FDA Issues Revised Guidance on Preventative Controls for Human Food

Trade Update • February 1, 2023

he Food and Drug Administration (FDA) issued draft guidance for industry on hazard analysis and risk-based preventive controls for human food.

Download the Draft Guidance here.

Purpose of Guidance

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, 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; rather, 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 they are present in the products you produce.

This guidance is intended to help you comply with the following specific preventive controls for human food (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.

Questions about your compliance on food imports? We are always here to help, contact us.


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