[Federal Register Volume 74, Number 96 (Wednesday, May 20, 2009)]
[Notices]
[Pages 23713-23715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-11744]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-8907-9; Docket ID No. EPA-HQ-ORD-2009-0243]
An Approach To Using Toxicogenomic Data in U.S. EPA Human Health
Risk Assessments: A Dibutyl Phthalate (DBP) Case Study
AGENCY: Environmental Protection Agency (EPA).
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ACTION: Notice of peer-review workshop and public comment period.
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SUMMARY: EPA is announcing that Eastern Research Group, Inc., an EPA
contractor for external scientific peer review, will convene an
independent panel of experts and organize and conduct an external peer-
review workshop to review the external review draft document titled,
``An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk
Assessments: A Dibutyl Phthalate Case Study'' (EPA/600/R-09/028A). The
EPA also is announcing a 30-day public comment period for the draft
document. The draft document was prepared by the National Center for
Environmental Assessment (NCEA) within EPA's Office of Research and
Development. EPA is interested in developing methods to use genomic
data most effectively in risk assessments performed at the Agency. NCEA
developed this draft report for the purpose of describing an approach
to using toxicogenomic data in risk assessment and illustrating the
approach with a case study.
The public comment period and the external peer-review workshop are
separate processes that provide opportunities for all interested
parties to comment on the document. EPA intends to forward public
comments that are submitted in accordance with this notice to the
external peer-review panel prior to the meeting for their
consideration. When finalizing the draft document, EPA intends to
consider any public comments that EPA receives in accordance with this
notice.
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.
Eastern Research Group, Inc. invites the public to register to
attend this workshop as observers. In addition, Eastern Research Group,
Inc. invites the public to give oral and/or provide written comments at
the workshop regarding the draft document under review. The draft
document and EPA's peer-review charge are available primarily via the
Internet on NCEA's home page under the Recent Additions and the Data
and Publications menus at http://www.epa.gov/ncea. In preparing a final
report, EPA will consider any comments and recommendations from the
external peer-review workshop and any public comments that EPA receives
in accordance with this notice.
DATES: The peer-review panel workshop will begin on Tuesday, June 23,
2009, at 8:30 a.m. and end at 4:30 p.m. Observers must register by
Monday, June 15, 2009, and indicate if they wish to make brief oral
statements at the workshop. The 30-day public comment period begins May
20, 2009, and ends June 19, 2009. Technical comments should be in
writing and must be received by EPA by June 19, 2009.
ADDRESSES: The peer-review workshop will be held at Holiday Inn
Capitol, 550 C Street, SW., Washington, DC 20024. The EPA contractor,
Eastern Research Group, Inc., is organizing, convening, and conducting
the peer-review workshop. To attend the workshop as an observer,
register by Monday, June 15, 2009, via the Internet at https://www2.ergweb.com/projects/conferences/peerreview/register-TgX.htm. You
may also register by e-mail at [email protected] (subject line: TgX in
Risk Assessment Peer Review Workshop), by phone: 781-674-7374 or toll
free at 800-803-2833, or by faxing a registration request to 781-674-
2906 (please reference the ``TgX in Risk Assessment Peer Review
Workshop'' and include your name, title, affiliation, full address and
contact information).
The draft ``An Approach to Using Toxicogenomic Data in U.S. EPA
Human Health Risk Assessments: A Dibutyl Phthalate Case Study'' is
available primarily via the Internet on NCEA's Internet 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 Information Management Team, NCEA; telephone: 703-347-8561;
facsimile: 703-347-8691. If you are requesting a paper copy, please
provide your name, mailing address, and the document title, ``An
Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk
Assessments: A Dibutyl Phthalate Case Study''. Copies are not available
from Eastern Research Group, Inc. Comments may be submitted
electronically via www.regulations.gov, by mail, by facsimile, or by
hand delivery/courier. Please follow the detailed instructions as
provided in the SUPPLEMENTARY INFORMATION section of this notice.
FOR FURTHER INFORMATION CONTACT: Questions regarding information,
registration, access or services for individuals with disabilities, or
logistics for the external peer-review workshop should be directed to
Laurie Waite, Eastern Research Group, Inc., 110 Hartwell Ave.,
Lexington, MA 02421; telephone: 781-674-7362; facsimile 781-674-2906;
e-mail [email protected]. To request accommodation of a disability,
please contact Laurie Waite, preferably at least 10 days prior to the
workshop, to give as much time as possible to process your request.
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].
If you need technical information about the document, please
contact Susan Y. Euling, National Center for Environmental Assessment
(NCEA); telephone: 703-347-8575; facsimile: 703-347-8692; e-mail
[email protected].
SUPPLEMENTARY INFORMATION:
I. Summary of Information About the Project/Document
The National Center for Environmental Assessment (NCEA) prepared
this draft document for the purpose of describing an approach to using
toxicogenomic data in risk assessment and illustrating the approach
with a case study. The approach and case study described in this draft
report were developed by a team of scientists at EPA laboratories and
centers, and outside organizations including The Hamner Institute, the
National Institute for Environmental Health Sciences, and the EPA's
Science to Achieve Results (STAR) Bioinformatics Center at the
University of Medicine and Dentistry of New Jersey and Rutgers
University. The approach outlined is expected to be useful to risk
assessors in EPA, as well as other federal agencies, and the scientific
community at large. A case study to test the approach for dibutyl
phthalate (DBP) is described. The case study presented in this draft
document is a separate activity from any of the ongoing IRIS human
health assessments for the phthalates.
II. Workshop Information
Members of the public may attend the workshop as observers, and
there will be a limited time for comments from the public. Pre-
registration is strongly recommended as space is limited, and
registrations will be accepted on a first-come, first-served basis. The
deadline for pre-registration is June 15, 2009. If space allows,
registrations will continue to be accepted after this date, including
on-site registrations. Time will be set aside to hear comments from
observers, and individuals will be limited to a maximum of five minutes
during the morning session of peer review
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workshop. Please let ERG know if you wish to make comments during the
workshop by registering on the Web site at https://www2.ergweb.com/projects/conferences/peerreview/register-TgX.htm and indicating your
intent to make oral comments.
III. How to Submit Technical Comments to the Docket at
www.regulations.gov.
Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2009-
0243, 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-
566-1752.
Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, Room 3334 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 by mail or hand delivery, please submit
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-
2009-0243. 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
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 regulations.gov or e-mail. The
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 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 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 regulations.gov
or in hard copy at the OEI Docket in the EPA Headquarters Docket
Center.
Dated: May 13, 2009.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. E9-11744 Filed 5-19-09; 8:45 am]
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