News Feature | March 10, 2015

The FDA's iRISK 2.0 Is Helping Make Food-Safety Compliance Easier

By Laurel Maloy, contributing writer, Food Online


A free tool provided by the FDA, the recently-upgraded iRISK 2.0 is helping users to perform measurable risk assessments of processes and procedures. It is designed to simplify and clarify the process of drafting of food-safety and food-defense plans.

Originally launched in 2012, this web-based, risk-assessment system has been enhanced with more user-friendly interfaces, modeling methodologies, data sharing, and data-reporting capabilities. The application can be downloaded here. On this page you may also access the Quick Start Tutorial and the User Guide, as well as a list of the changes made since the first version, iRISK 1.0. For a closer look at this application, to include the broader picture and the user’s role, the FDA has prepared a PDF to help you assess the value of this tool within in your own facility.

In conjunction with the release of the Food and Drug Administration’s (FDA’s) iRISK 2.0, the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) will also host a free webinar. JIFSAN will highlight the key features during its event, scheduled for Wednesday, March 11, from 11:00 am to 12:00 pm EDT. Though the event is free, registration is required and can be accomplished here. In the event you miss the registration deadline, you can visit to view the related enhancements and documents immediately following the webinar.

This comparative risk-assessment tool is proving to be valuable to the food-processing industry. Its value is illustrated in relevant case studies on microbial hazards extrapolated from FDA-iRISK and published in this peer-reviewed journal article. To also help you determine if iRISK 2.0 is the tool for you, you can take a look at the previous version here and now.  iRISK 2.0 will not be available until immediately after the JIFSAN webinar.

As an iRISK 2.0 user, you will be able to compare risks and actually predict how effective the preventive and control measures you put in place will be. Its new and improved features include:

  • The ability to more-quickly advance alternative scenarios
  • Graphical illustrations designed to enable users to more-clearly understand and verify the data
  • The capability to share data with other users, more-easily and quickly
  • Access to progressive-modeling methods not previously available
  • Choices on how best to productively report your results

The iRISK platform is designed to be a tool which the food-processing industry can evaluate the effectiveness of its food-safety plans. Under the Food Safety Modernization Act (FSMA), all facilities are required to have in place a food-safety plan. If not already in use, you may want to introduce your Hazard Analysis and Critical Control Points (HACCP) or Hazard Analysis and Risk-Based Preventive Control (HARPC) teams to this web-based tool. With this application, the FDA is making compliance easier, for free.