Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                CFSAN Constituent Updates

CFSAN Constituent Updates Home
          Food
          News & Events from CFSAN
          CFSAN Constituent Updates
          FDA Publishes Revised Draft Introduction and Appendix to the Preventive Controls for Human Food GuidanceCFSAN Constituent Updates FDA Publishes Revised Draft Introduction and Appendix to the Preventive Controls for Human Food Guidance
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintConstituent Update

January 30, 2024

The U.S. Food and Drug Administration (FDA) has released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry titled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft Guidance). The changes address comments the Agency received on the drafts that were made available in 2016; and provide additional context and information on hazards in food categories of current interest to ensure that the available draft documents adequately reflect the Agency’s current thinking on the most relevant food safety hazards.

The revised introduction includes additional information to better explain the purpose of the guidance and provide general information applicable to all chapters. This includes an expanded glossary of terms that are used and defined in later chapters, and the addition of three new sections on training, references, and resources. The training section provides general information on training relevant to the PCHF rule. The references section includes a comprehensive bibliography of references that have been used in certain chapters of the guidance, along with references we expect to include in future chapters that will be released. The new resources section features a compilation of resources that may be useful to someone using the guidance.

The second document released today is a revised draft of Appendix 1 “Known or reasonably foreseeable hazards (“potential hazards”).” As informed by stakeholder concerns over specific hazard-commodity associations and the Agency’s use of the Appendix during inspections, the FDA has made significant changes that include:

The addition of new sections and descriptions meant to better explain the purpose of the Appendix, how it was developed and how it should be used;
	Revisions to the product categories identified within the Appendix to better reflect food ingredients rather than finished products;
	Replacement of a series of process-related hazard tables with a discussion of those hazards;
	An updated discussion on food allergen hazards; and
	Citations to scientific, technical and regulatory information references, particularly for less-commonly known hazards identified for different food categories.Both the draft Introduction and Appendix 1 are available for public comment. The FDA encourages comments to be submitted to regulations.gov under Docket No. FDA-2016-D-2343 within 120 days of publication in the Federal Register.

                                                                                  Content current as of:
      01/30/2024
              
              
Regulated Product(s)
		 Food & BeveragesCFSAN Constituent Updates
 Subscribe to CFSAN Constituent Updates
                        Get email updates delivered to your inbox.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop