Currently, risk assessments of the potential human health effects asso
ciated with exposure to pathogens are utilizing the conceptual framewo
rk that was developed to assess risks associated with chemical exposur
es. However, the applicability of the chemical framework is problemati
c due to many issues that art: unique to assessing risks associated wi
th pathogens. These include, but are not limited to, an assessment of
pathogen/host interactions, consideration of secondary spread, conside
ration of short- and long-term immunity, and an assessment of conditio
ns that allow the microorganism to propagate. To address this concern,
a working group was convened to develop a conceptual framework to ass
ess the risks of human disease associated with exposure to pathogenic
microorganisms. The framework that was developed consists of three pha
ses: problem formulation, analysis (which includes characterization of
exposure and human health effects), and risk characterization. The fr
amework emphasizes the dynamic and iterative nature of the risk assess
ment process, and allows wide latitude for planning and conducting ris
k assessments in diverse situations, each based on the common principl
es discussed in the framework.