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

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Information about this document as published in the Federal Register.

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Environmental Protection Agency (U.S. EPA).


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


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.


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.


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:

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​ncea. Copies are not available from ERG.

Comments may be submitted electronically via, by mail, by facsimile, or by hand delivery/courier. Please follow the detailed instructions as provided in the SUPPLEMENTARY INFORMATION section of this notice.

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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—

Questions about the external peer-review workshop can be directed to ERG, through Kate Schalk (telephone—781-674-7374, or e-mail—

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—

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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

Submit your comments, identified by Docket ID No. EPA-HQ-ORD 2008-0547, by one of the following methods:

  • E-mail—;
  • 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 Start Printed Page 54401a.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, 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 or e-mail. The 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, 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​epahome/​dockets.htm.

Docket: Documents in the docket are listed in the 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 or in hard copy at the OEI Docket in the EPA Headquarters Docket Center.

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Dated: September 11, 2008.

Rebecca Clark,

Acting Director, National Center for Environmental Assessment.

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[FR Doc. E8-21959 Filed 9-18-08; 8:45 am]