Refusal of Inspection by a Foreign Food Establishment or Foreign Government

The American Frozen Food Institute (AFFI) appreciates the opportunity to submit comments regarding the Draft Guidance document Refusal of Inspection by a Foreign Food Establishment or Foreign Government ("Draft Guidance"). AFFI is the national trade association representing the interests of U.S. frozen food processors and their suppliers. AFFI members manufacture and distribute frozen foods throughout the United States and globally. Executive Summary AFFI is concerned that in the Draft Guidance, the Food and Drug Administration (FDA) takes an overly broad view of what constitutes a refusal of inspection. This is troubling because the consequence of refusing of inspection is that all food from the foreign facility is refused admission into the U.S. In our view, this is not the right enforcement tool for many of the activities listed in the Draft Guidance. In addition, we think that an expansive view of "refusal of inspection" is inconsistent with the statute. Accordingly, we encourage FDA to revise the Draft Guidance to narrow the scope of actions that are a "refusal of inspection" for which the consequence is refusal of admission of all food from the facility. We also respectfully request that FDA revise the Draft Guidance to outline the process by which a "refusal of inspection" decision is made and can be appealed. For more detailed comments, please refer to the attached document.