FDA Publishes Revised Draft Introduction and Appendix to the Preventive Controls for Human Food Guidance

What's New

May 30, 2024

FDA Extends Comment Period for the Draft Introduction and Appendix 1 to the Preventive Controls for Human Food Rule Draft Guidance

The FDA is extending the comment period for the Introduction, and Appendix 1, of the draft guidance on Preventive Controls for Human Food (PCHF) by an additional 60 days. These revised sections of the draft guidance were published on February 2, 2024, and were initially open for comment until June 3, 2024. The new deadline for comments is August 2, 2024. The FDA is extending the comment period in response to stakeholder requests to allow additional time for interested persons to develop and submit comments.

Electronic comments can be submitted through the Federal eRulemaking Portal at Regulations.gov. Written comments should be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All submissions received must include the Docket No. FDA-2016-D-2343.

Original Constituent 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U.S. Food and Drug Administration (FDA) has released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry titled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft Guidance).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.