Document ID: EPA-HQ-ORD-2004-0002-0027
Agency: epa
Document Type: Notice
Title: Draft Toxicological Review of Dichlorobenzenes: In Support of Summary Information on the Integrated Risk Information System (IRIS)
Posted Date: 2006-10-12T14:05:57Z

[Federal Register: October 12, 2006 (Volume 71, Number 197)]
[Notices]               
[Page 60139-60141]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12oc06-43]                         

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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

[[Page 60140]]

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 lydaym@orau.gov. 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 
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.
    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 
lydaym@orau.gov (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: 
galizia.audrey@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 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 http://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: ORD.Docket@epa.gov.
     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

[[Page 60141]]

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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