Regulatory programs and guidelines for the control of foodborne microb
ial agents have existed in the U.S. for nearly 100 years. However, inc
reased awareness of the scope and magnitude of foodborne disease, as w
ell as the emergence of previously unrecognized human pathogens transm
itted via the foodborne route, have prompted regulatory officials to c
onsider new and improved strategies to reduce the health risks associa
ted with pathogenic microorganisms in foods. Implementation of these p
roposed strategies will involve definitive costs for a finite level of
risk reduction. While regulatory decisions regarding the management o
f foodborne disease risk have traditionally been done with the aid of
the scientific community, a formal conceptual framework for the evalua
tion of health risks from pathogenic microorganisms in foods is warran
ted. Quantitative risk assessment (QRA), which is formally defined as
the technical assessment of the nature and magnitude of a risk caused
by a hazard, provides such a framework. Reproducing microorganisms in
foods present a particular challenge to QRA because both their introdu
ction and numbers may be affected by numerous factors within the food
chain, with all of these factors representing significant stages in fo
od production, handling, and consumption, in a farm-to-table type of a
pproach. The process of QRA entails four designated phases: (1) hazard
identification, (2) exposure assessment, (3) dose-response assessment
, and (4) risk characterization. Specific analytical tools are availab
le to accomplish the analyses required for each phase of the QRA. The
purpose of this paper is to provide a description of the conceptual fr
amework for quantitative microbial risk assessment within the standard
description provided by the National Academy of Sciences (NAS) paradi
gm. Each of the sequential steps in QRA are discussed in detail, provi
ding information on current applications, tools for conducting the ana
lyses, and methodological and/or data limitations to date. Conclusions
include a brief discussion of subsequent uncertainty and risk analysi
s methodologies, and a commentary on present and future applications o
f QRA in the management of the public health risks associated with the
presence of pathogenic microorganisms in the food supply.