FDA Releases Long-Awaited Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food

FDA Releases Long-Awaited Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food

August 25, 2016

Earlier this week, FDA released five chapters of a multi-chapter draft guidance on hazard analysis and risk-based preventive controls for human food. The long-awaited draft guidance is intended to help industry comply with certain requirements of the agency’s final rule for preventive controls for human food (PC rule) under the Food Safety Modernization Act (FSMA). The PC rule generally requires all FDA-registered domestic and foreign food facilities to establish and implement a food safety system, documented in a written food safety plan that is prepared by a preventive controls qualified individual (PCQI) and includes an analysis of hazards and implementation of risk-based preventive controls (PCs).