at low 
    levels (i.e., activity levels comparable to those for triazines).
    CFR citation: 40 CFR 721.2094.
    
    PMN Number P-93-1631
    
    Chemical name: (generic) Substituted naphtholazo-substituted 
    naphthalenyl-substituted azonaphthol chromium complex.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a dye. Based on 
    analogy to structurally similar substances, EPA is concerned that 
    cancer will occur in exposed workers. Based on submitted test data, 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. 
    EPA determined that use of the substance did not present an 
    unreasonable risk because significant worker or environmental exposure 
    is not expected because the substance was used as a liquid and was not 
    manufactured domestically. EPA has determined that domestic manufacture 
    of the substance and use as a solid may result in significant worker or 
    environmental exposure. Based on this information the PMN substance 
    meets the concern criteria at Sec. 721.170 (b)(4)(i) and (b)(1)(i)(D).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) 
    would help characterize the health effects of the PMN substance and a 
    chronic 60-day fish early life stage toxicity test in rainbow trout (40 
    CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 
    16486, April 15, 1996) (FRL-5363-1)) and a 21-day daphnid chronic 
    toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public 
    draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help 
    characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.981.
    
    PMN Number P-93-1654
    
    Chemical name: (generic) Substituted polyoxyethylene.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an emulsifier for 
    paint and adhesives. Based on submitted test data and analogy to 
    nonionic surfactants, EPA is concerned that toxicity to aquatic 
    organisms may occur at a concentration as low as 9 ppb of the PMN 
    substance in surface waters. EPA determined that use of the substance 
    as described in the PMN did not present an unreasonable risk because 
    the substance would not be released to surface waters. EPA has 
    determined that other uses of the substance may result in releases to 
    surface water at concentrations above 9 ppb. Based on this information 
    the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i).
    Recommended testing: EPA has determined that a fish acute toxicity 
    study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.7378.
    
    PMN Number P-94-209
    
    Chemical name: Phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-.
    CAS number: 134701-20-5.
    Basis for action: The PMN substance will be used as an antioxidant. 
    Based on submitted test data, there is concern for liver toxicity, 
    kidney toxicity, adrenal toxicity, and blood toxicity. Based on 
    submitted test data and analogy to phenols, EPA is also concerned that 
    toxicity to aquatic organisms will occur at concentrations as low as 1 
    ppb. EPA determined that use of the substance as described in the PMN 
    did not present an unreasonable risk because workers would not be 
    subject to significant dermal exposures and there were no significant 
    environmental releases. EPA has determined that other uses of the 
    substance may result in significant dermal exposures to workers and 
    significant environmental releases. Based on this information the PMN 
    substance meet the concern criteria at Sec. 721.170 (b)(3)(i) and 
    (b)(4)(i).
    Recommended testing: EPA has determined that a dermal absorption study, 
    a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 
    870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) 
    (FRL-5367-7)), a chronic 60-day fish early life stage toxicity test in 
    rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public 
    draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and a 21-day daphnid 
    chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline 
    (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help 
    characterize the health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.5725.
    
    PMN Number P-94-921
    
    Chemical name: Phenol, 4,4'-methylenebis[2,6-dimethyl-.
    CAS number: 5384-21-4.
    Effective date of section 5(e) consent order: July 5, 1995.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to 
    health and the environment.
    Toxicity concern: Similar phenols have been shown to cause kidney and 
    liver toxicity, and blood effects in test animals. In addition, chronic 
    fish and daphnid tests and a high bioconcentration potential indicated 
    a concern concentration of 6 ppb.
    Recommended testing: EPA has determined that a 90-day subchronic
    
    [[Page 3398]]
    
    oral toxicity test in rats (40 CFR 798.2650 or OPPTS 870.3100 test 
    guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) 
    would help to characterize the human health effects of the PMN 
    substance. EPA has also determined that a modified SCAS test (OPPTS 
    835.3210 test guideline (public draft; 61 FR 16486, April 15, 1996)) 
    (FRL-5363-1), an aerobic aquatic biodegradation test (40 CFR 796.3100 
    or OPPTS 835.3100 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1), and an anaerobic biodegradability of organic 
    chemicals (OPPTS 835.3400 test guideline (public draft; 61 FR 16486, 
    April 15, 1996)) (FRL-5363-1) would help to charactarize the 
    environmental effects. The PMN submitter has agreed not to exceed the 
    production volume limit without performing the 90-day subchronic 
    toxicity test.
    CFR citation: 40 CFR 721.5730.
    
    PMN Number P-94-1017
    
    Chemical name: Urea, tetraethyl-.
    CAS number: 1187-03-7.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on submitted test data EPA is concerned that toxicity to aquatic 
    organisms may occur at a concentration as low as 1 ppm of the PMN 
    substance in surface waters. Based on analogy to similar ureas and 
    submitted test data EPA is concerned that acute toxicity, mutagenicity, 
    developmental effects, and reproductive effects could occur to exposed 
    workers. EPA determined that use of the substance as described in the 
    PMN did not present an unreasonable risk because the substance would 
    not be released to surface waters and exposed workers would wear 
    adequate protective equipment to prevent dermal exposure. EPA has 
    determined that other uses of the substance may result in releases to 
    surface waters which exceed the concern concentration or dermal 
    exposure to workers. Based on this information the PMN substance meets 
    the concern criteria at Sec. 721.170 (b)(2), (b)(3)(ii), and (b)(4)(i).
    Recommended testing: EPA has determined that a chronic 60-day fish 
    early life stage toxicity test in rainbow trout (40 CFR 797.1600 or 
    OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 
    797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, 
    April 15, 1996) (FRL-5363-1)) would help characterize the environmental 
    effects of the PMN substance. EPA has determined that a dermal 
    developmental toxicity test in rabbits and rats (40 CFR 799.9370) (62 
    FR 43832, August 15, 1997) (FRL-5719-5) and a chromosome aberration 
    assay in mice (40 CFR 798.9538) (62 FR 43850, August 15, 1997) (FRL-
    5719-5) or a micronucleus assay in mice (40 CFR 798.9539) (62 FR 43853, 
    August 15, 1997) (FRL-5719-5) would help characterize the health 
    effects of the PMN substance. The PMN submitter has agreed to conduct 
    the health tests before reaching the production volume limit in the 
    SNUR.
    CFR citation: 40 CFR 721.9928.
    
    PMN Number P-94-1018
    
    Chemical name: Guanidine, pentaethyl-.
    CAS number: 13439-89-9.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on submitted test data, EPA is concerned that acute toxicity, 
    corrosivity, and neurotoxicity could occur to exposed workers. EPA 
    determined that use of the substance as described in the PMN did not 
    present an unreasonable risk because exposed workers would wear 
    adequate protective equipment to prevent dermal exposure. EPA has 
    determined that other uses of the substance may result in exposure to 
    workers. Based on this information the PMN substance meets the concern 
    criteria at Sec. 721.170 (b)(2) and (b)(3)(i).
    Recommended testing: None.
    CFR citation: 40 CFR 721.4085.
    
    PMN Number P-94-1019
    
    Chemical name: Ethanaminium, N-[bis(diethylamino)-methylene]-N-ethyl-, 
    bromide.
    CAS number: 89610-32-2.
    Basis for action: The PMN substance will be used as a catalyst. Based 
    on submitted test data, 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. EPA determined that use of the substance 
    as described in the PMN did not present an unreasonable risk because 
    the substance would not be released to surface waters. EPA has 
    determined that other uses of the substance may result in releases to 
    surface waters which exceed the concern concentration. Based on this 
    information the PMN substance meets the concern criteria at 
    Sec. 721.170(b)(4)(i).
    Recommended testing: EPA has determined that a chronic 60-day fish 
    early life stage toxicity test in rainbow trout (40 CFR 797.1600 or 
    OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 
    797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, 
    April 15, 1996) (FRL-5363-1)) would help characterize the environmental 
    effects of the PMN substance.
    CFR citation: 40 CFR 721.4090.
    
    PMN Number P-94-1143
    
    Chemical name: Butanoic acid, antimony (3+) salt.
    CAS number: 53856-17-0.
    Effective date of section 5(e) consent order: July 7, 1995.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to 
    health.
    Toxicity concern: Similar chemicals have been shown to cause cancer, 
    dermal and ocular irritation, cardiovascular effects, neurotoxic 
    effects, reproductive toxicity, and developmental toxicity in test 
    animals.
    Recommended testing: A pharmacokinetic test (OPPTS 870.8223 test 
    guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) is 
    recommended to help determine the bioavailability of the PMN substance 
    after dermal administration. The PMN submitter has agreed not to exceed 
    the production volume limit without performing this test.
    CFR citation: 40 CFR 721.1930.
    
    PMN Number P-94-1743
    
    Chemical name: (generic) Isophorone diisocyanate neopentyl glycol 
    adipate polyurethane prepolymer.
    CAS number: Not available.
    Effective date of section 5(e) consent order: December 8, 1995.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to human 
    health.
    Toxicity concern: Test data on the substance and similar diisocyanates 
    have shown them to cause skin sensitization and chronic lung toxicity 
    in test animals.
    Recommended testing: EPA has determined that the results of an acute 
    inhalation study (OPPTS 870.1300 test guideline (public draft; 61 FR 
    31522, June 20, 1996) (FRL-5367-7)), a 28-day subchronic inhalation 
    study in rats, (Organization for Economic Cooperation and Development 
    (OECD) guideline no. 412), and a 90-day subchronic inhalation toxicity 
    study in rats (40 CFR 798.2450 or OPPT 870.3465 test guideline (public 
    draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help to 
    characterize the health effects caused by the substance. The PMN 
    submitter has agreed not to exceed the
    
    [[Page 3399]]
    
    production volume limit without performing these tests.
    CFR citation: 40 CFR 721.8079.
    
    PMN Number P-94-2159
    
    Chemical name: (generic) Anthraquinone dye.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as described in the 
    PMN. Based on submitted test data and 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. 
    EPA determined that use of the substance as described in the PMN did 
    not present an unreasonable risk because the substance would not be 
    released to surface waters. EPA has determined that other uses of the 
    substance may result in releases to surface waters which exceed the 
    concern concentration. Based on this information the PMN substance 
    meets the concern criteria at Sec. 721.170 (b)(4)(i).
    Recommended testing: EPA has determined that a fish acute toxicity 
    study modified with humic acid (40 CFR 797.1400 or OPPTS 850.1085 test 
    guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) 
    would help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.723.
    
    PMN Number P-95-168
    
    Chemical name: Phosphonic acid, methylenebis-, tetrakis(1-methylethyl) 
    ester.
    CAS number: 1660-95-3.
    Effective date of section 5(e) consent order: September 20, 1995.
    Basis for section 5(e) consent order: The Order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to human 
    health.
    Toxicity concern: Similar dimethyl methyl phosphonate (DMMP) and 
    diisopropyl methylphosphonate (DIMP) chemical substances have been 
    shown to cause oncogenicity in test animals. In addition the PMN 
    substance was demonstrated to be a chromosome mutagen in a mouse 
    lymphoma study.
    Recommended testing: The Agency has determined that the results of a 2-
    year bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-
    5719-5) would help to characterize possible human effects of the 
    substance.
    CFR citation: 40 CFR 721.6075.
    
    PMN Number P-95-243
    
    Chemical name: Phenol, 4-(1,1-dimethylethyl)-, homopolymer.
    CAS number: 30813-81-1.
    Effective date of section 5(e) consent order: October 5, 1995.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to the 
    aquatic environment.
    Toxicity concern: The PMN substance has been shown to be toxic to 
    aquatic organisms. However, the substance also has the advantages of 
    eliminating or reducing volatile organic solvents, and reducing 
    exposures to residual monomers. EPA has evaluated two processor/use 
    sites where releases sometimes exceed the concern level. In light of 
    the benefits of the substance, EPA determined these releases did not 
    constitute an unreasonable risk and will allow releases at these sites 
    in the section 5(e) consent order and SNUR.
    Recommended testing: EPA has determined that an activated sludge 
    adsorption isotherm study (OPPTS 835.1110 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1), a chronic 60-day fish early 
    life stage toxicity test in rainbow trout (40 CFR 797.1600 or OPPTS 
    850.1400 test guideline (public draft; 61 FR 16486, April 15, 1996) 
    (FRL-5363-1)), a 21-day daphnid chronic toxicity test (40 CFR 797.1330 
    or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)), or a chironomid sediment toxicity test (OPPTS 
    850.1790 test guideline (public draft; 61 FR 16486, April 15, 1996) 
    (FRL-5363-1)) would help characterize possible effects of the PMN 
    substance in the aquatic environment. The consent order contains two 
    production limits. The PMN submitter has agreed not to exceed the first 
    production limit without performing the activated sludge adsorption 
    isotherm test. The PMN submitter has also agreed not to exceed the 
    second higher production limit without performing either the fish early 
    life stage with rainbow trout and the daphnid chronic toxicity tests, 
    or the chironomid sediment toxicity test, depending on the results of 
    the activated sludge adsorption isotherm test.
    CFR citation: 40 CFR 721.538.
    
    PMN Number P-95-535
    
    Chemical name: Reaction products of formalin (37%) with amine 
    C12.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an oilfield 
    chemical. Based on analogy to aliphatic amines, 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. EPA determined that use of 
    the substance as described in the PMN did not present an unreasonable 
    risk because the substance would not be released to surface waters. EPA 
    has determined that other uses of the substance may result in releases 
    to surface waters which exceed the concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.9285.
    
    PMN Numbers P-95-605/606
    
    Chemical name: (generic) Trifunctional ketoximino silane.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as described in the 
    PMN. Based on analogy of the hydrolysis product of the PMN substances 
    to similar compounds, EPA is concerned that cancer and blood effects 
    could occur to exposed workers. EPA determined that use of the 
    substances as described in the PMN did not present an unreasonable risk 
    because exposed workers would wear adequate protective equipment to 
    prevent dermal exposure. EPA has determined that other uses of the 
    substance may result in dermal exposure to workers. Based on this 
    information the PMN substance meets the concern criteria at 
    Sec. 721.170 (b)(1)(i)(D) and (b)(3)(iii).
    Recommended testing: EPA has determined that a 90-day subchronic study 
    in rats by the oral route (40 CFR 798.2650 or OPPTS 870.3100 test 
    guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) and 
    a 2-year, two-species bioassay (40 CFR 799.9420) (62 FR 43838, August 
    15, 1997) (FRL-5719-5) would help characterize the health effects of 
    the PMN substance.
    CFR citation: 40 CFR 721.9497.
    
    PMN Number P-95-633
    
    Chemical name: (generic) Sodium salt of azo acid dye.
    CAS number: Not available.
    Basis for action: The PMN substance will be used in a non-dispersive 
    use.
    
    [[Page 3400]]
    
    Based on analogy of the azo reduction products to structurally similar 
    substances, EPA is concerned that cancer and systemic toxicity will 
    occur in exposed workers. EPA determined that use of the substance did 
    not present an unreasonable risk because significant worker exposure is 
    not expected because the substance was not manufactured, processed, or 
    used as a powder. EPA has determined that manufacture, processing, and 
    use of the substance as a powder may result in significant worker 
    exposure. Based on this information the PMN substance meets the concern 
    criteria at Sec. 721.170 (b)(1)(i)(D) and (b)(3)(iii).
    Recommended testing: EPA has determined that a 90-day subchronic study 
    in rats by the oral route with special attention to the liver, kidney, 
    spleen, and blood (40 CFR 798.2650 or OPPTS 870.3100 test guideline 
    (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help 
    characterize the health effects of the substance.
    CFR citation: 40 CFR 721.980.
    
    PMN Number P-95-637
    
    Chemical name: 2-Pentene, 1,1,1,2,3,4,4,5,5,5-decafluoro-.
    CAS number: 72804-49-0.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on toxicity data submitted with the PMN, EPA identified health 
    concerns for neurotoxicity. EPA determined that use of the substance as 
    described in the PMN did not present an unreasonable risk because 
    significant human exposure is not expected. EPA has determined that use 
    of the substance other than as described in the PMN may result in 
    significant human exposure. Based on this information the PMN substance 
    meets the concern criteria at Sec. 721.170 (b)(3)(i).
    Recommended testing: None.
    CFR citation: 40 CFR 721.5708.
    
    PMN Number P-95-638
    
    Chemical name: Pentane 1,1,1,2,2,3,4,5,5,5,-decafluoro.
    CAS number: 138495-42-8.
    Basis for action: The PMN substance will be used as described in the 
    PMN. Based on toxicity data submitted with the PMN, EPA identified 
    health concerns for neurotoxicity. EPA determined that use of the 
    substance as described in the PMN did not present an unreasonable risk 
    because significant human exposure is not expected. EPA has determined 
    that use of the substance other than as described in the PMN may result 
    in significant human exposure. Based on this information the PMN 
    substance meets the concern criteria at Sec. 721.170(b)(3)(i).
    Recommended testing: None.
    CFR citation: 40 CFR 721.5645.
    
    PMN Number P-95-666
    
    Chemical name: (generic) Polyether acrylate.
    CAS number: Not available.
    Basis for action: The PMN substance will be used in a radiation curing 
    formulation. Based on analogy to acrylates, EPA identified concerns for 
    toxicity to aquatic organisms. EPA determined that use of the substance 
    as described in the PMN did not present an unreasonable risk because 
    significant environmental exposure is not expected. EPA has determined 
    that other uses may result in releases to water which are significant 
    environmental exposures. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.405.
    
    PMN Numbers P-95-677/724
    
    Chemical name: (generic) Antimony double oxide.
    CAS number: Not available.
    Effective date of section 5(e) consent order: March 12, 1996.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to human 
    health and the environment.
    Toxicity concern: Similar chemicals have been shown to cause cancer, 
    lung toxicity and ocular effects in test animals. In addition to human 
    health concerns, an aquatic toxicity concern has been identified if the 
    substance is released to surface waters. A concern concentration of 5 
    ppb has been established.
    Recommended testing: EPA has determined that a 2-year, one-species rat 
    inhalation bioassay, which has an additional holding period, analyses 
    of lung burdens, and determination of clearance rates of particles (as 
    described at (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-
    5719-5) would help characterize the carcinogenicity, lung toxicity and 
    ocular effects of the PMN substance. In addition, EPA has determined 
    that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 
    test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-
    1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 
    test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-
    1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 
    850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) 
    (FRL-5363-1)) would help characterize the environmental effects of the 
    PMN substances.
    CFR citation: 40 CFR 721.5547.
    
    PMN Numbers P-95-1103, P-95-1104, and P-96-1235
    
    Chemical name: (generic) Substituted resorcinols.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as components of a 
    material for integrated circuit fabrication. Based on submitted 
    toxicity data and analogy to phenols, EPA is concerned that toxicity to 
    aquatic organisms may occur at a concentration as low as 9 ppb of P-95-
    1103/P-95-1104 and 1 ppb of P-96-1235 in surface waters. EPA determined 
    that use of the substances as described in the PMNs did not present an 
    unreasonable risk because the substances would not be released to 
    surface waters in significant quantities. EPA has determined that other 
    uses of the substances may result in releases to surface waters which 
    exceed the concern concentration. Based on this information the PMN 
    substances meet the concern criteria at Sec. 721.170(b)(4)(i) and 
    (b)(4)(ii).
    Recommended testing: EPA has determined that a chronic 60-day fish 
    early life stage toxicity test in rainbow trout (40 CFR 797.1600 or 
    OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 
    797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, 
    April 15, 1996) (FRL-5363-1)) would help characterize the environmental 
    effects of P-95-1103 and P-95-1104. EPA has also determined that a fish 
    acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline 
    (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid 
    acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline 
    (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal 
    acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline 
    (public draft; 61 FR 16486,
    
    [[Page 3401]]
    
    April 15, 1996) (FRL-5363-1)) would help characterize the environmental 
    effects of P-96-1235.
    CFR citation: 40 CFR 721.9488.
    
