Document ID: EPA-HQ-ORD-2009-0243-0001
Agency: epa
Document Type: Notice
Title: An Approach To Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate (DBP) Case Study
Posted Date: 2009-05-20T04:00Z

[Federal Register: May 20, 2009 (Volume 74, Number 96)]
[Notices]               
[Page 23713-23715]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20my09-55]                         

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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).

[[Page 23714]]

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 meetings@erg.com (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 laurie.waite@erg.com. 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: ORD.Docket@epa.gov.
    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 
euling.susan@epa.gov.

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

[[Page 23715]]

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: ORD.Docket@epa.gov
     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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