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FSMA's Intentional Adulteration Rule (21 CFR 121) requires most large food facilities to have a written Food Defense Plan that identifies vulnerabilities and applies mitigation strategies against intentional contamination. We build the plan, run the vulnerability assessment, and document mitigation strategies for FDA inspection readiness.
What's Included:
Vulnerability assessment per FDA's Key Activity Types method
Identification of Actionable Process Steps (APS)
Mitigation strategy development for each APS
Food defense monitoring, corrective action, and verification procedures
Recordkeeping framework and reanalysis triggers
Who It's For:
Food facilities required to comply with the Intentional Adulteration Rule — generally facilities subject to FDA food facility registration that aren't categorized as "very small" (under $10M average annual sales). Very small businesses are exempt from full compliance but often choose to develop a plan voluntarily as best practice.
FAQs:
Q: How is this different from a HACCP Plan?
A: HACCP addresses unintentional hazards (microbial, chemical, physical). Food Defense addresses intentional contamination (sabotage, terrorism, insider threat). Both can be required for the same facility.
Q: Who at my company needs Food Defense training?
A: At minimum, your Food Defense Qualified Individual and any personnel working at Actionable Process Steps.
Q: Does the plan need to be updated periodically?
A: Yes — reanalysis is required every 3 years, after a significant change to your operation, or after a food defense incident. We include reanalysis triggers in the plan.
FSMA's Intentional Adulteration Rule (21 CFR 121) requires most large food facilities to have a written Food Defense Plan that identifies vulnerabilities and applies mitigation strategies against intentional contamination. We build the plan, run the vulnerability assessment, and document mitigation strategies for FDA inspection readiness.
What's Included:
Vulnerability assessment per FDA's Key Activity Types method
Identification of Actionable Process Steps (APS)
Mitigation strategy development for each APS
Food defense monitoring, corrective action, and verification procedures
Recordkeeping framework and reanalysis triggers
Who It's For:
Food facilities required to comply with the Intentional Adulteration Rule — generally facilities subject to FDA food facility registration that aren't categorized as "very small" (under $10M average annual sales). Very small businesses are exempt from full compliance but often choose to develop a plan voluntarily as best practice.
FAQs:
Q: How is this different from a HACCP Plan?
A: HACCP addresses unintentional hazards (microbial, chemical, physical). Food Defense addresses intentional contamination (sabotage, terrorism, insider threat). Both can be required for the same facility.
Q: Who at my company needs Food Defense training?
A: At minimum, your Food Defense Qualified Individual and any personnel working at Actionable Process Steps.
Q: Does the plan need to be updated periodically?
A: Yes — reanalysis is required every 3 years, after a significant change to your operation, or after a food defense incident. We include reanalysis triggers in the plan.