    PMN Number P-95-1128
    
    Chemical name: (generic) Brominated aromatic ester.
    CAS number: Not available.
    Effective date of section 5(e) consent order: November 5, 1996.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and 5(e)(1)(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: Similar chemicals have been shown to: (1) Degrade in 
    the environment resulting in substances that may cause aquatic 
    toxicity, and (2) form dibenzodioxins and dibenzofurans when 
    incinerated under combustion conditions of municipal incinerators. EPA 
    has determined that halogenated dioxins and furans are probable human 
    carcinogens and may cause toxic effects in aquatic and terrestrial 
    organisms.
    Recommended testing: The consent order contains two production volume 
    limits. The PMN submitter has agreed not to exceed the first production 
    volume limit without performing an incineration simulation study 
    (guidelines available from EPA) to help characterize the potential for 
    the formation of dibenzodioxins or dibenzofurans when plastics or 
    resins containing the substance are incinerated, and a porous pot test 
    (OPPTS 835.3220 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1) to determine the extent of environmental degradation 
    of the substance. The PMN submitter has also agreed not to exceed the 
    second, higher production volume limit without performing a shake flask 
    die-away test (OPPTS 835.3170 test guideline (public draft; 61 FR 
    16486, April 15, 1996) (FRL-5363-1), a fish bioconcentration test 
    (OPPTS 850.1730 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)), a fish acute toxicity study (40 CFR 797.1400 or 
    OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or 
    OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 
    or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)).
    CFR citation: 40 CFR 721.2925.
    
    PMN Number P-95-1213
    
    Chemical name: (generic) Hydroxy terminated polyester.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on analogy to esters, EPA is concerned that toxicity to aquatic 
    organisms may occur at a concentration as low as 200 ppb of the PMN 
    substance in surface waters. EPA determined that use of the substance 
    as described in the PMN did not present an unreasonable risk because 
    the substance would not be released to surface waters. EPA has 
    determined that other uses of the substance may result in releases to 
    surface water at concentrations above 200 ppb. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.6485.
    
    PMN Number P-95-1235
    
    Chemical name: 2-Naphthalenesulfonic acid, 3-[[4-[(2,4-dimethyl-6-
    sulfophenyl)azo]-2-methoxy-5-methylphenyl]azo]-4-hydroxy-7-
    (phenylamino)-, sodium salt, compd. With 2,2',2''-nitrilotris [ethanol] 
    (9CI).
    CAS number: 94213-53-3.
    Basis for action: The PMN substance will be used in an open non-
    dispersive use. Based on analogy of the azo reduction products to 
    similar substances, EPA is concerned that cancer, systemic toxicity, 
    developmental toxicity, methemoglobinemia, and skin sensitization will 
    occur in exposed workers. EPA determined that use of the substance did 
    not present an unreasonable risk because significant worker exposure is 
    not expected because the substance was not manufactured, processed, or 
    used as a powder or manufactured domestically. EPA has determined that 
    manufacture, processing, and use of the substance as a powder or 
    domestic manufacture may result in significant worker exposure. Based 
    on this information the PMN substance meets the concern criteria at 
    Sec. 721.170(b)(3)(iii).
    Recommended testing: EPA has determined that an Ames assay with the 
    Prival modification with a concurrent positive control would help 
    characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.5281.
    
    PMN Number P-95-1282
    
    Chemical name: (generic) Reaction product of dichlorobenzidine and 
    substituted alkylamide.
    CAS number: Not available.
    Effective date of section 5(e) consent order: July 29, 1996.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and 5(e)(1)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to 
    health.
    Toxicity concern: 3,3'-dichlorobenzidine (DCB) and possible reduction 
    products have been shown to cause oncogenicity and mutagenicity in test 
    animals.
    Recommended testing: The following studies would help characterize the 
    health effects of the PMN substance: Monitoring data to detect the 
    presence of DCB under actual conditions of use in polymer coloration or 
    sheet metal coating use (Az, R., Dewald B. and Scnaitmann, D. 1991. 
    Pigment Decomposition in Polymers in Applications at Elevated 
    Temperatures (Dyes and Pigments 15:1-14). Monitoring data would include 
    the following elements: Extrusion or other process), monitoring data to 
    detect airborne concentrations of DCB during high-temperature 
    coloration or sheet metal coating use (see TSCA section 8(e) data e.g., 
    section 8(e)-962 supp.), radio-labeled pharmacokinetic study (oral) in 
    rats on the pigment (with the radio-label on the DCB) (OPPTS 870.7485 
    test guideline (public draft; 60 FR 45158, August 30, 1995) (FRL-4973-
    2)) plus radio-label), and a 2-year, two-species bioassay (40 CFR 
    799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5).
    CFR citation: 40 CFR 721.9265.
    
    PMN Number P-95-1288
    
    Chemical name: 2-Naphthalenol, mono and dioctyl derivs.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on analogy to phenols, EPA is concerned that toxicity to aquatic 
    organisms may occur at a concentrations as low as 1 ppb of the PMN 
    substance in surface waters. EPA determined that use of the substance 
    as described in the PMN did not present an unreasonable risk because 
    the substance did not exceed a concentration of 1 ppb when released to 
    surface waters. EPA has determined that increased production
    
    [[Page 3402]]
    
    volume may result in releases to surface waters above 1 ppb. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.5255.
    
    PMN Number P-95-1317
    
    Chemical name: (generic) Hydrochlorofluorocarbon.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on toxicity data submitted with the PMN, EPA identified health 
    concerns for neurotoxicity. Based on analogy to structurally similar 
    chemicals, EPA identified health concerns for cardiac sensitization, 
    liver toxicity, kidney toxicity, and skin irritation. EPA determined 
    that use of the substance as described in the PMN did not present an 
    unreasonable risk because significant human exposure is not expected. 
    EPA has determined that use of the substance other than as described in 
    the PMN may result in significant human exposure. Based on this 
    information the PMN substance meets the concern criteria at 
    Sec. 721.170 (b)(3)(i) and (b)(3)(ii).
    Recommended testing: None.
    CFR citation: 40 CFR 721.4462.
    
    PMN Number P-95-1326
    
    Chemical name: 3,8-Dioxa-4,7-disiladecane, 4,4,7,7-tetraethoxy-.
    CAS number: 16068-37-4.
    Basis for action: The PMN substance will be used in treatment of 
    laminates for printed circuit boards and sol-gel ceramics. Based on 
    analogy to alkoxysilanes, EPA is concerned that a significant risk of 
    lung toxicity and severe irritation to skin, eyes, and mucous membranes 
    could occur. EPA determined that use of the substance did not present 
    an unreasonable risk because the substance would not be manufactured, 
    processed, or used in a manner that generated a vapor, mist, or aerosol 
    and significant worker inhalation exposure is not expected. EPA has 
    determined that manufacture, processing, or use of the substance in a 
    manner that generated a vapor, mist, or aerosol may result in 
    significant worker inhalation exposure. 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 90-day subchronic 
    inhalation study in rats (40 CFR 798.2450 or OPPTS 870.3465 test 
    guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) 
    would help characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.3155.
    
    PMN Number P-95-1347
    
    Chemical name: (generic) Aliphatic polyisocyanate.
    CAS number: Not available.
    Basis for action: The PMN substance will be used in an open non-
    dispersive use. Based on analogy to diisocyanates, there is concern for 
    lung toxicity, pulmonary sensitization, and irritation to mucous 
    membranes. EPA determined that use of the substance as described in the 
    PMN did not present an unreasonable risk because workers would not be 
    subject to significant inhalation exposures. EPA has determined that 
    uses of the substance that generate a mist, aerosol, or vapor may 
    result in significant inhalation exposures to workers. Based on this 
    information the PMN substance meet the concern criteria at 
    Sec. 721.170(b)(3)(ii).
    Recommended testing: EPA has also determined that a 90-day subchronic 
    inhalation study in rats (40 CFR 799.9346) (62 FR 43828, August 15, 
    1997) (FRL-5719-5) would help characterize the health effects of the 
    PMN substance.
    CFR citation: 40 CFR 721.6495.
    
    PMN Number P-95-1356
    
    Chemical name: (generic) Silylated polyurethane.
    CAS Number: Not available.
    Basis for action: The PMN substance will be used as a moisture curable 
    polymer. Based on analogy of the PMN substance to alkoxysilanes, EPA 
    expects irritation to mucous membranes and lung toxicity. EPA 
    determined that use of the substance as described in the PMN did not 
    present an unreasonable risk because there were no significant 
    inhalation exposures. EPA has determined that use of the substance 
    generating an aerosol or a mist may result in significant inhalation 
    exposures. 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 90-day subchronic 
    inhalation study (40 CFR 798.2450 or OPPTS 870.3465 test guideline 
    (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help 
    characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.8095.
    
    PMN Number P-95-1386
    
    Chemical name: Benzene, 1,1'-methylanebis[4-isocyanato-, homopolymer, 
    Bu alc.-blocked.
    CAS number: 186321-98-2.
    Basis for action: The PMN substance will be used as described in the 
    PMN. Based on analogy to diisocyanates, EPA is concerned that a 
    significant risk of oncogenicity, respiratory sensitization, and 
    chronic lung effects could occur. EPA determined that use of the 
    substance did not present an unreasonable risk because the substance 
    would not be manufactured, processed, or used in a manner that 
    generated a vapor, mist, or aerosol and significant worker inhalation 
    exposure is not expected. EPA has determined that manufacture, 
    processing, or use of the substance in a manner that generated a vapor, 
    mist, or aerosol may result in significant worker inhalation exposure. 
    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 90-day inhalation study 
    in rats (40 CFR 799.9346) (62 FR 43828, August 15, 1997) (FRL-5719-5) 
    would help characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.2535.
    
    PMN Number P-95-1411
    
    Chemical name: Propanedioic acid, [(4-methoxyphenyl)methylene]-, 
    bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester (9CI).
    CAS number: 147783-69-5.
    Effective date of section 5(e) consent order: November 22, 1995.
    Basis for section 5(e) consent order: The order was issued under 
    section 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to human 
    health.
    Toxicity concern: Similar chemicals have been shown to cause toxicity 
    to the immune system, liver, blood, the male reproductive system and 
    the G.I. tract in test animals.
    Recommended testing: A 90-day subchronic oral toxicity study in rats 
    (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 
    31522, June 20, 1996) (FRL-5367-7)) would help characterize the human 
    health effects. The PMN submitter has agreed not to exceed the 
    production volume limit without performing this test.
    
    [[Page 3403]]
    
    CFR citation: 40 CFR 721.4589.
    
    PMN Number P-95-1466
    
    Chemical name: (generic) Substituted aromatic aldehyde.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as described in the 
    PMN. Based on analogy to phenols and aldehydes EPA is concerned that 
    toxicity to aquatic organisms may occur at a concentration as low as 3 
    ppb of the PMN substance in surface waters. EPA determined that use of 
    the substance as described in the PMNs did not present an unreasonable 
    risk because the substance would not be released to surface waters. EPA 
    has determined that other uses of the substance may result in releases 
    to surface waters which exceed the concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.526.
    
    PMN Number P-95-1467
    
    Chemical name: Benzaldehyde, 2-hydroxy-5-nonyl-, oxime, branched.
    CAS number: 174333-80-3.
    Basis for action: The PMN substance will be used as described in the 
    PMN. Based on analogy to phenols, EPA is concerned that toxicity to 
    aquatic organisms may occur at a concentration as low as 1 ppb of the 
    PMN substance in surface waters. EPA determined that use of the 
    substance as described in the PMN did not present an unreasonable risk 
    because the substance would not be released to surface waters. EPA has 
    determined that other uses of the substance may result in releases to 
    surface waters which exceed the concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.528.
    
    PMN Numbers P-95-1557/1558
    
    Chemical name: (generic) Substituted imines.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as intermediates. 
    Based on 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 substances in surface waters. EPA determined that use of the 
    substances as described in the PMNs did not present an unreasonable 
    risk because the substances would not be released to surface waters. 
    EPA has determined that other uses of the substances may result in 
    releases to surface waters which exceed the concern concentration. 
    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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.4476.
    
    PMN Numbers P-95-1575/1576/1577
    
    Chemical name: Chromate(3-), bis[3-[[5-(aminosulfonyl)-2-
    hydroxyphenyl]azo]-4-hydroxy-7-[[2-oxo-1-[(phenylamino)carbonyl] 
    propyl]azo]-2-naphthalenesulfonato(3-)]-, trisodium (9CI) (P-95-1575), 
    Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-(aminosulfonyl)-2-
    hydroxyphenyl]azo]-4-hydroxy-2-naphthalene-sulfonato (3-)]-, trisodium 
    (9CI) (P-95-1576), Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-
    (aminosulfonyl)-2-hydroxyphenyl] azo]-4-hydroxy-2-naphthalenesulfonato 
    (3-)]-,-[[5-(aminosulfonyl) -2-hydroxyphenyl]azo]-4-hydroxy-7-[[2-
    hydroxy-1-[(phenylamino) carbonyl]-1-propenyl]azo]-2-
    naphthalenesulfonato(3-)]-, trisodium (9CI) (P-95-1577).
    CAS number: 119535-63-6 (P-95-1575), 118716-62-4 (P-95-1576), and 
    118716-61-3 (P-95-1577).
    Basis for action: The PMN substances will be used as leather dyes. 
    Based on analogy to similar substances, EPA is concerned that cancer, 
    developmental, kidney, and liver toxicity will occur in exposed 
    workers. EPA determined that use of the substances did not present an 
    unreasonable risk because significant worker exposure is not expected 
    because the substances were not manufactured, processed, or used as a 
    powder. EPA has determined that manufacture, processing, and use of the 
    substances as a powder may result in significant worker exposure. Based 
    on this information the PMN substances meet the concern criteria at 
    Sec. 721.170 (b)(1)(i)(B), (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5), 
    an oral 2-generation reproduction study in rats (40 CFR 799.9380) (62 
    FR 43834, August 15, 1997) (FRL-5719-5), and a 90-day subchronic 
    inhalation study in rats (40 CFR 798.2650 or OPPTS 870.3100 test 
    guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) 
    would help characterize the health effects of the PMN substances.
    CFR citation: 40 CFR 721.9575 (P-95-1575), 40 CFR 721.9576 (P-95-1576), 
    and 40 CFR 721.9577 (P-95-1577).
    
    PMN Number P-95-1578
    
    Chemical name: (generic) Hydrofluorocarbon alkyl ether.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on analogy to similar substances, EPA identified concerns for 
    cancer, cardiotoxicity, cardiosensitization, respiratory failure, 
    neurotoxicity, and irritation to membranes. Based on submitted test 
    data EPA identified concerns for acute toxicity. EPA determined that 
    use of the substance as described in the PMN did not present an 
    unreasonable risk because significant human exposure is not expected. 
    EPA has determined that use of the substance without the worker 
    protection cited in the PMN or if the substance is used other than as 
    an intermediate may result in significant human exposure. Based on this 
    information the PMN substance meets the concern criteria at 
    Sec. 721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
    Recommended testing: EPA has determined that a 2-year, two-species 
    bioassay (40 CFR 799.9420) (62 FR
    
    [[Page 3404]]
    
    43838, August 15, 1997) (FRL-5719-5) and a 90-day subchronic oral study 
    in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public 
    draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) will address the 
    potential health effects of the PMN substance.
    CFR citation: 40 CFR 721.3485.
    
    PMN Numbers P-95-1650/1651/1652/1653
    
    Chemical name: (generic) Alkyl phenyl polyetheramines.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as intermediates. 
    Based on analogy to aliphatic amines EPA is concerned that toxicity to 
    aquatic organisms may occur at a concentration as low as 3 ppb of the 
    PMN substances in surface waters. EPA determined that use of the 
    substances as described in the PMNs did not present an unreasonable 
    risk because the substances would not be released to surface waters. 
    EPA has determined that other uses of the substances may result in 
    releases to surface waters which exceed the concern concentration. 
    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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.6490.
    
    PMN Number P-95-1750
    
    Chemical name: (generic) Pentanediol light residues.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a solvent. Based on 
    potential consumer exposures, EPA has determined that the PMN substance 
    may cause significant or substantial human exposure. EPA determined 
    that use of the substance as described in the PMN did not cause 
    significant or substantial exposure from use as an industrial solvent. 
    EPA has determined that exposures from consumer use may result in 
    significant or substantial human exposures. Based on this information 
    activities other than those described in the PMN may result in 
    significant changes in human exposure.
    Recommended testing: EPA has determined that a 28-day oral study in 
    rats (OECD guideline no. 407), an acute rat oral study (OPPTS 870.1100 
    test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-
    7)), an ames assay (40 CFR 798.5265 or OPPTS 870.5265 test guideline 
    (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)), a mouse 
    micronucleus assay by the intraperitoneal route (40 CFR 799.9539) (62 
    FR 43853, August 15, 1997) (FRL-5719-5), and a developmental toxicity 
    study in one species by the oral route (40 CFR 799.9370) (62 FR 43832, 
    August 15, 1997) (FRL-5719-5) would help characterize possible health 
    effects of the substance. EPA will require any manufacturer importer, 
    or processor who distributes this substance for use in a consumer 
    product to perform this testing.
    CFR citation: 40 CFR 721.5650.
    
    PMN Number P-95-1772
    
    Chemical name: (generic) Polyalkyl phosphate.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a specialty 
    additive. Based on analogy to neutral organic substances, EPA expects 
    toxicity to aquatic organisms at surface water concentrations as low as 
    1 ppb. EPA determined that use of the substance as described in the PMN 
    did not present an unreasonable risk because the substance did not 
    exceed a concentration of 1 ppb when released to surface waters. EPA 
    has determined that other uses may result in releases to surface waters 
    above 1 ppb. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.5995.
    
    PMN Number P-95-1806
    
    Chemical name: (generic) Quaternary ammonium hydroxide.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an additive. Based 
    on analogy to cationic 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. EPA determined that use of the 
    substance as described in the PMN did not present an unreasonable risk 
    because the substance was not released to surface waters. EPA has 
    determined that other uses may result in releases to surface waters 
    above the concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.4467.
    
    PMN Number P-95-1825
    
    Chemical name: Thieno[3,4-b]-1,4-dioxin, 2,3-dihydro- (9CI).
    CAS number: 126213-50-1.
    Basis for action: The PMN substance will be used in an open non-
    dispersive use. Based on analogy to structurally similar substances, 
    EPA identified concerns for cancer and based on submitted test data EPA 
    identified concerns for liver toxicity and neurotoxicity. EPA 
    determined that use of the substance as described in the PMN did not 
    present an unreasonable risk because significant human exposure is not 
    expected. EPA has determined that use of the substance without the 
    worker protection cited in the PMN or if the substance is manufactured 
    domestically may result in significant human exposure. Based on this 
    information the PMN substance meets the concern criteria at 
    Sec. 721.170 (b)(1)(i)(C) and (b)(3)(i).
    Recommended testing: EPA has determined that a 2-year, two-species 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) 
    and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 
    870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) 
    (FRL-5367-7)) will address the potential health effects of the PMN 
    substance.
    CFR citation: 40 CFR 721.9662.
    
    PMN Number P-95-1891
    
    Chemical name: Siloxanes and silicones, Me hydrogen, reaction
    
    [[Page 3405]]
    
    products with 2,2,6,6-tetramethyl-4-(2-propenyloxy)piperdine.
    CAS number: 182635-99-0.
    Basis for action: The PMN substance will be used as an ultraviolet 
    light stabilizer for polymers. Based on analogy to hindered amines, 
    there is concern for toxicity to the immune system and the G.I. tract, 
    liver toxicity, blood toxicity, and toxicity to the male reproductive 
    system. EPA determined that use of the substance as described in the 
    PMN did not present an unreasonable risk because workers would not be 
    exposed by inhalation. EPA determined that use as a powder may result 
    in inhalation exposure to workers. 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 90-day subchronic 
    inhalation study in rats (40 CFR 798.2650 or OPPTS 870.3100 test 
    guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) 
    would characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.6170.
    
