FDA’s Center for Veterinary Medicine (CVM) completed a risk assessment in 2008 entitled “Animal Cloning: A Risk Assessment” on the potential risks presented by cloning food-producing animals. Among the goals of the risk assessment were the determination of whether somatic cell nuclear transfer (SCNT, the process used to produce the clones being considered in the risk assessment) poses any unique risks to animals involved in cloning relative to other assisted reproductive technologies (ARTs), and whether foods derived from animal clones or their progeny pose consumption risks greater than those posed by foods derived from their conventional counterparts. This guidance document describes FDA’s recommendations regarding the introduction of edible products from animal clones and their progeny into the food and feed supply. To the extent any parts of SCNT or animal clones, based on being derived from SCNT, meet the requirements for regulation as new animal drugs under the Federal Food, Drug, and Cosmetic Act (Act), this guidance also sets out FDA’s enforcement policy that FDA intends to exercise its enforcement discretion.

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