Document ID: EPA-HQ-ORD-2013-0680-0001
Agency: epa
Document Type: Notice
Title: Next Generation Risk Assessments: Incorporation of Recent Advances in Molecular, Computational, and Systems Biology; External Review Draft
Posted Date: 2013-09-30T04:00Z

[Federal Register Volume 78, Number 189 (Monday, September 30, 2013)]
[Notices]
[Pages 59927-59929]
From the Federal Register Online via the Government Printing 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

[[Page 59928]]

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: boyd.marieka@epa.gov. 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: 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 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: 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 comment. Electronic 
files should avoid the use of special characters, any form

[[Page 59929]]

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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