FDA Denies Hearing for Shell Egg Irradiation Rule
The Food and Drug Administration (FDA) has answered criticism of a July 21,
2000, final rule allowing “the safe use of ionizing radiation for the reduction
of Salmonella in fresh shell eggs,” and denied requests for a hearing on the
ground that the objections “do not raise issues of material fact or otherwise
provide a basis for revoking or modifying . . . the regulation.” FDA evidently
received 26 submissions contesting the final rule, which permits the irradiation
of fresh shell eggs at doses not to exceed 3.0 kiloGray (kGy), but only one
letter from Public Citizen raised specific issues within the rule’s scope.
The April 13, 2011, Federal Register notice responds to Public Citizen’s claims
that FDA misrepresented irradiation’s efficacy and its effect on vitamin A loss
and egg yolk carotenoids; that FDA raised the dose allowance to 3.0 kGY
without properly updating its analyses; and that FDA failed to follow all of
the 1980 recommendations put forth by the Bureau of Foods Irradiation Food
Committee. “Despite these allegations, Public Citizen has not established
that FDA overlooked significant information in the record while reaching its conclusion that the use of irradiation for the reduction of Salmonella in shell eggs is safe,” states FDA, which has declined to make any changes in its
rulemaking.
