[Federal Register Volume 63, Number 174 (Wednesday, September 9, 1998)]
[Proposed Rules]
[Pages 48157-48162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24036]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50628C; FRL-6020-8]
RIN 2070-AB27


Certain Chemical Substances; Proposed Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing a significant new use rule (SNUR) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for twelve 
chemical substances which were the subject of premanufacture notices 
(PMNs). This proposal would require certain persons who intend to 
manufacture, import, or process these substances for a significant new 
use to notify EPA at least 90 days before commencing any manufacturing, 
importing, or processing activities for a use designated by this SNUR 
as a significant new use. The required notice would provide EPA with 
the opportunity to evaluate the intended use and, if necessary, to 
prohibit or limit that activity before it can occur.
DATES: Written comments must be received by EPA by October 9, 1998.

ADDRESSES: Each comment must bear the docket control number OPPTS-
50628C and the name(s) of the chemical substance(s) subject to the 
comment. All comments should be sent in triplicate to: OPPT Document 
Control Officer (7407), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M St., SW., Rm. G-099, East Tower, 
Washington, DC 20460.
    Comments and data may also be submitted electronically to: 
[email protected]. Follow the instructions under Unit VII. of this 
document. No Confidential Business Information (CBI) should be 
submitted through e-mail.
    All comments which contain information claimed as CBI must be 
clearly marked as such. Three sanitized copies of any comments 
containing information claimed as CBI must also be submitted and will 
be placed in the public record for this rulemaking. Persons submitting 
information on any portion of which they believe is entitled to 
treatment as CBI by EPA must assert a business confidentiality claim in 
accordance with 40 CFR 2.203(b) for each portion. This claim must be 
made at the time that the information is submitted to EPA. If a 
submitter does not assert a confidentiality claim at the time of 
submission, EPA will consider this as a waiver of any confidentiality 
claim and the information may be made available to the public by EPA 
without further notice to the submitter.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, Rm. E-531, 401 
M St., SW., Washington, DC 20460, telephone: (202) 554-1404, TDD: (202) 
554-0551; e-mail: TSCA-H[email protected].

SUPPLEMENTARY INFORMATION:
    Electronic Availability: Electronic copies of this document are 
available from the EPA Home Page at the Federal Register-Environmental 
Documents entry for this document under ``Laws and Regulations'' 
(http://www.epa.gov/fedrgstr/).
    This proposed SNUR would require persons to notify EPA at least 90 
days before commencing the manufacture, import, or processing of twelve 
substances for the significant new uses designated herein. The required 
notice would provide EPA with information

[[Page 48158]]

with which to evaluate an intended use and associated activities.

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) of TSCA. 
Once EPA determines that a use of a chemical substance is a significant 
new use, section 5(a)(1)(B) of TSCA requires persons to submit a notice 
to EPA at least 90 days before they manufacture, import, or process the 
chemical substance for that use. Section 26(c) of TSCA authorizes EPA 
to take action under section 5(a)(2) of TSCA with respect to a category 
of chemical substances.
    Persons subject to this SNUR would comply with the same notice 
requirements and EPA regulatory procedures as submitters of 
premanufacture notices under section 5(a)(1) of TSCA. In particular, 
these requirements include the information submission requirements of 
TSCA section 5(b) and (d)(1), the exemptions authorized by section 
5(h)(1), (h)(2), (h)(3), and (h)(5) of TSCA, 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 of TSCA to control the 
activities for which it has received a SNUR notice. If EPA does not 
take action, section 5(g) of TSCA requires EPA 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.

II. Applicability of General Provisions

    General regulatory provisions applicable to SNURs are codified at 
40 CFR part 721, subpart A. On July 27, 1988 (53 FR 28354) and July 27, 
1989 (54 FR 31298), EPA promulgated amendments to the general 
provisions which apply to this SNUR. In the Federal Register of August 
17, 1988 (53 FR 31252), EPA promulgated a ``User Fee Rule'' (40 CFR 
part 700) under the authority of TSCA section 26(b). Provisions 
requiring persons submitting SNUR notices to submit certain fees to EPA 
are discussed in detail in that Federal Register document. Interested 
persons should refer to these documents for further information.

III. Background

    In the Federal Register of January 22, 1998 (63 FR 3393) (FRL-5720-
3), EPA issued several direct final SNURs, including SNURs for the 
twelve chemicals substances which are the subject of this proposal. EPA 
received notice of intent to submit adverse comments following 
publication for these twelve chemical substances. Therefore, as 
required by Sec. 721.160, a final SNUR removing these substances is 
being issued elsewhere in this issue of the Federal Register, and this 
proposed rule on the substances is being issued. In addition, the 
proposed SNUR for Sec. 721.658 has been changed based on submitted 
comments. The commenter noted that the direct final SNUR had required 
notification if the substances were released to water during processing 
and use, but the submitted PMNs had already identified potential water 
releases during use of the substance. Thus, EPA is now proposing to 
require notification if the substances are released to water during 
manufacturing and processing.

