21 CFR Part 121 - Mitigation Strategies to Protect Food Against Intentional Adulteration

What it says

Covered food facilities must prepare and implement a written food defense plan, developed by a Food Defense Qualified Individual, that includes a vulnerability assessment to identify actionable process steps, mitigation strategies for those steps, and procedures for monitoring, corrective actions and verification, aimed at acts intended to cause wide-scale public health harm. Exemptions apply, including for very small businesses.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The rule focuses on intentional acts intended to cause wide-scale harm, such as those by an attacker or insider, and is separate from economically motivated adulteration, which is addressed through the hazard analysis in Part 117.
• The vulnerability assessment looks at each point, step or procedure in the process and ranks the ones most vulnerable.
• Mitigation strategies are then applied at those actionable process steps, such as access controls.

What FDA inspectors look for

• Whether a food defense plan exists and was prepared by a qualified individual.
• Whether the vulnerability assessment covers the facility's processes and justifies its conclusions.
• Whether mitigation strategies are in place and monitored at the actionable process steps.

Related regulations