FDA Releases Sixth Chapter of Draft Guidance for the PC-Human Food Rule

Constituent Update

August 30, 2017

Today, the FDA announced the availability of guidance for food facilities that explains how to establish and implement a heat treatment, such as baking or cooking, to prevent contamination by disease-causing bacteria.

This is the sixth chapter of the draft guidance, entitled “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food,” designed to help food facilities comply with the preventive controls for human food rule, mandated by the FDA Food Safety Modernization Act.

The final rule, entitled “Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,” published on September 17, 2015, builds on previous food safety requirements and introduces others that together establish a more modern, preventive, and risk-based approach to food safety.

This draft guidance is intended to help food facilities comply with specific requirements of the rule, such as developing a written food safety plan, establishing preventive controls, and taking corrective actions. The FDA intends to publish at least 14 chapters of the guidance and will continue to announce the availability of each chapter as it becomes available.

A compliance date is approaching on September 18, 2017 for small businesses (those with fewer than 500 full-time employees) that are required to comply with the preventive controls for human food rule. To learn more about this and other FDA FSMA rules visit FDA.gov/FSMA.