[Federal Register Volume 63, Number 179 (Wednesday, September 16, 1998)]
[Proposed Rules]
[Pages 49518-49520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24843]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50633; FRL-6024-9]
RIN 2070-AB27


Proposed Revocation of Significant New Use Rules for Certain 
Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke significant new use rules (SNURs) 
for 6 substances promulgated under section 5(a)(2) of the Toxic 
Substances Control Act (TSCA) for certain chemical substances based on 
new data. Based on the new data the Agency no longer finds that 
activities not described in the corresponding TSCA section 5(e) consent 
order or the premanufacture notice (PMN) for these chemical substances 
may result in significant changes in human or environmental exposure.

DATES: Written comments must be received by EPA by October 16, 1998.

ADDRESSES: Each comment must bear the docket control number OPPTS-50633 
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 III. 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/).
    In the Federal Register referenced for each substance, EPA issued a 
SNUR establishing significant new uses for the substances listed in 
Unit II. of this preamble, OPPTS-50569A, September 18, l989 (54 FR 
38381); OPPTS-50582, August 15, 1990 (55 FR 33296); OPPTS-50613, 
October 4, 1993 (58 FR 51694); OPPTS-50623, December 2, 1996 (61 FR 
63726) (FRL-4964-3); and OPPTS-50628, January 22, l998 (63 FR 3393) 
(FRL-5720-3). Because of additional data EPA has received for these 
substances, EPA is hereby proposing to revoke the SNURs.

I. Rationale for Revocation of the Proposed Rule

    During EPA's review of the PMNs submitted under section 5(a)(1)(A) 
of TSCA for the chemical substances subject to this revocation, EPA 
concluded that promulgation of SNURs under section 5(a)(2) of TSCA was 
warranted based on the fact that activities not described in the TSCA 
section 5(e) consent orders or the PMN might result in significant 
changes in human or environmental exposure. Based on these findings, 
SNURs were promulgated defining such activities as ``significant new 
uses''.
    Based on new data, EPA has revoked, or will revoke the TSCA section 
5(e) consent orders that are the basis for these SNURs and no longer 
finds that activities not described in the TSCA section 5(e) consent 
orders or the PMN may result in significant changes in human or 
environmental exposure nor constitutes ``significant new uses''. The 
proposed revocation of SNURs for these substances is consistent with 
this finding. When this revocation becomes final, notice of intent to 
manufacture, import, or process these substances for a significant new 
use will no longer be required. In addition, export notification under 
section 12(b) of TSCA will no longer be required on the basis of these 
substances being subject to SNURs.

II. Proposed Revocations and Background

    EPA is proposing to revoke the significant new use and 
recordkeeping requirements under 40 CFR part 721, subpart E for several 
chemical substances. In this unit, EPA provides a description for each 
substance, including its premanufacture notice (PMN) number, chemical 
name (generic name if the specific name is claimed as CBI), CAS number 
(if assigned), the date of the revocation of the section 5(e) consent 
order (where applicable), a

[[Page 49519]]

summary of the reason for revoking the rule, Federal Register 
reference, docket number, and the CFR citation removed in the 
regulatory text section of this proposed rule. Further background 
information for the substances is contained in the rulemaking record 
referenced below in Unit III. of this preamble.

PMN Number P-88-1617

Chemical name: (generic) Terpenes and terpenoids, limonene fraction, 
polymer with substituted carbopolycycles.
CAS number: Not available.
Federal Register publication date and reference: August 15, 1990 (55 FR 
33296).
Docket number: OPPTS-50582.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the test data submitted pursuant to the TSCA section 5(e) 
consent order, EPA no longer finds that activities described as 
``significant new uses'' in the SNUR may result in significant changes 
in human exposure. Accordingly, EPA has determined that further 
regulation under TSCA section 5(a)(2) is not warranted at this time.
Toxicity results: An oral 28-day repeated dose neurotoxicity study in 
rats: A no observed adverse effect level (NOAEL) of 10 milligrams/
kilograms/day (mg/kg/day) was established for female rats based on a 
dose related depression in body weight gain at 100 mg/kg/day and 1000 
mg/kg/day. A NOAEL of 1000 mg/kg/day was established for male rats 
based on no effects observed at this dose level which was the highest 
dose tested.
CFR citation: 40 CFR 721.7360 (Formerly 40 CFR 721.2075).

