On December 20, 2013, the U.S. Food and Drug Administration published a proposed regulation to implement the food defense sections of the Food Safety Modernization Act. The rule requires domestic and foreign facilities registered with FDA under the Bioterrorism Act to write and implement a food defense plan. There are a number of exemptions contained in the rule including those for food holding activities (except in liquid storage tanks) and activities subject to the Produce Safety Rule. In addition animal food is not covered under the rule.
The food defense plan must include:
- Identification of actionable process steps
- Focused mitigation strategies
- Procedures for monitoring
- Corrective action procedures
- Verification procedures
A presentation by Erik Lieberman on the proposed regulation may be found below:
