GAO Report Criticizes FDA Handling of Irradiation Petitions

The U.S. Government Accountability Office (GAO) recently issued a report criticizing the Food and Drug Administration (FDA) for its handling of irradiated food products.

In response to congressional inquiries, GAO examined current and proposed FDA labeling requirements for irradiated foods, as well as “the extent to which FDA has effectively managed the petition review process for irradiated food.” Despite efforts to bolster public acceptance of irradiated products, FDA “has not effectively managed its petition review process, which is the vehicle to potentially allow more food products to be irradiated,” according to GAO.

The report describes ionizing radiation as a safe and effective process capable of eliminating “99.999 percent of E. coli 0157, Listeria and Campylobacter,” but notes that the current labeling scheme may suggest “these foods are less safe.” It also censures FDA’s failure to meet “key statutory and regulatory timeframes” for six currently active and pending food irradiation petitions. Required to complete the review process and issue an order within 180 days, FDA has purportedly taken, on average, 8.5 years to respond to these petitions. In addition, the agency has not documented pertinent decisions nor communicated this information to applicants. As GAO concluded, “These deficiencies limit the ability of petitioners to understand the actions FDA takes, the ability of petitioners to respond appropriately when FDA changes the requirements of the review process, and the transparency of the petition review process.”