The Intentional Adulteration (IA) rule
The Intentional Adulteration Rule is part of a suite of food safety regulations introduced in the USA during the previous decade as part of the Food Safety Modernization Act (FSMA). The IA rule, as it is known, applies to businesses within the United States and businesses that export food to the United States.
The Intentional Adulteration (IA) rule requires food businesses to:
- identify vulnerable parts of their food manufacturing processes,
- implement strategies to reduce the vulnerabilities,
- monitor and verify that those strategies are working, and
- keep records to show that these activities have been done.
The vulnerability assessment requirements are probably the most difficult part of the IA rule to perform and implement correctly. The US FDA has published draft guidance to help food businesses perform vulnerability assessments, however, the guidance document is 159 pages long and quite a complex document.
Introducing our new Vulnerability Assessment Tool
Food Fraud Advisors’ sister company AuthenticFoodCo has developed the Intentional Adulteration Vulnerability Assessment Tool to help food businesses perform and document a food defense vulnerability assessment. The tool identifies vulnerabilities to intentional adulteration, which is the deliberate contamination of food with a biological, chemical, radiological, or physical agent by an individual or group of individuals with the intent to cause wide scale public health harm. (U.S. Food and Drug Administration (2019)).
A vulnerability assessment for intentional adulteration is part of a food defense plan, a set of documents that describes a food business’ decision-making processes and subsequent actions taken to prevent acts of intentional adulteration from occurring at their food facility(s).
Easy to use
- Based on methods recommended by the U.S. FDA
- Creates a complete vulnerability assessment for a food manufacturing process
- Includes templates for mitigation strategies documentation and fundamental elements calculations
- Bonus resources including lists of ideas for mitigation strategies and challenge tests
- Comprehensive definitions page and detailed instructions for use
- Designed to meet the requirements of US FSMA Intentional Adulteration Rule
- Suitable for food defense plans in GFSI systems
- Simple to review and update
See it in action
How it works
Using the process flow chart or list of operational steps for a food product, users list and choose a food operation type from a comprehensive drop-down list in the spreadsheet (you may add you own if needed). The tool helps the user to decide if the step is a vulnerable to intentional adulteration using both the key activity types method and the three fundamental elements method as described by the U.S. FDA in the document Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry, Revised Draft Guidance (March 2019). Click here to download a free sample (instant download, no email required).
When all the process steps have been addressed, the user may print or export the results if desired, or save the excel file in a secure location.