Food Irradiation:

FDA Could Improve Its Documentation and Communication of Key Decisions on Food Irradiation Petitions

GAO-10-309R: Published: Feb 16, 2010. Publicly Released: Mar 18, 2010.

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According to the Centers for Disease Control and Prevention (CDC), pathogens such as Salmonella, E. coli, and Listeria cause an estimated 14 million cases of foodborne illnesses each year, resulting in about 60,000 hospitalizations and 1,800 deaths. Foodborne illness symptoms can range from mild gastroenteritis to life-threatening renal syndromes. The populations most susceptible to the more serious symptoms include very young children, individuals 60 years and older, pregnant women, and people who have a weakened immune system. In 2007, about 20 to 25 percent of the U.S. population was in this high-risk category. Moreover, consumers' vulnerability to foodborne illness is increasing as a result of changes in demographics, among other things. For example, older Americans will make up an estimated 20 percent of the U.S. population by 2015. The pathogens that account for much of the most severe foodborne illness can be greatly reduced by subjecting food to ionizing radiation, also known as food irradiation. Many experts believe that irradiation can be effectively incorporated into an establishment's food safety program to further ensure the safety of the food against pathogens. Irradiation can also be used as a phytosanitary treatment where it is applied at low doses to safeguard natural resources by replacing fumigation or other chemical treatments to eliminate particular plant pests from fruits and vegetables imported into the United States. This report responds to Congressional request for information on food irradiation. Our objectives were to determine (1) how Department of Health and Human Services' Food and Drug Administration's (FDA) 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.

Although FDA's and USDA's labeling requirements for irradiated foods have some commonalities, they differ in important ways. The requirements are similar in that both agencies generally require that labels on irradiated foods packaged for retail sale include the international food irradiation symbol--the radura and a statement disclosing that the food has been exposed to ionizing radiation. FDA and USDA also allow processors to add additional language to the labels to identify the source of the radiation and purpose of the treatment. However, FDA's and USDA's labeling requirements for irradiated foods differ in two important ways. 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. 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. 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. 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. FDA is required to notify petitioners, within specified time frames, about certain decisions it has made regarding the petitions. For example, FDA regulations require that within 15 days of receiving a petition submission, FDA must notify the petitioner as to whether FDA will accept the petition and file it in the federal docket. However, FDA did not do so for five of the six pending petitions.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: FDA agreed with our recommendation and in 2010, informed GAO that the agency formed a team to oversee the administrative process for reviewing irradiation petitions. Additionally, in 2011 FDA told us it began reviewing its administrative records for the irradiation petitions to identify and address deficiencies in the petition records and in 2012, added a quality control step to its procedures by having the project manager's supervisor review the administrative record for completeness. FDA has documented its key decisions and updated the documentation on the petitions.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

  2. Status: Closed - Implemented

    Comments: In 2011, FDA told us that the agency informed the petitioners of the review status of their petitions and communicated its decisions to the petitioners. In 2012 FDA told us and provided copies of communications sent to petitioners demonstrating that the agency continues to keep petitioners apprised of the review status of their petitions.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration


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