Wholesomeness Studies of Precooked (Enzyme-Inactivated) Chicken Products in Vacuum Sealed Containers Exposed to Doses of Ionizing Radiation Sufficient to Achieve 'Commercial Sterility' (Summary of Supporting Documents)

摘要

The document provides a synopsis and reference to the principal documents submitted to the Food and Drug Administration by the Agricultural Research Service, USDA, concerning the wholesomeness studies of precooked (enzyme inactivated) chicken products in vacuum sealed containers exposed to doses of ionizing radiation sufficient to achieve 'commercial sterility.' Reference is provided herein to the results of studies on (1) irradiation technology, (2) packaging technology, (3) processing technology, (4) microbiology of irradiated products, (5) radiolysis compounds, (6) animal and other studies of the nutritional value and/or wholesomeness of chicken products sterilized by ionizing radiation. On balance these studies supported the conclusion that the irradiation sterilized chicken products were wholesome, however, two of the studies namely the dominant lethal study and the chronic toxicity, oncogenicity, multigeneration reproductive study with mice had some possibly adverse findings which will require careful consideration before the process can be declared safe. These potentially adverse findings are summarized in this report.