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GAO: Transparency Needed on Irradiation at FDA

By Dan Flynn and Suzanna Schreck

The U.S. Food and Drug Administration (FDA) could improve transparency and recordkeeping on key decisions on irradiation petitions, according to a new report conducted by the Government Accountability Office (GAO).

This report was produced in response to a Congressional request for information on food irradiation.

According to the GAO, there were two objectives to the study the agency conducted.  To determine (1) how Department of Health and Human Services' FDA's current labeling requirements for irradiated food products compare with the Department of Agriculture's (USDA) labeling requirements and how FDA's proposed changes to its requirements might impact the amount of food that is irradiated and (2) the extent to which FDA has effectively managed the petition review process for irradiated food.

The GAO found that there are significant differences between the two federal food regulatory bodies and the FDA has major shortcomings in its petitions review process.

The study points out two important differences in how each agency deals with irradiation. "First, labels on food products subject to FDA jurisdiction do not have to be reviewed and preapproved by FDA before marketing. Rather, the processor is responsible for properly labeling its products. In fact, FDA officials told us that they do not collect information on how irradiated foods are labeled and marketed," said GAO in the report.

"In contrast, USDA reviews and preapproves all labels before use on meat and poultry products and has denied label submissions that do not meet its requirements."

"Second, FDA and USDA have different requirements when an irradiated ingredient is used in a multiingredient product. Specifically, FDA does not require the product's ingredient list to disclose that a particular ingredient has been irradiated, while USDA generally does."

The GAO also points out some glaring problems with the agency's response--or lack thereof--on irradiation petitions.

"For the six currently pending food irradiation petitions, FDA has not met key statutory and regulatory time frames for the review of food additive petitions--which include petitions for new uses of irradiation on food--and has failed to consistently document its decisions about these petitions," the report said.

"Moreover, FDA has not communicated key information to the affected petitioners. As a result, FDA's petition review process lacks transparency and leads to misunderstandings and confusion among petitioners."

The report "highlights the agency's lackluster performance" on overseeing food irradiation, said Wenonah Hauter, executive director of Food & Water Watch, in response to the GAO's findings. "[It] details poor communication by the FDA about decisions and policy on this controversial technology."

The GAO made two, pretty straightforward recommendations:

-To more effectively manage its food irradiation petitions, and to be consistent with FDA regulations, the Commissioner of the Food and Drug Administration should direct the Office of Food Additive Safety to document its key decisions in its administrative files.

-To more effectively manage its food irradiation petitions, and to be consistent with FDA regulations, the Commissioner of the Food and Drug Administration should direct the Office of Food Additive Safety to communicate its key decisions to its petitioners and, for new petitions, the status of its decisionmaking, consistent with regulatory time frames.

According to the FDA, both of these recommendations are in progress.

The entire GAO report is available on the organization's Website.

Full post as published by Food Safety News on March 23, 2010 (boomark / email).