[Federal Register Volume 78, Number 189 (Monday, September 30, 2013)]
[Notices]
[Pages 59927-59929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23679]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-9901-49-ORD; Docket ID No. EPA-HQ-ORD-2013-0680]
Next Generation Risk Assessment: Incorporation of Recent Advances
in Molecular, Computational, and Systems Biology [External Review
Draft]
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of public comment period and external peer review.
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SUMMARY: EPA is announcing a 45-day public comment period for the draft
document titled, ``Next Generation Risk Assessment: Incorporation of
Recent Advances in Molecular, Computational, and Systems Biology
[External Review Draft]'' (EPA/600/R-13/214A). EPA is also announcing
that Eastern Research Group, Inc., an EPA contractor, will select a
group of external experts to conduct an external peer review of the
draft document. The document was prepared by the National Center for
Environmental Assessment within
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EPA's Office of Research and Development (ORD) as part of the Agency's
Chemical Safety for Sustainability Research Program.
EPA is releasing this draft document for the purposes of public
comment and external peer review. This draft document 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. The public comment period and the external peer review are
separate processes that provide opportunities for all interested
parties to comment on the document. When finalizing the draft document,
EPA intends to consider the external peer reviewer's comments and any
public comments that EPA receives in accordance with this notice.
The draft document and EPA's peer review charge are available via
the Internet on the NCEA home page under the Recent Additions and the
Data and Publications menus at http://www.epa.gov/ncea.
DATES: The 45-day public comment period begins September 30, 2013, and
ends November 14, 2013. Technical comments should be in writing and
must be received by EPA by November 14, 2013.
ADDRESSES: The draft ``Next Generation Risk Assessment: Incorporation
of Recent Advances in Molecular, Computational, and Systems Biology
[External Review Draft]'' is available primarily via the Internet on
the NCEA home page under the Recent Additions and the Data and
Publications menus at http://www.epa.gov/ncea. A limited number of
paper copies will be available from Ms. Marieka Boyd by phone: 919-541-
0031; fax: 919-541-5078; or email: [email protected]. If you are
requesting a paper copy, please provide your name, your mailing
address, and the document title, ``Next Generation Risk Assessment:
Incorporation of Recent Advances in Molecular, Computational, and
Systems Biology [External Review Draft]'' (EPA/600/R-13/214A) to
facilitate processing of your request.
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 ORD Docket at the EPA Headquarters Docket Center;
telephone: 202-566-1752; facsimile: 202-566-9744; or email: [email protected].
For technical information, contact Dr. Lyle Burgoon, NCEA;
telephone: 919-541-7808; facsimile: 919-685-3473; or email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Information About the Project/Document
The Next Generation (NexGen) Risk Assessment project was initiated
in 2010 as a multi-year, multi-organization effort to consider new
molecular, computational, and systems biology approaches for use in
risk assessments. The specific aims of the NexGen effort, described in
this draft report, are to: (1) Demonstrate proof of concept that the
data and methods from recent advances in biology can inform risk
assessment; (2) identify which of the information resources and
practices are most useful for particular purposes (value of
information); (3) develop decision considerations for use of different
types of NexGen data and methods to inform different types of
assessments; and (4) identify priority research needs.
The ``Next Generation Risk Assessment: Incorporation of Recent
Advances in Molecular, Computational, and Systems Biology [External
Review Draft]'' presents the results and lessons learned from the
prototypes/case studies for use of molecular, computational, and
systems biology data in risk assessment. The prototype results
demonstrated proof of concept for an integrated approach to
incorporating molecular, computational, and systems biology data in
risk assessment and considered various data types for specific
assessment purposes. The lessons learned from this project suggested
research needs and near- and longer-term implications of incorporating
molecular, computational, and systems biology data in risk assessment.
II. How to Submit Technical Comments to the Docket at
www.regulations.gov
Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2013-
0680, by one of the following methods:
www.regulations.gov: Follow the on-line instructions for
submitting comments.
Email: [email protected].
Fax: 202-566-9744.
Mail: U.S. Environmental Protection Agency, EPA Docket
Center (ORD Docket), (Mail Code: 28221T), 1200 Pennsylvania Avenue NW.,
Washington, DC 20460. The phone 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 ORD Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Avenue NW., Washington, DC. The EPA Docket Center's 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-
2013-0680. 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 email. 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 email comment
directly to EPA without going through www.regulations.gov, your email
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
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of encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center home
page 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 ORD Docket
in the EPA Headquarters Docket Center.
Dated: September 19, 2013.
Debra B. Walsh,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2013-23679 Filed 9-27-13; 8:45 am]
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