On January 16, 2013, the Food and Drug Administration (FDA or the Agency) published in the Federal Register a proposed rule entitled Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (the ―Proposed Rule‖). The Proposed Rule amends the regulation for Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMPs) and adds requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. The Food Marketing Institute (FMI) appreciates the opportunity to comment on this important matter.

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