July 20, 2000

Today, FDA announced that it had approved the use of ionizing radiation on eggs in the shell to reduce the level of salmonella in the egg. While the process cannot assure elimination of every organism, it can achieve a considerable reduction. The likelihood of any remaining viable salmonella will depend on both the original microbial load and the dose applied.

The new regulation allows a dose up to 3 kGy. However, data in the petition showed that under the conditions of application tested, radiation doses near the maximum dose allowed had an effect on the color of the yolk and the viscosity of the egg. Nevertheless, doses up to 3kGy raise no safety concerns and will be allowed.

Elimination of salmonella in eggs treated by this process will depend on the salmonella levels in individual eggs and the dose that is absorbed by each egg. At doses likely to be practical, salmonella levels may be reduced 10-10,000 fold, depending on the distance of the egg from the radiation source. It is unlikely that a 5-log reduction would be achieved by this process alone. While, based on current knowledge, one cannot guarantee elimination of salmonella in all eggs, the total level of salmonella in eggs will decrease substantially and the fraction of eggs that contain viable salmonella should also decrease.

The irradiated eggs must be labeled in accordance with 21 CFR 179.26.

The final rule amending the food additive regulations to provide for the safe use of ionizing radiation for the reduction of Salmonella in fresh shell eggs, will be published in the July 21, 2000 Federal Register.

Food Safety Initiative Staff E-mail: chammett@cfsan.fda.gov

Office Number: (202) 260-8920 · FAX (202) 260-9653 CFSAN Web site: http://www.cfsan.fda.gov/