Background

The Food and Drug Administration has made technical amendments to its September 2015 final rules setting forth preventive controls for human and animal food to correct editorial and inadvertent errors. Both rules are amended with respect to the definitions of “audit,” “harvesting” and “small business” as well as provisions on exemptions, circumstances in which a preventive control is not required to be implemented, and procedures for submitting appeals. The animal food rule is also amended with respect to provisions on sanitation, holding and distribution, hazard analysis, validation, reanalysis, and modified requirements that apply to facilities solely engaged in the storage of unexposed packaged animal food.

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