Preventive Controls Guidance FDA

This document is addressed to those individuals (you) who are subject to the PCHF requirements of part 117. Establishing risk-based preventive controls enables you to apply a proactive and systematic approach to your food safety program through the establishment of preventive controls designed to protect your food products, and the consumer, from biological, chemical (including radiological), and physical hazards. Risk-based preventive controls will not give you a “zero-risk” system for manufacturing, processing, packing, and holding food; however, risk-based preventive controls are designed to minimize the risk of known or reasonably foreseeable food safety hazards that may cause illness or injury if present in the products you produce.

This guidance is intended to help you comply with the following specific PCHF requirements established in subparts C and G of part 117:

• A written food safety plan (FSP);
• Hazard analysis;
• Preventive controls;
• Monitoring;
• Corrective actions;
• Verification; and
• Associated records.

This guidance is not directed to persons who are exempt under 21 CFR 117.5. However, such persons may find some of the principles and recommendations in this guidance helpful in manufacturing, processing, packing, and holding human food.

• Download the full Hazard Analysis and Risk-Based Preventive Controls for Human Food – Draft Guidance (PDF: 1,077KB) – 24 Agoust 2016
• Small Entity Compliance Guide – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals – 01 November 2016