FD&C Act Section 418 - Hazard Analysis and Risk-Based Preventive Controls

What it says

Section 418, added by the FDA Food Safety Modernization Act, requires the owner, operator or agent in charge of a facility required to register to evaluate the hazards that could affect food manufactured, processed, packed or held there, to identify and implement preventive controls to significantly minimize or prevent those hazards, to monitor the controls, to take corrective actions, to verify their effectiveness, to keep records, and to reanalyze the plan periodically. FDA implements it through 21 CFR Part 117.

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

What it means in practice

• It moved the focus of food safety from reacting to problems to preventing them.
• The written food safety plan is the central document, prepared or overseen by a qualified individual.
• Exemptions and modified requirements exist for some businesses and activities.

What FDA inspectors look for

• Whether a hazard analysis and food safety plan exist.
• Whether preventive controls are implemented and monitored.
• Whether the plan has been reanalyzed as required.

Related regulations