95-21519. Significant New Uses of Certain Chemical Substances  

  • [Federal Register Volume 60, Number 168 (Wednesday, August 30, 1995)]
    [Rules and Regulations]
    [Pages 45072-45085]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-21519]
    
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Part 721
    
    [OPPTS-50622; FRL-4926-2]
    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 certain 
    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 October 30, 1995. This rule 
    shall be 
    
    [[Page 45073]]
    promulgated for purposes of judicial review at 1 p.m. Eastern Standard 
    Time on September 13, 1995. If EPA receives notice before September 29, 
    1995 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-50622 and 
    the names of the chemical substances 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, Rm. E-G99, 401 M St., SW., Washington, DC 20460. All 
    comments which are claimed confidential must be clearly marked as such. 
    Three additional sanitized copies of any comments containing 
    confidential business information (CBI) must also be submitted. 
    Nonconfidential versions of comments on this rule will be placed in the 
    rulemaking record and will be available for public inspection.
        Comments and data may also be submitted electronically by sending 
    electronic mail (e-mail) to: 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 file format or ASCII file 
    format. All comments and data in electronic form must be identified by 
    the docket number OPPTS-50622. No CBI should be submitted through e-
    mail. Electronic comments on this final rule may be filed online at 
    many Federal Depository Libraries. Additional information on electronic 
    submissions can be found in Unit X. of this document.
    
    FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
    Environmental Assistance Division (7408), Office of Toxic Substances, 
    Environmental Protection Agency, Rm. E-543B, 401 M St., SW., 
    Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 554-0551, 
    e-mail: TSCA-Hotline@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: 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 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 at 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 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 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 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 the 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), basis for 
    the action taken by EPA in the section 5(e) consent order or as a non-
    section 5(e) SNUR for the substance (including the statutory citation 
    and specific finding), toxicity concern, and the CFR citation assigned 
    in the regulatory text of this rule. The specific uses which are 
    designated as significant new uses are cited in the regulatory text 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 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 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 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 
    
    [[Page 45074]]
    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 P-93-1231, P-93-1315, P-94-212, P-
    94-343/344, P-94-506/507/508/509, P-94-615/616, P-94-697 through P-94-
    895, P-94-919, P-94-1080, P-94-1484, P-94-1561/1562/1563/1564, P-94-
    1634/1635/1636/1637/1638/1639, P-94-1705, and P-94-1771, which are 
    subject to a final TSCA 5(e) consent order. The 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 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 5(e) order is usually 
    completed within 1 to 2 years of notice of commencement. EPA's 
    experience with exposure-based SNURs requiring short-term testing is 
    that the SNUR is often revoked within 1 to 2 years when the test 
    results are received. Rather than issue and revoke SNURs in such a 
    short span of time, EPA will defer publication of exposure-based SNURs 
    until either a Notice of Commencement (NOC) or data demonstrating risk 
    are received unless the toxicity testing required is long-term. EPA is 
    issuing this explanation and notification as required in 40 CFR 
    721.160(a)(2) as it has determined that SNURs are not needed at this 
    time for these substances which are subject to a final 5(e) consent 
    order under TSCA.
        On March 29, 1994, EPA received a SNUN, P-94-1218, for 1,1,1-
    trifluoroethane which is subject to a SNUR at 40 CFR 721.4390. The 
    submitter was notifying EPA that it intended to exceed the production 
    volume limit for the substance. EPA allowed the 90-day review period to 
    expire without taking any action. EPA is in the process of revoking the 
    SNUR based on toxicity testing received for the substance. EPA is 
    issuing this explanation and notification as required in section 5(g) 
    of TSCA as it has not initiated any action to prohibit or limit 
    manufacture, process, distribute in commerce, use, or dispose of 1,1,1-
    trifluoroethane with respect to which notification or data was required 
    by the SNUR.
        The designation L-91-87 for the substance with the generic name 
    ``substituted phenol'' denotes a low-volume exemption which is an 
    exemption to premanufacture requirements of section 5(a)(1)(A) of TSCA. 
    The terms and requirements are described in Sec. 723.50.
    
    PMN Number P-85-619
    
    Chemical name: (generic) Tetrasubstituted aminocarboxylic acid.
    CAS number: Not available.
    Effective date of section 5(e) consent order: August 4, 1994.
    Basis for section 5(e) consent order: The order was issued under 
    section 5(e)(1)(A)(i) and (ii)(I) of TSCA based on a finding that this 
    substance may present an unreasonable risk of injury to health and the 
    environment.
    Toxicity concern: Test data on substances similar in structure to the 
    PMN substance have been shown to cause carcinogenicity and mutagenicity 
    in test animals and toxicity to aquatic organisms.
    Recommended testing: EPA has determined that the results of a 2-year 
    two-species rodent bioassay (40 CFR 798.3300) would help characterize 
    the carcinogenic effects of the PMN substance. A 96-hour bioassay in 
    algae (40 CFR 797.1050) and a 96-hour LC50 study in fish (40 CFR 
    797.1400) would help to characterize the environmental effects of the 
    substance.
    CFR citation: 40 CFR 721.2089.
    
    PMN Number P-85-941
    
    Chemical name: (generic) Substituted alkylamine salt.
    CAS number: Not available.
    Basis of action: The PMN substance will be used as described in the 
    PMN. Based on test data on the substance, EPA is concerned that 
    toxicity to aquatic organisms may occur at concentrations as low as 70 
    ppb (parts per billion) 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 concentration of 70 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) and a 
    21-day chronic daphnid toxicity test would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.562.
    