    PMN Number P-95-1950
    
    Chemical name: (generic) Substituted ethoxyethylamine phosphonate.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a scale inhibitor. 
    Based on analogy to polyanionic monomers, 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. EPA determined that use of 
    the substance as described in the PMN did not present an unreasonable 
    risk because the substance was not released to surface waters. EPA has 
    determined that other uses may result in releases to surface waters 
    above 30 ppb. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.6078.
    
    PMN Number P-95-2101
    
    Chemical name: Hydrazine, (2-fluorophenyl).
    CAS Number: 2368-80-1.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on analogy of the PMN substance to hydrazines EPA is concerned 
    that oncogenicity, liver and kidney effects, lung effects, and blood 
    effects will occur to exposed workers and that toxicity will occur to 
    aquatic organisms. EPA determined that use of the substance as 
    described in the PMN did not present an unreasonable risk because there 
    were no significant worker or environmental exposures. EPA has 
    determined that domestic manufacture of the substance may result in 
    significant worker and environmental exposures. Based on this 
    information the PMN substance meets the concern criteria at 
    Sec. 721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) 
    and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 
    870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) 
    (FRL-5367-7)) would help characterize the health effects of the PMN 
    substance. A fish acute toxicity study (40 CFR 797.1400 or OPPTS 
    850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) 
    (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 
    850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) 
    (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or 
    OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)) would help characterize the environmental effects 
    of the PMN substance.
    CFR citation: 40 CFR 721.4257.
    
    PMN Number P-96-19
    
    Chemical name: Lithiated metal oxide (LiNiO2).
    CAS number: 12031-65-1.
    Effective date of section 5(e) consent order: June 26, 1996.
    Basis for section 5(e) consent order: The order was issued under 
    section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to human 
    health and the environment.
    Toxicity concern: Similar chemicals have been shown to cause cancer and 
    systemic toxicity in test animals. In addition, based on Structure 
    Activity Relationship (SAR) analysis derived from test data on 
    structurally similar compounds, EPA expects toxicity to aquatic 
    organisms to occur at a concentration of 30 ppb PMN substance in 
    surface waters.
    Recommended testing: The results of a 90-day subchronic inhalation 
    toxicity study in rats (40 CFR 799.9346) (62 FR 43828, August 15, 1997) 
    (FRL-5719-5) and a 2-year, two-species bioassay via inhalation (40 CFR 
    799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) would help 
    characterize the human health concerns. The results of a fish acute 
    toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline 
    (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid 
    acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline 
    (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal 
    acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline 
    (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) conducted 
    using static method and nominal concentrations, would help to 
    characterize the toxicity of the substance. 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 toxicity test. The PMN submitter has also agreed not to 
    exceed the second higher production volume limit without performing the 
    bioassay.
    CFR citation: 40 CFR 721.5549.
    
    PMN Number P-96-33
    
    Chemical name: Cyclopropanecarboxaldehyde.
    CAS number: 1489-69-6.
    Effective date of section 5(e) consent order: November 27, 1996.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to human 
    health.
    Toxicity concern: Similar aldehydes have been shown to cause lung 
    irritation, carcinogenicity, mutagenicity, and liver toxicity in test 
    animals. Developmental effects are possible based on the acid.
    Recommended testing: EPA has determined that an in vitro mouse lymphoma 
    assay (40 CFR 799.9530) (62 FR 43846, August 15, 1997) (FRL-5719-5) and 
    an in vivo mouse micronucleus assay (40 CFR 799.9539) (62 FR 43853, 
    August 15, 1997) (FRL-5719-5), a 90-day inhalation test in rats (OECD 
    guideline no. 413), a 2-year, one-species bioassay (40 CFR 799.9420) 
    (62 FR 43838, August 15, 1997) (FRL-5719-5) would help characterize the 
    human health effects. The consent order contains two production volume 
    limits.
    
    [[Page 3406]]
    
    The PMN submitter has agreed not to exceed the first production volume 
    limit without performing the in vitro mouse lymphoma, in vivo mouse 
    micronucleus assays, and the 90-day inhalation test in rats. The PMN 
    submitter has also agreed not to exceed the second production volume 
    limit without performing a 2-year, one-species bioassay, which EPA may 
    elect not to require depending on the results of the mutagenicity 
    studies and the 90-day test.
    CFR citation: 40 CFR 721.2280.
    
    PMN Number P-96-92
    
    Chemical name: (generic) 1,4-benzenediol, 2-(1,1,3,3-tetramethylbutyl) 
    and Bis(dimethylamino substituted) carbomonocycle.
    CAS number: Not available.
    Basis for action: The PMN substance will be used in a consumer article. 
    Based on analogy to hydroquinones, 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. EPA determined that use of the 
    substance as described in the PMN did not present an unreasonable risk 
    because the substance would not be released to surface waters in 
    significant quantities. EPA has determined that other uses of the 
    substance may result in releases to surface waters which exceed the 
    concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.1155.
    
    PMN Number P-96-93
    
    Chemical name: Benzenamine, 4,4'-methylenebis[2-methyl-6-(1-
    methylethyl)]-.
    CAS number: 16298-38-7.
    Basis for action: The PMN substance will be used in a non-dispersive 
    use. Based on submitted test data 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. EPA determined that use of the 
    substance as described in the PMN did not present an unreasonable risk 
    because the substance would not be released to surface waters. EPA has 
    determined that other uses of the substance may result in releases to 
    surface waters which exceed the concern concentration. Based on this 
    information the PMN substance meets the concern criteria at 
    Sec. 721.170(b)(4)(i).
    Recommended testing: EPA has determined that a chronic 60-day fish 
    early life stage toxicity test in rainbow trout (40 CFR 797.1600 or 
    OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 
    797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, 
    April 15, 1996) (FRL-5363-1)) would help characterize the environmental 
    effects of the PMN substance.
    CFR citation: 40 CFR 721.1105.
    
    PMN Number P-96-236
    
    Chemical name: 1-Tridecyn-3-ol, 3-methyl.
    CAS Number: 100912-15-0.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on analogy of the PMN substance to 1-hexyn-3-ol and other 
    structurally similar substances, EPA is concerned that liver toxicity, 
    kidney toxicity, neurotoxicity, reproductive toxicity, and 
    cardiotoxicity will occur to exposed workers. EPA determined that use 
    of the substance as described in the PMN did not present an 
    unreasonable risk because significant worker exposures were not 
    expected. EPA has determined that domestic manufacture of the substance 
    or use of the substance without dermal protective equipment may result 
    in significant worker exposures. Based on this information the PMN 
    substance meets the concern criteria at Sec. 721.170(b)(3)(ii).
    Recommended testing: EPA has determined that an oral 2-generation 
    reproduction study in rats (40 CFR 799.9380) (62 FR 43834, August 15, 
    1997) (FRL-5719-5) and a 90-day subchronic oral study in rats (40 CFR 
    798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, 
    June 20, 1996) (FRL-5367-7)) would help characterize the health effects 
    of the PMN substance.
    CFR citation: 40 CFR 721.9830.
    
    PMN Number P-96-238
    
    Chemical name: (generic) Azo monochloro triazine reactive dye.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a dye. Based on 
    analogy to structurally similar substances and submitted test data, EPA 
    is concerned that liver toxicity, blood toxicity, oncogenicity, 
    neurotoxicity, and developmental toxicity will occur in exposed 
    workers. EPA determined that use of the substance did not present an 
    unreasonable risk because significant worker exposure is not expected 
    because the substance was manufactured, processed, or used as liquids. 
    EPA has determined that manufacture, processing, or use of the 
    substance as a solid may result in significant worker exposure. Based 
    on this information the PMN substance meets the concern criteria at 
    Sec. 721.170 (b)(3)(i), (b)(3)(ii), and (b)(3)(iii).
    Recommended testing: EPA has determined that an oral two-species 
    developmental toxicity test (40 CFR 799.9370) (62 FR 43832, August 15, 
    1997) (FRL-5719-5) and a 90-day subchronic oral study in rats (40 CFR 
    798.2650 or OPPT 870.3100 test guideline (public draft; 61 FR 31522, 
    June 20, 1996) (FRL-5367-7)) would help characterize the health effects 
    of the PMN substance.
    CFR citation: 40 CFR 721.9717.
    
    PMN Number P-96-273
    
    Chemical name: (generic) Chloroalkane.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on toxicity data submitted with the PMN and by analogy to 
    chlorinated solvents, EPA identified health concerns for liver 
    toxicity, kidney toxicity, neurotoxicity, and oncogenicity. EPA 
    determined that use of the substance as described in the PMN did not 
    present an unreasonable risk because significant human exposure is not 
    expected. EPA has determined that use of the substance other than as 
    described in the PMN may result in significant human exposure. Based on 
    this information the PMN substance meets the concern criteria at 
    Sec. 721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) 
    and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPT 
    870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) 
    (FRL-5367-7)) would help characterize the health effects of the PMN 
    substance.
    CFR citation: 40 CFR 721.2091.
    
    PMN Number P-96-346
    
    Chemical name: (generic) Aminofunctional alkoxy alkyl siloxane.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an adhesion 
    promoter.
    
    [[Page 3407]]
    
    Based on analogy to aliphatic amines and ethoxysilanes, 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. 
    EPA determined that use of the substance as described in the PMN did 
    not present an unreasonable risk because the substance was not released 
    to surface waters. EPA has determined that other uses may result in 
    releases to surface waters above 10 ppb. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.9515.
    
    PMN Numbers P-96-399/400/401/402/403/404
    
    Chemical name: (generic) Alkyl polycarboxylic acids, esters with 
    ethoxylated fatty alcohols, reaction products with maleic anhydride.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as site-limited 
    production intermediates. Based on analogy to nonionic surfactants, EPA 
    is concerned that toxicity to aquatic organisms may occur at a 
    concentration as low as 9 ppb of the PMN substances in surface waters. 
    EPA determined that use of the substances as described in the PMNs did 
    not present an unreasonable risk because the substances were not 
    released to surface waters. EPA has determined that other uses may 
    result in releases to surface waters. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.6477.
    
    PMN Numbers P-96-406/407/408
    
    Chemical name: (generic) Alkyltri, tetra, and pentaamines.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as industrial 
    lubricants and fuel additives. Based on 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 substances in surface waters. 
    EPA determined that use of the substances as described in the PMNs did 
    not present an unreasonable risk because the substances were not 
    released to surface waters. EPA has determined that other uses may 
    result in releases to surface waters. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.2350.
    
    PMN Numbers P-96-554/555/556/557/558/559/560/561/564/565
    
    Chemical name: (generic) Alkyl polycarboxylic acids, esters with 
    ethoxylated fatty alcohols.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as intermediates. 
    Based on analogy to nonionic surfactants, EPA is concerned that 
    toxicity to aquatic organisms may occur at a concentration as low as 20 
    ppb of the PMN substances in surface waters. EPA determined that use of 
    the substances as described in the PMN did not present an unreasonable 
    risk because the substances would not be released to surface waters. 
    EPA has determined that other uses of the substances may result in 
    releases to surface waters which exceed the concern concentration. 
    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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.6475.
    
    PMN Number P-96-573
    
    Chemical name: (generic) Ethoxylated alkyl quaternary ammonium 
    compound.
    CAS Number: Not available.
    Basis for action: The PMN substance will be used in an open dispersive 
    use. Based on analogy of the PMN substance to cationic surfactants, EPA 
    is concerned that toxicity to aquatic organisms may occur at a 
    concentration as low as 1 ppb of the PMN substance in surface waters. 
    EPA determined that use of the substance as described in the PMN did 
    not present an unreasonable risk because there were no significant 
    environmental exposures. EPA has determined that any use of the 
    substance other than for the specific use described in the PMN may 
    result in significant environmental exposures. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.655.
    
    PMN Number P-96-585
    
    Chemical name: (generic) Salt of a substituted polyalkylenepolyamine.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a processing aid. 
    Based on 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. EPA determined that use of the 
    substance as described in the PMN did not present an unreasonable risk 
    because the substance was not released to surface waters. EPA has 
    determined that other uses may result in
    
    [[Page 3408]]
    
    releases to surface waters. Based on this information the PMN substance 
    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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.6197.
    
    PMN Number P-96-702
    
    Chemical name: (generic) Substituted phenyl azo substituted sulfo 
    carbopolycycle.
    CAS number: Not available.
    Basis for action: The PMN substance will be used in an open 
    nondispersive use. EPA determined that use of the substance as 
    described in the PMN did not present an unreasonable risk because it 
    did not result in significant human or environmental exposure. EPA has 
    determined that increased use of the substance may result in 
    significant environmental and human exposure.
    Recommended testing: EPA has determined that a fish acute toxicity 
    study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an activated sludge 
    adsorption isotherm (OPPTS 835.1110 test guideline (public draft; 61 FR 
    16486, April 15, 1996) (FRL-5363-1) would help characterize the 
    environmental effects of the PMN substance. A murine immune allergic 
    response study (Toxicology and Applied Pharmacology 112:190-197 (1992)) 
    would help characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.2122.
    
    PMN Numbers P-96-767/773
    
    Chemical name: (generic) Substituted pyridine azo substituted phenyl.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as textile dyes. 
    Based on analogy to structurally similar substances, EPA is concerned 
    that liver toxicity, kidney toxicity, oncogenicity, blood toxicity, 
    neurotoxicity, and developmental toxicity will occur in exposed 
    workers. EPA determined that use of the substances did not present an 
    unreasonable risk because significant worker exposure is not expected 
    because the substances were not manufactured domestically. EPA has 
    determined that domestic manufacture of the substances may result in 
    significant worker exposure. Based on this information the PMN 
    substances meet the concern criteria at Sec. 721.170 (b)(1)(i)(C) and 
    (b)(3)(ii).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5), 
    a two-species oral developmental toxicity study (40 CFR 799.9370) (62 
    FR 43832, August 15, 1997) (FRL-5719-5), and a subchronic oral study in 
    rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 
    61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the 
    health effects of the PMN substances.
    CFR citation: 40 CFR 721.8780.
    
    PMN Number P-96-795
    
    Chemical name: (generic) Mixed fatty alkylamines, salt.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a processing aid. 
    Based on 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. EPA determined that use of the 
    substance as described in the PMN did not present an unreasonable risk 
    because the substance was not released to surface waters. EPA has 
    determined that other uses may result in releases to surface waters. 
    Based on this information the PMN substance 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.567.
    
    PMN Number P-96-813
    
    Chemical name: (generic) Phenothiazine derivative.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a mediator in 
    enzyme catalyzed reactions. Based on analogy to phenothiazines and 
    submitted toxicity data, EPA is concerned that blood toxicity, liver 
    toxicity, kidney effects, adrenal toxicity, spleen toxicity, 
    reproductive toxicity, and neurotoxicity will occur in exposed workers. 
    Based on submitted test data EPA is also concerned that toxicity to 
    aquatic organisms will occur at concentrations as low as 7 ppb. EPA 
    determined that use of the substance did not present an unreasonable 
    risk because the use as described in the PMN would not result in 
    significant worker exposure or environmental release. EPA has 
    determined that domestic manufacture of the substance as a powder may 
    result in significant worker exposure or environmental release. Based 
    on this information the PMN substance meets the concern criteria at 
    Sec. 721.170 (b)(3)(i), (b)(3)(ii), and (b)(4)(i).
    Recommended testing: EPA has determined that a 90-day subchronic 
    inhalation study in rats (40 CFR 798.2650 or OPPTS 870.3100 test 
    guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)), a 
    chronic 60-day fish early life stage toxicity test in rainbow trout (40 
    CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 
    16486, April 15, 1996) (FRL-5363-1)) and a 21-day daphnid chronic 
    toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public 
    draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help 
    characterize the health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.5913.
    
    PMN Number P-96-824
    
    Chemical name: (generic) Acrylate ester.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a monomer. Based on 
    analogy to acrylates, EPA identified concerns for toxicity to aquatic 
    organisms at concentrations as low as 6 ppb. EPA determined that use of 
    the substance as described in the PMN did not present an unreasonable 
    risk because significant environmental exposure is not expected. EPA 
    has determined that other uses may result in releases to water which 
    are significant environmental exposures. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test
    
    [[Page 3409]]
    
    guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), 
    and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 
    test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-
    1)) would help characterize the environmental effects of the PMN 
    substance.
    CFR citation: 40 CFR 721.2805.
    
    PMN Number P-96-866
    
    Chemical name: (generic) Derivative of substituted carbomonocyclic 
    carboxylic acid-amine distillation stream byproduct reaction product.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a processing aid. 
    Based on 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. EPA determined that use of the 
    substance as described in the PMN did not present an unreasonable risk 
    because the substance was not released to surface waters. EPA has 
    determined that other uses may result in releases to surface waters. 
    Based on this information the PMN substance 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.2082.
    
    PMN Number P-96-897
    
    Chemical name: (generic) Terpene residue distillates.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an odor enhancer. 
    Based on analogy to neutral organic substances, 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. EPA determined that use of 
    the substance as described in the PMN did not present an unreasonable 
    risk because the substance would not be released to surface waters 
    above a level of 10 ppb. EPA has determined that other uses of the 
    substance may result in releases to surface waters which exceed the 
    concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.9635.
    
    PMN Number P-96-941
    
    Chemical name: (generic) Ceteareth-25 sorbate.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on analogy to nonionic surfactants, EPA is concerned that 
    toxicity to aquatic organisms may occur at a concentration as low as 1 
    ppb of the PMN substance in surface waters. EPA determined that use of 
    the substance as an intermediate did not present an unreasonable risk 
    because the substance would not be released to surface waters in 
    significant amounts. EPA has determined that other uses of the 
    substance may result in releases to surface waters which significantly 
    exceed the concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.2145.
    
    PMN Number P-96-942
    
    Chemical name: Methanone, [5-[[3-(2H-benzotriazol-2-yl)-2-hydroxy-5-
    (1,1,3,3- tetramethylbutyl)phenyl]methyl]-2-hydroxy-4-
    (octyloxy)phenyl]phenyl-.
    CAS number: 162245-07-0.
    Effective date of section 5(e) consent order: September 24, 1996.
    Basis for section 5(e) consent order: The order was issued under 
    section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to human 
    health. Toxicity concern: Section 8(e) data and data on analogous 
    hindered phenol benzotriazoles have shown similiar substances to cause 
    increased organ weight (liver and kidney, with associated 
    histopathology at higher doses); hematological effects (decreased 
    hemoglobin, packed cell volume, and erythrocytes); and immune systems 
    effects(weight changes in thymus, spleen, lymph nodes; decreased 
    leukocytes) in test animals.
    Recommended testing: EPA has determined that a 90-day gavage study in 
    rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 
    61 FR 31522, June 20, 1996) (FRL-5367-7)) with special attention to 
    hematology would help characterize systemic toxicity and reproductive 
    toxicity. The PMN submitter has agreed not to exceed the production 
    volume limit without performing this test.
    CFR citation: 40 CFR 721.4885.
    
    PMN Numbers P-96-945/946/947/948
    
    Chemical name: (generic) Mixture of hydrochlorofluoro alkanes and 
    hydrochlorofluoro alkene.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as intermediates. 
    Based on analogy to similar substances, EPA is concerned that lung 
    toxicity, neurotoxicity, irritation, oncogenicity, liver toxicity, 
    kidney toxicity, and cardiac sensitization will occur in exposed 
    workers. EPA determined that use of the substance as an intermediate 
    did not present an unreasonable risk because it did not result in 
    significant worker exposure. EPA has determined that use other than an 
    intermediate may result in significant worker exposure. 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 90-day subchronic oral 
    study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public 
    draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) and a 2-year, two-
    species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) 
    (FRL-5719-5) would help characterize the health effects of the PMN 
    substance.
    CFR citation: 40 CFR 721.4464.
    
    PMN Numbers P-96-950/951
    
    Chemical name: (generic) Polymers of C13C15 
    oxoalcohol ethoxolate, ammonia, and maleic anhydride.
    
