FDA-iRISK® is a web-based interactive risk assessment tool developed by the Human Foods Program in the U.S. Food and Drug Administration (FDA). FDA-iRISK version 5.0, now freely available, includes new and advanced features and enhancements. This food safety modeling tool enables users to conduct quantitative analyses on a wide range of food safety hazards, rank risks from both microbial and chemical hazards in foods, and compare the effectiveness of prevention and control measures, expressed as public-health metrics. Risk managers and other stakeholders can use FDA-iRISK to inform food safety priorities and risk management decisions.

FDA-iRISK has many built-in functions and automated features that allow users to conduct fully quantitative, fully probabilistic risk assessments relatively rapidly and efficiently. This peer-reviewed tool enables users to enter data and create scenarios that mathematically simulate food-hazard combinations and conditions at any point in the food chain, through to consumption, to reflect real-world food safety issues. By modifying the scenarios and data to reflect existing or possible changes in various practices in the food chain, users can evaluate the impact that interventions would be expected to have on consumer exposure and foodborne illness.

Since the initial launch of FDA-iRISK in 2012, FDA has continued to expand this innovative tool. FDA-iRISK provides a modeling framework with foundational features that enable users to explicitly assess and separate the effects of variability from those of uncertainty (by probabilistic second-order Monte Carlo simulation). It provides features that enable users to streamline sensitivity analysis parameterization, to report the proportion of food units exceeding a concentration threshold, and to combine scenarios from different repositories in a single risk ranking. FDA-iRISK 5.0 includes new features with which users can, for example, predict the effect of sampling from linkage to outputs from the FDA-OC App; import data from ComBase to predict the impact of pathogen growth and inactivation; correlate consumption across life stages for chronic chemical scenarios; utilize an expanded flexible approach to defining diets; and visualize intermediate estimates (e.g., prevalence and concentration), exposure estimates, and risk estimates. FDA-iRISK is made available to help promote risk-based thinking and risk-based approaches to food safety management.

For more information about FDA-iRISK 5.0, please see FDA's fact sheet for a general audience or a technical audience.

Quick Start Guide

User Guide

Peer-reviewed journal article on FDA-iRISK and case studies on microbial hazards

Peer-reviewd journal article on FDA-iRISK and rapid risk assessment

Peer-reviewd journal article on FDA-iRISK and modeling between-lot/within-lot variability   (supplemental materials)

FDA-iRISK Named a Central Component of EFSA's Risk-Ranking Toolbox