    PMN Number P-86-1491
    
    Chemical name: (generic) 3-Hydroxy-1,1-dimethylbutyl derivative.
    CAS number: Not available.
    Effective date of section 5(e) consent order: January 21, 1987.
    Basis for section 5(e) consent order: The order was issued under 
    section 5(e)(1)(A)(i) and (ii)(I) of TSCA based on a finding that this 
    substance may present an unreasonable risk of injury to human health.
    Toxicity concern: Test data on substances similar in structure to the 
    PMN substance have been shown to cause carcinogenicity in test animals.
    Recommended testing: EPA has determined that the results of a 2-year 
    two-species rodent bioassay (40 CFR 798.3300) would help characterize 
    the carcinogenic effects of the PMN substance
    CFR citation: 40 CFR 721.4466.
    
    PMN Number P-87-1036
    
    Chemical name: (generic) Substituted 1,6-dihydroxynaphthalene.
    CAS number: Not available.
    Effective date of section 5(e) consent order: October 30, 1987.
    Basis for section 5(e) consent order: The order was issued under 
    section 5(e)(1)(A)(i), (ii)(I), and (ii)(II) of TSCA based on a finding 
    that this substance may present an unreasonable risk of injury to human 
    health and that this substance is expected to be produced in 
    substantial quantities and that there may be significant or substantial 
    human exposure.
    Toxicity concern: Test data on substances similar in structure to the 
    PMN substance have been shown to cause carcinogenicity and reproductive 
    effects in test animals.
    Recommended testing: EPA has determined that the results of a 90-day 
    subchronic dermal study (40 CFR 798.2650) and a 2-year two-species 
    rodent bioassay (40 CFR 798.3300) would help characterize the health 
    effects of the PMN substance. The PMN submitter has agreed not to 
    exceed the production volume limit without performing the 90-day 
    subchronic study.
    CFR citation: 40 CFR 721.5192.
    
    PMN Numbers P-88-998/999
    
    Chemical name: (generic) Fluorene-containing diaromatic amines.
    CAS number: Not available. 
    
    [[Page 45075]]
    
    Basis of action: The PMN substances will be used as matrix resins. 
    Based on data on the PMN substances, EPA is concerned that toxicity to 
    aquatic organisms may occur at concentrations 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 the substances 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 substances meet 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) and a 
    21-day chronic daphnid toxicity test would help characterize the 
    environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.3760.
    
    PMN Number P-91-818
    
    Chemical name: (generic) Alkyldi(alkyl oxyhydroxypropyl) derivative, 
    phosphoric acid esters, potassium salts.
    CAS number: Not available.
    Basis of action: The PMN substance will be used as a mining chemical. 
    Based on data on the PMN substance, EPA is concerned that toxicity to 
    aquatic organisms may occur at concentrations 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 did not exceed a concentration of 30 ppb when 
    released to surface waters. EPA has determined domestic manufacture or 
    consumer use 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)(i).
    Recommended testing: EPA has determined that a chronic 60-day fish 
    early life stage toxicity test in rainbow trout (40 CFR 797.1600) and a 
    21-day chronic daphnid toxicity test would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.6110.
    
    PMN Number P-93-633
    
    Chemical name: (generic) Aliphatic ester.
    CAS number: Not available.
    Effective date of section 5(e) consent order: September 28, 1994.
    Basis for section 5(e) consent order: The order was issued under 
    section 5(e)(1)(A)(i) and (ii)(I) of TSCA based on a finding that this 
    substance may present an unreasonable risk of injury to health.
    Toxicity concern: Similar chemicals have been shown to cause liver and 
    developmental toxicity in test animals.
    Recommended testing: The Agency has determined that the results of a 
    90-day subchronic toxicity (40 CFR 798.2650) and developmental toxicity 
    (oral route) (40 CFR 798.4900) studies would help characterize liver 
    and developmental effects.
    CFR citation: 40 CFR 721.2815.
    
    PMN Number P-93-955
    
    Chemical name: (generic) Formaldehyde, polymer with substituted 
    phenols, glycidyl ether.
    CAS number: Not available.
    Effective date of section 5(e) consent order: June 16, 1994.
    Basis for section 5(e) consent order: The order was issued under 
    section 5(e)(1)(A)(i) and (ii)(I) of TSCA based on a finding that this 
    substance may present an unreasonable risk of injury to health and the 
    environment.
    Toxicity concern: The PMN substance has been shown to cause systemic 
    effects in test animals. Similar chemicals have been shown to cause 
    systemic toxicity, reproductive toxicity, mutagenicity, and oncogencity 
    in test animals. Similar chemicals have been shown to cause toxicity to 
    aquatic organisms.
    Recommended testing: A 90-day subchronic (oral) toxicity test with 
    special attention to the testes will help to characterize the systemic 
    and reproductive effects. The PMN submitter has agreed not to exceed 
    the production volume limit without performing this test. A 2-year, 
    two-species rodent (oral) bioassay study (40 CFR Sec. 798.3300) would 
    be required to evaluate the potential oncogenic effects of the PMN 
    substance. A 96-hour bioassay in algae (40 CFR 797.1050), a 48-hour 
    LC50 test in daphnia (40 CFR 797.1300), and a 96-hour LC50 test in 
    freshwater fish (40 CFR 797.1400) would be required to evaluate the 
    environmental effects which may be caused by the PMN substance. The 
    algal test should be conducted with static conditions and measured 
    concentrations.
        The remaining tests should be conducted with flow-through 
    conditions and measured concentrations. To evaluate worker exposure 
    from the potential dusting of the PMN substance, simulation of shipping 
    and handling conditions using the following 2-step set of tests from 
    the current version of the American Society of Testing and Materials 
    (ASTM) guidelines would be required. Drop tests for the PMN substance 
    in their shipping containers should be conducted according to ASTM 
    Method D959--Drop test for Filled Bags and ASTM Method D997--Drop Test 
    for Loaded Cylindrical Containers. The PMN substance in the bags or 
    containers in the studies above should be tested using ASTM Method 
    D999--Vibration Testing of Shipping Containers.
        After the 2-step set of tests is complete, the particle size 
    distribution of the PMN substance from the shipping containers should 
    be measured using ASTM Method D 1921--Standard Test Methods for 
    Particle Size (Sieve Analysis) of Plastic Materials, using wire-cloth 
    sieves meeting the requirements of ASTM D11--Standard Specifications 
    for Wire-Cloth Sieves for Testing Purposes.
    CFR citation: 40 CFR 721.7046.
    
