[Federal Register Volume 64, Number 223 (Friday, November 19, 1999)]
[Proposed Rules]
[Pages 63275-63277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30241]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50637; FRL-6385-8]
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 2 substances promulgated under section 5(a)(2) of the Toxic 
Substances Control Act (TSCA) 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 for these chemical 
substances may result in significant changes in human or environmental 
exposure.

DATES: Comments, identified by docket control number OPPTS-50637, must 
be received on or before December 20, 1999.
ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION.'' To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPPTS-50637 in the subject line on the first page of 
your response.

FOR FURTHER INFORMATION CONTACT: For general information contact: Joe 
Carra, Deputy Director, Office of Pollution Prevention and Toxics 
(7401), Environmental Protection Agency, 401 M St., SW., Washington, DC 
20460; telephone numbers: (202) 554-1404 and TDD: (202) 554-0551; e-
mail address: TSCA-H[email protected].
    For technical information contact: James Alwood, Chemical Control 
Division (7405), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
telephone number: (202) 260-1857; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this 
proposed rule. Potentially affected categories and entities may 
include, but are not limited to:


------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Chemical manufacturers            325                 Manufacturers,
                                                       importers,
                                                       processors, and
                                                       users of
                                                       chemicals
------------------------------------------------------------------------
Petroleum and coal product        324                 Manufacturers,
 industries                                            importers,
                                                       processors, and
                                                       users of
                                                       chemicals
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table in this unit 
could also be affected. The North American Industrial Classification 
System (NAICS) codes have been provided to assist you and others in 
determining whether or not this action applies to certain entities. To 
determine whether you or your business is affected by this action, you 
should carefully examine the applicability provisions in 40 CFR 721.5. 
If you have any questions regarding the applicability of this action to 
a particular entity, consult the technical person listed under ``FOR 
FURTHER INFORMATION CONTACT.''

B. How Can I Get Additional Information, Including Copies of this 
Document or Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register-Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-50637. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as confidential business information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in

[[Page 63276]]

those documents. The public version of the official record does not 
include any information claimed as CBI. The public version of the 
official record, which includes printed, paper versions of any 
electronic comments submitted during an applicable comment period, is 
available for inspection in the TSCA Nonconfidential Information 
Center, North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., 
Washington, DC. The Center is open from noon to 4 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Center 
is (202) 260-7099.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPPTS-50637 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Document Control Office 
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: OPPT Document 
Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M 
St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
DCO is (202) 260-7093.
    3. Electronically. You may submit your comments electronically by 
e-mail to: ``[email protected],'' or mail your computer disk to the 
address identified above. Do not submit any information electronically 
that you consider to be CBI. Electronic comments must be submitted as 
an ASCII file avoiding the use of special characters and any form of 
encryption. Comments and data will also be accepted on standard disks 
in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic 
form must be identified by docket control number OPPTS-50637. 
Electronic comments may also be filed online at many Federal Depository 
Libraries.

D. How Should I Handle CBI Information That I Want to Submit to the 
Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the technical person identified under ``FOR FURTHER 
INFORMATION CONTACT.''

E. What Should I Consider as I Prepare My Comments for EPA?

    We invite you to provide your views on the various options we 
propose, new approaches we have not considered, the potential impacts 
of the various options (including possible unintended consequences), 
and any data or information that you would like the Agency to consider 
during the development of the final action. You may find the following 
suggestions helpful for preparing your comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the proposed rule.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register referenced for each substance, OPPTS-
50591C, July 22, 1992, 57 FR 32441 and OPPTS-50615, May 27, 1994, 59 FR 
27474 establishing significant new uses for the substances, EPA issued 
a SNUR. Because of additional data EPA has received for these 
substances, EPA is proposing to revoke the 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 the substances, including its premanufacture notice 
(PMN) number, chemical name (generic name if the specific name is 
claimed as CBI), CAS number (if assigned), basis for the revocation of 
the TSCA section 5(e) consent order for the substance, and the CFR 
citation removed in the regulatory text section of this proposed rule. 
Further background information for the substances is contained in Unit 
I.B.2 of this document.