IV. Substance Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for the following chemical substances under part 721, subpart E.

PMN Number P-94-209

Chemical name: Phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-.
CAS number: 134701-20-5.
Basis for action: The PMN substance will be used as an antioxidant. 
Based on submitted test data, there is concern for liver toxicity, 
kidney toxicity, adrenal toxicity, and blood toxicity. Based on 
submitted test data and analogy to phenols, EPA is also concerned that 
toxicity to aquatic organisms will occur at concentrations as low as 1 
part per billion (ppb). EPA determined that use of the substance as 
described in the PMN did not present an unreasonable risk because 
workers would not be subject to significant dermal exposures and there 
were no significant environmental releases. EPA has determined that 
other uses of the substance may result in significant dermal exposures 
to workers and significant environmental releases. Based on this 
information the PMN substance meets the concern criteria at 
Sec. 721.170 (b)(3)(i) and (b)(4)(i).
Recommended testing: EPA has determined that a dermal absorption study, 
a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 
870.3100 test guideline (63 FR 41845, August 5, 1998) (FRL-5740-1)), a 
chronic 60-day fish early life stage toxicity test in rainbow trout (40 
CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 
16486, April 15, 1996) (FRL-5363-1)), and a 21-day daphnid chronic 
toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public 
draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help 
characterize the health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.5725.

PMN Number P-95-1466

Chemical name: (generic) Substituted aromatic aldehyde.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the 
PMN. Based on analogy to phenols and aldehydes, EPA is concerned that 
toxicity to aquatic organisms may occur at a concentration as low as 3 
ppb of the PMN substance in surface waters. EPA determined that use of 
the substance as described in the PMNs did not present an unreasonable 
risk because the substance would not be released to surface waters. EPA 
has determined that other uses of the substance may result in releases 
to surface waters which exceed the concern concentration. Based on this 
information the PMN substance meets the concern criteria at 
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity 
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.526.

PMN Number P-95-1467

Chemical name: Benzaldehyde, 2-hydroxy-5-nonyl-, oxime, branched.
CAS number: 174333-80-3.
Basis for action: The PMN substance will be used as described in the 
PMN. Based on analogy to phenols, EPA is concerned that toxicity to 
aquatic organisms may occur at a concentration as low as 1 ppb of the 
PMN substance in surface waters. EPA determined that use of the 
substance as described in the PMN did not present an unreasonable risk 
because the substance would not be released to surface waters. EPA has

[[Page 48159]]

determined that other uses of the substance may result in releases to 
surface waters which exceed the concern concentration. Based on this 
information the PMN substance meets the concern criteria at 
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity 
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.528.

PMN Number P-96-585

Chemical name: (generic) Salt of a substituted polyalkylenepolyamine.
CAS number: Not available.
Basis for action: The PMN substance will be used as a processing aid. 
Based on analogy to aliphatic amines, EPA is concerned that toxicity to 
aquatic organisms may occur at a concentration as low as 1 ppb of the 
PMN substance in surface waters. EPA determined that use of the 
substance as described in the PMN did not present an unreasonable risk 
because the substance was not released to surface waters. EPA has 
determined that other uses may result in 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 a fish acute toxicity 
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.6197.

PMN Number P-96-795

Chemical name: (generic) Mixed fatty alkylamines, salt.
CAS number: Not available.
Basis for action: The PMN substance will be used as a processing aid. 
Based on analogy to aliphatic amines, EPA is concerned that toxicity to 
aquatic organisms may occur at a concentration as low as 1 ppb of the 
PMN substance in surface waters. EPA determined that use of the 
substance as described in the PMN did not present an unreasonable risk 
because the substance was not released to surface waters. EPA has 
determined that other uses may result in releases to surface waters. 
Based on this information the PMN substance meets the concern criteria 
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity 
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.567.

PMN Number P-96-866

Chemical name: (generic) Derivative of substituted carbomonocyclic 
acid-amine distillation stream byproduct reaction product.
CAS number: Not available.
Basis for action: The PMN substance will be used as a processing aid. 
Based on analogy to aliphatic amines, EPA is concerned that toxicity to 
aquatic organisms may occur at a concentration as low as 1 ppb of the 
PMN substance in surface waters. EPA determined that use of the 
substance as described in the PMN did not present an unreasonable risk 
because the substance was not released to surface waters. EPA has 
determined that other uses may result in releases to surface waters. 
Based on this information the PMN substance meets the concern criteria 
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity 
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.2082.

