The Food Marketing Institute (FMI) is pleased to respond to the Food and Drug Administration’s (FDA’s) request for comments on the Agency’s implementation of Section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). As discussed more fully below, much of the information that FDA is considering requiring food retailers to maintain is already held by the industry and is routinely used to conduct efficient product investigations in recall situations. However, given the enormous volume of records involved, FDA’s regulations should utilize the existing system, rather than requiring the food industry to develop new records specifically for purposes of this regulation. An undertaking of this nature would be inordinately expensive and would provide no additional protection against

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