PMN Number P-86-1322

Chemical name: Mixture of: 1,3-benzenediamine, 2-methyl-4,6-bis 
(methylthio)- and 1,3-benzenediamine, 4-methyl-2,6-bis (methylthio)-.
CAS number: 104983-85-9 and 102093-68-5.
Revocation of section 5(e) consent order: May 21, 1998.
Federal Register publication date and reference: September 18, 1989 (54 
FR 38381).
Docket number: OPPTS-50569A.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the test data submitted pursuant to the TSCA section 5(e) 
consent order, EPA no longer finds that activities described as 
``significant new uses'' in the SNUR may result in significant changes 
in human exposure. Accordingly, EPA has determined that further 
regulation under TSCA section 5(a)(2) is not warranted at this time.
Toxicity results: A 2-year chronic/carcinogenicity study was found to 
be negative at the doses tested. A NOAEL was established at 100 parts 
per million (ppm) (4.7 mg/kg/day) in males and 200 ppm (11.9 mg/kg/day) 
which were the highest doses tested.
CFR citation: 40 CFR 721.1525 (Formerly 40 CFR 721.557).

PMN Numbers P-91-1190 and P-91-1191

Chemical name: (generic) Substituted dichlorobenzothiazoles.
CAS number: Not available.
Federal Register publication date and reference: October 4, l993 (58 FR 
51694).
Docket number: OPPTS-50613.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the data submitted pursuant to the significant new use 
notice, EPA no longer finds that activities described as ``significant 
new uses'' in the SNUR may result in significant changes in human 
exposure. Accordingly, EPA has determined that further regulation is 
not warranted at this time.
CFR citation: 40 CFR 721.1740.

PMN Number P-94-2159

Chemical name: (generic) Anthraquinone dye.
CAS number: Not available.
Federal Register publication date and reference: January 22, 1998 (63 
FR 3393).
Docket number: OPPTS-50628.
Basis for revocation: Pursuant to 40 CFR 720.75(e), the submitter 
withdrew the PMN. Therefore, a new PMN is required before anyone may 
commence manufacture or import. Since the PMN requirement is applicable 
to the substance, a SNUR is unwarranted at this time and EPA is 
revoking the SNUR.
CFR citation: 40 CFR 721.723.

PMN Number P-94-2061

Chemical name: (generic) Benzotriazole derivative.
CAS number: Not available.
Revocation of section 5(e) consent order: March 17, 1998.
Federal Register publication date and reference: December 2, 1996 (61 
FR 63726).
Docket number: OPPTS-50623.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the test data submitted pursuant to the consent order, 
EPA no longer finds that activities described as ``significant new 
uses'' in the SNUR may result in significant changes in human exposure. 
Accordingly, EPA has determined that further regulation under TSCA 
section 5(a)(2) is not warranted at this time.
Toxicity results: The 90-day oral study in rats demonstrated a NOAEL of 
1000 mg/kg/day. Inhalation exposures during manufacturing and 
processing to workers may approach 214 mg/kg/day. The margin of 
exposure (MOE) for workers is 467 during manufacturing/processing and 
5,882 for use. The MOEs are adequate given the estimates for 
inhalation.
CFR citation: 40 CFR 721.1737.

III. 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-50633 (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 12 noon to 4 p.m., Monday through Friday, excluding legal 
holidays. The official rulemaking record is located in the TSCA 
Nonconfidential Information Center Rm. NE-B607, 401 M St., SW., 
Washington, DC.
    Electronic comments can be sent directly to EPA at:
    [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-50633. Electronic comments on this 
proposed rule may be filed online at many Federal Depository Libraries.

IV. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This proposed rule revokes or eliminates an existing regulatory 
requirement and does not contain any new or amended requirements. As 
such, the Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993). Since 
this proposed rule does not impose any requirements, it does not 
contain any information collections subject to approval under the 
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or require any 
other action under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4). Nor does it require special considerations as 
required by

[[Page 49520]]

Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994) or require 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).
    In addition, pursuant to section 605(b) of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has determined 
that SNUR revocations, which eliminate requirements without imposing 
any new ones, have no adverse economic impacts. The Agency's generic 
certification for SNUR revocations 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: September 9, 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).

Sec. Sec. 721.723, 721.1525, 721.1737, 721.1740, 721.7360   [Removed]

    2. By removing Sec. Sec. 721.723, 721.1525, 721.1737, 721.1740, and 
721.7360.

[FR Doc. 98-24843 Filed 9-15-98; 8:45 am]
BILLING CODE 6560-50-F