FSMA Final Rule for Preventive Controls for Human Food - 21 CFR Part 117: Hazard Analysis, Preventive Controls (Process/Allergen/Sanitation/Supply Chain), Monitoring, Corrective Actions, Verification, Recall Plan and Qualified Facility Exemption

What FSMA Final Rule for Preventive Controls for Human Food - 21 CFR Part 117: Hazard Analysis, Preventive Controls (Process/Allergen/Sanitation/Supply Chain), Monitoring, Corrective Actions, Verification, Recall Plan and Qualified Facility Exemption requires

This regulation requires domestic and foreign food facilities registered under section 415 of the FD&C Act to develop and implement a written food safety plan that includes hazard analysis and risk-based preventive controls to minimize or prevent biological, chemical, and physical hazards. Key requirements include process, allergen, sanitation, and supply-chain controls, monitoring, corrective actions, verification, and a recall plan as specified in the rule.

Pillar: Food & Hospitality · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated: 2026-04-24

Primary source: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food

SHA-256 integrity: 58d002431ddfc0c2b70c102a23a6842a5c2fe0b38e560db742ec423551de7c3d

Primary Citations — 5 traced to source

• FSMA Final Rule for Preventive Controls for Human Food, https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food, Hazard analysis, 2015
• FSMA Final Rule for Preventive Controls for Human Food, https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food, Preventive controls, 2015

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