The Food and Drug Administration has issued a revised draft introduction and appendix 1 to its draft guidance for industry on hazard analysis and risk-based preventive controls for human food.

According to the FDA, the revised introduction includes additional information to better explain the purpose of the guidance as well as 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, while the references section includes a comprehensive bibliography of references that have been used in certain chapters of the guidance along with references the FDA expects to include in future chapters that will be released. The new resources section, meanwhile, features a compilation of resources that may be useful to those using the guidance.

The revised draft of appendix 1 (known or reasonably foreseeable hazards) includes 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; the 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.

For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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