[Federal Register Volume 71, Number 197 (Thursday, October 12, 2006)]
[Notices]
[Pages 60139-60141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16925]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-8230-6; Docket ID No. EPA-HQ-ORD-2004-0002]
Draft Toxicological Review of Dichlorobenzenes: In Support of
Summary Information on the Integrated Risk Information System (IRIS)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Extension of Public Comment Period, Rescheduled
External Peer Review Panel Meeting, and Meeting Format Change.
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SUMMARY: The EPA is extending the public comment period and
rescheduling an external peer review panel meeting to review selected
sections of the EPA National Center for Environmental Assessment (NCEA)
final draft document titled, ``Toxicological Review of
Dichlorobenzenes: In Support of Summary Information on the Integrated
Risk Information System (IRIS)'' (EPA/635/R-03/015), regarding the
inhalation reference concentration (RfC) and inhalation cancer
assessment for 1,4-dichlorobenzene. The EPA is also changing the format
of this external peer review meeting to include both a teleconference
and an in-person panel meeting.
On July 11, 2006, EPA published a Federal Register notice (71 FR
39113) announcing a comment period that ended August 9 and an external
peer review panel meeting (by teleconference) that was scheduled for
August 16. On August 11, 2006, EPA published a second Federal Register
notice announcing an extension of the public comment period to October
10 and a rescheduling of the external peer review meeting to October
30. EPA is extending the public comment period to October 17, 2006,
rescheduling the external peer review meeting to November 3, 2006, and
changing the format to include both a face-to-face meeting and a
teleconference option for participation. This extended public comment
period and change in format for the external peer review are in
response to requests from the public.
The public comment period and the external peer review meeting are
separate processes that provide opportunities for all interested
parties to comment on the document. In addition to consideration by
EPA, all public comments submitted in accordance with this notice will
also be forwarded to EPA's contractor, the Oak Ridge Institute for
Science and Education (ORISE), for consideration by the external peer
review panel prior to the meeting.
As previously stated in 71 FR 39113 and 71 FR 46220, 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.
ORISE invites the public to register to attend this peer review
panel meeting as observers, either in person or by telephone. In
addition, ORISE invites the public to give brief oral comments at the
meeting regarding the draft document under review. The draft document
and EPA's peer review charge are available via the Internet on NCEA's
home page under the Recent Additions menu at http://www.epa.gov/ncea.
When finalizing this draft report, EPA will consider ORISE's report of
the comments and recommendations from the external peer reviewers and
any public comments that EPA receives in accordance with this notice.
DATES: The period for submission of comments on the final draft
document will end on October 17, 2006. Technical
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comments should be in writing and must be received by EPA by October
17, 2006. Comments submitted to the EPA by October 17, 2006, will be
provided to the external peer review panel prior to the panel review
meeting. The peer review will be on November 3, 2006, and will begin at
9 a.m. and end approximately at 1 p.m., eastern time.
ADDRESSES: The external peer review panel meeting will be held at the
American Geophysical Union, 2000 Florida Avenue, NW., Washington, DC
20009-1277. Under an Interagency Agreement between 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 attend the meeting, register by October 17, 2006, by
calling ORISE at (865) 576-2922, sending a facsimile to (865) 241-3168,
or sending an e-mail to Margaret Lyday at [email protected]. Interested
parties may also register via the Internet at http://www.orau.gov/dichlorobenzene. You must register by October 17, 2006, if you wish to
provide brief oral comments or if you plan to use the teleconference
option at the peer review panel meeting.
The draft ``Toxicological Review of Dichlorobenzenes: In Support of
Summary Information on the Integrated Risk Information System (IRIS)''
(EPA/635/R-03/015) 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
[email protected]. 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.
Copies of the study by Aiso et al. (2005), referenced in the
SUPPLEMENTARY INFORMATION section of this notice, are available from
the IRIS Hotline in paper or electronic format or via the docket at
http://www.regulations.gov. If you are requesting a copy from the IRIS
Hotline, please provide your name, mailing address or e-mail address,
and document citation: Aiso et al. (2005) Carcinogenicity and chronic
toxicity in mice and rats exposed by inhalation to parA-dichlorobenzene
for two years. J Vet Med Sci 67(10):1019-1029. EPA is providing this
study in the interest of transparency. EPA is not endorsing or
supporting the study or its findings.
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 for the external peer review panel meeting and teleconference
should be directed to Margaret Lyday, ORISE, P.O. Box 117, MS 17, Oak
Ridge, TN 37831-0117, at (865) 576-2922, (865) 241-3168 (facsimile), or
[email protected] (e-mail).
If you have questions about the document, contact Audrey Galizia,
Chemical Manager, National Center for Environmental Assessment;
telephone: (732) 906-6887; facsimile: (732) 452-6429; e-mail:
[email protected].
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 can be used as a resource for 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.
1,4-Dichlorobenzene is widely used as a space deodorant for toilets
and refuse containers, as a moth repellent in moth balls or crystals,
and in other pesticide applications. The current IRIS assessment for
1,4-dichlorobenzene was placed on the database in 1994 and contains an
inhalation RfC. A reassessment of the potential health effects of
dichlorobenzenes has been undertaken. The draft assessment for
dichlorobenzenes (including the 1,2-, 1,3-, and 1,4-isomers) was
subject to an external peer review and 30-day public comment period in
February 2004 (69 FR 4514, January 30, 2004). The scope of the current
external peer review and public comment is limited to the analyses
based on a chronic inhalation bioassay of 1,4-dichlorobenzene published
in the peer-reviewed literature (Aiso et al., 2005. J Vet Med Sci
67(10):1019-29) that was not included in the February 2004 external
peer review draft. This study was identified originally as an
unpublished study report by the Japan Bioassay Research Center (JBRC,
1995). Data from Aiso et al. (2005) were used subsequently in the
quantitative dose-response assessments for the 1,4-dichlorobenzene RfC
and inhalation cancer assessment.
II. Panel Meeting Information
Members of the public may attend the panel meeting as observers,
and there will be a limited time for comments from the public. To make
oral comments at the commencement of the peer review meeting, you must
pre-register with ORISE indicating your intent to do so. Space is
limited, and reservations will be accepted on a first-come, first-
served basis.
III. How to Submit Technical Comments to the Docket at http://www.regulations.gov
Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to make hand deliveries or visit the
Public Reading Room to view documents. Consult EPA's Federal
Register notice at 71 FR 38147 (July 5, 2006) or the EPA Web site at
http://www.epa.gov/epahome/dockets.htm for current information on
docket operations, locations and telephone numbers. The Docket
Center's mailing address for U.S. mail and the procedure for
submitting comments to www.regulations.gov are not affected by the
flooding and will remain the same.
Submit your comments, identified by Docket ID No. EPA-HQ-ORD 2004-
0002 by one of the following methods:
http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: [email protected].
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, 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
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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 by mail or hand delivery, please submit one
unbound original with pages numbered consecutively, 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-
2004-0002. 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: October 5, 2006.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. E6-16925 Filed 10-11-06; 8:45 am]
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