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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 (EPA).


Notice of availability.


EPA is announcing the availability of a final report titled, “Problem Formulation for Human Health Risk Assessments of Pathogens in Land-Applied Biosolids” EPA/600/R-08/035F, which was prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development (ORD).


This document will be available on or about May 26, 2011.


The document will be available electronically through the NCEA Web site at​ncea. A limited number of paper copies will be available from the EPA's National Service Center for Environmental Publications (NSCEP), P.O. Box 42419, Cincinnati, OH 45242; telephone: 1-800-490-9198; facsimile: 301-604-3408; e-mail: Please provide your name, your mailing address, the title and the EPA number of the requested publication.

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The Information Management Team, National Center for Environmental Assessment (8601P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Telephone: 703-347-8561; fax: 703-347-8691; e-mail:

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This document may be useful to Federal, State or local risk assessors and managers, contractors, or other parties interested in conducting microbial risk assessments on land-applied biosolids. In particular, this document provides concepts and planning considerations for conducting human health risk assessments on potential pathogens in land-applied biosolids. The document does not represent guidance, nor does it constitute a risk assessment for pathogens in land-applied biosolids. As one component of U.S. EPA's action plan for its biosolids program (​ncea/​cfm/​recordisplay.cfm?​deid=​231964), this document summarizes the existing literature; defines critical pathogen stressors; develops conceptual models linking the most likely stressors, pathways and health responses of concern; evaluates the overall quality and utility of available risk assessment data; highlights existing tools and methodologies; and provides an outline of an Analysis Plan that identifies gaps in knowledge and research and methods needed to provide more scientifically defensible assessments relevant to U.S. EPA's decision needs. The document has been updated and revised by EPA based on comments received from the public and an independent, external panel of scientific experts (73 FR 54400).

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Dated: May 18, 2011.

Darrell A. Winner,

Acting Director, National Center for Environmental Assessment.

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[FR Doc. 2011-13106 Filed 5-25-11; 8:45 am]