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          Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human FoodSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food
					
		
		January 2024


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2016-D-2343
	    	    		    Issued by:
		    Guidance Issuing Office
          Center 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;
	Monitoring;
	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.

**Download the Draft Guidance**

Federal Register Notices

Federal Register Notice for Introduction and Appendix 1
	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 & 16Chapter Downloads

Download the full Draft Guidance (PDF: 4.95MB)

**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 General Information Applicable to This Guidance (PDF: 2.24MB)
	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: Known or Reasonably Foreseeable Hazards (“Potential Hazards”) (PDF: 937KB)
	Appendix 2: Food Safety Plan Forms (PDF: 261KB)
	Appendix 3: Bacterial Pathogen Growth and Inactivation (PDF: 165KB)Related Information

FSMA Final Rule for Preventive Controls for Human Food
	Constituent Update: FDA Publishes Revised Draft Introduction and Appendix to the Preventive Controls for Human Food Guidance (January 2024)
	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)Submit Comments
	   		  			    		Submit Comments Online
					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:
						Dockets Management
							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.

                                                                                  Content current as of:
      01/30/2024
         
                  
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