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Microbial Risk Assessment Guideline: Pathogenic Microorganisms with Focus on Food and Water
Risk Assessment Forum
Federal Register Notices
Scientists from the Environmental Protection Agency (EPA), U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) and joined by scientists from other federal agencies developed the Guideline for Microbial Risk Assessment: Pathogenic Microorganisms with Focus on Food and Water (231 pp, 1.24Mb, About PDF). This document provides a common framework to perform microbial risk assessment (MRA). It lays out a flexible set of approaches, methods, and tools for use to conduct their microbial risk assessment and provide more transparency to the process and results. This guideline addresses issues specific to microbial risk, e.g., secondary transmission, immune status, and growth and die-off of organisms, as well as addressing concepts generic to classical chemical risk assessment.
When used by participating agencies, this product will promote greater consistency in the way that participating agencies conduct their assessments and provide more transparency.
The link to the Guideline for Microbial Risk Assessment: Pathogenic Microorganisms with Focus on Food and Water may also be found on the USDA’s FSIS website.
Related Links
Microbial Risk Assessment Guideline: Pathogenic Microorganisms with Focus on Food and Water (External Review Draft) (217 pp, 2.37Mb, About PDF). This is the draft document that was reviewed by the peer review panel.
Guideline for Microbial Risk Assessment: Pathogenic Microorganisms with Focus on Food and Water (182 pp, 1Mb, About PDF). This is the report issued by the peer review panel.
Response to Peer Review Comments of the External Review Draft of the Microbial Risk Assessment Guideline: Pathogenic Microorganisms with Focus on Food and Water (30 pp, 986 KB, About PDF). This document lists the changes that were made to the MRA Guideline in response to the peer review report.
Supporting Materials
MRA Framework: The first step in development of risk assessment guidance is often the creation of an organizing framework. EPA's Office of Water working with the International Life Sciences Institute, ILSI, developed a framework. This framework is currently in use by EPA and others and is available here (27 pp, 619KB, About PDF)
The EPA Risk Assessment Forum panel identified the need to look at all available frameworks and conduct a comparison. A paper on the topic was commissioned and is available below.
Thesaurus The Office of Water also developed, with assistance of a contractor, a comprehensive Thesaurus for microbial risks.
Frameworks Comparison: The Microbial Risk Assessment Frameworks, Principles and Approaches*(147 pp, 596 Kb, About PDF) document was produced under a contract to the EPA by Dr. Rebecca Parkin, George Washington University School of Public Health and Health Services, and Environmental Research Group.
Approaches for conducting MRA are rapidly evolving for decision-making about microbial pathogen-related health risks. The purposes of this paper was to identify the similarities and differences of current MRA frameworks, describe key scientific challenges, compare diverse applications of the frameworks, and provide insight for development of guidance for conducting MRA. Online searches and contacts with experts were used to identify current frameworks and completed MRAs. The scope of the search was worldwide, but the comparison of applications was limited to government-sponsored MRAs.
Workshop on Challenges to Integrating Immunotoxicological and Microbial Risk Assessment for Susceptible Populations and Life Stages, and Real World Application of Microbial Risk Assessment Methods (30 pp, 157KB, About PDF).
The EPA Risk Assessment Forum (RAF) convened a workshop of Agency, interagency and invited experts to address the intersection of human life stages, immunotoxicity impacts, and microbial disease susceptibility.
The workshop was held on February 12-13, 2007 at the Crystal City Marriott in Arlington, Virginia. A wrap-up session was held on March 20, 2007 in Washington, D.C., to identify lessons learned and next steps.