[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Pages 55470-55471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8054]



[FRL-8221-8; Docket ID No. EPA-HQ-ORD-2006-0756]

Evaluation of the Carcinogenicity of Ethylene Oxide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.


SUMMARY: EPA is announcing a 30-day 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 
    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 later in 2006 (time and place to be 
specified in a separate Federal Register notice). 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 30-day public comment period begins September 22, 2006, and 
ends October 23, 2006. Technical comments should be in writing and must 
be received by EPA by October 23, 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.'' Please provide your name, your mailing address, the 
title, and the EPA number of the requested publication.
    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 (U.S. EPA, 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 by other organizations 
(IARC, 1994; Health Canada, 2001; CalEPA, 1999; EOIC, 2001).

II. How To Submit Technical Comments to the Docket at 

    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, Room B102, 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

[[Page 55471]]

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 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: September 15, 2006.
George W. Alapas,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 06-8054 Filed 9-21-06; 8:45 am]