| February 16, 2001 |
On February 16, 2001, FDA published in the Federal Register a final rule announcing that it had expanded the conditions of safe use for X-ray, and electron beam energy sources for the treatment of prepackaged foods with ionizing irradiation. The amended regulation now permits all packaging materials that had previously been permitted for use during the gamma irradiation of prepackaged food to now be used during X-ray and electron beam irradiation of prepackaged food. The regulation does not alter the types of energy sources, the maximum dose, the maximum dose rate, or the types of foods that may be treated with ionizing radiation.
The treatment of food with ionizing radiation reduces the amount of pathogens in and on the food. While the process cannot assure elimination of every organism, it can achieve a considerable reduction. The likelihood of any remaining viable pathogen will depend on both the original microbial load and the dose applied. In order to prevent recontamination of irradiated food, the food is often irradiated in its final package. The allowed packaging materials are listed in 21 CFR 179.45 Packaging materials for use during the irradiation of prepackaged food. Thus, irradiation of food packaging materials is incidental to the radiation treatment of prepackaged foods for the control of pathogenic and spoilage organisms in the food.
The packaging materials listed in §179.45 have previously been determined to be safe for use during the gamma irradiation of food. Because X-ray and electron beam sources do not induce higher levels of radiolysis products in polymers that could potentially migrate to food than gamma radiation, the Agency found that electron beam and X-ray sources of radiation may be safely used with all packaging materials currently listed in §179.45.
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Food Safety Initiative Staff E-mail: chammett@cfsan.fda.gov |
Office Number: (202) 260-8920 · FAX (202) 260-9653 CFSAN Web site: http://www.cfsan.fda.gov/ |
Hypertext updated by dms 2001-FEB-20