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.

Appendix 1 identifies the potential hazards in foods and processes.

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 (coming soon)

Chapter 8: Use of Formulation as a Process Control (coming soon)

Chapter 9: Use of Dehydration/Drying as a Process Control (coming soon)

Chapter 10: Sanitation Controls (coming soon)

Chapter 11: Food Allergen Controls (coming soon)

Chapter 12: Preventive Controls for Chemical Hazards (coming soon)

Chapter 13: Preventive Controls for Physical Hazards (coming soon)

Chapter 14: Recall Plans (coming soon)

Chapter 15 – Supply-Chain Program for Human Food Products

Chapter 18: Validation of a Process Control (coming soon)

Appendix 1 – Potential Hazards for Foods and Processes

Appendix 2 – Food Safety Plan Forms

Appendix 3 – Bacterial Pathogen Growth and Inactivation

Appendix 4: Sanitation and Hygienic Zoning (coming soon)


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