FDA Issues Updated Appendix 1, Part of the Hazards Guidance Document

FDA issued the updated Appendix 1 of their Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry document.  Appendix 1 is the  Known or Reasonably Foreseeable Hazards (“Potential Hazards”), a tool to help assist companies conducting the hazard analysis as part of preparation of the hazard analysis.  Table 1 of this appendix lists biological hazards and Table 2 lists chemical hazards.  In the previous version there was a table 3 that looked at process related hazards, but this aspect is now just listed in text.

The document can be found here.
Draft Guidance for Industry Hazard Analysis and Risk-Based Preventive Controls for Human Food: Appendix 1 (January 2024) (fda.gov)

FSPCA will be adopting this into their new updated version 2.0 of the Preventive Controls for Human Foods Curriculum on track to come out this year.

We will have to do some work on it before providing additional comment.

https://www.fda.gov/food/cfsan-constituent-updates/fda-publishes-revised-draft-introduction-and-appendix-preventive-controls-human-food-guidance?utm_medium=email&utm_source=govdelivery
FDA Publishes Revised Draft Introduction and Appendix to the Preventive Controls for Human Food Guidance
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U.S. Food and Drug Administration (FDA) has released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry titled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft Guidance).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.

A1.1 Purpose of Appendix 1

The guidance in Appendix 1 is intended to help you identify known or reasonably foreseeable 

biological, chemical, and physical hazards for each type of food manufactured, processed, 

packed, or held at your facility. Identifying known or reasonably foreseeable hazards is one step 

in determining, through your hazard analysis, which hazards require a preventive control. (See 

21 CFR 117.130(a)(1).) Throughout this guidance:

• We use the term “potential hazard” as a synonym for “known or reasonably foreseeable hazard” for the following reasons:
• Some users of this Appendix 1 could be more familiar with the term “potential hazard” because “potential hazard” is used in food safety systems such as HACCP that are similar to, but not the same as, the system of hazard analysis and risk-based preventive controls in part 117; 
• “Potential hazard” is a term that is used in some training materials to help emphasize during training that a known or reasonably foreseeable hazard is still being evaluated to determine whether it is a hazard requiring a preventive control for a food; and
• Form 2-B in Appendix 2 of this guidance (Hazard Analysis) uses the term “potential hazard” as a shorthand for “known or reasonably foreseeable hazard” due to space limitations.2 
• With the exception of Form 2-B, when appropriate, in this guidance we use3 the combined term “known or reasonably foreseeable hazard (“potential hazard”)” (or, depending on context, “known or reasonably foreseeable (“potential”) hazard”) so that this guidance:
• consistently uses the term used in the regulatory text of part 117 to unambiguously direct you to the regulatory requirements that are the subject of this guidance; 
• consistently uses a term that could be more familiar to some users of this guidance; and
• consistently reminds you that a known or reasonably foreseeable hazard is still being 
• evaluated to determine whether it is a hazard requiring a preventive control for a food