    PMN Number P-93-987
    
    Chemical name: (generic) Mixture of nitrated alkylated phenols.
    CAS number: Not available.
    Basis of action: The PMN substance will be used as a polymerization 
    inhibitor. Based on test data on the substance, EPA is concerned that 
    toxicity to aquatic organisms may occur at 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 would not be released to surface waters 
    above a concentration of 1 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) and a 
    21-day chronic daphnid toxicity test would help characterize the 
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.5769.
    
    PMN Number P-93-1649
    
    Chemical name: (generic) Alkylated urea.
    CAS number: Not available.
    Effective date of section 5(e) consent order: August 25, 1994.
    Basis for section 5(e) consent order: The order was issued under 
    section 5(e)(1)(A)(i) and (ii)(I) of TSCA based on a finding that this 
    substance may present an unreasonable risk of injury to human health.
    Toxicity concern: Similar chemicals have been shown to cause 
    neurotoxicity 
    
    [[Page 45076]]
    and developmental toxicity in test animals.
    Recommended testing: A dermal developmental toxicity study (40 CFR 
    798.4900) and a 90-day dermal subchronic study (40 CFR 798.2250 and 
    NTIS: PB91-154617) would help characterize the potential adverse 
    neurotoxic and developmental effects of this 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 dermal developmental toxicity study. The PMN submitter 
    has also agreed not to exceed the second production volume limit 
    without performing the 90-day dermal subchronic study.
    CFR citation: 40 CFR 721.9892.
    
    PMN Number P-94-24
    
    Chemical name: Ethanaminium, N-ethyl-2-hydroxy-N,N-bis(2-hydroxyethyl)-
    , diester with C12-18 fatty acids, ethyl sulfates (salts).
    CAS number: Not available.
    Effective date of section 5(e) consent order: April 24, 1994.
    Basis for section 5(e) consent order: The order was issued under 
    section 5(e)(1)(A)(i), (ii)(I), and (ii)(II), of TSCA based on findings 
    that this substance may present an unreasonable risk of injury to the 
    environment, is expected to be produced in substantial quantities, and 
    may reasonably be expected to enter the environment in substantial 
    quantities.
    Recommended testing: EPA has also determined that a modified SCAS test 
    (semicontinuous activated sludge procedure), a soil sediment adsorption 
    isotherm test (40 CFR 796.2750), a fish acute toxicity study modified 
    with humic acid (40 CFR 797.1400), a fish acute toxicity study (40 CFR 
    797.1400), a daphnid acute toxicity study (40 CFR 797.1300), and an 
    algal acute toxicity study (40 CFR 797.1050) would help characterize 
    possible environmental effects of the substance. The PMN submitter has 
    agreed not to exceed the production volume limit without performing 
    these tests.
    CFR citation: 40 CFR 721.3152.
    
    PMN Number P-94-47
    
    Chemical name: (generic) Polyurethane polymer.
    CAS number: Not available.
    Effective date of section 5(e) consent order: August 3, 1994.
    Basis for section 5(e) consent order: The order was issued under 
    section 5(e)(1)(A)(i) and (ii)(I) of TSCA based on a finding that this 
    substance may present an unreasonable risk of injury to human health.
    Toxicity concern: Similar chemicals have been shown to cause 
    respiratory and dermal sensitization in test animals.
    Recommended testing: EPA has determined that a dermal sensitization 
    study (40 CFR 798.4100), a pulmonary sensitization study (Karol method 
    or equivalent), and a 90-day subchronic inhalation study (40 CFR 
    798.2450) will help characterize the health effects of the PMN 
    substance. The PMN submitter has agreed not to exceed the production 
    volume limit without performing these studies.
    CFR citation: 40 CFR 721.8090.
    
    PMN Number P-94-1042
    
    Chemical name: (generic) Methylenebis benzotriazolyl phenols.
    CAS number: Not available.
    Effective date of section 5(e) consent order: September 1, 1994.
    Basis for section 5(e) consent order: The order was issued under 
    section 5(e)(1)(A)(i) and (ii)(I) of TSCA based on a finding that this 
    substance may present an unreasonable risk of injury to human health.
    Toxicity concern: Similar chemicals have been shown to cause systemic 
    and reproductive toxicity in test animals.
    Recommended testing: A 90-day gavage study in rats (40 CFR 
    Sec. 798.2650) to help characterize systemic and reproductive effects. 
    The PMN submitter has agreed not to exceed the production volume limit 
    without performing this test.
    CFR citation: 40 CFR 721.5763.
    
    PMN Number P-94-1453
    
    Chemical name: (generic) Hydrochloro fluorocarbon.
    Basis of action: The PMN substance will be used as an intermediate. 
    Based on analogy to similar substances, the PMN substance may cause 
    cancer and cardiac sensitization. EPA has determined that persons 
    exposed to the PMN substance through inhalation may be at risk for 
    these toxic effects. EPA determined that use of the substance as 
    described in the PMN did not present an unreasonable risk because there 
    were no significant worker exposures from use as an intermediate. EPA 
    has determined that worker exposures from use other than an 
    intermediate may result in significant exposures. 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 cardiac sensitization 
    study in dogs and a 2-year two-species oral bioassay (40 CFR 798.3300) 
    will help to characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.4463.
    
