Code of Federal Regulations Title 21. Food and Drugs § 21.179.25 General provisions for food irradiation

(a) Any firm that treats foods with ionizing radiation shall comply with the requirements of parts 110 and 117 of this chapter and other applicable regulations.

(b) Food treated with ionizing radiation shall receive the minimum radiation dose reasonably required to accomplish its intended technical effect and not more than the maximum dose specified by the applicable regulation for that use.

(c) Packaging materials subjected to irradiation incidental to the radiation treatment and processing of prepackaged food shall be in compliance with § 179.45, shall be the subject of an exemption for such use under § 170.39 of this chapter, or shall be the subject of an effective premarket notification for a food contact substance for such use submitted under § 170.100 of this chapter.

(d) Radiation treatment of food shall conform to a scheduled process. A scheduled process for food irradiation is a written procedure that ensures that the radiation dose range selected by the food irradiation processor is adequate under commercial processing conditions (including atmosphere and temperature) for the radiation to achieve its intended effect on a specific product and in a specific facility. A food irradiation processor shall operate with a scheduled process established by qualified persons having expert knowledge in radiation processing requirements of food and specific for that food and for that irradiation processor's treatment facility.

(e) A food irradiation processor shall maintain records as specified in this section for a period of time that exceeds the shelf life of the irradiated food product by 1 year, up to a maximum of 3 years, whichever period is shorter, and shall make these records available for inspection and copy by authorized employees of the Food and Drug Administration. Such records shall include the food treated, lot identification, scheduled process, evidence of compliance with the scheduled process, ionizing energy source, source calibration, dosimetry, dose distribution in the product, and the date of irradiation.