Irradiation petition process needs improvement
March 23, 2010
WASHINGTON –The Food and Drug Administration’s documentation and communication of key decisions on petitions relating to food irradiation could be improved, according to a report published by the Government Accountability Office.
The American Meat Institute said the G.A.O. report was requested to determine how F.D.A. and U.S. Department of Agriculture labeling requirements for irradiated food products differ, how changes proposed by the F.D.A. to its requirements may change the amount of irradiated food sold and the extent to which the F.D.A. has effectively managed the petition review process.
Although the U.S.D.A. requires that any irradiation label on a U.S.D.A.-inspected product must be pre-approved, labels on F.D.A.-regulated products do not require pre-approval, even though the processor is responsible for proper labeling, the report noted.
The F.D.A. has also not met deadlines for communicating with petitioners about their petitions, the G.A.O. found. The agency said six petitions have been active and pending on average about 8.5 years and some for 10 years.
“While F.D.A. is proposing changes to its labeling requirements for irradiated food that may increase the amount of food that is irradiated, it has not effectively managed its petition review process, which is the vehicle to potentially allow more food products to be irradiated,” according to the report.
Two specific actions were recommended by the G.A.O: the F.D.A. should document its key decisions in administrative files and communicate its key decisions to its petitioners. For new petitions, the status of the F.D.A.’s decision-making should be consistent with regulatory time frames.
Food industry executives believe labeling requirements for irradiated food products “suggest to consumers that these foods are less than safe,” the G.A.O. said in the report. The F.D.A. has proposed eliminating labeling requirements for irradiated foods in cases when the irradiation does not cause a material change in the food — when irradiation does not alter the characteristics, such as nutritional property, ordinarily found in the food — or a material change in the consequences that may result from use of the food.
"U.S.D.A. officials also concurred that the proposal could change the amount of food irradiated and noted that the current labeling requirements are a deterrent to increasing the marketability and sale of these products. U.S.D.A. officials told us that U.S.D.A. follows F.D.A.’s lead with issues concerning the safety of irradiated foods,” according to the G.A.O. “They also said any change in F.D.A.’s labeling requirements would impact U.S.D.A. because there is a goal for federal agencies to have consistent regulations.
“Consequently, the U.S.D.A. said it would consider modifying its own labeling requirements for irradiated foods after F.D.A. finalized its proposed rule. However, U.S.D.A. would have to go through its own rulemaking process before making any changes.”
to read the entire report.