    PMN Number P-94-1487
    
    Chemical name: (generic) Thiaalkanethiol.
    CAS number: Not available.
    Basis of action: The PMN substance will be used as an surfactant. Based 
    on analogy to anionic surfactants, EPA is concerned that toxicity to 
    aquatic organisms may occur at concentrations 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 domestic manufacture of the substance may result in 
    releases to surface waters. Based on this information, the PMN 
    substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
    Recommended testing: EPA has determined that an algal acute toxicity 
    study (40 CFR 797.1050), a chronic 60-day fish early life stage 
    toxicity test in rainbow trout (40 CFR 797.1600), a 21-day chronic 
    daphnid toxicity test, a ready biodegradability test, and a modified 
    SCAS test would help characterize the environmental effects of the PMN 
    substance.
    CFR citation: 40 CFR 721.9656.
    
    PMN Numbers P-89-1125, L-91-87, P-92-41, P-92-511, P-94-1527, and P-94-
    1755
    
    Chemical name: (generic) Substituted phenol.
    CAS number: Not available.
    Basis of action: The PMN substance has been the subject of six 
    different PMN notices. Based on test data on the PMN substance and by 
    analogy to phenols, EPA is concerned that toxicity to aquatic organisms 
    may occur at concentrations as low as 1 ppb of the PMN substance in 
    surface waters. EPA determined that use of the substance as described 
    in several of the PMNs did not present an unreasonable risk because the 
    substance did not exceed a concentration of 1 ppb when released to 
    surface waters. The only PMN where releases over 1 ppb were expected 
    has been withdrawn. EPA has determined that other uses and increased 
    production 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)(i).
    Recommended testing: EPA has determined that an algal acute toxicity 
    study (40 CFR 797.1050), a chronic 60-day fish early life stage 
    toxicity test in rainbow trout (40 CFR 797.1600), and a 21-day chronic 
    daphnid toxicity test would help characterize the 
    
    [[Page 45077]]
    environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.5867.
    
    PMN Number P-94-1631
    
    Chemical name: (generic) Thiadiazole derivative.
    CAS number: Not available.
    Basis of action: The PMN substance will be used as a coloring agent. 
    Based on analogy of the substance to neutral organic substances, EPA is 
    concerned that toxicity to aquatic organisms may occur at 
    concentrations as low as 90 ppb of the PMN substance in surface waters. 
    Based on analogy of the substance to other thiadiazoles, EPA is 
    concerned for developmental toxicity 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 above a concentration of 90 ppb and significant worker 
    exposure would not occur because the substance was used in an enclosed 
    process, was not manufactured domestically, and was not used as a 
    powder. EPA has determined that other uses of the substance may result 
    in significant worker exposure and 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) and 
    (b)(3)(ii).
    Recommended testing: EPA has determined that a fish acute toxicity 
    study (40 CFR 797.1400), a daphnid acute toxicity study (40 CFR 
    797.1300), and an algal acute toxicity study (40 CFR 797.1050) would 
    help characterize the environmental effects of the PMN substance. EPA 
    has determined that a developmental toxicity study (40 CFR 708.4900) 
    would help characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.9658.
    
    PMN Number P-94-1810
    
    Chemical name: (generic) Amine aldehyde condensate.
    CAS number: Not available.
    Basis of action: The PMN substance will be used as a fuel additive. 
    Based on analogy to aliphatic amines, EPA is concerned that toxicity to 
    aquatic organisms may occur at concentrations as low as 1 ppb of the 
    PMN substance in surface waters. 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), a daphnid acute toxicity study (40 CFR 
    797.1300), and an algal acute toxicity study (40 CFR 797.1050) would 
    help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.639.
    
    PMN Number P-94-1864
    
    Chemical name: (generic) Dialkylamido imidazoline.
    CAS number: Not available.
    Basis of action: The PMN substance will be used as a site-limited 
    intermediate. Based on analogy to aliphatic amines, EPA is concerned 
    that toxicity to aquatic organisms may occur at concentrations as low 
    as 6 ppb of the PMN substance in surface waters. EPA determined that 
    use of the substance as a site-limited intermediate did not present an 
    unreasonable risk because the substance would not exceed the concern 
    concentration when 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), a daphnid acute toxicity study (40 CFR 
    797.1300), and an algal acute toxicity study (40 CFR 797.1050) would 
    help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.4473.
    
    PMN Number P-94-2166
    
    Chemical name: Sodium perthiocarbonate.
    CAS number: Not available.
    Basis of action: The PMN substance will be used as an oil well 
    additive. Based on test data on a structurally similar substance, EPA 
    is concerned that toxicity to aquatic organisms may occur at 
    concentrations 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), a daphnid acute toxicity study (40 CFR 
    797.1300), and an algal acute toxicity study (40 CFR 797.1050) would 
    help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.9526.
    
