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Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition
In 21 Code of Federal Regulations (CFR) part 117 (part 117), we have established our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food.” We published the final rule establishing part 117 in the Federal Register of September 17, 2015 (80 FR 55908). Part 117 establishes requirements for current good manufacturing practice for human food (CGMPs), for hazard analysis and risk-based preventive controls for human food (PCHF), and related requirements.
The PCHF requirements implement the provisions of the FDA Food Safety Modernization Act (FSMA), established in section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350g). Part 117 includes several complete or partial exemptions from the PCHF requirements. See 21 CFR 117.5 for a list and description of these exemptions.
This document is directed to those persons (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, 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 PCHF requirements established in subparts C and G of part 117:
- A written food safety plan (FSP);
- Hazard analysis;
- Preventive controls;
- 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.
We intend this draft guidance to include the 16 chapters listed in the Table of Contents. We will announce the availability of each draft chapter for public comment as the chapter becomes available, rather than delaying release of individual draft chapters until all the draft chapters are available. Those chapters that you see listed in the Table of Contents as “coming soon” are not yet available.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
Federal Register Notices
- Federal Register Notice for Chapters 1-5
- Federal Register Notice for Chapter 6
- Federal Register Notice for Chapter 14
- Federal Register Notice for Chapter 15
- Federal Register Notice for Chapters 11 & 16
Note: The tables in Appendix 1 encompass more than 200 pages. To reduce the printed size of this document (which includes all of the available chapters in this guidance), we have not included those tables. To access the tables in Appendix 1, see the separate Appendix 1 (complete with tables)
- Introduction and Purpose (PDF: 68KB)
- Chapter 1: The Food Safety Plan (PDF: 99KB)
- Chapter 2: Conducting a Hazard Analysis (PDF: 201KB)
- Chapter 3: Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food (PDF: 488KB)
- Chapter 4: Preventive Controls (PDF: 499KB)
- Chapter 5: Application of Preventive Controls and Preventive Control Management Components (PDF: 146KB)
- Chapter 6: Use of Heat Treatments as a Process Control (PDF: 384KB)
- Chapter 7: Use of Time/Temperature as a Process Control (Coming Soon)
- Chapter 8: Use of Product Formulation or Drying/Dehydrating as a Process Control for Biological Hazards (Coming Soon)
- Chapter 9: Validation of a Process Control for a Bacterial Pathogen (Coming Soon)
- Chapter 10: Sanitation Controls (Coming Soon)
- Chapter 11: Food Allergen Program (PDF: 1MB)
- Chapter 12: Preventive Controls for Chemical Hazards (Coming Soon)
- Chapter 13: Preventive Controls for Physical Hazards (Coming Soon)
- Chapter 14: Recall Plan (PDF: 118KB)
- Chapter 15: Supply-Chain Program for Human Food Products (PDF: 920KB)
- Chapter 16: Acidified Foods (PDF: 413KB)
- Chapter 17: Classification of Food as Ready to Eat or Not Ready to Eat (Coming Soon)
- Appendix 1: Potential Hazards for Foods and Processes (PDF: 1 MB)
- Appendix 2: Food Safety Plan Forms (PDF: 261KB)
- Appendix 3: Bacterial Pathogen Growth and Inactivation (PDF: 165KB)
- FSMA Final Rule for Preventive Controls for Human Food
- Constituent Update: FDA Releases Two New Chapters of Draft Guidance for the Preventive Controls for Human Food Rule (September 2023)
- Webinar: Preventive Controls Hazard Analysis and Risk-Based Draft Guidance (August 2018)
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-2343.