FDA said it decided the 3.0 kGy dose in fresh shell eggs is safe for consumers.

FDA Denies Hearing on Egg Irradiation Rule

The agency rejected all 26 opposing comments it received, including a letter from Public Citizen that FDA addressed point by point.

The Food and Drug Administration has rejected a request to hold a public hearing on its final rule allowing for irradiation of fresh shell eggs to reduce Salmonella pathogens. The denial was announced in the April 13 Federal Register, but it comes more than a decade after FDA issued the rule itself on July 21, 2000. The rule permits irradiation at doses not to exceed 3.0 kiloGray (kGy).

Public Citizen raised several points in its letter opposing the rule. FDA received 25 other opposing submissions, some of which asked for a hearing, but said these voiced general opposition and offered no evidence that could be weighed at a hearing.

Public Citizen's letter said the rule underestimated the amount of vitamin A that will be retained after irradiation of an egg. Irradiation at the specified level will cause no more than about 35 percent of the vitamin A to be retained, according to the letter, and FDA acknowledged "stating a vitamin A retention in the range of 20.1 to 35.5 percent is more appropriate in light of the maximum petitioned dose." But FDA concluded "the effect on health from this vitamin loss is not significant because a variety of foods provide vitamin A and the intake of other foods can compensate for any loss."

The final rule was issued in response to a 1998 food additive petition submitted by Edward S. Josephson of the University of Rhode Island Food Science and Nutrition Research Center. He initially asked for a maximum irradiation dose of 1.7 kGy but subsequently amended the petition to a maximum dose of 3.0 kGy; Public Citizen alleged this higher dose is unsafe. FDA said it conducted additional chemistry and toxicology reviews and decided the 3.0 kGy dose is safe for consumers.

For more information about the denials, contact Teresa A. Croce at FDA's Center for Food Safety and Applied Nutrition in College Park, Md., at 301-436-1281.

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