Increased awareness of the scope and magnitude of foodborne disease, as well as the emergence of
previously unrecognized human pathogens, have prompted regulatory officials to consider new and improved
strategies to reduce the health risks associated with pathogenic microorganisms in foods. While regulatory
decisions regarding the management of foodborne disease risk have always been made with the aid of the
scientific community, the development of formal risk analyses provides a conceptual and transparent
framework for evaluating the public health benefits associated with the selection of various policy options.
The risk analysis paradigm includes three elements—risk assessment, risk management, and risk
communication—and allows regulatory officials to focus finite resources on those hazards that pose
the greatest risk to public health.
Risk assessment is a scientifically based process of evaluating hazards and the likelihood of exposure to
those hazards, and then estimating the resulting public health impact. It provides a scientific framework
for understanding the impact of a wide variety of variables by considering several key questions, such as:
- What are the factors that result in risk to the public's health?
- What is the likelihood of harm?
- How much harm could occur?
- How much can that harm be reduced by various intervention strategies?
Risk assessments may be qualitative, semi-quantitative, or quantitative. Qualitative assessments usually
identify a high, medium, or low level of risk. Semi-quantitative assessments may be used to prioritize
risks in relation to one another. Quantitative assessments are often used to identify and evaluate food
safety control points or estimate the benefits of various intervention strategies.
Each risk assessment has four parts, as widely recognized in the international scientific and regulatory
risk assessment communities and by such authoritative bodies as the National Academy of Sciences and the
Codex Alimentarius Commission. First, risk assessors and risk managers must clarify the public health
hazard that is the subject of the assessment and any possible policy options that are under consideration.
Next, the risk assessors must evaluate the adverse health effects caused by the public health hazard.
Then, an exposure assessment must be conducted to estimate the likelihood that the hazard will be present
in food, and if present, at what level. Next, a dose-response model is constructed to figure out at what
dose or concentration that hazard will cause illness or death.
In the final step of the risk assessment, known as risk characterization, all of the information gathered
during the risk assessment process is integrated to show who is at greatest risk, which variables contribute
most to the risk of foodborne illness, and which intervention strategies would lead to the greatest
reduction of risk.
FSIS has completed several risk assessments, including
those for Salmonella Enteritidis in eggs, E. coli O157:H7 in ground beef, and
Listeria monocytogenes in ready-to-eat meat and poultry products. FSIS contracted with Harvard
University's School of Public Health for a risk assessment on bovine spongiform encephalopathy (BSE).
In addition, USDA recently established a food safety risk assessment committee to enhance coordination and
communication among various USDA agencies as they plan and conduct activities related to risk assessments.
The committee will utilize the agencies' combined expertise, allowing USDA to focus its resources on those
hazards that pose the greatest risk to public health.
The risk management phase involves using all of the information gathered during the assessment to evaluate
policy options. Risk managers consider the results of the risk assessment in the context of other policy
considerations such as cost, feasibility, and the social impact of implementing certain policies. This phase
identifies, selects, and implements measures that can be applied to reduce the risk identified during the
Risk communication not only refers to communicating the results of the risk analysis to the general public,
but also to the ongoing communication among risk assessors, managers, scientists, regulators, and various
stakeholders during the entire process. Risk assessors and managers must communicate in order to ensure
that all affected parties fully understand the process of and information generated by the risk analysis.
Last Modified: July 2003