DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 179
[Docket No. 2005N-0272]
Irradiation in the Production, Processing and Handling of Food
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
SUMMARY: The Food and Drug Administration (FDA) is proposing to revise its labeling regulations applicable to foods (including dietary supplements) for which irradiation has been approved by FDA.
FDA is proposing that only those irradiated foods in which the irradiation causes a material change in the food, or a material change in the consequences that may result from the use of the food, bear the radura logo and the term “irradiated,” or a derivative thereof, in conjunction with explicit language describing the change in the food or its conditions of use.
For purposes of this rulemaking, we are using the term “material change” to refer to a change in the organoleptic,
nutritional, or functional properties of a food, caused by irradiation, that the consumer could not identify at the point of purchase in the absence of appropriate labeling.
FDA is also proposing to allow a firm to petition FDA for use of an alternate term to “irradiation” (other than “pasteurized”).
In addition, FDA is proposing to permit a firm to use the term “pasteurized” in lieu of “irradiated,” provided it notifies the agency that the irradiation process being used meets the criteria specified for use of the term “pasteurized” in the Federal Food, Drug, and Cosmetic Act (the act) and the agency does not object to the notification.
This proposed action is in response to the Farm Security and Rural Investment Act of 2002 (FSRIA) and, if finalized, will provide consumers with more useful information than the current