FSMA Rules and Guidance for Industry

Here’s a list of the FSMA Rules and Guidance issued by the FDA to help industry comply with certain requirements in the Preventive Controls for Human Food rule. They are also individually listed below.

Chapter 3 identifies the hazards in foods and Chapter 4 describes the preventive controls that may be used.

Introduction and Purpose

Chapter 1: The Food Safety Plan

Chapter 2: Conducting a Hazard Analysis

Chapter 3: Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food

Chapter 4: Preventive Controls

Chapter 5: Application of Preventive Controls and Preventive Control Management Components

Chapter 6: Use of Heat Treatments as a Process Control

Chapter 7: Use of Time/Temperature Control as a Process Control (not yet published)

Chapter 8: Use of Formulation as a Process Control (not yet published)


For tips on how to use the Guidance on Preventive Controls for Human Food, please view this video.