[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Notices]
[Pages 44117-44119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17675]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9836-4; Docket ID No. EPA-HQ-ORD-2006-0756]


Notice of a Public Comment Period on the Draft IRIS 
Carcinogenicity Assessment for Ethylene Oxide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

-----------------------------------------------------------------------

SUMMARY: EPA is announcing a 45-day public comment period on the draft 
IRIS assessment titled, ``Evaluation of the Inhalation Carcinogenicity 
of Ethylene Oxide'' (EPA/635/R-13/128a) and on the draft peer review 
charge questions. The draft assessment and draft peer review charge 
questions were prepared by the National Center for Environmental 
Assessment (NCEA) within the EPA Office of Research and Development 
(ORD). The 45-day public comment period on the draft Evaluation of the 
Inhalation Carcinogenicity of Ethylene Oxide and on the draft peer 
review charge questions begins on the day EPA posts the draft 
assessment and the draft peer review charge questions on the IRIS Web 
site and ends 45 days later. EPA anticipates posting the draft 
assessment and draft charge questions on or around July 23, 2013. 
Shortly after the draft carcinogenicity assessment is posted on the 
IRIS Web site, EPA will initiate a peer review of the draft assessment, 
which EPA anticipates will be undertaken by the Science Advisory Board. 
EPA is releasing this draft carcinogenicity assessment for the purpose 
of public comment. This draft assessment is not final, as described in 
EPA's information quality guidelines, and it does not represent and 
should not be construed to represent Agency policy or views.

DATES: The 45-day public comment period on the draft Evaluation of the 
Inhalation Carcinogenicity of Ethylene Oxide and on the draft peer 
review charge questions begins on the day EPA posts the draft 
assessment and the draft peer review charge questions on the IRIS Web 
site and ends 45 days later. The draft assessment and peer review 
charge questions will be posted to the IRIS Web site at http://www.epa.gov/IRIS. Comments should be in writing and received by EPA 
within 45 days after posting the draft carcinogenicity assessment and 
the draft peer review charge questions on the IRIS Web site. EPA 
anticipates posting the draft assessment and draft charge questions on 
or around July 23, 2013.

ADDRESSES: The draft IRIS carcinogenicity assessment titled, 
``Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide'' is 
available primarily via the Internet on the IRIS Web site at http://www.epa.gov/IRIS. A limited number of paper copies are available from 
the Information Management Team (Address: Information Management Team, 
National Center for Environmental

[[Page 44118]]

Assessment [Mail Code: 8601P], U.S. Environmental Protection Agency, 
1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone: 703-347-
8561; facsimile: 703-347-8691). If you request a paper copy, please 
provide your name, mailing address, and the draft assessment title. 
Comments may be submitted electronically via http://www.regulations.gov, by email, 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 draft 
assessment, please contact Jennifer Jinot, U.S. Environmental 
Protection Agency, National Center for Environmental Assessment, Mail 
Code 8623P, 1200 Pennsylvania Avenue NW., Washington, DC 20460; 
telephone: 703-347-8597; facsimile: 703-347-8690; or email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The draft IRIS assessment of the inhalation carcinogenicity of 
ethylene oxide was prepared by the National Center for Environmental 
Assessment (NCEA) within the EPA Office of Research and Development 
(ORD). The public has been provided an opportunity to comment on a 
previous external review draft of the Evaluation of the Inhalation 
Carcinogenicity of Ethylene Oxide. On September 22, 2006, EPA released 
an external review draft ``Evaluation of the Carcinogenicity of 
Ethylene Oxide'' (EPA/635/R-06/003) for public comment. This draft was 
reviewed by EPA's Science Advisory Board on January 18 and 19, 2007. 
The expert panel's final report, Review of the Office of Research and 
Development (ORD) Draft Assessment entitled, ``Evaluation of the 
Carcinogenicity of Ethylene Oxide'' (EPA-SAB-08-004), was made 
available on December 21, 2007.
    The draft IRIS carcinogenicity assessment titled, ``Evaluation of 
the Inhalation Carcinogenicity of Ethylene Oxide'' (EPA/635/R-13/128a) 
has been revised in response to the peer review and public comments 
received on the external review draft released in September 2006. This 
notice announces a new public comment period on the current revised 
draft carcinogenicity assessment in advance of an upcoming peer review 
and in accordance with applicable information quality guidelines. The 
external peer review comments and EPA responses on the previous draft 
assessment are summarized in Appendix H of the draft. EPA is releasing 
this revised draft assessment for the purposes of additional public 
comment and subsequent peer review. This draft assessment is not final, 
as described in EPA's information quality guidelines, and it does not 
represent and should not be construed to represent Agency policy or 
views.
    In addition to an opportunity for public comment announced in this 
notice, EPA will initiate a peer review of the draft IRIS 
carcinogenicity assessment and will announce the details of the peer 
review in a separate Federal Register Notice. EPA seeks additional 
external peer review on how the Agency responded to the SAB panel 
recommendations, the exposure-response modeling of epidemiologic data, 
including new analyses since the 2007 external peer review, and on the 
adequacy, transparency, and clarity of the revised draft. The peer 
review will include an opportunity for the public to address the peer 
reviewers. EPA will announce the date, time and procedures for public 
participation in the peer review meeting in a separate Federal Register 
Notice and in an announcement on the IRIS Web site.

II. Information About IRIS

    EPA's IRIS Program is a human health assessment program that 
evaluates quantitative and qualitative risk information on effects that 
may result from exposure to chemical substances found in the 
environment. Through the IRIS Program, EPA provides the highest quality 
science-based human health information for more than 550 chemical 
substances that can be used in human health risk assessments to support 
the Agency's regulatory activities and decisions to protect public 
health. When supported by available data, IRIS provides health effects 
information and toxicity values for chronic health effects (including 
cancer and effects other than cancer). Government agencies and others 
combine IRIS toxicity values with exposure information to characterize 
public health risks of chemical substances; this information is then 
used to support risk management decisions designed to protect public 
health.

III. How To Submit Comments to the Docket at http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2006-
0756, by one of the following methods:
     http://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     Email: [email protected].
     Facsimile: 202-566-9744.
     Mail: Office of Environmental Information (OEI) Docket 
(Mail Code: 28221T), U.S. Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460. The telephone number is 
202-566-1752. If you provide comments by mail, 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.
     Hand Delivery: The OEI Docket is located in the EPA 
Headquarters Docket Center, EPA West Building, Room 3334, 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. 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 
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 http://www.regulations.gov, including any personal information provided, 
unless comments include 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 email. The 
http://www.regulations.gov Web site is an ``anonymous access'' system, 
which means that EPA will not know your identity or contact information 
unless you provide it in the body of your comments. If you send email 
comments directly to EPA without going through http://www.regulations.gov, your email address will be automatically captured 
and included as part of the comments that are placed in the public 
docket and made available on the Internet. If you

[[Page 44119]]

submit electronic comments, EPA recommends that you include your name 
and other contact information in the body of your comments and with any 
disk or CD-ROM you submit. If EPA cannot read your comments due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comments. Electronic files should 
avoid the use of special characters and 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 
at http://www.regulations.gov or in hard copy at the OEI Docket in the 
EPA Headquarters Docket Center.

    Dated: July 15, 2013.
Abdel M. Kadry,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2013-17675 Filed 7-22-13; 8:45 am]
BILLING CODE 6560-50-P