    [[Page 3410]]
    
    CAS number: Not available.
    Basis for action: The PMN substances will be used as described in the 
    PMN. Based on structure activity relationships to nonionic surfactants-
    alkylethoxylates, EPA is concerned that toxicity to aquatic organisms 
    may occur at a concentration as low as 9 ppb of the PMN substances in 
    surface waters. EPA determined that use of the substances as described 
    in the PMNs did not present an unreasonable risk because the substances 
    would not be released to surface waters. EPA has determined that other 
    uses of the substances may result in releases to surface waters which 
    exceed the concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.6505.
    
    PMN Number P-96-1176
    
    Chemical name: Cyclohexanamine, N,N-dimethyl-, compd. with alpha-
    isotridecyl-omega-hydroxypoly(oxy-1,2-ethanediyl) phosphate.
    CAS Number: 164383-18-0.
    Basis for action: The PMN substance will be used as a pigment 
    dispersant for color dispersion. Based on analogy to phosphate based 
    anionic surfactants, EPA expects toxicity to aquatic organisms at 
    surface water concentrations as low as 20 ppb. EPA determined that use 
    of the substance as described in the PMN did not present an 
    unreasonable risk because there were no significant environmental 
    exposures. EPA has determined that any use of the substance other than 
    for the specific use described in the PMN may result in significant 
    exposures. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance
    CFR citation: 40 CFR 721.2222.
    
    PMN Number P-96-1177
    
    Chemical name: Tungstate (W12(OH)2O386-) hexasodium (9CI).
    CAS Number: 12141-67-2.
    Basis for action: The PMN substance will be used in an open non-
    dispersive use. Based on submitted test data, EPA is concerned that 
    hepatotoxicity, kidney toxicity, neurotoxicity, reproductive toxicity, 
    eye and skin irritation, and toxicity to the GI tract, spleen, lungs, 
    pancreas, urinary bladder, and the lymph system may occur. EPA 
    determined that use of the substance as described in the PMN did not 
    present an unreasonable risk because there were no significant 
    inhalation exposures. EPA has determined that any use of the substance 
    other than for the specific use described in the PMN may result in 
    significant inhalation exposures. Based on this information the PMN 
    substance meets the concern criteria at Sec. 721.170(b)(3)(i).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) 
    and a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or 
    OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 
    1996) (FRL-5367-7)) would help characterize the health effects of the 
    PMN substance.
    CFR citation: 40 CFR 721.9840.
    
    PMN Number P-96-1216
    
    Chemical name: Benzoic acid, 3-amino-, diazotized, coupled with 6-
    amino-4-hydroxy-2-naphthalenesulfonic acid, diazotized, (3-
    aminophenyl)phosphonic acid and diazotized 2,5-diethoxybenzenamine.
    CAS number: 163879-69-4.
    Basis for action: The PMN substance will be used as a coloring 
    material. Based on submitted toxicity data on the PMN substance and 
    analogy to the azo reduction products, EPA is concerned that eye 
    irritation, skin sensitization, reproductive toxicity in males, blood 
    toxicity, liver toxicity, kidney toxicity, reproductive toxicity, 
    spleen effects, oncogenicity, neurotoxicity, and developmental toxicity 
    will occur in workers exposed via inhalation. EPA determined that use 
    of the substance as described in the PMN does not present an 
    unreasonable risk. Significant worker inhalation exposure is not 
    expected because the substance will not be manufactured, processed, or 
    used as a powder. EPA has determined that manufacture, processing, and 
    use of the substance as a powder may result in significant worker 
    inhalation exposure. Based on this information the PMN substance meets 
    the concern criteria at Sec. 721.170 (b)(1)(i)(D), (b)(3)(i), and 
    (b)(3)(iii).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) 
    and a 2-generation reproductive toxicity study (40 CFR 799.9380) (62 FR 
    43834, August 15, 1997) (FRL-5719-5) would help characterize the human 
    health effects of the PMN substance.
    CFR citation: 40 CFR 721.1705.
    
    PMN Number P-96-1233
    
    Chemical name: (generic) Reaction product of epoxy with anhydride and 
    glycerol and glycol.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as molding compound. 
    Based on analogy to diepoxides and 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. Based on analogy to similar 
    substances there is concern for oncogenicity, developmental toxicity, 
    reproductive toxicity, and neurotoxicity to exposed workers. EPA 
    determined that use of the substance as described in the PMN did not 
    present an unreasonable risk because the substance would not be 
    released to surface waters and workers would not be exposed by 
    inhalation. EPA has determined that other uses or uses as a powder may 
    result in releases to surface waters which exceed the concern 
    concentration or inhalation exposure to workers. Based on this 
    information the PMN substance meets the concern criteria at 
    Sec. 721.170 (b)(1)(i)(c), (b)(3)(ii), and (b)(4)(ii).
    Recommended testing: EPA has determined that a fish acute toxicity 
    study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance. EPA has also determined 
    that a 2-year, two-species oral bioassay (40 CFR 799.9420) (62 FR 
    43838, August 15, 1997) (FRL-
    
    [[Page 3411]]
    
     5719-5), a 90-day subchronic inhalation study in rats (40 CFR 798.2650 
    or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 
    1996) (FRL-5367-7)), and a two-species oral developmental toxicity test 
    (40 CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) would 
    characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.9270.
    
    PMN Number P-96-1239
    
    Chemical name: (generic) Aliphatic polyisocyanate homopolymer.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on analogy to structurally similar substances, EPA is concerned 
    that pulmonary sensitization and irritation will occur in exposed 
    workers. EPA determined that use of the substance did not present an 
    unreasonable risk because significant worker exposure is not expected 
    because the substance was used as an intermediate. EPA has determined 
    that use other than an intermediate may result in significant worker 
    exposure. 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 90-day inhalation study 
    in rats (40 CFR 799.9346) (62 FR 43828, August 15, 1997) (FRL-5719-5) 
    would help characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.4259.
    
    PMN Number P-96-1240
    
    Chemical name: Poly(oxy-1,2-ethanediyl), -sulfo--[1-
    [(4-nonylphenoxy)methyl]-2-(2-propenyloxy)ethoxy]-, branched, ammonium 
    salts.
    CAS number: 184719-88-8.
    Basis for action: The PMN substance will be used as an emulsifier. 
    Based on analogy to structurally similar substances and submitted test 
    data, EPA is concerned that kidney toxicity, reproductive toxicity, 
    developmental toxicity, and oncogenicity will occur in exposed workers. 
    EPA determined that use of the substance did not present an 
    unreasonable risk because significant worker exposure is not expected 
    because the substance was not manufactured domestically. EPA has 
    determined that domestic manufacture of the substance may result in 
    significant worker exposure. Based on this information the PMN 
    substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(C), 
    (b)(3)(i), (b)(3)(ii), and (b)(3)(iii).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5), 
    a two-species oral developmental toxicity test (40 CFR 799.9370) (62 FR 
    43832, August 15, 1997) (FRL-5719-5), and a 90-day subchronic oral 
    study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public 
    draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help 
    characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.539.
    
    PMN Number P-96-1263
    
    Chemical name: (generic) Substituted phenyl azo substituted 
    sulfocarbopolycle, sodium salt.
    CAS number: Not available.
    Basis for action: The PMN substance will be used in a destructive use. 
    Based on analogy to structurally similar substances, EPA is concerned 
    that oncogenicity, blood effects, developmental toxicity, and 
    neurotoxicity will occur in workers exposed via inhalation. EPA 
    determined that use of the substance as described in the PMN does not 
    present an unreasonable risk. Significant worker inhalation exposure is 
    not expected because the substance will not be manufactured, processed, 
    or used as a powder. EPA has determined that manufacture, processing, 
    and use of the substance as a solid may result in significant worker 
    inhalation exposure. Based on this information the PMN substance meets 
    the concern criteria at Sec. 721.170(b)(3)(iii).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5), 
    a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or OPPTS 
    870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) 
    (FRL-5367-7)), and a two-species oral developmental toxicity test (40 
    CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) would 
    characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.9545.
    
    PMN Numbers P-96-1280/1281/1504/1505/1506/1507/1508
    
    Chemical name: (generic) Quaternary ammonium alkyletherpropyl 
    trialkylamine halides.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as industrial 
    production aids. Based on analogy to aliphatic amines and cationic 
    surfactants, EPA is concerned that toxicity to aquatic organisms may 
    occur at a concentration as low as 2 ppb of the PMN substances in 
    surface waters. EPA determined that use of the substances as described 
    in the PMN did not present an unreasonable risk because the substances 
    would not be released to surface waters. EPA has determined that other 
    uses of the substances may result in releases to surface waters which 
    exceed the concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.4095.
    
    PMN Number P-96-1288
    
    Chemical name: (generic) Hydrofluoroalkene.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on analogy to structurally similar substances, EPA is concerned 
    that lung toxicity, neurotoxicity, irritation, oncogenicity, liver 
    toxicity, kidney toxicity, and cardiac sensitization will occur in 
    exposed workers. EPA determined that use of the substance as an 
    intermediate did not present an unreasonable risk because it did not 
    result in significant worker exposure. EPA has determined that use 
    other than an intermediate may result in significant worker exposure. 
    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 90-day subchronic oral 
    study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public 
    draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) and a 2-year, two-
    species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) 
    (FRL-5719-5) would help characterize the health and environmental 
    effects of the PMN substance.
    CFR citation: 40 CFR 721.4465.
    
    PMN Number P-96-1315
    
    Chemical name: 9H-Thioxanthen-9-one, 2,4-diethyl.
    CAS number: 82799-44-8.
    
    [[Page 3412]]
    
    Basis for action: The PMN substance will be used as a 
    photopolymerization initiator. Based on analogy to neutral organic 
    substances, 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. EPA determined that use of the substance as described 
    in the PMN did not present an unreasonable risk because the substance 
    would not be released to surface waters in significant quantities. EPA 
    has determined that other uses of the substance may result in releases 
    to surface waters which exceed the concern concentration. 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 chronic 60-day fish 
    early life stage toxicity test in rainbow trout (40 CFR 797.1600 or 
    OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)), a 21-day daphnid chronic toxicity test (40 CFR 
    797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, 
    April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 
    CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 
    16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.9664.
    
    PMN Number P-96-1319
    
    Chemical name: (generic) Nitro methyl quinoline.
    CAS number: Not available.
    Basis for action: The PMN substance will be used in a destructive use. 
    Based on analogy to structurally similar substances, there is concern 
    for oncogenicity, mutagenicity, blood toxicity, and neurotoxicity. EPA 
    determined that use of the substance as described in the PMN did not 
    present an unreasonable risk because the substance would not be 
    released to surface waters in significant amounts and workers would not 
    be exposed by inhalation. EPA has determined that use without 
    appropriate respiratory protection may result in significant inhalation 
    exposure to workers and disposal other than by incineration may result 
    in significant drinking water exposures to exposed populations. 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 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) 
    and a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or 
    OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 
    1996) (FRL-5367-7)) would characterize the human health effects of the 
    PMN substance.
    CFR citation: 40 CFR 721.9080.
    
    PMN Numbers P-96-1337/1338/1339
    
    Chemical name: (generic) Amine substituted metal salts.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as catalysts. Based 
    on analogy to structurally similar compounds, EPA is concerned that 
    toxicity to aquatic organisms may occur at a concentration as low as 4 
    ppb of the PMN substances in surface waters. EPA determined that use of 
    the substances as described in the PMN did not present an unreasonable 
    risk because the substances would not be released to surface waters in 
    significant quantities. EPA has determined that other uses of the 
    substances may result in releases to surface waters which exceed the 
    concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.640.
    
    PMN Number P-96-1410
    
    Chemical name: (generic) Substituted bisaniline.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as paper dye 
    intermediate. Based on analogy to neutral organics, 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. EPA determined that 
    use of the substance as described in the PMN did not present an 
    unreasonable risk because the substance would not be released to 
    surface waters in significant quantities. EPA has determined that other 
    uses of the substance may result in releases to surface waters which 
    exceed the concern concentration. 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 chronic 60-day fish 
    early life stage toxicity test in rainbow trout (40 CFR 797.1600 or 
    OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)), a 21-day daphnid chronic toxicity test (40 CFR 
    797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, 
    April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 
    CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 
    16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.1805.
    
    PMN Number P-96-1427
    
    Chemical name: (generic) Stilbene diglycidyl ether.
    CAS number: Not available.
    Effective date of section 5(e) consent order: March 14, 1997.
    Basis for section 5(e) consent order: The order was issued under 
    section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to 
    health.
    Toxicity concern: Diglycidyl ether of bisphenol A (DGEBA), other 
    similar chemicals, and epoxides have been shown to cause mutagenicity, 
    oncogenicity, male reproductive toxicity and mucous membrane irritation 
    in test animals.
    Recommended testing: EPA has determined that a 90-day subchronic oral 
    toxicity study with attention to the male and female reproductive 
    organs (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 
    61 FR 31522, June 20, 1996) (FRL-5367-7)) would help to characterize 
    the reproductive toxicity. The PMN submitter has agreed not to exceed 
    the production volume limit without performing this test. A 2-year 
    bioassay on bisphenol A-diglycidyl ether (40 CFR 799.9420) (62 FR 
    43838, August 15, 1997) (FRL-5719-5) would be required to evaluate the 
    carcinogenicity effects which may be caused by the PMN substance. This 
    study will serve as a surrogate for a carcinogenicity study on the PMN 
    substance. The order does not require submission of the oncogenicity 
    study 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 study or other relevant information.
    CFR citation: 40 CFR 721.3465.
    
    [[Page 3413]]
    
    PMN Number P-96-1430
    
    Chemical name: (generic) Alkylpoly(oxyalkylene)amine.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on analogy to aliphatic amines 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. EPA determined that use of the 
    substance as an intermediate did not present an unreasonable risk 
    because it did not result in significant environmental exposure. EPA 
    has determined that use other than an intermediate may result in 
    significant environmental exposure. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.641.
    
    PMN Number P-96-1478
    
    Chemical name: (generic) Ethoxylated alcohol, phosphated, amine salt.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a polymer 
    suspension agent. Based on analogy to phosphate ester surfactants EPA 
    is concerned that toxicity to aquatic organisms may occur at a 
    concentration as low as 8 ppb of the PMN substance in surface waters. 
    EPA determined that use of the substance as described in the PMN did 
    not present an unreasonable risk because significant releases of the 
    substance is not expected to surface waters. EPA has determined that 
    other uses of the substance may result in releases to surface waters 
    which exceed the concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.643.
    
    PMN Numbers P-96-1510/1511/1512/1513/1514
    
    Chemical name: (generic) Alkyletherpropyl dialkylamine.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as intermediates. 
    Based on 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 substances in surface waters. EPA determined that use of the 
    substances as described in the PMN did not present an unreasonable risk 
    because there was not significant releases of the substances to surface 
    waters. EPA has determined that uses other than as an intermediate may 
    result in releases to surface waters which exceed the concern 
    concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.2345.
    
    PMN Number P-96-1536
    
    Chemical name: 2-pyrrolidone, 1-ethenyl-3-ethylidene-, (E)-.
    CAS number: 153954-47-3.
    Basis for action: The PMN substance will be used as a crosslinker in a 
    polymerization reaction. Based on analogy to structurally similar 
    chemicals, EPA identified health concerns for oncogenicity, 
    mutagenicity, neurotoxicity, and developmental toxicity. EPA determined 
    that use of the substance as described in the PMN did not present an 
    unreasonable risk because significant human exposure is not expected. 
    EPA has determined that use of the substance without impervious gloves 
    may result in significant human exposure. 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 2-year, two-species 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) 
    and a two-species oral developmental toxicity test (40 CFR 799.9370) 
    (62 FR 43832, August 15, 1997) (FRL-5719-5) will address the potential 
    health effects of the PMN substance as there is concern and potential 
    from all routes of exposure.
    CFR citation: 40 CFR 721.9010.
    
    PMN Number P-96-1588
    
    Chemical name: (generic) Hydrochloride salt of a mixed fatty 
    amidoamine.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a processing aid. 
    Based on 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. EPA determined that use of the 
    substance as described in the PMN did not present an unreasonable risk 
    because the substance was not released to surface waters. EPA has 
    determined that other uses may result in releases to surface waters. 
    Based on this information the PMN substance 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.637.
    
    PMN Number P-96-1649
    
    Chemical name: (generic) Modified silicone resin.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a polymerization 
    initiator. Based on analogy to neutral organic chemicals, EPA is 
    concerned that toxicity to aquatic organisms may occur at a 
    concentration as low as 5 ppb of the PMN substance in surface waters. 
    EPA determined that use of the substance as described in the PMN did 
    not present an unreasonable risk because the substance would not be
    
    [[Page 3414]]
    
    released to surface waters in significant quantities. EPA has 
    determined that other uses of the substance may result in releases to 
    surface waters which exceed the concern concentration. 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 chronic 60-day fish 
    early life stage toxicity test in rainbow trout (40 CFR 797.1600 or 
    OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)), a 21-day daphnid chronic toxicity test (40 CFR 
    797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, 
    April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 
    CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 
    16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.9499.
    
    PMN Number P-96-1652
    
    Chemical name: Phosphinothioic acid, bis(2,4,4-trimethylpentyl)- (9Cl).
    CAS number: 132767-86-3.
    Basis for action: The PMN substance will be used as a solvent 
    extraction reagent. Based on analogy to phosphate-based dialkyl anionic 
    surfactants and neutral organics, 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. EPA determined that use of the 
    substance as described in the PMN did not present an unreasonable risk 
    because the substance would not be released to surface waters in 
    significant quantities. EPA has determined that other uses of the 
    substance may result in releases to surface waters which exceed the 
    concern concentration. 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 chronic 60-day fish 
    early life stage toxicity test in rainbow trout (40 CFR 797.1600 or 
    OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 
    1996) (FRL-5363-1)), a 21-day daphnid chronic toxicity test (40 CFR 
    797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, 
    April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 
    CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 
    16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.6045.
    
    PMN Numbers P-96-1661/95-1654
    
    Chemical name: (generic) Alkoxysilane ester.
    CAS number: Not available.
    Basis for action: The PMN substance will be used in coatings and as a 
    filler. EPA determined that use of the substance as described in the 
    PMN did not present an unreasonable risk because it did not result in 
    significant human exposure. EPA has determined that increased use of 
    the substance may result in significant human exposure.
    Recommended testing: EPA has determined that a 90-day subchronic 
    inhalation toxicity study in rats (40 CFR 799.9346) (62 FR 43828, 
    August 15, 1997) (FRL-5719-5) would help characterize the health 
    effects of the PMN substance.
    CFR citation: 40 CFR 721.537.
    
    PMN Numbers P-97-57/58/59/60/61
    
    Chemical name: (generic) Alkyl substituted quaternary ammonium 
    chloride.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as surface active 
    agents. Based on submitted test data and analogy to monoalkyl 
    quaternary surfactants EPA is concerned that toxicity to aquatic 
    organisms may occur at a concentration as low as 4 ppb of the PMN 
    substances in surface waters. EPA determined that use of the substances 
    as described in the PMNs did not present an unreasonable risk because 
    the substances would not be released to surface waters during 
    manufacturing and processing. EPA has determined that other uses of the 
    substances may result in releases to surface waters which exceed the 
    concern concentration. Based on this information the PMN substances 
    meet the concern criteria at Sec. 721.170 (b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that a fish acute toxicity 
    study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.658.
    
    PMN Number P-97-131
    
    Chemical name: 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'[[2-amino-
    4-[(3-butoxy-2-hydroxypropyl)amino]phenyl]azo]-3,3'-dimethyl[1,1'-
    biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt.
    CAS number: 103580-64-9.
    Basis for action: The PMN substance will be used in ball point pen ink. 
    Based on potential dimethylbenzidine, aniline, and triaminobenzene azo 
    reduction products there is concern for oncogenicity, mutagenicity, 
    developmental toxicity, liver toxicity, blood toxicity, and 
    neurotoxicity. EPA determined that use of the substance as described in 
    the PMN did not present an unreasonable risk because the substance 
    would not be released to surface waters in significant amounts and 
    workers would not be exposed by inhalation. EPA has determined that 
    domestic manufacture, use as a powder, or additional releases to 
    surface water may result in drinking water exposure or inhalation 
    exposure to workers. Based on this information the PMN substance meets 
    the concern criteria at Sec. 721.170 (b)(1)(i)(D) and (b)(3)(iii).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5), 
    a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or OPPTS 
    870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) 
    (FRL-5367-7)), and a two-species oral developmental toxicity test (40 
    CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) would 
    characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.5279.
    
