How FSMA Is Changing Hazard Analysis

By Omar Oyarzabal, Ph.D., University of Vermont Extension

Now that FSMA implementation has begun, there are several questions on what are the best approaches to develop risk-based food safety plans with preventive controls for compliance with these new regulations. Several terms have been clarified by FSMA, including the definition of a food facility. The actual definition of “hazard,” which is quite a technical definition, has also been expanded with these new regulations.

Sometimes, I hear the terms “hazard analysis” and “risk assessment” used interchangeably, as if they were synonyms. But they are not. In FSMA, the hazard analysis is defined as the “process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore must be addressed in the food safety plan.” Identifying the significant hazards requires identifying all known, or reasonably foreseeable, hazards and then evaluating the severity and the probability of these hazards occurring. In risk assessment, the hazard identification is a similar step, but the rest of the processes are different and include hazard characterization, exposure assessment, risk characterization, and sometimes dose-response assessment. In risk assessment, the output is risk characterization, which is not achievable by just doing hazard analysis.