Risk Ranking Framework Prototype to Evaluate Potential High
Threat Agents

Don Schaffner

Rutgers University

The IFT/FDA risk ranking framework or model was developed by an expert panel, coordinated by the Institute of Food Technologists.  The panel was composed of experts in microbial and chemical risk assessment, as well as industry and academic food scientists with expertise in microbiology and toxicology.  The funding for the project was primarily provided by the FDA, with funding for some of the modeling provided by the Rutgers Food Risk Analysis Initiative and IFT.  The primary purpose of the model is to provide the FDA with a flexible tool for ranking the relative risk of chemical and microbial hazards (primarily, but not exclusively those that are unintentional added) for all food products regulated by the agency.  The framework has been implemented on two separate and distinct platforms.  An internet browser accessible version was developed to permit storage of data in a central repository, and to allow a potentially large number of users to add data and generate reports.  An Analytica version of the model has also been developed to allow interested users to see a detailed explanation of the inner working of the model and calculations not possible over the web.  The model allows the user to input data by hazard (linking hazards to certain commodities) or by commodity (linking commodities to certain hazards).  Once a particular food and hazard are identified, the user then estimates the effect of various stages (primary production, processing, distribution and end user handling) on the prevalence and concentration of the risk.  The framework uses a concept called the Pseudo-DALY which allows the user to select from a variety of templates that aggregate impact based on duration and severity, or design their own template.  The framework allows for the selection of a variety of dose response models needed to capture the impact of microbial as well as chemical hazards and includes places for the user to document the rational and reference for any dose response used.  NHANES data are used to estimate consumption/exposure.  The framework allows the user to select from 4 different population groups (entire US, females 16-49 yrs, children 1-6 yrs and the elderly 65+ yrs).  The model generates reports which allow for grouping risk by hazard or food, sorting by rank or name, and the exclusion of foods hazard or combinations that are still in development.