    PMN Number P-97-136
    
    Chemical name: (generic) Alkoxylated fatty acid amide alkylsulfate 
    salt.
    CAS number: Not available.
    Basis for action: The PMN substance will be used to soften cellulose. 
    Based on analogy to dialkyl cationic surfactants 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. EPA determined that 
    industrial uses of the substance did not present an unreasonable risk 
    because it did not result in significant environmental exposure. EPA 
    has determined that non-industrial uses may result in significant 
    environmental exposure. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-
    
    [[Page 3415]]
    
     1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 
    test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-
    1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 
    850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) 
    (FRL-5363-1)) would help characterize the environmental effects of the 
    PMN substance.
    CFR citation: 40 CFR 721.720.
    
    PMN Numbers P-97-143/144
    
    Chemical name: (generic) Polymers of styrene, cyclohexyl methacrylate 
    and substituted methacrylate.
    CAS number: Not available.
    Basis for action: The PMN substances will be used as coating resins. 
    Based on analogy to structurally similar substances, there is concern 
    for oncogenicity, mutagenicity, reproductive toxicity in males, 
    developmental toxicity, lung and skin sensitization, and membrane 
    irritation. EPA determined that use of the substances as described in 
    the PMN did not present an unreasonable risk because significant worker 
    exposure is not expected. EPA has determined that domestic manufacture 
    may result in significant inhalation exposure to workers. Based on this 
    information the PMN substances meets the concern criteria at 
    Sec. 721.170(b)(1)(i)(C) and (b)(3)(ii).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5), 
    a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or OPPTS 
    870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) 
    (FRL-5367-7)), and a two-species oral developmental toxicity test (40 
    CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) would 
    characterize the human health effects of the PMN substances.
    CFR citation: 40 CFR 721.9492.
    
    PMN Number P-97-193
    
    Chemical name: 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, 
    coupled with diazotized 4-butylbenzenamine, diazotized 4,4'-
    cyclohexylidenebis[benzenamine] and m-phenylenediamine, sodium salt.
    CAS number: 182238-09-1.
    Basis for action: The PMN substance will be used in ink. Based on 
    potential aniline and triaminobenzene azo reduction products and 
    submitted test data, there is concern for oncogenicity, mutagenicity, 
    and blood toxicity. EPA determined that use of the substance as 
    described in the PMN did not present an unreasonable risk because 
    workers would not be exposed by inhalation. EPA has determined that 
    domestic manufacture and use as a powder, may result in inhalation 
    exposure to workers. Based on this information the PMN substance meets 
    the concern criteria at Sec. 721.170 (b)(1)(i)(D) and (b)(3)(iii).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) 
    and a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or 
    OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 
    1996) (FRL-5367-7)) would characterize the human health effects of the 
    PMN substance.
    CFR citation: 40 CFR 721.5280.
    
    PMN Number P-97-217
    
    Chemical name: 1H-Imidazole, 2-ethyl-4,5-dihydro-4-methyl-.
    CAS number: 931-35-1.
    Basis for action: The PMN substance will be used as an epoxy catalyst. 
    Based on analogy to aliphatic amines, EPA is concerned that toxicity to 
    aquatic organisms may occur at a concentration as low as 40 ppb of the 
    PMN substance in surface waters. EPA determined that use of the 
    substance as described in the PMN did not present an unreasonable risk 
    because the substance would not be released to surface waters in 
    significant quantities. EPA has determined that other uses of the 
    substance may result in releases to surface waters which exceed the 
    concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.4468.
    
    PMN Number P-97-264
    
    Chemical name: Silane, (3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
    heptadecafluorodecyl)trimethoxy-.
    CAS number: 83048-65-1.
    Basis for action: The PMN substance will be used in coatings, plastics, 
    and greases. Based on analogy to alkoxysilanes, 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. Based on analogy to 
    alkoxysilanes and perfluoro compounds, there is concern for lung 
    toxicity, irritation to mucuous membranes, liver toxicity, blood 
    toxicity, immunosuppression, and reproductive toxicity. EPA determined 
    that use of the substance as described in the PMN did not present an 
    unreasonable risk because the substance would not be released to 
    surface waters and workers would not be exposed by inhalation. EPA has 
    determined that other uses of the substance may result in inhalation 
    exposures to workers and releases to surface waters which exceed the 
    concern concentration. Based on this information the PMN substance meet 
    the concern criteria at Sec. 721.170 (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that a fish acute toxicity 
    study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance. EPA has also determined 
    that a 2-year, two-species oral bioassay (40 CFR 799.9420) (62 FR 
    43838, August 15, 1997) (FRL-5719-5), a 90-day subchronic inhalation 
    study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public 
    draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)), and an oral 
    reproductive toxicity test in rats (40 CFR 799.9380) (62 FR 43834, 
    August 15, 1997) (FRL-5719-5) would help characterize the health 
    effects of the PMN substance.
    CFR citation: 40 CFR 721.9503.
    
    PMN Number P-97-302
    
    Chemical name: Hexadecanoic acid, ethenyl ester.
    CAS number: 693-38-9.
    Basis for action: The PMN substance will be used as a component in 
    adhesive formulations. Based on analogy to vinyl acetate and other 
    similar substances, there is concern for neurotoxicity, mutagencity, 
    oncogenicity, liver toxicity, developmental toxicity and reproductive 
    toxicity. EPA determined that use of the substance as described in the 
    PMN did not present an unreasonable risk because workers would not be 
    subject to significant exposures. EPA has determined that other use of 
    the substance may result in significant exposures to workers. Based on 
    this information the PMN substance
    
    [[Page 3416]]
    
    meets the concern criteria at Sec. 721.170 (b)(1)(i)(C) and (b)(3)(ii).
    Recommended testing: EPA has determined that a 2-year, two-species oral 
    bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5), 
    a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 
    870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) 
    (FRL-5367-7)), an oral two-species developmental toxicity test (40 CFR 
    799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5), and an oral 
    reproductive toxicity test in rats (40 CFR 799.9380) (62 FR 43834, 
    August 15, 1997) (FRL-5719-5) would help characterize the health 
    effects of the PMN substance.
    CFR citation: 40 CFR 721.4158.
    
    PMN Number P-97-304
    
    Chemical name: (generic) Disubstituted thiadiazolsulfone.
    CAS number: Not available.
    Basis for action: The PMN substance will be used in an enclosed use. 
    Based on analogy to N-heterocycles there are concerns for developmental 
    toxicity. Based on submitted toxicity data there are concerns for 
    neurotoxicity, mutagenicity, and irritation to eyes, lungs, and mucous 
    membranes . EPA determined that use of the substance as described in 
    the PMN did not present an unreasonable risk because workers would not 
    be subject to significant exposures. EPA has determined that uses of 
    the substance in a non-enclosed process and other than for the specific 
    use designated in the PMN may result in significant exposures to 
    workers. Based on this information the PMN substance meet the concern 
    criteria at Sec. 721.170 (b)(3)(i) and (b)(3)(ii).
    Recommended testing: EPA has determined that a 90-day subchronic oral 
    study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public 
    draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) and a two-species oral 
    developmental toxicity test (40 CFR 799.9370) (62 FR 43832, August 15, 
    1997) (FRL-5719-5) would characterize the human health effects of the 
    PMN substance.
    CFR citation: 40 CFR 721.9659.
    
    PMN Number P-97-314
    
    Chemical name: (generic) Disubstituted thiadiazole.
    CAS number: Not available.
    Basis for action: The PMN substance will be used in an enclosed use. 
    Based on analogy to N-heterocycles there are concerns for developmental 
    toxicity. Based on submitted toxicity data there are concerns for 
    neurotoxicity, mutagenicity, and irritation to eyes, lungs, and mucous 
    membranes. EPA determined that use of the substance as described in the 
    PMN did not present an unreasonable risk because workers would not be 
    subject to significant exposures. EPA has determined that uses of the 
    substance in a non-enclosed process and other than for the specific use 
    designated in the PMN may result in significant exposures to workers. 
    Based on this information the PMN substance meet the concern criteria 
    at Sec. 721.170 (b)(3)(i) and (b)(3)(ii).
    Recommended testing: EPA has determined that a 90-day subchronic oral 
    study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public 
    draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) and a two-species oral 
    developmental toxicity test (40 CFR 799.9370) (62 FR 43832, August 15, 
    1997) (FRL-5719-5) would characterize the human health effects of the 
    PMN substance.
    CFR citation: 40 CFR 721.9657.
    
    PMN Number P-97-328
    
    Chemical name: (generic) Ethylenediamine, substituted, sodium salt.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as an intermediate. 
    Based on analogy to polyanionic monomers and n-halo-nitro compounds, 
    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. 
    EPA determined that use of the substance as described in the PMN did 
    not present an unreasonable risk because significant releases of the 
    substance is not expected to surface waters. EPA has determined that 
    uses other than as an intermediate may result in releases to surface 
    waters which exceed the concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.3565.
    
    PMN Number P-97-417
    
    Chemical name: (generic) Potassium salt of polyolefin acid.
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a fuel additive. 
    Based on analogy to fatty acid anionic surfactants, EPA is concerned 
    that toxicity to aquatic organisms may occur at a concentration as low 
    as 800 ppb of the PMN substance in surface waters. EPA determined that 
    use of the substance as described in the PMN did not present an 
    unreasonable risk because significant releases of the substance is not 
    expected to surface waters. EPA has determined that uses other than as 
    a fuel additive may result in releases to surface waters which exceed 
    the concern concentration. 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; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
    study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
    study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
    61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.7375.
    
    IV. Objectives and Rationale of the Rule
    
        During review of the PMNs submitted for the chemical substances 
    that are subject to this SNUR, EPA concluded that for 25 of the 163 
    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 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) orders.
        In the other 138 cases for which the proposed uses are not 
    regulated under a TSCA section 5(e) 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,
    
    [[Page 3417]]
    
    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) order are 
    subject to similar requirements. Issuance of a SNUR for a chemical 
    substance does not signify that the substance is listed on the TSCA 
    Inventory. Manufacturers, importers, and processors are responsible for 
    ensuring that a new chemical substance subject to a final SNUR is 
    listed on the TSCA Inventory.
    
    V. Direct Final Procedures
    
        EPA is issuing these SNURs as direct final rules, 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 23, 1998, unless 
    EPA receives a written notice by February 23, 1998 that someone wishes 
    to make adverse or critical comments on EPA's action. If EPA receives 
    such a notice, EPA will publish a notice 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.
    
    VI. Test Data and Other Information
    
        EPA recognizes that section 5 of TSCA does not require developing 
    any particular test data before submission of a SNUN. Persons are 
    required only to submit test data in their possession or control and to 
    describe any other data known to or reasonably ascertainable by them. 
    In cases where a TSCA section 5(e) 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) 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 orders 
    required submissions at least 12 weeks) before reaching the specified 
    production limit. Listings of the tests specified in the TSCA section 
    5(e) 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.
    
    VII. Procedural Determinations
    
        EPA is establishing through this rule some significant new uses 
    which have been claimed as CBI subject to Agency confidentiality 
    regulations at 40 CFR part 2. EPA is required to keep this information 
    confidential to protect the CBI of the original PMN submitter. EPA 
    promulgated a procedure to deal with the situation where a specific 
    significant new use is CBI. This procedure appears in 40 CFR 
    721.1725(b)(1) and is similar to that in 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 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).
    
    VIII. Applicability of Rule to Uses Occurring Before Effective Date 
    of the Final Rule
    
        To establish a significant ``new'' use, EPA must determine that the 
    use is not ongoing. The chemical substances subject to this rule have 
    recently undergone premanufacture review. TSCA section 5(e) orders have 
    been issued for 24 substances and notice submitters are prohibited by 
    the TSCA section 5(e) orders from undertaking activities which EPA is 
    designating as significant new uses. In cases where EPA has not 
    received a NOC and the substance has not been added to the TSCA 
    Inventory, no other person may commence such activities without first 
    submitting a PMN. For substances for which an NOC has not been 
    submitted
    
    [[Page 3418]]
    
    at this time, EPA has concluded that the uses are not ongoing. However, 
    EPA recognizes in cases when chemical substances identified in this 
    SNUR are added to the TSCA Inventory prior to the effective date of the 
    rule, the 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, 123 of the 163 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) 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.
    
    IX. Economic Analysis
    
        EPA has evaluated the potential costs of establishing significant 
    new use notice requirements for potential manufacturers, importers, and 
    processors of the chemical substance subject to this rule. EPA's 
    complete economic analysis is available in the public record for this 
    rule (OPPTS-50628).
    
    X. Public Record and Electronic Submissions
    
        The official record for this rulemaking, as well as the public 
    version, has been established for this rulemaking under docket control 
    number OPPTS-50628 (including comments and data submitted 
    electronically as described below). A public version of this record, 
    including printed, paper versions of electronic comments, which does 
    not include any information claimed as CBI, is available for inspection 
    from 12 noon to 4 p.m., Monday through Friday, excluding legal 
    holidays. The official rulemaking record is located in the TSCA 
    Nonconfidential Information Center, Rm. NE-B607, 401 M St., SW., 
    Washington, DC.
        Electronic comments can be sent directly to EPA at:
        oppt.ncic@epamail.epa.gov
    
    
        Electronic comments must be submitted as an ASCII file avoiding the 
    use of special characters and any form of encryption. Comments and data 
    will also be accepted on disks in WordPerfect in 5.1/6.1 or ASCII file 
    format. All comments and data in electronic form must be identified by 
    the docket control number OPPTS-50628. Electronic comments on this 
    proposed rule may be filed online at many Federal Depository Libraries.
        The OPPTS harmonized test guidelines referenced in this document 
    are available on EPA's World Wide Web site under ``Researchers and 
    Scientists,'' ``Environmental Test Methods & Guidelines'' (http://
    www.epa.gov/epahome/research.htm).
    
    XI. Regulatory Assessment Requirements
    
        Under Executive Order 12866, entitled ``Regulatory Planning and 
    Review'' (58 FR 51735, October 4, 1993), this action is not a 
    ``significant regulatory action'' subject to review by the Office of 
    Management and Budget (OMB). In addition, this action does not impose 
    any enforceable duty or contain any unfunded mandate as described in 
    the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4), or 
    require prior consultation with State officials as also specified in 
    Executive Order 12875, entitled ``Enhancing the Intergovernmental 
    Partnership'' (58 FR 58093, October 28, 1993). Nor does it 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), or additional OMB review 
    in accordance with Executive Order 13045, entitled ``Protection of 
    Children from Environmental Health Risks and Safety Risks'' (62 FR 
    19885, April 23, 1997).
        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 rules, 
    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, 
    OPPE Regulatory Information Division, U.S. Environmental Protection 
    Agency (Mail Code 2137), 401 M Street, S.W., Washington, D.C. 20460, 
    with a copy to the Office of Information and Regulatory Affairs, Office 
    of Management and Budget, 725 17th St., N.W., Washington, DC 20503, 
    marked ``Attention: Desk Officer for EPA.'' Please remember to include 
    the OMB control number in any correspondence, but do not submit any 
    completed forms to these addresses.
        In addition, pursuant to section 605(b) of the Regulatory 
    Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has previously 
    certified, as a generic matter, that the promulgation of a SNUR does 
    not have a significant adverse economic impact on a substantial number 
    of small entities. The Agency's generic certification for promulgation 
    of new SNURs appears on June 2, 1997 (62 FR 29684) (FRL-5597-1), and 
    was provided to the Chief Counsel for Advocacy of the Small Business 
    Administration.
    
    XII. Submission to Congress and the General Accounting Office
    
        Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
    Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a 
    report containing this rule and other required
    
    [[Page 3419]]
    
    information to the U.S. Senate, the U.S. House of Representatives, and 
    the Comptroller General of the General Accounting Office prior to 
    publication of this rule in today's Federal Register. This 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: January 6, 1998.
    
    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. 721.405 to subpart E to read as follows:
    
    
    Sec. 721.405   Polyether acrylate.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    polyether acrylate (PMN P-95-666) is subject to 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.
        3. By adding new Sec. 721.524 to subpart E to read as follows:
    
    
    Sec. 721.524   Alcohols, C6-12, ethoxylated, reaction 
    product with maleic anhydride.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    alcohols, C6-12, ethoxylated, reaction product with maleic 
    anhydride (PMN P-88-1108) is subject to reporting under this section 
    for the significant new uses described in paragraph (a)(2) of this 
    section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in Sec. 721.90 
    (a)(4), (b)(4), and (c)(4) (N = 300).
        (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.
        4. By adding new Sec. 721.526 to subpart E to read as follows:
    
    
    Sec. 721.526   Substituted aromatic aldehyde.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    substituted aromatic aldehyde (PMN P-95-1466) is subject to 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.
        5. By adding new Sec. 721.528 to subpart E to read as follows:
    
    
    Sec. 721.528   Benzaldehyde, 2-hydroxy-5-nonyl-, oxime, branched.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as benzaldehyde, 2-
    hydroxy-5-nonyl-, oxime, branched (PMN P-95-1467; CAS No. 174333-80-3) 
    is subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in 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.
        6. By adding new Sec. 721.537 to subpart E to read as follows:
    
    
    Sec. 721.537   Organosilane ester.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    organosilane ester (PMN P-96-1661/P-95-1654) is subject to 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(r) (370,000 kilogram (kg)) (90-day 
    subchronic inhalation study in rats-(40 CFR 799.9346) (62 FR 43828, 
    August 15, 1997) (FRL-5719-5). 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)(i)(A), (a)(2)(i)(B), 
    (a)(2)(i)(C), and (a)(2)(i)(D) of this section.
        (A) Each study required to be performed pursuant to this section 
    must be scientifically valid. Scientific valid means that the study was 
    conducted according to:
        (1) The test guidelines specified in paragraph (a)(2)(i) 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)(i) 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)(i) of this section (e.g., 
    40 CFR part 797 or part 798) provide
    
    [[Page 3420]]
    
    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)(i)(D)(2) of this 
    section, 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)(i)(D)(2)(i) or (a)(2)(i)(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)(i)(C)(3) of this section, the person shall comply with paragraph 
    (a)(2)(i)(C)(3) of this section. If there is insufficient time for the 
    person to comply with paragraph (a)(2)(ii)(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)(i)(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)(i)(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)(i) of this section if notified in writing by EPA that 
    it is unnecessary to conduct that study.
        (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.
        7. By adding new Sec. 721.538 to subpart E to read as follows:
    
    
    Sec. 721.538   Phenol, 4-(1,1-dimethylethyl)-, homopolymer.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as phenol, 4-(1,1-
    dimethylethyl)-, homopolymer (PMN P-95-243; CAS No. 30813-81-1) is 
    subject to reporting under this section for the significant new uses 
    described in paragraph (a)(3) of this section.
        (2) High moleculation weight exemption. A batch of the chemical 
    substance may be exempt from the provisions of this rule if the average 
    number molecular weight of the substance is greater than 1,000 and the 
    low molecular weight species below 1,000 and 500 are less than 25 
    percent and 10 percent, respectively. To be eligible for this 
    exemption, the batch must be individually measured.
        (3) The significant new uses are:
        (i) Hazard communication program. Requirements as specified in 
    Sec. 721.72 (a), (b), (d), (f), (g)(3)(i), (g)(4)(i), and (g)(5). The 
    label and material safety data sheet (MSDS) as required by this 
    paragraph shall also include the following statement: This substance is 
    toxic to aquatic invertebrate.
        (ii) Industrial, commercial, and consumer activites. Requirements 
    as specified in Sec. 721.80(q).
        (iii) Release to water. Requirements as specified in Sec. 721.90 
    (a)(4) and (b)(4) (N = 9). When calculating the surface water 
    concentrations according to the instructions in Sec. 721.91, the 
    statement that the amount of the substance that will be released will 
    be calculated before the substance enters control technology does not 
    apply. Instead, if the waste stream containing the substance will be 
    treated using primary and secondary wastewater treatment with control 
    of suspended solids, before release, then the amount of the substance 
    reasonably likely to be removed from the waste stream by such treatment 
    may be subtracted in calculating the number of kilograms released. No 
    more than 95 percent removal efficiency may be attributed to such 
    treatment. These requirements do not apply to the sites specifically 
    exempted in the TSCA section 5(e) consent order for this substance.
        (b) Specific requirements. The 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), (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.
        8. By adding new Sec. 721.539 to subpart E to read as follows:
    
