US Food and Drug Agency

“ Studies addressing these questions have been used, however, when they provided data useful to the identification of hazards or risks. Similarly, the Risk Assessment does not attempt to parse out the relative effectiveness of different cloning techniques or different laboratories in generating live animals. Results of cloning in species not commonly used for food have been employed only as they have utility as model systems (e.g., mice as models for livestock) . ”

“ Unpublished data were provided to us in raw, unanalyzed form, which we subsequently analyzed. CVM determined whether a particular publication or dataset was relevant to the analysis. These judgments were framed by the two overarching objectives of the Risk Assessment: determining whether cloning poses any health risks to the animals involved in the cloning process, and whether any hazards arise during the development of clones or their progeny that may pose food consumption risks. ”

“ Following an overview of the available data on animal clones, the report indicated that the most likely mechanism for generating hazards to clones would stem from reprogramming of the donor cell genome, and that any harms that might result from that reprogramming would be observed early in a clone’s development. ”