FDA-iRISK® 4.2
A Comparative Risk-Assessment Tool
PUBLISHED ON Oct 4, 2012
LAST UPDATED Mar 30, 2021
Metadata Updated: March 30, 2021

FDA-iRISK® is a Web-based risk-assessment tool developed by the U.S. Food and Drug Administration (FDA). Version 4.2 is now available and includes a number of advanced features and enhancements. This food-safety modeling tool enables users to compare and rank risks from multiple microbial and chemical hazards and predict effectiveness of prevention and control measures, expressed as public-health metrics. Risk managers and other stakeholders can use FDA-iRISK to inform food-safety policy and management decisions.

FDA-iRISK has many built-in features that allow users to conduct fully quantitative, fully probabilistic risk assessments relatively rapidly and efficiently. This peer-reviewed tool enables users to build scenarios that mathematically simulate food-safety issues at any points in the food chain, up through consumption, to reflect real-world food safety issues. Users can assess the impact of interventions, for example, by varying their data to explore how changes in various practices in the food chain would be likely to affect public-health outcomes.

Since the initial launch of FDA-iRISK in 2012, FDA has continued to expand this innovative tool. Version 4.2 enables users to include second-order Monte Carlo simulation (to separate the effects of variability from those of uncertainty), incorporate predictive models (for microbial growth and inactivation), and access a range of features and enhancements (such as streamlined sensitivity analysis parameterization, more ways of reporting results, improved data importing and sharing, and greater ease of use). Users now also have the ability to report the proportion of contaminated servings that exceed a concentration threshold, and to combine scenarios from different repositories in a single risk ranking.

For more information about FDA-iRISK 4.2, 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

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