    PMN Number P-94-2177
    
    Chemical name: (generic) Trisodium chloro[(trisubstituted 
    heteromonocycleamino) propylamino] triazinylaminohydroxyazo 
    naphthalenetrisulfonate.
    CAS number: Not available.
    Basis of action: The PMN substance will be used as a fiber-reactive 
    dye. Based on toxicity data for the substance, EPA is concerned that 
    toxicity to aquatic organisms may occur at concentrations as low as 100 
    ppb of the PMN substance in surface waters. Based on toxicity data for 
    the substance, EPA is concerned for neurological effects, kidney 
    toxicity, and liver toxicity 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 above a concentration of 100 ppb and significant worker 
    exposure would not occur because the substance was not manufactured 
    domestically. EPA has determined that domestic manufacture of the 
    substance may result in releases to surface waters which exceed the 
    concern concentration and significant worker exposure. Based on this 
    information, the PMN substance meets the concern criteria at 
    Sec. 721.170(b)(4)(i) and (b)(3)(i).
    Recommended testing: EPA has determined that a chronic 60-day fish 
    early life stage toxicity test in rainbow trout (40 CFR 797.1600) and a 
    21-day chronic daphnid toxicity test would help characterize the 
    environmental effects of the PMN substance and a 90-day subchronic oral 
    study in rats (40 CFR 798.2650) would help characterize the health 
    effects of the PMN substance.
    CFR citation: 40 CFR 721.5282.
    
    PMN Number P-94-2230
    
    Chemical name: (generic) Polyglycerin mono(4-nonyl phenyl) ether.
    CAS number: Not available.
    Basis of action: The PMN substance will be employed in a contained use. 
    Based on analogy to nonionic surfactants and alcohol ethoxylates, EPA 
    is concerned that toxicity to aquatic organisms may occur at 
    concentrations as low as 400 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 45078]]
    released to surface waters. EPA has determined that other uses, 
    increased production volume, and domestic manufacture 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), a daphnid acute toxicity study (40 CFR 
    797.1300), and an algal acute toxicity study (40 CFR 797.1050) would 
    help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.3486.
    
    PMN Number P-95-17
    
    Chemical name: Benzene, 2-bromo-1,4-dimethoxy-.
    CAS number: 25245-34-5.
    Basis of action: The PMN substance will be used as an intermediate. 
    Based on analogy to neutral organic compounds, EPA is concerned that 
    toxicity to aquatic organisms may occur at concentrations as low as 200 
    ppb of the PMN substance in surface waters. Based on analogy to 
    halogenated aromatic compounds, EPA is concerned that the substance may 
    cause liver and kidney toxicity to exposed workers. 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 and 
    significant worker exposure would not occur. EPA has determined that 
    other uses of the substance may result in releases to surface waters 
    which exceed the concern concentration and significant worker exposure. 
    Based on this information, the PMN substance meets the concern criteria 
    at Sec. 721.170(b)(4)(ii) and (b)(3)(ii).
    Recommended testing: EPA has determined that a fish acute toxicity 
    study (40 CFR 797.1400), a daphnid acute toxicity study (40 CFR 
    797.1300), and an algal acute toxicity study (40 CFR 797.1050) would 
    help characterize the environmental effects of the PMN substance and a 
    90-day subchronic oral study in rats (40 CFR 798.2650) would help 
    characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.1193.
    
    PMN Number P-95-85
    
    Chemical name: (generic) Substituted naphthalenesulfonic acid, alkali 
    salt.
    CAS number: Not available.
    Basis of action: The PMN substance will be used as a reactive textile 
    dye. Based on analogy to similar substances, EPA is concerned that 
    respiratory sensitization will occur in exposed workers. EPA determined 
    that use of the substance did not present an unreasonable risk because 
    significant worker exposure would not occur 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)(3)(ii).
    Recommended testing: EPA has determined that a respiratory 
    sensitization study (Sarlo, K. and Clark, E.D., A Tier Approach for 
    Evaluating the Respiratory Allergenicity of Low Molecular Weight 
    Chemicals, Fundamental and Applied Toxicology 18:107-114 (1992)) would 
    help characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.5278.
    
    PMN Number P-95-86
    
    Chemical name: (generic) Benzenesulfonic acid, amino substituted 
    phenylazo-.
    CAS number: Not available.
    Basis of action: The PMN substance will be used as a textile dye. Based 
    on analogy of the azo reduction products to a similar substance, EPA is 
    concerned that developmental, reproductive, and kidney toxicity will 
    occur in exposed workers. EPA determined that use of the substance did 
    not present an unreasonable risk because the substance would not be 
    manufactured as a powder and significant worker exposure would not 
    occur. EPA has determined that manufacture 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)(3)(iii).
    Recommended testing: EPA has determined that a 90-day subchronic oral 
    study in rats (40 CFR 798.2650), a two-generation reproduction study 
    (40 CFR 798.4700), and a developmental toxicity study (40 CFR 708.4900) 
    would help characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.1643.
    
    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 9 of the 26 
    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, 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 section 5(e) orders.
        In the other 17 cases for which the proposed uses are not regulated 
    under a 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: EPA will receive 
    notice of any company's intent to manufacture, import, or process a 
    listed chemical substance for a significant new use before that 
    activity begins; 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; 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; and all manufacturers, importers, and 
    processors of the same chemical substance which is subject to a 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 [insert date 60 days 
    after date of publication in the Federal Register], unless EPA receives 
    a written notice by [insert date 30 days after date of publication in 
    the Federal Register] 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 
    
    [[Page 45079]]
    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 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 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 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 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. 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. Section 5(e) orders have been 
    issued for nine substances and notice submitters are prohibited by the 
    section 5(e) orders from undertaking activities which EPA is 
    designating as significant new uses. In cases where EPA has not 
    received a Notice of Commencement (NOC) and the substance has not been 
    added to the Inventory, no other person may commence such activities 
    without first submitting a PMN. For substances for which an NOC has not 
    been submitted at this time, EPA has concluded that the uses are not 
    ongoing. However, EPA recognizes in cases when chemical substances 
    identified in this SNUR are added to the Inventory prior to the 
    effective date of the rule, the substances may be manufactured, 
    imported, or processed by other persons for a significant new use as 
    defined in this rule before the effective date of the rule. However, 23 
    of the 26 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 
    
    [[Page 45080]]
    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 SNUN 
    requirements for potential manufacturers, importers, and processors of 
    the chemical substances subject to this rule. EPA's complete economic 
    analysis is available in the public record for this rule (OPPTS-50622).
    
