This order is effective June 20, 2011, except as to any provisions that may be stayed by the filing of proper objections. Either electronic or written objections and requests to FDA-1990-F-0390 may be submitted for a hearing but must be received by April 21, 2011. Submit electronic objections at the Federal eRulemaking Portal: http://www.regulations.gov. Written submissions may be faxed to 301-827-6870 or mailed to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
In a notice published in the Federal Register of March 15, 1990 (55 FR 9772), FDA announced that a food additive petition (FAP 0M4181) had been filed by Alpha Omega Technology Inc., 1279 Route 46 East, Parsippany, NJ 07054. The petition proposed to amend the food additive regulations in SEC 179.26 Ionizing radiation for the treatment of food (21 CFR 179.26) to provide for the safe use of a source of irradiation to treat finfish and shellfish.
FDA noted that the data provided in the petition indicated that there was very little margin of safety with regard to the concern for C. botulinum outgrowth and toxin elaboration, particularly in irradiated fish stored at temperatures between 46 and 50 degrees Fahrenheit. FDA therefore requested data demonstrating that products irradiated at the maximum dose requested and subjected to some temperature abuse would show evidence of spoilage before showing evidence of toxicity. Alpha Omega Technology Inc., according to the FDA, has been unresponsive to these requests, and other efforts to contact the petitioner regarding the petition have not been successful.
From the April 4, 2011, Prepared Foods E-dition