Food and Drug Regulations

B.26.005 A request that a food be added or a change made to the table to this Division shall be accompanied by a submission to the Director containing the following information:

• (a) the purpose and details of the proposed irradiation, including the source of ionizing radiation and the proposed frequency of and minimum and maximum dose of ionizing radiation;

• (b) data indicating that the minimum dose of ionizing radiation proposed to be used accomplishes the intended purpose of the irradiation and the maximum dose of ionizing radiation proposed does not exceed the amount required to accomplish the purpose of the irradiation;

• (c) information on the nature of the dosimeter used, the frequency of the dosimetry on the food and data pertaining to the dosimetry and phantoms used to assure that the dosimetry readings reflect the dose absorbed by the food during irradiation;

• (d) data indicating the effects, if any, on the nutritional quality of the food, raw and ready-to-serve, under the proposed conditions of irradiation and any other processes that are combined with the irradiation;

• (e) data establishing that the irradiated food has not been significantly altered in chemical, physical or microbiological characteristics to render the food unfit for human consumption;

• (f) where the Director so requests, data establishing that the proposed irradiation is safe under the conditions proposed for the irradiation;

• (g) the recommended conditions of storage and shipment of the irradiated food including the time, temperature and packaging and a comparison of the recommended conditions for the same food that has not been irradiated;

• (h) details of any other processes to be applied to the food prior to or after the proposed irradiation; and

• (i) such other data as the Director may require to establish that consumers and purchasers of the irradiated food will not be deceived or misled as to the character, value, composition, merit or safety of the irradiated food.