A HACCP plan is a form of process and risk control (Buchanan and Whiting, 1998). Traditional HACCP plans do not quantify the influence of multiple control points and their variations or attempt to link a critical control point to a measurable impact on public health. Each critical control point is usually evaluated separately from the other processing steps and critical control points.

The risk assessment provides the underlying support for a HACCP plan by quantitatively determining the degree of control an entire process and each individual process operation contributes to the safety of the food (Buchanan and Whiting, 1998; Serra et al., 1999). Establishing an acceptable or tolerable level of risk for a food is a social and value decision, not a scientific decision. The tolerable level of risk is not necessarily constant for different pathogens or foods. The severity of disease (Listeria vs. Salmonella), the susceptibility of various subpopulations (children for E. coli 0157:H7), and established customs (raw oysters, sunny-side up fried eggs) affect the level of risk that is acceptable to the consumer. The dose-response relationship can establish the amount and frequency of pathogen consumption that achieves a tolerable level of risk (ICMSF, 1998). This amount and frequency is termed the food safety objective. The risk assessment, in consultation with risk management, will evaluate the entire process from raw ingredients to consumption and establish a series of process steps that meet the food safety objective. The risk managers will then select the specific process to be used, also taking into consideration quality, cost, and feasibility (Morales and McDowell, 1998). The selected process risk assessment specifies what each step will achieve, for example, 7 log10 units of inactivation or less than 1 log10 unit growth. These are termed performance criteria. Similar to the entire process, there may be multiple means to achieve a specific performance criterion. Many time-temperature combinations, for example, can result in the 7 logi0 units of inactivation. The selection of the specific combination will again be based on quality, cost, engineering, and other criteria. The specific combination selected is termed the process criteria and becomes the critical control points. Thus the exposure assessment tied to an accepted food safety objective provides the mechanism to create a HACCP plan. Even without designating an acceptable level of risk, the exposure assessment can determine the equivalence of different processes. This principle of equivalence and the use of risk assessment to compare the safety of different food processes will only become more important in national and international food trade (ICMSF, 1998; Lupien and Kenny, 1998).

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