On April 4, 2007, FDA published proposed regulations for the labeling of irradiated foods and dietary supplements. The proposed revisions are in response to the Farm Security and Rural Investment Act of 2002, which directed FDA to propose changes to the current regulations at 21 C.F.R. Part 179, and to amend the definition of “pasteurization” in section 403(h)(3) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”). The proposed regulations address three issues: 1) when an irradiated food or dietary supplement does not need to be labeled “irradiated”; 2) when an irradiated food may be labeled “pasteurized” rather than “irradiated;” and (3) when a manufacturer may use an alternative term for “irradiated.”
The most significant revision is FDA’s proposal that an irradiated food need not be labeled with the radura symbol and a radiation disclosure statement unless the irradiation causes a material change. FDA explains in the preamble that a material change is “a change in the organoleptic, nutritional, or functional properties of a food . . . that the consumer could not identify at the point of purchase,” e.g., irradiation of bananas to slow the ripening process. The effect of irradiation is not material if the change is “within the range of characteristics normally found.” FDA asks for comments with respect to the Agency’s position that the extension of shelf life by inactivating micro organisms and other pests does not constitute a material change. FDA is also soliciting comments regarding material and non-material irradiation-induced changes.
An irradiated product that is materially changed must be labeled with the radura symbol and a radiation disclosure statement. The proposed regulations provide two alternatives to labeling the product as “irradiated.” These proposals are essentially restatements of statutory provisions. The option for use of “pasteurized” rather than “irradiated” incorporates the definition of pasteurization in FDC Act § 403(h)(3) allowing an irradiated food to be labeled “pasteurized” provided that certain conditions are met. The manufacturer must notify FDA and submit data showing the effectiveness of the irradiation process 120 days before a manufacturer plans to label an irradiated product as “pasteurized.” If during those 120 days FDA has not objected to the proposed use, the manufacturer may label the irradiated product as “pasteurized.” In addition to the term “pasteurized,” alternative terms are permitted. For use of an alternative term, the manufacturer must submit a petition to FDA rather than a notification. A petition must contain data that “show consumer understanding of the purpose and intent of the proposed alternative labeling.” This option has been available since 2002 under an FDA guidance document. To date, FDA has not received a petition requesting the use of an alternative for irradiated foods. Because the proposed regulations will reduce the number of foods that must be labeled with a radiation disclosure, future use of this provision seems unlikely.
Written comments to the proposed regulations should be submitted to Docket No. 2005N-0272 by July 3, 2007.