    
    Sec. 721.539   Poly(oxy-1,2-ethanediyl), -sulfo--[1-
    [(4-nonylphenoxy)methyl]-2-(2-propenyloxy)ethoxy]-, branched, ammonium 
    salts.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as Poly(oxy-1,2-
    ethanediyl), -sulfo--[1-[(4-nonylphenoxy)methyl]-2-
    (2-propenyloxy)ethoxy]-, branched, ammonium salts (PMN P-96-1240; CAS 
    No. 184719-88-8) is subject to reporting under this section for the 
    significant new uses described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in 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) 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.
        9. By adding new Sec. 721.567 to subpart E to read as follows:
    
    
    Sec. 721.567   Mixed fatty alkylamines, salt.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as mixed fatty 
    alkylamines (PMN P-96-795) is subject to reporting under this
    
    [[Page 3421]]
    
    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.
        10. By adding new Sec. 721.637 to subpart E to read as follows:
    
    
    Sec. 721.637   Hydrochloride salt of a mixed fatty amidoamine.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    hydrochloride salt of a mixed fatty amidoamine (PMN P-96-1588) is 
    subject to 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.
        11. By adding new Sec. 721.640 to subpart E to read as follows:
    
    
    Sec. 721.640   Amine substituted metal salts.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as amine 
    substituted metal salts (PMNs P-96-1337/1338/1339) are subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in Sec. 721.90 
    (a)(4), (b)(4), and (c)(4) (N = 4).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        12. By adding new Sec. 721.641 to subpart E to read as follows:
    
    
    Sec. 721.641   Alkylpoly(oxyalkylene)amine.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    alkylpoly(oxyalkylene)amine (PMN P-96-1430) is subject to 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(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.
        13. By adding new Sec. 721.643 to subpart E to read as follows:
    
    
    Sec. 721.643   Ethoxylated alcohol, phosphated, amine salt.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as an ethoxylated 
    alcohol, phosphated, amine salt (PMN P-96-1478) is subject to 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)(4), (b)(4), and (c)(4) (N = 8).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        14. By adding new Sec. 721.655 to subpart E to read as follows:
    
    
    Sec. 721.655   Ethoxylated alkyl quaternary ammonium compound.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    ethoxylated alkyl quaternary ammonium compound (PMN P-96-573) is 
    subject to 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(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.
        15. By adding new Sec. 721.658 to subpart E to read as follows:
    
    
    Sec. 721.658   Alkyl substituted quaternary ammoniums.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as alkyl 
    substituted quaternary ammoniums (PMNs P-97-57/58/59/60/61) are subject 
    to reporting under this section for the significant new uses described 
    in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in Sec. 721.90 
    (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.
    
    [[Page 3422]]
    
        16. By adding new Sec. 721.720 to subpart E to read as follows:
    
    
    Sec. 721.720   Alkoxylated fatty acid amide, alkylsulfate salt.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    alkoxylated fatty acid amide, alkylsulfate salt (PMN P-97-136) is 
    subject to 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(l).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        17. By adding new Sec. 721.723 to subpart E to read as follows:
    
    
    Sec. 721.723   Anthraquinone dye.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    anthraquinone dye (PMN P-94-2159) is subject to 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.
        18. By adding new Sec. 721.977 to subpart E to read as follows:
    
    
    Sec. 721.977   Aryloxyarene.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    aryloxyarene (PMN P-92-314) is subject to 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)(3)(ii), (g)(4)(iii), and 
    (g)(5). The label and MSDS as required by this paragraph shall also 
    include the following statement: This substance may be toxic to 
    sediment organisms.
        (ii) 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), (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.
        19. By adding new Sec. 721.980 to subpart E to read as follows:
    
    
    Sec. 721.980   Sodium salt of azo acid dye.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    sodium salt of azo acid dye (PMN P-95-633) is subject to eporting 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.
        20. By adding new Sec. 721.981 to subpart E to read as follows:
    
    
    Sec. 721.981   Substituted naphtholoazo-substituted naphthalenyl-
    substituted azonaphthol chromium complex.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    substituted naphtholoazo-substituted naphthalenyl-substituted 
    azonaphthol chromium complex (PMN P-93-1631) is subject to 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), (v)(2), (w)(2), and (x)(2).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        21. By adding new Sec. 721.1105 to subpart E to read as follows:
    
    
    Sec. 721.1105   Benzenamine, 4,4'-methylenebis[2-methyl-6-(1-
    methylethyl)]-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as benzenamine, 4,4'-
    methylenebis[2-methyl-6-(1-methylethyl)]- (PMN P-96-93; CAS No. 16298-
    38-7) is subject to reporting under this section for the significant 
    new uses described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in 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.
        22. By adding new Sec. 721.1155 to subpart E to read as follows:
    
    
    Sec. 721.1155   1,4-benzenediol, 2-(1,1,3,3-tetramethylbutyl)-and 
    Bis(dimethylamino substituted)carbomonocycle.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 1,4-
    benzenediol, 2-(1,1,3,3-tetramethylbutyl)- and Bis
    
    [[Page 3423]]
    
    (dimethylamino substituted)carbomonocycle (PMN P-96-92) is subject to 
    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)(4), (b)(4), and (c)(4) (N = 1).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        23. By adding new Sec. 721.1705 to subpart E to read as follows:
    
    
    Sec. 721.1705   Benzoic acid, 3-amino-, diazotized, coupled with 6-
    amino-4-hydroxy-2-naphthalenesulfonic acid, diazotized, (3-
    aminophenyl)phosphonic acid and diazotized 2,5-diethoxybenzenamine.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance generically identified as benzoic 
    acid, 3-amino-, diazotized, coupled with 6-amino-4-hydroxy-2-
    naphthalenesulfonic acid, diazotized, (3-amino-phenyl)phosphonic acid 
    and diazotized 2,5-diethoxybenzenamine (PMN P-96-1216; CAS No. 163879-
    69-4) is subject to reporting under this section for the significant 
    new uses described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in 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.
        24. By adding new Sec. 721.1805 to subpart E to read as follows:
    
    
    Sec. 721.1805   Substituted bisaniline.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    substituted bisaniline (PMN P-96-1410) 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) Release to water. Requirements as specified in Sec. 721.90 
    (a)(4), (b)(4), and (c)(4) (N = 4).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        25. By adding new Sec. 721.1930 to subpart E to read as follows:
    
    
    Sec. 721.1930   Butanoic acid, antimony (3+) salt.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as butanoic acid, 
    antimony (3+) salt (PMN P-94-1143; CAS No. 53856-17-0) 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)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1 
    percent), and (c).
        (ii) Hazard communication program. Requirements as specified in 
    Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
    (g)(1)(i), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), (g)(2)(v), 
    and (g)(5). The label and MSDS as required by this paragraph shall also 
    include the following statement: This substance may cause neurologic 
    effects. This substance may cause cardiovascular effects. This 
    substance may cause ocular irritation.
        (iii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(p) (675,000 kg).
        (b) Specific requirements. The 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.
        26. By adding new Sec. 721.2082 to subpart E to read as follows:
    
    
    Sec. 721.2082   Derivative of substituted carbomonocyclic carboxylic 
    acid-amine distillation stream byproduct reaction product.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    derivative of substituted carbomonocyclic carboxylic acid-amine 
    distillation stream byproduct reaction product (PMN P-96-866) is 
    subject to 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.
        27. By adding new Sec. 721.2091 to subpart E to read as follows:
    
    
    Sec. 721.2091   Chloroalkane.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    chloroalkane (PMN P-96-273) is subject to 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(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.
    
    [[Page 3424]]
    
        28. By adding new Sec. 721.2094 to subpart E to read as follows:
    
    
    Sec. 721.2094   N,N'-di(alkyl heteromonocycle)amino chlorotriazine.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as N,N'-
    di(alkyl heteromonocycle)amino chlorotriazine (PMN P-93-1369) is 
    subject to 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) (this respirator meets the minimum 
    requirement for persons exposed via inhalation during manufacture), 
    (a)(5)(ii), (a)(5)(iv), (a)(5)(v) (these three respirators meet the 
    minimum requirements for persons exposed via inhalation during 
    processing and use), (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), 
    (b) (concentration set at 0.1 percent), and (c).
        (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)(iv), (g)(1)(vii), (g)(1)(viii), (g)(1)(ix), (g)(2)(ii), 
    (g)(2)(iii), (g)(2)(iv), (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(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), (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.
        29. By adding new Sec. 721.2122 to subpart E to read as follows:
    
    
    Sec. 721.2122   Substituted phenyl azo substituted sulfo 
    carbopolycycle.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    substituted phenyl azo substituted sulfo carbopolycycle (PMN P-96-702) 
    is subject to 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(r) (204,000 kg) (activated sludge 
    adsorption isotherm- OPPTS 835.1110 test guideline (public draft; 61 FR 
    16486, April 15, 1996) (FRL-5363-1), daphnid acute toxicity-
    Sec. 797.1300, fish acute toxicity-Sec. 797.1400, murine immune 
    allergic response study (Toxicology and Applied Pharmacology 112:190-
    197 (1992)). A person may not manufacture or import the substance 
    beyond the following aggregate production volume limits, unless that 
    person conducts the following corresponding studies on the substance 
    and submits all final reports and underlying data in accordance with 
    the procedures and criteria specified in paragraphs (a)(2)(i)(A), 
    (a)(2)(i)(B), (a)(2)(i)(C), and (a)(2)(i)(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)(i) 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)(i) 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)(i) 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)(i)(D)(2) of this 
    section, 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 paragraph (a)(2)(i)(D)(2)(i) or (a)(2)(i)(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)(i)(C)(3) of this section, the person shall comply with paragraph 
    (a)(2)(i)(C)(3) of this section. If there is insufficient time for the 
    person to comply with paragraph (a)(2)(i)(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)(i)(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)(i)(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)(i) of this section if notified in writing by EPA that 
    it is unnecessary to conduct that study.
        (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.
        30. By adding new Sec. 721.2145 to subpart E to read as follows:
    
    [[Page 3425]]
    
    Sec. 721.2145   Ceteareth-25 sorbate.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    ceteareth-25 sorbate (PMN P-96-941) is subject to 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(g).
        (ii) [Reserved]
        (b) Specific requirements. The provision 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.
        31. By adding new Sec. 721.2222 to subpart E to read as follows:
    
    
    Sec. 721.2222   Cyclohexanamine, N,N-dimethyl-, compd. with alpha-
    isotridecyl-omega-hydroxypoly(oxy-1,2-ethanediyl) phosphate.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as cyclohexanamine, 
    N,N-dimethyl-, compd. with alpha-isotridecyl-omega-hydroxypoly(oxy-1,2-
    ethanediyl) phosphate (PMN P-96-1176; CAS No. 164383-18-0) is subject 
    to reporting under this section for the significant new uses described 
    in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial and consumer activities. Requirements as 
    specified in 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.
        32. By adding new Sec. 721.2280 to subpart E to read as follows:
    
    
    Sec. 721.2280   Cyclopropanecarboxaldehyde.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 
    cyclopropanecarboxaldehyde (PMN P-96-33) is subject to 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)(iii), (a)(5)(xii), 
    (a)(5)(xiii), (a)(5)(xiv), (a)(6)(v), (b) (concentration set at 1.0 
    percent), and (c). Each person who is reasonsonably likely to be 
    exposed by inhalation to the PMN substance in vapor form during loading 
    of rail cars is provided with, and is required to wear, at a minimum, a 
    National Institute for Occupational Safety and Health (NIOSH) approved 
    category 19C Type C supplied-air respirator operated in pressure demand 
    or other positive pressure mode and equipped with a full facepiece with 
    an assigned protection factor (APF) of 200. As an alternative to the 
    respiratory requirements in this section, manufacturers, importers, and 
    processors may use the new chemical exposure limits provisions, 
    including sampling and analytical methods which have previously been 
    approved by EPA for this substance, found in the TSCA section 5(e) 
    consent order for this substance.
        (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)(ii), (g)(1)(iv), (g)(1)(ix), (g)(2)(ii), 
    (g)(2)(iii), (g)(2)(iv), and (g)(5).
        (iii) Industrial, commercial, and consumer activites. 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.
        33. By adding new Sec. 721.2345 to subpart E to read as follows:
    
    
    Sec. 721.2345   Alkyletherpropyl dialkylamines.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified as alkyletherpropyl 
    dialkylamines (PMNs P-96-1510/1511/1512/1513/1514) are subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in 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.
        34. By adding new Sec. 721.2350 to subpart E to read as follows:
    
    
    Sec. 721.2350   Alkyltri, tetra, and pentaamines.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as 
    alkyltri, tetra, and pentaamines (PMNs P-96-406/407/408) are subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in 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.
        35. By adding new Sec. 721.2535 to subpart E to read as follows:
    
    
    Sec. 721.2535   Benzene, 1,1'-methylanebis[4-isocyanato-, homopolymer, 
    Bu alc.-blocked.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as benzene, 1,1'-
    methylanebis[4-isocyanato-, homopolymer, Bu alc.-blocked (PMN P-95-
    1386; CAS No. 186321-98-2) 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:
    
    [[Page 3426]]
    
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(y)(1).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        36. By adding new Sec. 721.2805 to subpart E to read as follows:
    
    
    Sec. 721.2805   Acrylate ester.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    acrylate ester (PMN P-96-824) is subject to reporting under this 
    section for the significant new uses described in paragraph (a)(2) of 
    this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in 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.
        37. By adding new Sec. 721.2925 to subpart E to read as follows:
    
    
    Sec. 721.2925   Brominated aromatic ester.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    brominated aromatic ester (PMN P-95-1128) is subject to 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)(3)(1), (g)(3)(ii), 
    (g)(4)(iii), and (g)(5).
        (ii) [Reserved]
        (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), (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.
        38. By adding new Sec. 721.3085 to subpart E to read as follows:
    
    
    Sec. 721.3085   Brominated phthalate ester.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    brominated phthalate ester (PMN P-90-581) is subject to 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(q).
        (ii) Hazard communication program. A significant new use of this 
    substance 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 this substance, the employer becomes aware that 
    this substance 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 a 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 substance from the employer within 5 years from the 
    date the employer becomes aware of the new information described in 
    paragraph (a)(2)(i)(A) of this section, are provided an MSDS as 
    described in Sec. 721.72(c) containing the information required under 
    paragraph (a)(2)(i)(A) of this section 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 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.
        39. By adding new Sec. 721.3155 to subpart E to read as follows:
    
    
    Sec. 721.3155   3,8-Dioxa-4,7-disiladecane, 4,4,7,7-tetraethoxy-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 3,8-dioxa-4,7-
    disiladecane, 4,4,7,7-tetraethoxy- (PMN P-95-1326; CAS No. 16068-37-4) 
    is subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(y)(1).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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. 721.3465 to subpart E to read as follows:
    
    
    Sec. 721.3465   Stilbene diglycidyl ether.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as stilbene diglycidyl 
    ether (PMN P-96-1427) is subject to 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)(ii),
    
    [[Page 3427]]
    
    (a)(5)(iv), (a)(5)(v), (a)(6)(i), (b) (concentration set at 0.1 
    percent), and (c). As an alternative to the respiratory protection 
    requirements of this section, manufacturers, importers, and processors 
    of this substance may follow the terms of the new chemical exposure 
    limits section in the TSCA section 5(e) consent order for this 
    substance.
        (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)(ii), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), 
    (g)(2)(iv), (g)(2)(v), and (g)(5). The label and MSDS as required by 
    this paragraph shall also include the following statement: When using 
    this substance use respiratory protection or maintain workplace 
    airborne concentrations at or below an 8-hour time-weighted average of 
    0.5 milligram (mg)/meter (m3).
        (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.
        41. By adding new Sec. 721.3485 to subpart E to read as follows:
    
    
    Sec. 721.3485   Hydrofluorocarbon alkyl ether.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    hydrofluorocarbon alkyl ether (PMN P-95-1578) is subject to reporting 
    under this section for the significant new uses described in paragraph 
    (a)(2) of this section. Non-spray uses are exempt from the provisions 
    of this rule.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63 (a)(4), (a)(5)(iii), and (a)(6)(v).
        (ii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(g).
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    Sec. 721.125 (a), (b), (c), (d), 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.
        42. By adding new Sec. 721.3488 to subpart E to read as follows:
    
    
    Sec. 721.3488   Poly(oxy-1,2-ethanediyl), alpha substituted-omega-
    hydroxy-, C16-20 alkyl ethers.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    poly(oxy-1,2-ethanediyl), alpha substituted-omega-hydroxy-, 
    C16-20 alkyl ethers (PMN P-87-323) is subject to 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. 721.90 (a)(4), (b)(4), and (c)(4) (N = 20).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        43. By adding new Sec. 721.3565 to subpart E to read as follows:
    
    
    Sec. 721.3565   Ethylenediamine, substituted, sodium salt.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    ethylenediamine, substituted, sodium salt (PMN P-97-328) is subject to 
    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(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.
        44. By adding new Sec. 721.4085 to subpart E to read as follows:
    
    
    Sec. 721.4085   Guanidine, pentaethyl-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as guanidine, 
    pentaethyl- (PMN P-94-1018; CAS No. 13439-89-9) 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), (a)(2)(i), and (a)(3).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    Sec. 721.125 (a), (b), (c), (d), and (e) 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.
        45. By adding new Sec. 721.4090 to subpart E to read as follows:
    
    
    Sec. 721.4090   Ethanaminium, N-[bis(diethylamino)-methylene]-N-ethyl-, 
    bromide.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as ethanaminium, N-
    [bis(diethylamino)-methylene]-N-ethyl-, bromide (PMN P-94-1019; CAS No. 
    89610-32-2) is subject to reporting under this section for the 
    significant new uses described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in 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.
        46. By adding new Sec. 721.4095 to subpart E to read as follows:
    
    [[Page 3428]]
    
    Sec. 721.4095   Quaternary ammonium alkyltherpropyl trialkylamine 
    halides.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as 
    quaternary ammonium alkyltherpropyl trialkylamine halides (PMNs P-96-
    1280/81/1504/1505/1506/1507/1508) are subject to reporting under this 
    section for the significant new uses described in paragraph (a)(2) of 
    this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in 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.
        47. By adding new Sec. 721.4158 to subpart E to read as follows:
    
    
    Sec. 721.4158   Hexadecanoic acid, ethenyl ester.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as hexadecanoic acid, 
    ethenyl ester (PMN P-97-302; CAS No. 693-38-9) 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) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80 (f) and (j).
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    Sec. 721.125 (a), (b), (c), (d), (e), and (i) are applicable to 
    manufacturers, importers, and processors of this substance.
        (2) Limitations or revocation of certain notification requirements. 
    The provisions of Sec. 721.185 apply to this section.
        48. By adding new Sec. 721.4257 to subpart E to read as follows:
    
    
    Sec. 721.4257   Hydrazine, (2-fluorophenyl).
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as hydrazine, (2-
    fluorophenyl) (PMN P-95-2101; CAS No. 2368-80-1) is subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in 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) 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.
        49. By adding new Sec. 721.4259 to subpart E to read as follows:
    