    X. Rulemaking Record
    
        A record has been established for this rulemaking under docket 
    number OPPTS-50622 (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 public record is located in the TSCA Nonconfidential 
    Information Center, Rm. NE-B607, 401 M St., SW., Washington, DC 20460.
        Electronic comments can be sent directly to EPA at:
        ncic@epamail.epa.gov
    
        Electronic comments must be submitted as an ASCII file avoiding the 
    use of special characters and any form of encryption.
        The official record for this rulemaking, as well as the public 
    version, as described above will be kept in paper form. Accordingly, 
    EPA will transfer all comments received electronically into printed, 
    paper form as they are received and will place the paper copies in the 
    official rulemaking record which will also include all comments 
    submitted directly in writing. The official rulemaking record is the 
    paper record maintained at the address in ``ADDRESSES'' at the 
    beginning of this document.
    
    XI. Regulatory Assessment Requirements
    
    A. Executive Order 12866
    
        Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
    Agency must determine whether the regulatory action is ``significant'' 
    and therefore subject to all the requirements of the Executive Order 
    (i.e., Regulatory Impact Analysis, review by the Office of Management 
    and Budget (OMB)). Under section 3(f), the order defines a 
    ``significant regulatory action'' as an action likely to lead to a 
    rule:
        (1) Having an annual effect on the economy of $100 million or more, 
    or adversely and materially affecting a sector of the economy, 
    productivity, competition, jobs, the environment, public health or 
    safety, or State, local or tribal governments or communities (``also 
    referred to as economically significant'').
        (2) Creating serious inconsistency or otherwise interfering with an 
    action taken or planned by another agency.
        (3) Materially altering the budgetary impacts of entitlement, 
    grants, user fees, or loan programs or the rights and obligations of 
    recipients thereof.
        (4) Raising novel legal or policy issues arising out of legal 
    mandates, the President's priorities, or the principles set forth in 
    this Executive Order.
        Pursuant to the terms of this Executive Order, it has been 
    determined that this rule is not ``significant'' and is therefore not 
    subject to OMB review.
    
    B. Regulatory Flexibility Act
    
        Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), EPA has 
    determined that this rule would not have a significant impact on a 
    substantial number of small businesses. EPA has determined that 
    approximately 10 percent of the parties affected by this rule could be 
    small businesses. However, EPA expects to receive few SNUNs for these 
    substances. Therefore, EPA believes that the number of small businesses 
    affected by this rule will not be substantial, even if all of the SNUR 
    notice submitters were small firms.
    
    C. Paperwork Reduction Act.
    
        OMB has approved the information collection requirements contained 
    in this rule under the provisions of the Paperwork Reduction Act (44 
    U.S.C. 3501 et seq.), and has assigned OMB control number 2070-0012. 
    Public reporting burden for this collection of information is estimated 
    to vary from 30 to 170 hours per response, with an average of 100 hours 
    per response, including time for reviewing instructions, searching 
    existing data sources, gathering and maintaining the data needed, and 
    completing and reviewing the collection of information.
        Send comments regarding the burden estimate or any other aspect of 
    this collection of information, including suggestions for reducing this 
    burden, to Chief, Information Policy Branch (2131), U.S. Environmental 
    Protection Agency, 401 M St., SW., Washington, DC 20460; and to Office 
    of Information and Regulatory Affairs, Office of Management and Budget, 
    Washington, DC 20503, marked ``Attention: Desk Officer for EPA.'' The 
    final rule will respond to any OMB or public comments on the 
    information requirements contained in this final rule.
    
    List of Subjects in 40 CFR Part 721
    
        Environmental protection, Chemicals, Hazardous materials, Reporting 
    and recordkeeping requirements, Significant new uses.
    
        Dated: August 21, 1995.
    Frank D. Kover,
    Acting 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. 721.562 to subpart E to read as follows:
    
    
    Sec. 721.562  Substituted alkylamine salt.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    substituted alkylamine salt (PMN P-85-941) 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) Release to water. Requirements as specified in 
    Sec. 721.90(a)(4), (b)(4), and (c)(4) (where n = 70).
        (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. 721.639 to subpart E to read as follows:
    
    
    Sec. 721.639  Amine aldehyde condensate.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    amine aldehyde condensate (PMN P-94-1810) is subject to reporting under 
    this section for the 
    
    [[Page 45081]]
    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.
        4. By adding new Sec. 721.1193 to subpart E to read as follows:
    
    
    Sec. 721.1193  Benzene, 2-bromo-1,4-dimethoxy-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as benzene, 2-bromo-
    1,4-dimethoxy- (PMN P-95-17, CAS No. 25245-34-5) is subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Release to water. Requirements as specified in 
    Sec. 721.90(a)(1), (b)(1), and (c)(1).
        (ii) 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 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.
        5. By adding new Sec. 721.1643 to subpart E to read as follows:
    
    
    Sec. 721.1643  Benzenesulfonic acid, amino substituted phenylazo-.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    benzenesulfonic acid, amino substituted phenylazo- (PMN P-95-86) 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(w)(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 (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.
        6. By adding new Sec. 721.2089 to subpart E to read as follows:
    
