Document ID: EPA-HQ-ORD-2013-0680-0004
Agency: epa
Document Type: Notice
Title: Next Generation Risk Assessment: Incorporation of Recent Advances in Molecular, Computational, and Systems Biology; External Review Draft; Extension of Comment Period
Posted Date: 2013-11-13T05:00Z

[Federal Register Volume 78, Number 219 (Wednesday, November 13, 2013)]
[Notices]
[Pages 68058-68060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27153]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9902-84-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 extension of public comment period to January 13, 
2014.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing 
an extension of the public comment period for 60 days 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). The original Federal 
Register notice announcing the public comment period was published on 
September 30, 2013. At the request of the American Chemistry Council, 
the public comment deadline is extended to January 13, 2014. The draft 
document explores how new molecular, computational, and systems biology 
data can better inform risk assessment. This draft document is 
available for public review and comment and is undergoing independent 
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

[[Page 68059]]

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 reviewers' comments and any 
public comments that EPA receives in accordance with this notice.

DATES: The public comment period began on September 30, 2013, and is 
being extended to end on January 13, 2014. Technical comments should be 
in writing and must be received by EPA by January 13, 2014.

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 www.epa.gov/ncea. A limited number of CD-ROM 
copies will be available from Ms. Marieka Boyd by phone: 919-541-0031; 
fax: 919-541-5078; or email: boyd.marieka@epa.gov. If you are 
requesting a CD-ROM 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: Docket_ORD@epa.gov. For technical information, contact Dr. Lyle Burgoon, NCEA; 
telephone: 919-541-7808; facsimile: 919-685-3473; or email: 
burgoon.lyle@epa.gov.

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 document, 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. Extension of Comment Period

    The EPA is extending the deadline for submitting comments on the 
draft document ``Next Generation Risk Assessment: Incorporation of 
Recent Advances in Molecular, Computational, and Systems Biology 
[External Review Draft]'' to January 13, 2014. The original deadline 
for comments was November 14, 2013. EPA's decision responds to a 
request from the American Chemistry Council to extend the comment 
deadline. The EPA believes that this extension will assist in providing 
an adequate amount of additional time for the public to review the 
draft document and to provide written 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-2013-
0680, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for 
submitting comments.
     Email: Docket_ORD@epa.gov.
     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

[[Page 68060]]

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 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: November 5, 2013.
Debra B. Walsh,
Acting Deputy Director, National Center for Environmental Assessment.
[FR Doc. 2013-27153 Filed 11-12-13; 8:45 am]
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