Contains Nonbinding Recommendations
Draft — Not for Implementation
Please Note: This guidance is being distributed for comment purposes only.
How to Comment
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance through February 21, 2017.
Submitting Comments Electronically
Submitting Written Comments
Submit written comments to:
Division of Dockets Management (HFA-305),
Food and Drug Administration,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852
All comments should be identified with the docket number FDA-2016-D-2343.
For questions regarding this draft document contact FDA’s Technical Assistance Network by submitting the inquiry form.
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 14 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.
- Download the full Hazard Analysis and Risk-Based Preventive Controls for Human Food - Draft Guidance (PDF: 1,077KB)
Individual Chapter Downloads
- 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 Six - Use of Heat Treatments as a Process Control (coming soon)
- Chapter Seven – Use of Time/Temperature Control as a Process Control (coming soon)
- Chapter Eight – Use of Formulation as a Process Control (coming soon)
- Chapter Nine – Use of Dehydration/Drying as a Process Control (coming soon)
- Chapter Ten - Sanitation Controls (coming soon)
- Chapter Eleven – Food Allergen Controls (coming soon)
- Chapter Twelve – Preventive Controls for Chemical Hazards (coming soon)
- Chapter Thirteen – Preventive Controls for Physical Hazards (coming soon)
- Chapter Fourteen – Recall Plans (coming soon)
- Appendix 1: Potential Hazards for Foods and Processes (PDF: 1,804 KB)
- Appendix 2: Food Safety Plan Forms (PDF: 261KB)
- Appendix 3: Bacterial Pathogen Growth and Inactivation (PDF: 165KB)
- Appendix 4 – Sanitation and Hygienic Zoning (coming soon)
This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact FDA’s Technical Assistance Network by submitting a form.