On December 24, 2013, the Food and Drug Administration (FDA or the Agency) published in the Federal Register a proposed rule entitled Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (“Proposed Rule”). The Proposed Rule requires domestic and foreign facilities that are required to register under the Federal Food, Drug and Cosmetic Act (FD&C Act) to address hazards that may be intentionally introduced by acts of terrorism. These food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. The Proposed Rule is being issued to implement the Food Safety Modernization Act (FSMA).

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