    
    Sec. 721.2089  Tetrasubstituted aminocarboxylic acid.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    tetrasubstituted aminocarboxylic acid (PMN P-85-619) is subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Hazard communication program. Requirements as specified in 
    Sec. 721.72(a), (b), (c), (d), (f), (g)(1)(vii), (g)(2)(iii), 
    (g)(3)(ii), (g)(4)(ii), (g)(4)(iii), and (g)(5).
        (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) through (h) 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.
        7. By adding new Sec. 721.2815 to subpart E to read as follows:
    
    
    Sec. 721.2815  Aliphatic ester.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    aliphatic ester (PMN P-93-633) 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) (concentration set at 1.0 percent), 
    (f), (g)(1)(iv), (g)(1)(ix), and (g)(5). In addition, the following 
    human health and environmental hazard and precautionary statements 
    shall appear on each label as specified in Sec. 721.72(b) and the 
    material safety data sheet (MSDS) as specified in Sec. 721.72(c): This 
    substance may not be used for any application that generates a dust, 
    mist, or aerosol. Avoid inhalation and ingestion.
        (ii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(y)(1) and (y)(2).
        (b) Specific requirements. The 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.
        8. By adding new Sec. 721.3152 to subpart E to read as follows:
    
    
    Sec. 721.3152  Ethanaminium, N-ethyl-2-hydroxy-N,N-bis(2-hydroxyethyl)-
    , diester with C12-18 fatty acids, ethyl sulfates (salts).
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance ethanaminium, N-ethyl-2-hydroxy-
    N,N-bis(2-hydroxyethyl)-, diester with C12-18 fatty acids, ethyl 
    sulfates (salts) (P-94-24) 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. A significant new use of this 
    substance is any manner or method of manufacture, import, or processing 
    associated with any use of this substance without providing risk 
    notification as follows:
        (A) If as a result of the test data required under the 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 
    material safety data sheet (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 
    
    [[Page 45082]]
    MSDS before the substance is reintroduced into the workplace.
        (B) The employer must ensure that persons who will receive, or who 
    have received, this 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.
        (ii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(p) (1,900,000 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), (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.
        9. By adding new Sec. 721.3486 to subpart E to read as follows:
    
    
    Sec. 721.3486  Polyglycerin mono(4-nonylphenyl) ether.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    polyglycerin mono(4-nonylphenyl) ether (PMN P-94-2230) 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.
        10. By adding new Sec. 721.3760 to subpart E to read as follows:
    
    
    Sec. 721.3760  Fluorene-containing diaromatic amines.
    
        (a) Chemical substances and significant new uses subject to 
    reporting. (1) The chemical substances identified generically as 
    fluorene-containing diaromatic amines (PMN P-88-998 and P-88-999) 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) (where 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.
        11. By adding new Sec. 721.4463 to subpart E to read as follows:
    
    
    Sec. 721.4463  Hydrochlorofluorocarbon.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    hydrochlorofluorocarbon (PMN P-94-1453) 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.
        12. By adding new Sec. 721.4466 to subpart E to read as follows:
    
    
    Sec. 721.4466  3-Hydroxy-1,1-dimethylbutyl derivative.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 3-
    hydroxy-1,1-dimethylbutyl derivative (PMN P-86-1491) is subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63(a)(1), (a)(2)(i), (a)(2)(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)(1)(vii), (g)(2)(i), (g)(2)(v), and (g)(5).
        (iii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(k).
        (iv) Disposal. Requirements as specified in Sec. 721.85(a)(1) and 
    (a)(2).
        (v) Release to water. Requirements as specified in 
    Sec. 721.90(a)(3).
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    Sec. 721.125(a) through (k) are applicable to manufacturers, importers, 
    and processors of this substance.
        (2) Limitations or revocation of certain notification requirements. 
    The provisions of Sec. 721.185 apply to this section.
        13. By adding new Sec. 721.4473 to subpart E to read as follows:
    
    
    Sec. 721.4473  Dialkylamidoimidazoline.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as 
    dialkylamidoimidazoline (PMN P-94-1864) 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 
    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.
        14. By adding new Sec. 721.5192 to subpart E to read as follows: 
    
    [[Page 45083]]
    
    
    
    Sec. 721.5192  Substituted 1,6-dihydroxy naphthalene.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    substituted 1,6-dihydroxy naphthalene (PMN P-87-1036) is subject to 
    reporting under this section for the significant new uses described in 
    paragraph (a)(2) of this section.
        (2) The significant new uses are:
        (i) Protection in the workplace. Requirements as specified in 
    Sec. 721.63(a)(1), (a)(2)(i), (a)(2)(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)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(v), and (g)(5).
        (iii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(f), (k), and (q).
        (iv) Disposal. Requirements as specified in Sec. 721.85(a)(1) and 
    (a)(2).
        (v) Release to water. Requirements as specified in 
    Sec. 721.90(a)(3).
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    Sec. 721.125(a) through (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.
        15. By adding new Sec. 721.5278 to subpart E to read as follows:
    
    
    Sec. 721.5278  Substituted naphthalenesulfonic acid, alkali salt.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    substituted naphthalenesulfonic acid, alkali salt (PMN P-95-85) 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.
        16. By adding new Sec. 721.5282 to subpart E to read as follows:
    
    
    Sec. 721.5282  Trisodium chloro [(trisubstituted heteromonocycle amino) 
    propylamino]triazinylamino hydroxyazo naphthalenetrisulfonate.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    trisodium chloro[(trisubstituted heteromonocycleamino) 
    propylamino]triazinyl aminohydroxyazo naphthalenetrisulfonate (PMN P-
    94-2177) 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.
        17. By adding new Sec. 721.5763 to subpart E to read as follows:
    