PMN Number P-96-1588

Chemical name: (generic) Hydrochloride salt of a mixed fatty 
amidoamide.
CAS number: Not available.
Basis for action: The PMN substance will be used as a processing aid. 
Based on analogy to aliphatic amines, EPA is concerned that toxicity to 
aquatic organisms may occur at a concentration as low as 2 ppb of the 
PMN substance in surface waters. EPA determined that use of the 
substance as described in the PMN did not present an unreasonable risk 
because the substance was not released to surface waters. EPA has 
determined that other uses may result in releases to surface waters. 
Based on this information the PMN substance meets the concern criteria 
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity 
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity 
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity 
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.637.

PMN Numbers P-97-57/58/59/60/61

Chemical name: (generic) Alkyl substituted quaternary ammonium 
chloride.
CAS number: Not available.
Basis for action: The PMN substances will be used as surface active 
agents. Based on submitted test data and analogy to monoalkyl 
quaternary surfactants EPA is concerned that toxicity to aquatic 
organisms may occur at a concentration as low as 4 ppb of the PMN 
substances in surface waters. EPA determined that use of the substances 
as described in the PMNs did not present an unreasonable risk because 
the substances would not be released to surface waters during 
manufacturing and processing. EPA has determined that other uses of the 
substances may result in releases to surface waters which exceed the 
concern concentration. Based on this information the PMN substances 
meets the concern criteria at Sec. 721.170 (b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity 
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 
61

[[Page 48160]]

FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study 
(40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 
16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study 
(40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 
16486, April 15, 1996) (FRL-5363-1)) would help characterize the 
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.658.

V. Applicability of SNUR to Uses Occurring Before Effective Date of 
the Final SNUR

    EPA has decided that the intent of section 5(a)(1)(B) of TSCA is 
best served by designating a use as a significant new use as of the 
date of proposal rather than as of the effective date of the rule. 
Because this SNUR was first published on January 22, 1998, as a direct 
final rule, that date will serve as the date after which uses would be 
considered to be new uses. If uses which had commenced between that 
date and the effective date of this rulemaking were considered ongoing, 
rather than new, any person could defeat the SNUR by initiating a 
significant new use before the effective date. This would make it 
difficult for EPA to establish SNUR notice requirements. Thus, persons 
who begin commercial manufacture, import, or processing of the 
substances for uses that would be regulated through this SNUR after 
January 22, 1998, would have to cease any such activity before the 
effective date of this proposed rule. To resume their activities, such 
persons would have to comply with all applicable SNUR notice 
requirements and wait until the notice review period, including all 
extensions, expires. EPA, not wishing to unnecessarily disrupt the 
activities of persons who begin commercial manufacture, import, or 
processing for a proposed significant new use before the effective date 
of the SNUR, has promulgated provisions to allow such persons to comply 
with this proposed SNUR before it is promulgated. If a person were to 
meet the conditions of advance compliance as codified at Sec. 721.45(h) 
(53 FR 28354, July 17, 1988), 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 
substances between proposal 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.

VI. Economic Analysis

    EPA has evaluated the potential costs of establishing significant 
new use notice requirements for potential manufacturers, importers, and 
processors of the chemical substances at the time of the direct final 
rule. The analysis is unchanged for the substances in this proposed 
rule. The Agency's complete economic analysis is available in the 
public record for this proposed rule (OPPTS-50628C).

VII. Public Record and Electronic Submissions

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket control 
number OPPTS-50628C (including comments and data submitted 
electronically as described below). The record includes basic 
information considered by the Agency in developing this proposed rule. 
EPA will supplement the record with additional information as it is 
received.
    EPA will accept additional materials for inclusion in the record at 
any time between this proposal and designation of the complete record. 
EPA will identify the complete rulemaking record by the date of 
promulgation A public version of this record, including printed, paper 
versions of electronic comments, which does not include any information 
claimed as CBI, is available for inspection from 12 noon to 4 p.m., 
Monday through Friday, excluding legal holidays. The official 
rulemaking record is located in the TSCA Nonconfidential Information 
Center, Rm. NE-B607, 401 M St., SW., Washington, DC.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    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 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number OPPTS-50628C. Electronic comments on this 
proposed rule may be filed online at many Federal Depository Libraries.
    The OPPTS harmonized test guidelines referenced in this document 
are available on EPA's World Wide Web site (http://www.epa.gov/epahome/
research.htm) under the heading ``Test Methods and Guidelines/OPPTS 
Harmonized Test Guidelines''.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), this action is not a 
``significant regulatory action'' subject to review by the Office of 
Management and Budget (OMB). In addition, this action does not impose 
any enforceable duty or contain any unfunded mandate as described in 
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Nor does it 
involve special considerations of environmental justice related issues 
as required by Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or additional OMB review 
in accordance with Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997).
    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., an agency may not conduct or sponsor, and a person is not 
required to respond to a collection of information that requires OMB 
approval under the PRA, unless it has been approved by OMB and displays 
a currently valid OMB control number. The OMB control numbers for EPA's 
regulations, after initial display in the preamble of the final rules, 
are listed in 40 CFR part 9. The information collection requirements 
related to this action have already been approved by OMB pursuant to 
the PRA under OMB control number 2070-0012 (EPA ICR No. 574). This 
action does not impose any burden requiring additional OMB approval.
    If an entity were to submit a significant new use notice to the 
Agency, the annual burden is estimated to average between 30 and 170 
hours per response. This burden estimate includes the time needed to 
review instructions, search existing data sources, gather and maintain 
the data needed, and complete, review and submit the required 
significant new use notice.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
OPPE Regulatory Information Division, U.S. Environmental Protection 
Agency (Mail Code 2137), 401 M St., SW.,