    
    Sec. 721.4259   Aliphatic polyisocyanate homopolymer.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    aliphatic polyisocyanate homopolymer (PMN P-96-1239) is subject to 
    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(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.
        50. By adding new Sec. 721.4462 to subpart E to read as follows:
    
    
    Sec. 721.4462   Hydrochlorofluorocarbon.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    hydrochlorofluorocarbon (PMN P-95-1317) is subject to 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(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.
        51. By adding new Sec. 721.4464 to subpart E to read as follows:
    
    
    Sec. 721.4464   Mixture of hydrofluoro alkanes and hydrofluoro alkene.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as a 
    mixture of hydrofluoro alkanes and hydrofluoro alkene (PMNs P-96-945/
    946/947/948) are subject to reporting under this section for the 
    significant new uses described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in 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 specified as 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.
        52. By adding new Sec. 721.4465 to subpart E to read as follows:
    
    
    Sec. 721.4465   Hydrofluoroalkane.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    hydrofluoroalkane (PMN P-96-1288) is subject to 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(h).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part
    
    [[Page 3429]]
    
    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.
        53. By adding new Sec. 721.4467 to subpart E to read as follows:
    
    
    Sec. 721.4467   Quaternary ammonium hydroxide.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    quaternary ammonium hydroxide (PMN P-95-1806) is subject to 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.
        54. By adding new Sec. 721.4468 to subpart E to read as follows:
    
    
    Sec. 721.4468   1H-Imidazole, 2-ethyl-4,5-dihydro-4-methyl-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 1H-imidazole, 2-
    ethyl-4,5-dihydro-4-methyl- (PMN P-97-217; CAS No. 931-35-1) 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)(4), (b)(4), and (c)(4) (N = 40).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        55. By adding new Sec. 721.4469 to subpart E to read as follows:
    
    
    Sec. 721.4469   Imidazolethione.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    imidazolethione (PMNs P-91-1131 and P-90-564) is subject to reporting 
    under this section for the significant new uses described in paragraph 
    (a)(2) of this section. Formulations or mixtures containing the PMN 
    substance in concentrations at or below 10 percent by weight or volume 
    are exempt from the provisions of this rule.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
    (c).
        (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)(ix), (g)(2)(i), (g)(2)(v), and (g)(5). The label and MSDS 
    as required by this paragraph shall also include the following 
    statements: This substance may cause thyroid cancer. This substance may 
    cause thyroid effects.
        (b) Specific requirements. The 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), and (h) 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.
        56. By adding new Sec. 721.4476 to subpart E to read as follows:
    
    
    Sec. 721.4476   Substituted imines.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as 
    substituted imines (PMNs P-95-1557/1558) are subject to reporting under 
    this section for the significant new uses described in paragraph (a)(2) 
    of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in 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.
        57. By adding new Sec. 721.4589 to subpart E to read as follows:
    
    
    Sec. 721.4589   Propanedioic acid, [(4-methoxyphenyl)methylene]-, 
    bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester (9CI).
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as propanedioic acid, 
    [(4-methoxyphenyl)methylene]-, bis(1,2,2,6,6-pentamethyl-4-piperidinyl) 
    ester (9CI) (PMN P-95-1411; CAS No. 147783-69-5) is subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63 (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(6)(i), (b) 
    (concentration set at 1.0 percent), and (c). As an alternative to the 
    respiratory protection requirements of this section, manufacturers, 
    importers, and processors of this substance may follow the terms of the 
    new chemical exposure limits section in the TSCA section 5(e) consent 
    order for this substance.
        (ii) Hazard communication program. Requirements as specified in 
    Sec. 721.72 (a), (b), (c), (d), (e), (f), (g)(1)(iv), (g)(1)(vi), 
    (g)(1)(viii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), 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), (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.
        58. By adding new Sec. 721.4885 to subpart E to read as follows:
    
    [[Page 3430]]
    
    Sec. 721.4885   Methanone, [5-[[3-(2H-benzotriazol-2-yl)-2-hydroxy-5-
    (1,1,3,3-tetramethylbutyl)phenyl]methyl]-2-hydroxy-4-(octyloxy) 
    phenyl]phenyl-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as methanone, [5-[[3-
    (2H-benzotriazol-2-yl)-2-hydroxy-5-(1,1,3,3-
    tetramethylbutyl)phenyl]methyl]-2-hydroxy-4-(octyloxy)phenyl]phenyl- 
    (PMN P-96-942; CAS No.162245-07-0) is subject to the 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)(ii), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), 
    (a)(6)(i), (b) (concentration set at 1.0 percent), and (c). As an 
    alternative to the respiratory protection requirements of this section, 
    manufacturers, importers, and processors of this substance may follow 
    the terms of the new chemical exposure limits section in the TSCA 
    section 5(e) consent order for this substance.
        (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)(iv), (g)(1)(vi), (g)(1)(viii), (g)(2)(ii), 
    (g)(2)(iv), 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), (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.
        59. By adding new Sec. 721.5255 to subpart E to read as follows:
    
    
    Sec. 721.5255   2-Naphthalenol, mono and dioctyl derivs.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 2-naphthalenol, 
    mono and dioctyl derivs (PMN P-95-1288) is subject to 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)(4), (b)(4), and (c)(4) (where N = 1). When calculating the surface 
    water concentrations according to the instructions in Sec. 721.91, the 
    statement that the amount of the substance that will be released will 
    be calculated before the substance enters control technology does not 
    apply. Instead, if the waste stream containing the substance will be 
    treated before release, then the amount of the substance reasonably 
    likely to be removed from the waste stream by such treatment may be 
    subtracted in calculating the number of kilograms released. No more 
    than 90 percent removal efficiency may be attributed to such treatment.
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        60. By adding new Sec. 721.5279 to subpart E to read as follows:
    
    
    Sec. 721.5279   2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'2-amino-
    4-[(3-butoxy-2-hydroxypropyl)amino]phebyl]azo]-3,3'-dimethyl[1,1'-
    biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 2,7-
    naphthalenedisulfonic acid, 4-amino-3-[[4'2-amino-4-[(3-butoxy-2-
    hydroxypropyl)amino]phebyl]azo]-3,3'-dimethyl[1,1'-biphenyl]-4-yl]azo]-
    5-hydroxy-6-(phenylazo)-, disodium salt (PMN P-97-131; CAS No. 103580-
    64-9) is subject to reporting under this section for the significant 
    new uses described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80 (f), (v)(1), (w)(1), and (x)(1).
        (ii) Release to water. Requirements as specified in Sec. 721.90 
    (a)(4), (b)(4), and (c)(4) (N = 40).
        (b) Specific requirements. The 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), (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.
        61. By adding new Sec. 721.5280 to subpart E to read as follows:
    
    
    Sec. 721.5280   2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, 
    coupled with diazotized 4-butylbenzenamine, diazotized 4,4'-
    cyclohexylidenebis[benzenamine] and m-phenylenediamine, sodium salt.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 2,7-
    naphthalenedisulfonic acid, 4-amino-5-hydroxy-, coupled with diazotized 
    4-butylbenzenamine, diazotized 4,4'-cyclohexyl-idenebis[benzenamine] 
    and m-phenylenediamine, sodium salt (PMN P-97-193; CAS No. 182238-09-1) 
    is subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80 (f), (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.
        62. By adding new Sec. 721.5281 to subpart E to read as follows:
    
    
    Sec. 721.5281   2-Naphthalenesulfonic acid, 3-[[4-[(2,4-dimethyl-6-
    sulfophenyl)azo]-2-methoxy-5-methylphenyl]azo]-4-hydroxy-7-
    (phenylamino)-, sodium salt, compd. With 2,2',2''-nitrilotris [ethanol] 
    (9CI).
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 2-
    Naphthalenesulfonic acid, 3-[[4-[(2,4-dimethyl-6-sulfophenyl)azo]-2-
    methoxy-5-methylphenyl]azo]-4-hydroxy-7-(phenylamino)-, sodium salt, 
    compd. With 2,2',2''-nitrilotris [ethanol] (9CI) (PMN P-95-1235; CAS 
    No. 94213-53-3) is subject to reporting under this section for the 
    significant new uses described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80 (f), (v)(1), (w)(1), and (x)(1).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part
    
    [[Page 3431]]
    
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements 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.
        63. By adding new Sec. 721.5547 to subpart E to read as follows:
    
    
    Sec. 721.5547   Antimony double oxide.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as 
    antimony double oxide (PMNs P-95-677 and P-95-724) 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) Hazard communication program. Requirements as specified in 
    Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
    (f), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(3)(ii), and (g)(5). The 
    label and MSDS as required by this paragraph shall also include the 
    following statements: These substances may cause lung toxicity. When 
    using these substances avoid any applications of these substances which 
    could cause inhalation exposures. When using these substances keep in 
    liquid form only.
        (ii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80 (f), (v)(1), (v)(2), (w)(1), (w)(2), 
    (x)(1), (x)(2), (y)(1), and (y)(2). Manufacturing, processing or use in 
    any form which could cause inhalation exposures.
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements specified in 
    Sec. 721.125 (a), (b), (c), (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.
        64. By adding new Sec. 721.5549 to subpart E to read as follows:
    
    
    Sec. 721.5549   Lithiated metal oxide.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    lithiated metal oxide (LiNiO2) (PMN P-96-19; CAS No. 12031-
    65-1) is subject to reporting under this section for the significant 
    new uses described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(iv), 
    (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.
        (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)(iv), (g)(1)(vii), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), 
    (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)4)(i), 
    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), (b)(4), and (c)(4) (N = 30).
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        65. By adding new Sec. 721.5645 to subpart E to read as follows:
    
    
    Sec. 721.5645   Pentane 1,1,1,2,3,4,4,5,5,5,-decafluoro.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as pentane 
    1,1,1,2,3,4,4,5,5,5,-decafluoro (PMN P-95-638 and SNUN P-97-79; CAS No. 
    138495-42-8) is subject to reporting under this section for the 
    significant new uses described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(j) and uses other than as described in the 
    significant new use notice.
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        66. By adding new Sec. 721.5650 to subpart E to read as follows:
    
    
    Sec. 721.5650   Pentanediol light residues.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    pentanediol light residues (PMN P-95-1750) is subject to 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(o).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        67. By adding new Sec. 721.5708 to subpart E to read as follows:
    
    
    Sec. 721.5708   2-Pentene, 1,1,1,2,3,4,4,5,5,5-decafluoro-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 2-Pentene, 
    1,1,1,2,3,4,4,5,5,5-decafluoro- (PMN P-95-637; CAS No.72804-49-0) is 
    subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in 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 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.
    
    [[Page 3432]]
    
        68. By adding new Sec. 721.5725 to subpart E to read as follows:
    
    
    Sec. 721.5725   Phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as phenol, 2,4-
    dimethyl-6-(1-methylpentadecyl)-) (PMN P-94-209; CAS No. 134701-20-5) 
    is subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63 (a)(2)(i) and (a)(3).
        (ii) 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), 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.
        69. By adding new Sec. 721.5730 to subpart E to read as follows:
    
    
    Sec. 721.5730   Phenol, 4,4''-methylenebis[2,6-dimethyl-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as phenol, 4,4''-
    methylenebis[2,6-dimethyl- (PMN P-94-921) is subject to 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)(ii), (a)(5)(iv), (a)(5)(v), 
    (a)(6)(i), (b) (concentration set at 1 percent), and (c).
        (ii) Hazard communication program. Requirements as specified in 
    Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1 percent), 
    (f), (g)(1)(iv), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and 
    (g)(5). The label and MSDS as required by this paragraph shall also 
    include the following statements: This substance may cause blood 
    effects. This substance may cause chronic effects.
        (iii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80 (g), (l), 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. 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.
        70. By adding new Sec. 721.5913 to subpart E to read as follows:
    
    
    Sec. 721.5913   Phenothiazine derivative.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    phenothiazine derivative (PMN P-96-813) is subject to 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).
        (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, and importers 
    of this substance.
        (2) Limitations or revocation of certain notification requirements. 
    The provisions of Sec. 721.185 apply to this section.
        71. By adding new Sec. 721.5995 to subpart E to read as follows:
    
    
    Sec. 721.5995   Polyalkyl phosphate.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    polyalkyl phosphate (PMN P-95-1772) is subject to reporting under this 
    section for the significant new uses described in paragraph (a)(2) of 
    this section.
        (2) The significant new uses are:
        (i) Releases to water. Requirements as specified in Sec. 721.90 
    (a)(4), (b)(4), and (c)(4) (N = 1 ppb).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        72. By adding new Sec. 721.6045 to subpart E to read as follows:
    
    
    Sec. 721.6045   Phosphinothioic acid, bis(2,4,4-trimethylpentyl)- 
    (9CI).
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as phosphinothioic 
    acid, bis(2,4,4-trimethylpentyl)- (9CI) (PMN P-96-1652; CAS No. 132767-
    86-3) is subject to reporting under this section for the significant 
    new uses described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in Sec. 721.90 
    (a)(4), (b)(4), and (c)(4) (N = 10). When calculating the surface water 
    concentrations according to the instructions in Sec. 721.91, the 
    statement that the amount of the substance that will be released will 
    be calculated before the substance enters control technology does not 
    apply. Instead, if the waste stream containing the substance will be 
    treated using carbon adsorption treatment before release, then the 
    amount of the substance reasonably likely to be removed from the waste 
    stream by such treatment may be subtracted in calculating the number of 
    kilograms released. No more than 99 percent removal efficiency may be 
    attributed to such treatment.
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        73. By adding new Sec. 721.6075 to subpart E to read as follows:
    
    
    Sec. 721.6075   Phosphonic acid, 1,1-methylenebis-tetrakis(1-
    methylethyl) ester.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as phosphonic acid, 
    1,1-methylenebis-tetrakis(1-methylethyl) ester (PMN P-95-168) is 
    subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
    
    [[Page 3433]]
    
        (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)(iii), (a)(2)(iv), (a)(3), (b) 
    (concentration set at 0.1 percent), and (c).
        (ii) Hazard communication program. Requirements as specified in 
    Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
    (f), (g)(2)(i), (g)(2)(v), and (g)(5). The label and MSDS required by 
    this paragraph shall also include the following statement: This 
    substance may cause mutagenicity.
        (b) Specific requirements. The 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) through (h) 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.
        74. By adding new Sec. 721.6078 to subpart E to read as follows:
    
    
    Sec. 721.6078   Substituted ethoxyethylamine phosphonate.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    substituted ethoxyethylamine phosphonate (PMN P-95-1950) is subject to 
    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.
        75. By adding new Sec. 721.6165 to subpart E to read as follows:
    
    
    Sec. 721.6165   Polysubstituted piperidine.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    polysubstituted piperdine (PMN P-93-568) is subject to 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)(4), (b)(4), and (c)(4) (N = 30).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        76. By adding new Sec. 721.6170 to subpart E to read as follows:
    
    
    Sec. 721.6170   Siloxanes and silicones, Me hydrogen, reaction products 
    with 2,2,6,6-tetramethyl-4-(2-propenyloxy)piperdine.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as siloxanes and 
    silicones, Me hydrogen, reaction products with 2,2,6,6-tetramethyl-4-
    (2-propenyloxy)piperdine (PMN P-95-1891; CAS No. 182635-99-0) is 
    subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in 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.
        77. By adding new Sec. 721.6197 to subpart E to read as follows:
    
    
    Sec. 721.6197   Salt of a substituted polyalkylenepolyamine.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a salt 
    of a substituted polyalkylenepolyamine (PMN P-96-585) is subject to 
    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.
        78. By adding new Sec. 721.6475 to subpart E to read as follows:
    
    
    Sec. 721.6475   Alkyl polycarboxylic acids, esters with ethoxylated 
    fatty alcohols.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as alkyl 
    polycarboxylic acids, esters with ethoxylated fatty alcohols (PMNs P-
    96-554/555/556/557/558/559) are subject to reporting under this section 
    for the significant new uses described in paragraph (a)(1)(i) 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 these substances.
        (2) Limitations or revocation of certain notification requirements. 
    The provisions of Sec. 721.185 apply to this section.
        (3) Chemical substance and significant new uses subject to 
    reporting. The chemical substances identified generically as alkyl 
    polycarboxylic acids, esters with ethoxylated fatty alcohols (PMN P-96-
    560/561/564/565) are subject to reporting under this section for the 
    significant new uses described in paragraph (a)(2) of this section.
        (i) The significant new uses are:
        (A) Release to water. Requirements as specified in Sec. 721.90 
    (a)(1), (b)(1), and (c)(1).
        (B) [Reserved]
        (ii) Specific requirements. The provisions of subpart A of this 
    part apply to this section except as modified by this paragraph.
    
    [[Page 3434]]
    
        (A) Recordkeeping. Recordkeeping requirements as specified in 
    Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
    importers, and processors of these substances.
        (B) Limitations or revocation of certain notification requirements. 
    The provisions of Sec. 721.185 apply to this section.
        79. By adding new Sec. 721.6477 to subpart E to read as follows:
    
    
    Sec. 721.6477   Alkyl polycarboxylic acids, esters with ethoxylated 
    fatty alcohols, reaction products with maleic anhydride.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as alkyl 
    polycarboxylic acids, esters with ethoxylated fatty alcohols, reaction 
    products with maleic anhydride (PMNs P-96-399/400/401/402/403/404) are 
    subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in 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.
        80. By adding new Sec. 721.6485 to subpart E to read as follows:
    
    
    Sec. 721.6485   Hydroxy terminated polyester.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    hydroxy terminated polyester (PMN P-95-1213) is subject to 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 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.
        81. By adding new Sec. 721.6490 to subpart E to read as follows:
    
    
    Sec. 721.6490   Alkyl phenyl polyetheramines.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as alkyl 
    phenyl polyetheramines (PMNs P-95-1650/1651/1652/1653) are subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in 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.
        82. By adding new Sec. 721.6495 to subpart E to read as follows:
    
    
    Sec. 721.6495   Aliphatic polyisocyanate.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    aliphatic polyisocyanate (PMN P-95-1347) is subject to 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(y)(1).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        83. By adding new Sec. 721.6505 to subpart E to read as follows:
    
    
    Sec. 721.6505   Polymers of C13C15 oxoalcohol 
    ethoxolates.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as 
    polymers of C13C15 oxoalcohol ethoxolates (PMNs 
    P-96-950/951) are subject to reporting under this section for the 
    significant new uses described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in 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.
        84. By adding new Sec. 721.7375 to subpart E to read as follows:
    
    
    Sec. 721.7375   Potassium salt of polyolefin acid.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    potassium salt of polyolefin acid (PMN P-97-417) is subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) 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.
        85. By adding new Sec. 721.7378 to subpart E to read as follows:
    
    
    Sec. 721.7378   Substituted polyoxyethylene.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    substituted polyoxyethylene (PMN P-93-1654) is
    
    [[Page 3435]]
    
    subject to 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(j) (use as an emulsifier for paint and 
    adhesives).
        (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.
        86. By adding new Sec. 721.8079 to subpart E to read as follows:
    
    
    Sec. 721.8079   Isophorone diisocyanate neopentyl glycol adipate 
    polyurethane prepolymer.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    isophorone diisocyanate neopentyl glycol adipate polyurethane 
    prepolymer (PMN P-94-1743) is subject to reporting under this section 
    for the significant new uses described in paragraph (a)(2) of this 
    section. Non-spray uses are exempt from the provisions of this rule.
        (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)(iii), (a)(5)(viii), 
    (a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), 
    and (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), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
    (g)(2)(iv), (g)(2)(v), and (g)(5). Manufacturers, importers, and 
    processors who implement the product stewardship provisions of the TSCA 
    section 5(e) consent order for these substances are exempt from the 
    requirements of Sec. 721.63 and Sec. 721.72.
        (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) through (i) are applicable to manufacturers, 
    importers, and processors of this substance. Manufacturers, importers, 
    and processors who implement the product stewardship provisions and 
    keep records as required by the TSCA section 5(e) consent order for 
    these substances are exempt from the requirements of Sec. 721.125.
        (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) Applicability of Sec. 721.5. The provisions of Sec. 721.5 do 
    not apply to manufacturers, importers, and processors, implementing the 
    product stewardship provisions in the TSCA section 5(e) consent order 
    for this substance.
        87. By adding new Sec. 721.8095 to subpart E to read as follows:
    
