FSMA's Intentional Adulteration Rule: Mitigation Strategies Protect Consumers And Your Brand

By Edwin VelezRivera, director of food safety, Registrar Corp

On May 27, 2016, the FDA finalized the last of its seven foundational rules under FSMA. Titled “Mitigation Strategies to Protect Food Against Intentional Adulteration,” the rule is commonly referred to by industry as the “Food Defense” or the “Intentional Adulteration” rule. Published in the Federal Register last month, this rule imposes new requirements concerning food defense on many FDA-registered food facilities, both here in the U.S. and abroad.

The Intentional Adulteration rule (21 CFR Part 121) requires certain FDA-registered food facilities to prepare, or have prepared, and implement a written Food Defense Plan. The written Food Defense Plan must contain three main elements: a vulnerability assessment, mitigation strategies, and mitigation strategy management components. These requirements are the minimum measures necessary to provide assurances that hazards that relate to intentional adulteration intended to cause wide-scale public health harm will be significantly minimized or prevented.