[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-Hotline@epa.gov.
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: alwood.jim@epa.gov.
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: oppt.ncic@epa.gov,'' 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
