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FDA Eases the Way for Food Irradiation and Labeling

Date: Jun 01, 2007


The U.S. Food and Drug Administration (FDA) has recently eliminated a long-standing barrier to irradiating prepackaged foods and also finally proposed label changes. Both moves should make irradiated food products more available to the consumer, with their consequent affect on safety.

Exempt packaging materials

In the first case, the FDA has determined that under certain circumstances, prepackaged food can be irradiated without the packaging material being the subject of a food additive regulation or a food-contact notification. Instead, the agency determined that such materials may be considered exempt via its Threshold of Regulation (TOR) policy.

By way of background, irradiation has long been recognized as an effective and safe way to kill harmful bacteria, including E. coli, salmonella and listeria, among others, that may be present in food and food packaging materials. However, increased use of irradiation to enhance food safety has long been severely limited by the small number of packaging materials and additives cleared for this use in the food additive regulations, as well as by the FDA's daunting data requirements before it would clear any other packaging materials.

The agency has finally recognized that some uses of ionizing radiation are just not going to be problematic. In a TOR exemption letter for the irradiation of food-contact materials incidental to the radiation treatment of prepackaged food, the FDA has determined that no regulations are necessary for the irradiation of otherwise compliant food packaging materials, provided that the following conditions are met:

1. The radiation processing is done in compliance with Title 21 C.F.R. Part 179. 2. The packaging materials are subjected to radiation not exceeding 3 kGy. 3. The packaged food is irradiated either in a verifiably oxygen-free environment or while frozen and contained under vacuum.

Label changes

The labeling of irradiated food also is the subject of a proposed rule. (See 72 Fed. Reg. 16291, Apr. 4, 2007), and it's about time. The FDA is now proposing to amend the regulations to require only those irradiated foods in which irradiation causes a material change in the food's characteristics (such as organoleptic, nutritional or functional properties) to bear the radura logo and the term "irradiated".

The FDA also is proposing to allow the use of alternate terms (such as "pasteurized") if supportive data is provided in a notification. The Agency would have 120 days to object to the notification; otherwise, the food could be labeled with the alternative terms.

The FDA will accept comments on the proposed rule until July 3, 2007.

Used with permission. Copyright FOOD & DRUG PACKAGING, May, 2007.

For further information about this article, please contact George G. Misko at 202-434-4170 or by email at misko@khlaw.com