[[Page 48161]]

Washington, DC 20460, with a copy to the Office of Information and 
Regulatory Affairs, Office of Management and Budget, 725 17th St., NW., 
Washington, DC 20503, marked ``Attention: Desk Officer for EPA''. 
Please remember to include the OMB control number in any 
correspondence, but do not submit any completed forms to these 
addresses.
    In addition, pursuant to section 605(b) of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has previously 
certified, as a generic matter, that the promulgation of a SNUR does 
not have a significant adverse economic impact on a substantial number 
of small entities. The Agency's generic certification for promulgation 
of new SNURs appears on June 2, 1997 (62 FR 29684) (FRL-5597-1) and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing Intergovernmental 
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a 
regulation that is not required by statute and that creates a mandate 
upon a State, local or tribal government, unless the Federal government 
provides the funds necessary to pay the direct compliance costs 
incurred by those governments. If the mandate is unfunded, EPA must 
provide to the OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's proposed rule does not create an unfunded federal mandate 
on State, local or tribal governments. The proposed rule does not 
impose any enforceable duties on these entities. Accordingly, the 
requirements of section 1(a) of Executive Order 12875 do not apply to 
this proposed rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the proposed rule, a description of the 
extent of EPA's prior consultation with representatives of affected 
tribal governments, a summary of the nature of their concerns, and a 
statement supporting the need to issue the regulation. In addition, 
Executive Order 13084 requires EPA to develop an effective process 
permitting elected and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's proposed rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this proposed rule.

List of Subjects in 40 CFR Part 721

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

    Dated: August 31, 1998.

Charles M. Auer,

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

    Therefore, it is proposed that 40 CFR part 721 be amended as 
follows:

PART 721--[AMENDED]

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

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

    2. By adding new Sec. 721.526 to subpart E to read as follows:


Sec. 721.526   Substituted aromatic aldehyde (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted aromatic aldehyde (PMN P-95-1466) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    3. By adding new Sec. 721.528 to subpart E to read as follows:


Sec. 721.528   Benzaldehyde, 2-hydroxy-5-nonyl-, oxime, branched.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzaldehyde, 2-
hydroxy-5-nonyl-, oxime, branched (PMN P-95-1467; CAS No. 174333-80-3) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    4. By adding new Sec. 721.567 to subpart E to read as follows:


Sec. 721.567   Mixed fatty alkylamines, salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as mixed 
fatty alkylamines, salt (PMN P-96-795) 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

[[Page 48162]]

(a), (b), (c), and (k) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    5. By adding new Sec. 721.637 to subpart E to read as follows:


Sec. 721.637   Hydrochloride salt of a mixed fatty amidoamide 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
hydrochloride salt of a mixed fatty amidoamide (PMN P-96-1588) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    6. By adding new Sec. 721.658 to subpart E to read as follows:


Sec. 721.658   Alkyl substituted quaternary ammonium chloride 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as alkyl 
substituted quaternary ammonium chloride (PMNs P-97-57/58/59/60/61) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1) and (b)(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.
    7. By adding new Sec. 721.2082 to subpart E to read as follows:


Sec. 721.2082   Derivative of substituted carbomonocyclic acid-amine 
distillation stream byproduct reaction product (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
derivative of substituted carbomonocyclic acid-amine distillation 
stream byproduct reaction product (PMN P-96-866) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    8. By adding new Sec. 721.5725 to subpart E to read as follows:


Sec. 721.5725   Phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phenol, 2,4-
dimethyl-6-(1-methylpentadecyl)- (PMN P-94-209; CAS No. 134701-20-5) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(2)(i) and (a)(3).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    9. By adding new Sec. 721.6197 to subpart E to read as follows:


Sec. 721.6197   Salt of a substituted polyalkylenepolyamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a salt 
of a substituted polyalkylenepolyamine (PMN P-96-585) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[FR Doc. 98-24036 Filed 9-8-98; 8:45 am]
BILLING CODE 6560-50-F