[Federal Register Volume 71, Number 155 (Friday, August 11, 2006)]
[Pages 46220-46222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13205]



[FRL-8208-6; 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 and Rescheduled 
External Peer Review Panel Meeting.


SUMMARY: The EPA is extending the public comment period and 
rescheduling an external peer review panel meeting to review selected 
sections of the 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), related to the 
inhalation reference concentration (RfC) and inhalation cancer 
assessment for 1,4-dichlorobenzene. The document was prepared by the 
National Center for Environmental Assessment (NCEA) within EPA's Office 
of Research and Development.
    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 that was scheduled for August 16. EPA is 
extending the public comment period to October 10, 2006, in response to 
requests. The external peer review panel meeting will be held on 
October 30, 2006.
    As previously stated in 71 FR 39113, 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 period for submission of comments on the final draft 
document will end on October 10, 2006. Technical comments should be in 
writing and must be received by EPA by October 10, 2006. Comments 
submitted to the EPA by October 10, 2006, will be provided to the 
external peer review panel prior to the teleconference meeting. The 
peer review panel meeting will be conducted on October 30, 2006, by 

[[Page 46221]]

and will begin at 1 p.m. and end at 4 p.m. 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 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 obtain the teleconference call-in number and access code, 
register by October 10, 2006, 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/dichlorobenzene.
    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 
    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. If you are requesting a 
copy, 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 does not endorse or support 
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 teleconference 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), 
[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].


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.
    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. How To Submit Technical Comments to the Docket at 

    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 online 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) 
     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 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, 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

[[Page 46222]]

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: August 4, 2006.
P.W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. E6-13205 Filed 8-10-06; 8:45 am]