The Food Safety Modernization Act will soon have a dramatic impact on the food safety and regulatory landscape for facilities producing products regulated by the FDA. The Preventive Controls for Human Foods proposed rule, which is expected to be published as a final rule this month, will significantly change the way food manufacturing companies document their food safety systems. The traditional approach of using the HACCP (Hazard Analysis Critical Control Point) system will transition to the new HARPC (Hazard Analysis Risk-Based Preventive Controls) system. The change will be required by the new FDA regulatory standard defined in 21 CFR 117.26(a).
Food Safety Plan Requirements
FDA regulated facilities will be required to have a written and implemented Food Safety Plan. The Food Safety Plan must include the following contents: Hazard Analysis, Preventive Controls, Supplier Program, Recall Program, Monitoring Procedures, Corrective Action Procedures, and Verification Procedures.
The Food Safety Plan requirements are much more comprehensive than the traditional HACCP plan by itself. A HARPC hazard analysis includes more detailed hazard identification and hazard evaluation