Document ID: EPA-HQ-ORD-2008-0547-0001
Agency: epa
Document Type: Notice
Title: Draft Problem Formulation for Human Health Risk Assessments of Pathogens in Land-Applied Biosolids
Posted Date: 2008-09-19T04:00Z

[Federal Register: September 19, 2008 (Volume 73, Number 183)]
[Notices]               
[Page 54400-54401]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se08-53]                         

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8717-4; Docket ID No. EPA-HQ-ORD-2008-0547]

 
Draft Problem Formulation for Human Health Risk Assessments of 
Pathogens in Land-Applied Biosolids

AGENCY: Environmental Protection Agency (U.S. EPA).

ACTION: Notice of Public Comment Period and External Peer-Review 
Workshop.

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SUMMARY: The U.S. EPA is announcing the release of a pre-dissemination, 
external review draft titled, ``Problem Formulation for Human Health 
Risk Assessments of Pathogens in Land-applied Biosolids'' (EPA/600/R-
08/035A), for both public comment and external peer review. The public 
comment period will span 45 days. Eastern Research Group (ERG), under 
contract with EPA, will convene an independent panel of experts and 
organize and conduct an external peer-review workshop to review the 
draft document. Both the U.S. EPA and ERG invite the public to register 
to attend this workshop. Additional information regarding both 
submissions and registration is provided in the remainder of the 
document.
    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. In addition to consideration by 
EPA, all public comments submitted in accordance with this notice will 
also be forwarded to the external peer-review panel for review prior to 
the workshop.
    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.

DATES: The 45-day public comment period will begin September 19, 2008 
and end November 3, 2008. Technical comments should be provided in 
writing and must be received by the U.S. EPA by November 3, 2008. 
Comments received after this date will only be considered if time 
permits and might not be included for discussion at the external peer-
review workshop. The external peer-review workshop will be held on 
November 19, 2008, starting at 8:30 a.m. and adjourning by 5 p.m.

ADDRESSES: The external peer-review workshop will be held at U.S. EPA's 
Andrew W. Briedenbach Environmental Research Center (AWBERC), Rooms 
120-126, 26 W. Martin Luther King Drive, Cincinnati, Ohio 45268. ERG is 
organizing, convening, and conducting the peer-review workshop. 
Registration to attend the external review workshop must be completed 
prior to November 12, 2008, via one of the following methods:
     Online via the Internet--https://www2.ergweb.com/projects/
conferences/peerreview/register-biosolids.htm
     Telephone--781-674-7374 (registration line).
     Sending an e-mail to meetings@erg.com, subject line 
``Biosolid Peer Review.'' When making reservations to attend the 
external peer-review workshop, individuals must indicate whether they 
plan to provide brief oral comments to the external review panel. Space 
is limited, and reservations will be accepted on a first-come, first-
served basis.
    Electronic copies of the external review draft document and the 
U.S. EPA Peer-Review Charge can be accessed at that National Center for 
Environmental Assessment (NCEA)'s homepage under the ``Recent 
Additions'' and the ``Data and Publications'' menus at http://
www.epa.gov/ncea. Copies are not available from ERG.
    Comments may be submitted electronically via http://
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 about the public comment 
period can be directed to the OEI Docket Center (telephone--202-566-
1752; Fax: 202-566-1753; or e-mail_ORD.Docket@epa.gov).
    Questions about the external peer-review workshop can be directed 
to ERG, through Kate Schalk (telephone--781-674-7374, or e-mail_
Kate.Schalk@erg.com).
    Questions about the draft document can be directed to Michael 
Troyer, NCEA, U.S. EPA, 26 W. Martin Luther King Drive, Cincinnati, OH 
45268, Telephone--513-569-7399; or e-mail_troyer.michael@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Information About the Document

    In January 2004, the U.S. EPA released a final Action Plan for 
setting new priorities for the biosolids program, which included the 
Agency's response to the National Research Council's 2002 report 
entitled, Biosolids Applied to Land: Advancing Standards and Practice. 
This current, external review draft document is an important step in 
the Agency's response because it aims to improve problem formulation 
and strengthen the analysis plans associated with the conduct of 
quantitative microbial risk assessments on land-applied biosolids.

II. How To Submit Technical Comments to the Docket at 
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD 2008-
0547, by one of the following methods:
     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; or
     Hand Delivery--The OEI Docket is located in the EPA 
Headquarters Docket Center, EPA West Building, Room 3334, 1301 
Constitution Ave., NW., Washington, DC. The OEI Docket Center Public 
Reading Room is open from 8:30

[[Page 54401]]

a.m. to 4:30 p.m., Monday through Friday, excluding national holidays.
    The OEI Docket Center telephone number is 202-566-1744. Special 
arrangements should be made for deliveries of boxed information.
    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-
2008-0547. 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 http://www.regulations.gov or e-
mail. The http://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 e-mail comment directly to EPA without going through http://
www.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 http://www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the http://
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 OEI Docket in the EPA 
Headquarters Docket Center.

    Dated: September 11, 2008.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. E8-21959 Filed 9-18-08; 8:45 am]

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