This document addresses the entire risk assessment process from an introduction to terminology and roles of the participants to planning the risk assessment, identifying and characterizing the hazard, assessing how the size of an outbreak may be affected by the dose (exposure assessment) or how the severity of the disease may be affected by the pathogen and its response within the human host (dose-response assessment). The document describes the importance of addressing the routes of exposure, transport media, uncertainties and assumptions for exposure and the other components of the risk assessment paradigm when characterizing risk, and also provides information about microbial risk management and risk communication.

The goal of this document is to produce a more harmonized treatment of microbial risk assessment across participating federal agencies.