PMN Number P-88-1763

Chemical name: Ethane, 2-chloro-1,1,1,2-tetrafluoro-.
CAS number: 2837-89-0.
Federal Register publication date and reference: July 22, 1992 (57 FR 
32441).
Docket number: OPPTS-50591C.
Basis for revocation of SNUR: EPA received and evaluated the following 
toxicity testing. A chronic inhalation study in rats showed no 
significant effects at 2,000, 10,000 or 50,000 parts per million (ppm). 
For a 90-day inhalation study in mice, the No Observed Adverse Effect 
Level (NOAEL) was 15,000 ppm with reduced response to sound at 50,000 
ppm. In a 90-day inhalation study in rats, the NOAEL was 5,000 ppm 
(3,200 mg/kg/day) for males based on lower serum triglyceride levels 
and decreased arousal at 15,000 ppm; the NOAEL for females was 15,000 
ppm. In a 28-day inhalation study in rats, the PMN substance caused 
lethargy at 50,000 ppm. In a developmental toxicity study in rats by 
inhalation, the only effects were reduced maternal weight gain and 
reduced response to sound at 50,000 ppm. There were no fetal effects. 
In a rabbit development toxicity study (inhalation), there was reduced 
activity in maternal animals at 50,000 ppm. In addition, a cardiac 
sensitization study in dogs, showed effects at 25,000 ppm but not at 
10,000 ppm. The substance was negative in the Ames assay and the mouse 
micronucleus assay. Based on the assessment of these test data, EPA 
determined that it could no longer support an unreasonable risk finding 
under section 5(e) of TSCA and has revoked the consent order. EPA can 
no longer make the finding that activities not described in the TSCA 
section 5(e) consent order may result in significant changes in human 
exposure.
CFR citation: 40 CFR 721.3180.

PMN Number P-93-1235

Chemical name: 2-Propenoic acid 3-(trimethoxysilyl) propyl ester.
CAS number: Not available.
Federal Register publication date and reference: May 27, 1994 (59 FR 
27474).

[[Page 63277]]

Docket number: OPPTS-50615.
Basis for revocation of SNUR: Based on short term studies on a series 
of acrylate substances and long term dermal bioassays on triethylene 
glycol diacrylate and triethylene glycol dimethacrylate, EPA no longer 
supports a carcinogenicity concern for this substance. Based on that 
assessment, EPA can no longer make the finding that activities not 
described in the PMN may result in significant changes in human 
exposure.
CFR citation: 40 CFR 721.8654.

B. What is the Agency's Authority for Taking this Action?

    During review of the PMNs submitted for the chemical substances 
that are the subject of this proposed revocation, EPA concluded that 
regulation was warranted based on available information that indicated 
activities not described in the TSCA section 5(e) consent order or the 
PMN might result in significant changes in human or environmental 
exposure as described in section 5(a)(2) of TSCA. Based on these 
findings, SNURs were promulgated.
    EPA has revoked the TSCA section 5(e) consent order that is the 
basis for one of the SNURs and no longer finds that activities other 
than those described in the TSCA section 5(e) consent order or the PMN 
may result in significant changes in human or environmental exposure. 
The revocation of SNUR provisions for these substances is consistent 
with the findings set forth in the preamble to the proposed revocation 
of each individual SNUR.
    Therefore, EPA is proposing to revoke the SNUR provisions for these 
chemical substances. When this revocation becomes final, EPA will no 
longer require notice of intent to manufacture, import, or process 
these substances. In addition, export notification under section 12(b) 
of TSCA will no longer be required.

III. Regulatory Assessment Requirements

    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 any prior consultation as specified by 
Executive Order 12875, entitled ``Enhancing the Intergovernmental 
Partnership'' (58 FR 58093, October 28, 1993), or special 
considerations 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 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).
    On August 4, 1999, President Clinton issued a new executive order 
on Federalism, Executive Order 13132 (64 FR 43255, August 10, 1999), 
which will take effect on November 2, 1999. In the interim, the current 
Executive Order 12612 (52 FR 41685, October 30, 1987) on Federalism 
still applies. This proposed rule will not have a substantial direct 
effect on States, on the relationship between the national government 
and the States, or on the distribution of power and responsibilities 
among the various levels of government, as specified in Executive Order 
12612.
    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.

List of Subjects in 40 CFR Part 721

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

    Dated: November 1, 1999.

Ward Penberthy,

Acting 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. 721.3180, 721.8654   [Removed]

    2. By removing Sec. Sec. 721.3180 and 721.8654.

[FR Doc. 99-30241 Filed 11-18-99; 8:45 am]
BILLING CODE 6560-50-F