[Federal Register Volume 71, Number 197 (Thursday, October 12, 2006)]
[Pages 60143-60144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16921]



[FRL-8230-7; Docket ID No. EPA-HQ-ORD-2006-0756]

Evaluation of the Carcinogenicity of Ethylene Oxide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Extension of Public Comment Period.


SUMMARY: EPA is announcing an extension of the public comment period 
for the draft document titled, ``Evaluation of the Carcinogenicity of 
Ethylene Oxide'' (EPA/635/R-06/003). The document was prepared by the 
National Center for Environmental Assessment within EPA's Office of 
Research and Development. On September 22, EPA published a Federal 
Register notice (71 FR 55470) announcing a 30-day comment period that 
ends October 23, 2007. EPA is extending the public comment period to 
December 8, 2006, in response to requests.
    As previously stated in 71 FR 55470, EPA is releasing this draft 
document solely for the purpose of seeking public comment and for 
review by the EPA Science Advisory Board (SAB) via a meeting to be held 
at a later date (time and place to be specified in a separate Federal 
Register notice). This document has not been formally disseminated by 
EPA. It does not determination. EPA will consider any public comments 
submitted in accordance with this notice when revising the document.

DATES: The public comment period began September 22, 2006, and ends 
December 8, 2006. Technical comments should be in writing and must be 
received by EPA by December 8, 2006.

ADDRESSES: The draft ``Evaluation of the Carcinogenicity of Ethylene 
Oxide'' is available primarily via the Internet on the National Center 
for Environmental Assessment's home page under the Recent Additions and 
the Data and Publications menus at http://www.epa.gov/ncea. A limited 
number of paper copies are available from the Technical Information 
Staff, NCEA-W; telephone: 202-564-3261; facsimile: 202-565-0050. If you 
are requesting a paper copy, please provide your name, your mailing 
address, and the document title, ``Evaluation of the Carcinogenicity of 
Ethylene Oxide''.
    Comments may be submitted electronically via 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: For information on the public comment 
period, contact the Office of Environmental Information Docket; 
telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail: 
[email protected].
    For technical information, contact Henry D. Kahn, D.Sc., NCEA; 
telephone: 202-564-3269; facsimile: 202-565-0079; or e-mail: 
[email protected].


I. Information About the Project/Document

    Ethylene oxide (EtO) is a gas at room temperature. It is 
manufactured from ethylene and used primarily as a chemical 
intermediate in the manufacture of ethylene glycol. It is also used as 
a sterilizing agent for medical equipment and as a fumigating agent for 
spices. The largest sources of human exposure are in occupations 
involving contact with the gas in production facilities and in 
hospitals that sterilize medical equipment. EtO can also be inhaled by 
residents living near production or sterilizing/fumigating facilities.
    This draft assessment document characterizes the potential for a 
carcinogenic health hazard from human inhalation exposure to EtO. This 
is accomplished by a weight-of-evidence evaluation as to how likely EtO 
is to be a human carcinogen, as well as an evaluation of related dose-
response information which leads to the development of lifetime cancer 
risk estimates per unit of exposure. This assessment, when finalized, 
will be posted to EPA's Integrated Risk Information System (IRIS) 
database. The document was prepared by EPA's National Center for 
Environmental Assessment (NCEA). EPA last published a health assessment 
of the potential carcinogenicity of EtO in 1985.
    The current assessment reviews the more recently developed database 
on the carcinogenicity of EtO, pertinent data from the 1985 assessment, 
and several reviews and assessments issued

[[Page 60144]]

by other organizations (IARC, 1994; Health Canada, 2001; CalEPA, 1999; 
EOIC, 2001).

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 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 2006-
0756 by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for 
submitting comments.
     E-mail: [email protected].
     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-
     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 submit 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-
2006-0756. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the closing date will 
be marked ``late,'' and may only be considered if time permits. It is 
EPA's policy to include all comments it receives in the public docket 
without change and to make the comments available online at 
www.regulations.gov, including any personal information provided, 
unless a 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 www.regulations.gov or e-mail. 
The 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 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: Documents in the docket are listed in the 
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 materials, 
such as copyrighted material, are publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in www.regulations.gov or in hard copy at the OEI Docket in the EPA 
Headquarters Docket Center.

    Dated: October 4, 2006.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. E6-16921 Filed 10-11-06; 8:45 am]