Not Everythings Well with FDAs Bioterrorism Act

Testifying was David French, the Senior Vice President of Government Relations for the International Foodservice Distributors Association (IFDA). French characterizes the FDA record keeping regulations as a “rigidly bureaucratic and one-size-fits-all rule.” Noting that one aspect of the rule requires companies to retain lot numbers or other identifiers for each article of food sent or received, French points out that distributors hand food in pallet and case sizes. Since lot numbers usually appear only on individual packages, it would mean that distributors would have to break open pallets and cases which might contain food from multiple lots. “There is no government or industry standard for location or presentation of lot numbers, so they may appear on product packages or on cases,” says French, “or they may be embedded on the UPC code or stand alone, and may take a variety of forms. This is a key point, and an issue that has the people in charge of logistics and operations in IFDA member companies very worried.”

Another concern expressed by French is the amount of time for producing required records in response to an official FDA request, which is four hours during normal business hours. While the organization understands the need for quick response to such requests, it feels that to have FDA impose criminal liability – which it has the right to do – for violation during such a short time, is inappropriate. A third issue for IFDA is the matter of access to records. “Because the Bioterrorism Act gives FDA access to highly sensitive commercial information,” notes French, “it is important that the new records access authority be used appropriately and not abused and that strong protection be put in place to prevent inappropriate release of sensitive information.”

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