On May 27 FDA issued the last of the seven major rules under the Food Safety Modernization Act entitled Mitigation Strategies to Protect Food Against Intentional Adulteration, otherwise known as the Food Defense Rule. The rule will cover approximately 9,800 food facilities and is estimated to cost as much as $930 million to implement in the first year.
The rule requires covered facilities to create and maintain written food defense plans. The plans must identify vulnerabilities, actionable process steps (places where contamination could occur), mitigation strategies, procedures for food monitoring, corrective actions and verification. Food defense plans must be reanalyzed every three years.