[Federal Register: December 29, 2006 (Volume 71, Number 250)]
[Notices]
[Page 78434-78436]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29de06-74]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-8263-9; Docket ID No. EPA-HQ-ORD-2006-1009]
Draft Toxicological Review of 2,2,4-Trimethylpentane: In Support
of Summary Information on the Integrated Risk Information System (IRIS)
AGENCY: Environmental Protection Agency (EPA).
[[Page 78435]]
ACTION: Notice of public comment period and external peer review panel
meeting.
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SUMMARY: The EPA is announcing a public comment period and an external
peer review panel meeting to review the draft document titled,
``Toxicological Review of 2,2,4-Trimethylpentane: In Support of Summary
Information on the Integrated Risk Information System (IRIS)'' (NCEA-S-
2202), related to the human health assessment for 2,2,4-
trimethylpentane. The document was prepared by the National Center for
Environmental Assessment (NCEA) within EPA's Office of Research and
Development.
EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination. EPA will consider any public comments
submitted in accordance with this notice when revising the document.
DATES: The 45-day public comment period begins on December 29, 2006 and
ends February 12, 2007. Technical comments should be in writing and
must be received by EPA by February 12, 2007. The peer review panel
meeting will be conducted on February 28, 2007, by teleconference and
will begin at 1 p.m. and end at 4 pm. Members of the public may call
into the teleconference meeting and are invited to provide oral
statements at the commencement of the teleconference. (For more
information refer to the instructions for registration provided in the
ADDRESSES section of this notice.)
ADDRESSES: The external peer review panel meeting will be held by
teleconference. Under an Interagency Agreement with EPA and the
Department of Energy, the Oak Ridge Institute of Science and Education
(ORISE) is organizing, convening, and conducting the peer review panel
meeting. To obtain the teleconference call-in number and access code,
register by February 14, 2007, by calling ORISE, P.O. Box 117, MS 17,
Oak Ridge, TN 37831-0117, at (865) 576-2922 or (865) 241-3168
(facsimile). Interested parties may also register on-line at: http://www.orau.gov/trimethylpentane.
Public comments submitted to the EPA by
February 12, 2007 will be provided to the external peer review panel
prior to the teleconference meeting.
The draft, ``Toxicological Review of 2,2,4-Trimethylpentane: In
Support of Summary Information on the Integrated Risk Information
System (IRIS)'' (NCEA-S-2202) is available primarily via the Internet
on NCEA's home page under the Recent Additions menu at http://www.epa.gov/ncea.
A limited number of paper copies are available by
contacting the IRIS Hotline at (202) 566-1676, (202) 566-1749
(facsimile), or hotline.iris@epa.gov. If you are requesting a paper
copy, please provide your name, mailing address, the document title,
and the EPA number of the requested publication. Copies are not
available from ORISE.
Technical comments may be submitted electronically via
http://www.regulations.gov, by mail, by facsimile, or by hand delivery/
courier. Please follow the detailed instructions provided in the
SUPPLEMENTARY INFORMATION section of this notice.
FOR FURTHER INFORMATION CONTACT: Questions regarding registration and
logistics should be directed to Margaret Lyday, ORISE, P.O. Box 117, MS
17, Oak Ridge, TN 37831-0117, at (865) 576-2922 or (865) 241-3168
(facsimile), lydaym@orau.gov (email).
If you have questions about the document, contact John Stanek,
Chemical Manager, National Center for Environmental Assessment;
telephone: (919) 541-1048; facsimile: (919) 541-0248; email:
stanek.john@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Information About the Document
IRIS is a database that contains Agency scientific positions on
potential adverse human health effects that may result from chronic (or
lifetime) exposure to specific chemical substances found in the
environment. The database (available on the Internet at http://www.epa.gov/iris
) contains qualitative and quantitative health effects
information for more than 500 chemical substances that may be used to
support the first two steps (hazard identification and dose-response
evaluation) of the risk assessment process. When supported by available
data, the database provides oral reference doses (RfDs) and inhalation
reference concentrations (RfCs) for chronic health effects, and oral
slope factors and inhalation unit risks for carcinogenic effects.
Combined with specific exposure information, government and private
entities use IRIS to help characterize public health risks of chemical
substances in a site-specific situation and thereby support risk
management decisions designed to protect public health.
2,2,4-Trimethylpentane, also known as isooctane or
isobutyltrimethylmethane, is a hydrocarbon used primarily in deriving
high-octane fuels. It comprises about 10% of unleaded gasoline. 2,2,4-
Trimethylpentane is released into the environment through the
manufacture, use, and disposal of products associated with the gasoline
and petroleum industry. The current assessment posted on IRIS (1991)
does not include an evaluation of the oral non-cancer or the cancer
literature; for the inhalation RfC, a message indicates that the health
effects data for 2,2,4-trimethylpentane were considered inadequate for
the derivation of an inhalation RfC. A review of the more recent
literature identified mechanistic studies, gavage studies, and
toxicokinetic studies, the majority of which were designed to
specifically address and characterize the involvement of
alpha2u-globulin accumulation in the renal toxicity observed
in the male rat. Little or no evaluation of other endpoints in tissues/
organs other than the kidney was reported. Therefore, the major issues
discussed in the draft assessment are: (1) the association of TMP-
induced renal effects in male rats with alpha2u-globulin
accumulation, and (2) the lack of studies with sufficient duration and
dose-response information for any endpoint from which to derive
reference values.
II. How to Submit Technical Comments to the Docket at
http://www.regulations.gov
Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2006-
1009 by one of the following methods:
http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: ORD.Docket@epa.gov.
Fax: (202) 566-1753.
Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is (202)
566-1752.
Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is
(202) 566-1744. Such deliveries are only accepted during the
docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
If you provide comments in writing, please submit one unbound
original with pages numbered consecutively,
[[Page 78436]]
and three copies of the comments. For attachments, provide an index,
number pages consecutively with the comments, and submit an unbound
original and three copies.
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2006-1009. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov
or e-mail. The http://www.regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
http://www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the EPA
Headquarters Docket Center.
Dated: December 20, 2006.
George Alapas,
Deputy Director, National Center for Environmental Assessment.
[FR Doc. E6-22431 Filed 12-28-06; 8:45 am]
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