FDA RELEASES DRAFT SUMMARY OF RISK ASSESSMENT FOR ANIMAL CLONING, HOLDS PUBLIC MEETING OF ITS ADVISORY COMMITTEE

The U.S. Food and Drug Administration (FDA) on October 31, 2003, released a draft executive summary of its assessment of food and animal health aspects of animal cloning1,2. The draft report was discussed at a public meeting of FDAs Veterinary Medicine Advisory Committee (VMAC) on November 4. These developments renewed public debate on whether and under what conditions the products of cloned animals might be permitted to enter the food supply. Draft Risk Assessment The draft risk assessment2 evaluated the effects of cloning on the health and safety of food products from cloned animals. It built upon the findings of a recent National Research Council study3 considering several data sets not then available. By far, the most information was available for cloned cattle, followed by swine; rela-tively little information was available for goats or sheep. The draft assessment compared the effects of cloning on animal health with those of other assisted reproductive technologies (ARTs) such as artificial insemination, in vitro fertilization, and blastomere nuclear transfer. Most cloned embryos fail to develop, and most pregnancies terminate spontaneously due to fetal abnormalities or problems with placentation. None of the adverse outcomes noted among neonatal cloned animalssuch as large offspring syndrome and under-developed respiratory, cardiovascular, and renal systemsare qualitativel