    
    Sec. 721.8095   Silylated polyurethane.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    silylated polyurethane (PMN P-95-1356) is subject to 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(y)(1).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        88. By adding new Sec. 721.8780 to subpart E to read as follows:
    
    
    Sec. 721.8780   Substituted pyridine azo substituted phenyl.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as 
    substituted pyridine azo substituted phenyl (PMNs P-96-767 and P-96-
    773) are subject to reporting under this section for the significant 
    new uses described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in 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) and (i) are applicable to manufacturers and importers 
    of this substance.
        (2) Limitations or revocation of certain notification requirements. 
    The provisions of Sec. 721.185 apply to this section.
        89. By adding new Sec. 721.9005 to subpart E to read as follows:
    
    
    Sec. 721.9005   2-Pyrrolidinone, 1,1'-(2-methyl-1,5-pentanediyl)bis-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 2-pyrrolidinone, 
    1,1'-(2-methyl-1,5-pentanediyl)bis- (PMN P-93-761; CAS No. 146453-62-5) 
    is subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63 (a)(1), (a)(2)(i) (There must be no permeation of the PMN 
    substance greater than 0.08 grams (g)/minutes (min) centimeter 
    (cm2) after 8 hours of testing in accordance with the most 
    current version of the American Society for Testing and Materials 
    (ASTM) F739 ``Standard Test Method for Resistance of Protective 
    Clothing Materials to Permeation by Liquids or Gases.'' The results of 
    all glove permeation testing must be reported in accordance with the 
    most current version of (ASTM) F1194 ``Guide for Documenting the 
    Results of Chemical Permeation Testing of Protective Clothing 
    Materials.'' Manufacturers, importers, and processors must submit such 
    glove test data to the Agency and must receive written Agency approval 
    for each type of glove tested prior to use of such gloves. The 
    following gloves have been tested in accordance with the ASTM F739 
    method and found to satisfy the requirements for use by EPA: Ansell 
    Edmond/8-352/Neoprene rubber, 0.097 cm thick. Gloves may not be used 
    for a time period longer than they are actually tested and must be 
    replaced at the end of each work shift), (a)(2)(ii), (a)(2)(iii), 
    (a)(3), (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
    
    [[Page 3436]]
    
    1.0 percent), (f), (g)(l)(iii), (g)(l)(iv), (g)(2)(i), (g)(2)(iii), 
    (g)(2)(v), and (g)(5). The label and MSDS as required by this paragraph 
    shall also include the following statement: This substance is expected 
    to enhance the absorption of other chemicals into skin or other 
    materials.
        (iii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80 (o), (q), and (k) (use other than as a heat 
    transfer fluid).
        (b) Specific requirements. The 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.
        90. By adding new Sec. 721.9010 to subpart E to read as follows:
    
    
    Sec. 721.9010   2-pyrrolidone, 1-ethenyl-3-ethylidene-, (E)-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 2-pyrrolidone, 1-
    ethenyl-3-ethylidene-, (E)- (PMN P-96-1536; CAS No. 153954-47-3) is 
    subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63 (a)(2)(i) and (a)(3).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    Sec. 721.125 (a), (b), (c), (d), and (e) 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.
        91. By adding new Sec. 721.9080 to subpart E to read as follows:
    
    
    Sec. 721.9080   Nitro methyl quinoline.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as nitro 
    methyl quinoline (PMN P-96-1319) is subject to 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)(ii), (a)(5)(iv), (a)(5)(v), and (a)(6)(i).
        (ii) Disposal. Requirements as specified in Sec. 721.85 (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), and (j) 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.
        92. By adding new Sec. 721.9265 to subpart E to read as follows:
    
    
    Sec. 721.9265   Reaction product of dichlorobenzidine and substituted 
    alkylamide.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    reaction product of dichlorobenzidine and substituted alkylamide (PMN 
    P-95-1282) is subject to 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), (e), (f), and (g)(5). The label and 
    MSDS as required by this paragraph shall also include the following 
    statements: At temperatures above 200  deg.C, this substance decomposes 
    to produce a suspect human carcinogen, 3',3' dichlorobenzidine. Do not 
    heat above 200  deg.C or 392  deg.F.
        (ii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(f) and processing or use of the PMN 
    substance at temperatures above 200  deg.C.
        (b) Specific requirements. The 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), (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.
        93. By adding new Sec. 721.9270 to subpart E to read as follows:
    
    
    Sec. 721.9270   Reaction product of epoxy with anhydride and glycerol 
    and glycol.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    reaction product of epoxy with anhydride and glycerol and glycol (PMN 
    P-96-1233) is subject to 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), (x)(1) and (y)(2).
        (ii) 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), (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.
        94. By adding new Sec. 721.9285 to subpart E to read as follows:
    
    
    Sec. 721.9285   Reaction products of formalin (37%) with amine 
    C12.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    reaction products of formalin (37%) with amine C12 (PMN P-
    95-535) is subject to 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.
        95. By adding new Sec. 721.9488 to subpart E to read as follows:
    
    [[Page 3437]]
    
    Sec. 721.9488   Substituted resorcinols.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as 
    substituted resorcinols (PMNs P-95-1103, P-95-1104, and P-96-1235) are 
    subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in Sec. 721.90 
    (a)(4), (b)(4), and (c)(4) (N = 9).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. The recordkeeping requirements 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.
        96. By adding new Sec. 721.9492 to subpart E to read as follows:
    
    
    Sec. 721.9492   Polymers of styrene, cyclohexyl methacrylate and 
    substituted methacrylate.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as 
    polymers of styrene, cyclohexyl methacrylate and substituted 
    methacrylate (PMNs P-97-143/144) are subject to reporting under this 
    section for the significant new uses described in paragraph (a)(2) of 
    this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in 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) 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.
        97. By adding new Sec. 721.9497 to subpart E to read as follows:
    
    
    Sec. 721.9497   Trifunctional ketoximino silane.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as 
    trifunctional ketoximino silane (PMNs P-95-605 and P-95-606) are 
    subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63 (a)(1), (a)(2)(i), and (a)(3).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    Sec. 721.125 (a), (b), (c), (d), and (e) 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.
        98. By adding new Sec. 721.9499 to subpart E to read as follows:
    
    
    Sec. 721.9499   Modified silicone resin.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    modified silicone resin (PMN P-96-1649) is subject to 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)(4), (b)(4), and (c)(4) (N = 5).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        99. By adding new Sec. 721.9503 to subpart E to read as follows:
    
    
    Sec. 721.9503   Silane, (3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
    heptadecafluorodecyl)trimethoxy-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as silane, 
    (3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl) trimethoxy- 
    (PMN P-97-264; CAS No. 83048-65-1) is subject to reporting under this 
    section for the significant new uses described in paragraph (a)(2) of 
    this section.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63 (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xv), 
    (a)(6)(ii), and (a)(6)(v).
        (ii) Release to water. Requirements as specified in Sec. 721.90 
    (a)(4), (b)(4), and (c)(4) (N = 10).
        (b) Specific requirements. The 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), 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.
        100. By adding new Sec. 721.9515 to subpart E to read as follows:
    
    
    Sec. 721.9515   Aminofunctional alkoxy alkyl siloxane.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    aminofunctional alkoxy alkyl siloxane (PMN P-96-346) is subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) 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.
        101. By adding new Sec. 721.9545 to subpart E to read as follows:
    
    
    Sec. 721.9545   Substituted phenyl azo substituted sulfocarbopolycle, 
    sodium salt.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    substituted phenyl azo substituted sulfocarbopolycle, sodium salt (PMN 
    P-96-1263) is subject to 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
    
    [[Page 3438]]
    
    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.
        102. By adding new Sec. 721.9575 to subpart E to read as follows:
    
    
    Sec. 721.9575   Chromate(3-), bis[3-[[5-(aminosulfonyl)-2-
    hydroxyphenyl]azo]-4-hydroxy-7-[[2-oxo-1-[(phenylamino)carbonyl] 
    propyl]azo]-2-naphthalenesulfonato(3-)]-, trisodium (9CI).
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as chromate(3-), 
    bis[3-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4-hydroxy-7-[[2-oxo-1-
    [(phenylamino)carbonyl] propyl]azo]-2-naphthalene sulfonato(3-)]-, 
    trisodium (9CI) (PMN P-95-1575; CAS No. 119535-63-6) is subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in 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.
        103. By adding new Sec. 721.9576 to subpart E to read as follows:
    
    
    Sec. 721.9576   Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-
    (aminosulfonyl)-2-hydroxyphenyl]azo]-4-hydroxy-2-naphthalene-sulfonato 
    (3-)]-, trisodium (9CI).
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as chromate(3-), 
    bis[7-[(aminohydroxyphenyl)azo]-3-[[5-(aminosulfonyl)-2-
    hydroxyphenyl]azo]-4-hydroxy-2-naphthalene-sulfonato (3-)]-, trisodium 
    (9CI) (PMN P-95-1576; CAS No. 118716-62-4) is subject to reporting 
    under this section for the significant new uses described in paragraph 
    (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in 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.
        104. By adding new Sec. 721.9577 to subpart E to read as follows:
    
    
    Sec. 721.9577   Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-
    (aminosulfonyl)-2-hydroxyphenyl] azo]-4-hydroxy-2-naphthalene sulfonato 
    (3-)]-,-[[5-(aminosulfonyl) -2-hydroxyphenyl]azo]-4-hydroxy-7-[[2-
    hydroxy-1-[(phenylamino) carbonyl]-1-propenyl]azo]-2-
    naphthalenesulfonato(3-)]-, trisodium (9CI).
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as chromate(3-), 
    bis[7-[(aminohydroxyphenyl)azo]-3-[[5-(aminosulfonyl)-2-hydroxy phenyl] 
    azo]-4-hydroxy-2-naphthalenesulfonato (3-)]-,-[[5-(aminosulfonyl) -2-
    hydroxyphenyl]azo]-4-hydroxy-7-[[2-hydroxy-1-[(phenylamino) carbonyl]-
    1-propenyl]azo]-2-naphthalene sulfonato(3-)]-, trisodium (9CI) (PMN P-
    95-1577; CAS No. 118716-61-3) is subject to reporting under this 
    section for the significant new uses described in paragraph (a)(2) of 
    this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in 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.
        105. By adding new Sec. 721.9635 to subpart E to read as follows:
    
    
    Sec. 721.9635   Terpene residue distillates.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as terpene 
    residue distillates (PMN P-96-897) is subject to 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)(4), (b)(4), and (c)(4) (N = 10).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        106. By adding new Sec. 721.9657 to subpart E to read as follows:
    
    
    Sec. 721.9657   Disubstituted thiadiazole.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    disubstituted thiadiazole (PMN P-97-314) is subject to 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 (a),(b), (c), and (j).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        107. By adding new Sec. 721.9659 to subpart E to read as follows:
    
    
    Sec. 721.9659   Disubstituted thiadiazosulfone.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    disubstituted thiadiazosulfone (PMN P-97-304) is
    
    [[Page 3439]]
    
    subject to 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 (a),(b), (c), and (j).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        108. By adding new Sec. 721.9662 to subpart E to read as follows:
    
    
    Sec. 721.9662   Thieno[3,4-b]-1,4-dioxin, 2,3-dihydro- (9CI).
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as thieno[3,4-b]-1,4-
    dioxin, 2,3-dihydro- (9CI) (PMN P-95-1825; CAS No. 126213-50-1) is 
    subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63 (a)(1), (a)(2)(i), (a)(4), (a)(5)(xii), (a)(5)(xiii), 
    (a)(5)(xiv), and (a)(6)(v).
        (ii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(f).
        (b) Specific requirements. The 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.
        109. By adding new Sec. 721.9664 to subpart E to read as follows:
    
    
    Sec. 721.9664   9H-Thioxanthen-9-one,2,4-diethyl.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 9H-thioxanthen-9-
    one,2,4-diethyl (PMN P-96-1315; CAS No. 82799-44-8) 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)(4), (b)(4), and (c)(4) (N = 1).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        110. By adding new Sec. 721.9717 to subpart E to read as follows:
    
    
    Sec. 721.9717   Azo monochloro triazine reactive dye.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an azo 
    monochloro triazine reactive dye (PMN P-96-238) is subject to reporting 
    under this section for the significant new uses described in paragraph 
    (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80 (v)(2), (w)(2), and (x)(2).
        (ii) [Reserved]
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    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.
        111. By adding new Sec. 721.9825 to subpart E to read as follows:
    
    
    Sec. 721.9825   Phenyl substituted triazolinones.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as phenyl 
    substituted triazolinones (PMNs P-93-204, P-94-1870, P-94-1871, P-94-
    1872, P-94-1873, and P-94-1874) 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)(2)(i), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(iv), 
    (a)(5)(v), (a)(5)(vi), (a)(6)(i), (b) (concentration set at 1.0 
    percent), and (c). The imperviousness of the gloves selected pursuant 
    to (a)(2)(i) of this section must be demonstrated by actual testing 
    under (a)(3)(i) of this section and not by manufacturer specifications. 
    In addition, there must be no permeation of the chemical substance 
    greater than 15 g/day-cm2 as a daily cumulative 
    total when tested in accordance with the most current version of the 
    American Society for Testing and Materials (ASTM) F739 ``Standard Test 
    Method for Resistance of Protective Clothing Materials to Permeation by 
    Liquids or Gases'' or ASTM F1383 ``Standard Test Method for Resistance 
    of Protective Clothing Materials to Permeation by Liquids or Gases 
    Under Conditions of Intermittent Contact.''
        (A) For conditions of exposure which are intermittent, gloves may 
    be tested in accordance with the most current version of ASTM F1383 
    ``Standard Test Method for Resistance of Protective Clothing Materials 
    to Permeation by Liquids or Gases Under Conditions of Intermittent 
    Contact,'' provided the contact time in testing is greater than or 
    equal to the expected duration of dermal contact, and the purge time 
    used in the testing is less than or equal to the expected duration of 
    non-contact during the intermittent cycle of dermal exposure in the 
    workplace. If ASTM F1383 is used for testing, the company must submit 
    to the Agency a description of worker activities involving the chemical 
    substance which includes daily frequencies and durations of potential 
    worker exposures.
        (B) The results of all glove permeation testing must be reported in 
    accordance with the most current version of (ASTM) F1194 ``Guide for 
    Documenting the Results of Chemical Permeation Testing of Protective 
    Clothing Materials.'' The company must submit all test data to the 
    Agency and must receive written Agency approval for each type of glove 
    tested prior to use of such gloves. Gloves must be discarded and 
    replaced with such frequency as to ensure that they will reliably 
    provide an impervious barrier to the chemical substances under normal 
    and expected conditions of exposure within the work area. Gloves that 
    have been damaged or are defective shall not be used. For PMNs P-94-
    1871 through P-94-1874, EPA has approved North Safety Butyl Rubber 
    gloves (32 mils thick). For P-93-204 and P-94-1870, EPA has approved 
    North Safety Butyl Rubber gloves (32 mils thick) only if used in 
    combination with a chemical-resistant glove that has been demonstrated 
    (EPA review not required) impermeable to the solvent,
    
    [[Page 3440]]
    
    e.g., North Silvershield gloves and North 4H gloves.
        (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)(iv), (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)(i), and (g)(5).
        (iii) Release to water. Requirements as specified in Sec. 721.90 
    (a)(4), (b)(4), and (c)(4) (N = 5 for all the chemical substances 
    subject to the provisions of this rule combined). However, contrary to 
    the requirements specified in Sec. 721.91, if the waste stream 
    containing the chemical substances will be treated using activated 
    carbon adsorption, then the amount of chemical substances reasonably 
    likely to be removed from the waste stream by such treatment may be 
    subtracted in calculating the number of kilograms released. No more 
    than the following percent removal efficiencies may be attributed to 
    such treatment for each PMN: P-93-204, 99 percent; P-94-1870, 98 
    percent; P-94-1871, 97 percent; P-94-1872, 92 percent; P-94-1873, 90 
    percent; P-94-1874, 73 percent.
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), 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.
        112. By adding new Sec. 721.9830 to subpart E to read as follows:
    
    
    Sec. 721.9830   1-Tridecyn-3-ol, 3-methyl.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 1-tridecyn-3-ol, 3-
    methyl (PMN P-96-236; CAS No. 100912-15-0) 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) Worker protection. Requirements as specified in Sec. 721.63 
    (a)(1), (a)(2)(i), and (a)(3).
        (ii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(f).
        (b) Specific requirements. The 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 (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.
        113. By adding new Sec. 721.9840 to subpart E to read as follows:
    
    
    Sec. 721.9840   Tungstate (W12(OH)2O386-) hexasodium (9CI).
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as tungstate 
    (W12(OH)2O386-) hexasodium (9CI) (PMN P-96-1177; CAS No. 12141-67-2) is 
    subject to reporting under this section for the significant new uses 
    described in paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in 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), (d), (e), and (i) are applicable to 
    manufacturers, importers, and processors of this substance.
        (2) Limitations or revocation of certain notification requirements. 
    The provisions of Sec. 721.185 apply to this section.
        114. By adding new Sec. 721.9928 to subpart E to read as follows:
    
    
    Sec. 721.9928   Urea, tetraethyl-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as urea, tetraethyl- 
    (PMN P-94-1017; CAS No. 1187-03-7) is subject to reporting under this 
    section for the significant new uses described in paragraph (a)(2) of 
    this section.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63 (a)(1), (a)(2)(i), and (a)(3).
        (ii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(r) (445,000 kg) (a dermal developmental 
    toxicity study in mice and rats and either a chromosome aberration 
    assay in mice (40 CFR 798.5385) or a micronucleus assay in mice (40 CFR 
    798.5395)). A person may not manufacture or import the substance beyond 
    the following aggregate production volume limits, unless that person 
    conducts the following corresponding studies on the substance and 
    submits all final reports and underlying data in accordance with the 
    procedures and criteria specified in paragraphs (a)(2)(i)(A), 
    (a)(2)(i)(B), (a)(2)(i)(C), and (a)(2)(i)(D) of this section.
        (A) Each study required to be performed pursuant to this section 
    must be scientifically valid. Scientific valid means that the study was 
    conducted according to:
        (1) The test guidelines specified in paragraph (a)(2)(i) 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)(i) 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)(i) 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)(ii)(D)(2) of this 
    section, 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 paragraph (a)(2)(ii)(D)(2)(i) or (a)(2)(ii)(D)(2)(ii) 
    of this section.
    
    [[Page 3441]]
    
        (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)(ii)(C)(3) of this section, the person shall comply with 
    paragraph (a)(2)(ii)(C)(3) of this section. If there is insufficient 
    time for the person to comply with paragraph (a)(2)(ii)(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)(ii)(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)(ii)(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)(i) of this section if notified in writing by EPA that 
    it is unnecessary to conduct that study.
        (iii) 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), (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.
    
    [FR Doc. 98-1074 Filed 1-21-98; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
3/23/1998
Published:
01/22/1998
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
98-1074
Dates:
The effective date of this rule is March 23, 1998. This rule shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on February 5, 1998.
Pages:
3394-3441 (48 pages)
Docket Numbers:
OPPTS-50628, FRL-5720-3
RINs:
2070-AB27: Significant New Use Rule (SNUR); Chemical-Specific SNURs To Extend Provisions of Section 5(e) Orders
RIN Links:
https://www.federalregister.gov/regulations/2070-AB27/significant-new-use-rule-snur-chemical-specific-snurs-to-extend-provisions-of-section-5-e-orders
PDF File:
98-1074.pdf
CFR: (126)
40 CFR 721.125(a)
40 CFR 721.72(a)
40 CFR 721.170(b)(4)(i)
40 CFR 721.170(b)(4)(ii)
40 CFR 721.170(b)(3)(ii)
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