    
    Sec. 721.5763  Methylenebisbenzotriazolyl phenols.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    methylenebisbenzotriazolyl phenols (P-94-1042) 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)(6)(i), (b)(concentration set at 1.0 percent) and 
    (c). Requirements as specified in Sec. 721.63(a)(5)(i) apply during 
    manufacture of the PMN substance. Requirements as specified in 
    Sec. 721.63(a)(5)(iii) through (a)(5)(vii) apply during use of the PMN 
    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)(iv), (g)(1)(vi), (g)(2)(iii), (g)(2)(iv), and (g)(5).
        (iii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(l) and (q).
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    Sec. 721.125 (a) through (d) and (f) through (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) Determining whether a specific use is subject to this section. 
    The provisions of Sec. 721.575(b)(1) apply to this section.
        18. By adding new Sec. 721.5769 to subpart E to read as follows:
    
    
    Sec. 721.5769  Mixture of nitrated alkylated phenols.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as a mixture of 
    nitrated alkylated phenols (PMN P-93-987) 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).
        (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.
        19. By adding new Sec. 721.5867 to subpart E to read as follows:
    
    
    Sec. 721.5867  Substituted phenol.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    substituted phenol (PMN P-89-1125, L-91-87, P-92-41, P-92-511, P-94-
    1527, P-94-1755) is subject to reporting under this section for the 
    significant new uses described in paragraph (a)(2) of this section. 
    
    [[Page 45084]]
    
        (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).
        (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.
        20. By adding new Sec. 721.6110 to subpart E to read as follows:
    
    
    Sec. 721.6110  Alkyldi(alkyloxyhydroxypropyl) derivative, phosphoric 
    acid esters, potassium salts.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    alkyldi(alkyloxyhydroxypropyl) derivative, phosphoric acid esters, 
    potassium salts (PMN P-91-818) is subject to reporting under this 
    section for the significant new uses described in paragraph (a)(2) of 
    this section.
        (2) The significant new uses are:
        (i) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(f) and (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.
        21. By adding new Sec. 721.7046 to subpart E to read as follows:
    
    
    Sec. 721.7046  Formaldehyde, polymer with substituted phenols, glycidyl 
    ether.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as 
    formaldehyde, polymer with substituted phenols, glycidyl ether (P-93-
    955) 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)(6)(i), (b) (concentration set at 
    0.1 percent), and (c). Requirements as specified in Sec. 721.63 
    (a)(5)(i) apply during manufacturing only. Requirements as specified in 
    Sec. 721.63(a)(5)(i) through (a)(5)(vii) apply during processing for 
    workers exposed greater than 17 days per year or during use.
        (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)(vi), (g)(1)(vii), (g)(2)(i) through (g)(2)(v), 
    (g)(3)(i), (g)(3)(ii), (g)(4)(i), (g)(4)(iii), and (g)(5).
        (iii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(b), (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) through (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.
        22. By adding new Sec. 721.8090 to subpart E to read as follows:
    
    
    Sec. 721.8090  Polyurethane polymer.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    polyurethane polymer (P-94-47) 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)(iii), (a)(5)(viii) through 
    (a)(5)(xi), (a)(6)(ii), (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) through (g)(2)(v), and (g)(5).
        (iii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(q).
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    Sec. 721.125(a) through (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.
        23. By adding new Sec. 721.9526 to subpart E to read as follows:
    
    
    Sec. 721.9526  Sodium perthiocarbonate.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as sodium 
    perthiocarbonate (PMN P-94-2166) 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.
        24. By adding new Sec. 721.9656 to subpart E to read as follows:
    
    
    Sec. 721.9656  Thiaalkanethiol.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as a 
    thiaalkanethiol (PMN P-94-1487) 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 
    
    [[Page 45085]]
    provisions of Sec. 721.185 apply to this section.
        25. By adding new Sec. 721.9658 to subpart E to read as follows:
    
    
    Sec. 721.9658  Thiadiazole derivative.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified as a thiadiazole 
    derivative (PMN P-94-1631) 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(a), (c), (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) (where n = 90).
        (b) Specific requirements. The 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.
        26. By adding new Sec. 721.9892 to subpart E to read as follows:
    
    
    Sec. 721.9892  Alkylated urea.
    
        (a) Chemical substance and significant new uses subject to 
    reporting. (1) The chemical substance identified generically as an 
    alkylated urea (PMN P-93-1649) 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) Protection in the workplace. Requirements as specified in 
    Sec. 721.63(a)(1), (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 1.0 percent), 
    (f), (g)(1)(iii), (g)(1)(ix), (g)(2)(i), (g)(2)(iii), (g)(2)(v), and 
    (g)(5).
        (iii) Industrial, commercial, and consumer activities. Requirements 
    as specified in Sec. 721.80(l) and (q).
        (b) Specific requirements. The provisions of subpart A of this part 
    apply to this section except as modified by this paragraph.
        (1) Recordkeeping. Recordkeeping requirements as specified in 
    Sec. 721.125(a) through (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. 721.575(b)(1) apply to this section.
    [FR Doc. 95-21519 Filed 8-29-95; 8:45 am]
    BILLING CODE 6560-50-F
    
    

Document Information

Effective Date:
10/30/1995
Published:
08/30/1995
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
95-21519
Dates:
The effective date of this rule is October 30, 1995. This rule shall be promulgated for purposes of judicial review at 1 p.m. Eastern Standard Time on September 13, 1995. If EPA receives notice before September 29, 1995 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 ...
Pages:
45072-45085 (14 pages)
Docket Numbers:
OPPTS-50622, FRL-4926-2
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:
95-21519.pdf
CFR: (40)
40 CFR 798.2650)
40 CFR 721.90(a)(1)
40 CFR 721.72(a)
40 CFR 721.63(a)(1)
40 CFR 721.90(a)(3)
More ...