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FDA Allows Irradiation of Shellfish to Control Foodborne Pathogens

The U.S. Food and Drug Administration (FDA) today announced that it is amending its current food additive regulations to allow the safe use of ionizing radiation on crustaceans (e.g., crab, shrimp, lobster, crayfish, and prawns) to control foodborne pathogens and extend shelf life.

In a Center for Food Safety and Nutrition (CFSAN) Constituent Update, the agency said its action responds to a food additive petition submitted by the National Fisheries Institute. "Our decision is based on a rigorous safety assessment that considered 1) potential toxicity, 2) the effect of irradiation on nutrients, and 3) potential microbiological risk that may result from treating crustaceans with ionizing radiation," agency officials explained. The evaluation also considered previous evaluations of the safety of irradiation of other foods including poultry, meat, molluscan shellfish, iceberg lettuce, and fresh spinach. This rule covers raw, frozen, cooked, partially cooked, shelled, or dried crustaceans, or cooked, or ready-to-cook, crustaceans processed with spices or small amounts of other food ingredients.

At the maximum permitted dose of 6.0 kiloGray, this new use of ionizing radiation will reduce, but not entirely eliminate, the number of pathogenic (illness causing) microorganisms in or on crustaceans. The maximum dosage of irradiation approved is capable of reducing a number of pathogens that may be found in crustaceans, including Listeria, Vibrio, and E. coli. Irradiation is not a substitute for proper food-handling practices; therefore crustaceans treated with ionizing radiation must be stored, handled, and cooked in the same way as non-irradiated foods.

Under 21 CFR 179.26(c), we require that irradiated foods bear the international symbol for irradiation (radura) and carry the statement "Treated with radiation" or "Treated by irradiation" on the food label. Consumers will continue to be able to identify irradiated foods, including crustaceans, by the presence of the irradiation statement and symbol on the label. For foods not in package form, the logo and phrase must be displayed to the purchaser with either the labeling of the bulk container plainly in view or a counter sign, car, or other appropriate device bearing the information that the product has been treated with radiation. We do not require that multi-ingredient foods that contain ingredients that have been irradiated (e.g., spices) be labeled if the food itself has not been irradiated, nor do we require labeling of irradiated food served in restaurants.

Submit comments electronically to the FDA docket through Docket No. FDA-2001-F-0049 (formerly Docket No. 01F-0047) on Regulations.gov.

To submit comments by mail, send to FDA at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All submissions must include the agency name and docket number.

For more information, see the following: