title: The US FDA and animal cloning: risk and regulatory approach.
abstract: The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used.
authors.affiliation: Center for Veterinary Medicine, US Food and Drug Administration, Department of Health and Human Services, HFV-100, Rockville, MD 20855, USA. larisa.rudenko@fda.hhs.gov
authors.forename: Larisa
authors.initials: L
authors.lastname: Rudenko
authors.forename: John C
authors.initials: JC
authors.lastname: Matheson
mesh_terms: D000818:Animals; D000829:Animals, Domestic / Q000235:genetics*; D001709:Biotechnology / Q000331:legislation & jurisprudence* / Q000592:standards; D002417:Cattle / Q000235:genetics; D019976:Cloning, Organism / Q000662:veterinary*; D003257:Consumer Product Safety; D006041:Goats / Q000235:genetics; D006801:Humans; D018570:Risk Assessment; D012308:Risk Management; D013552:Swine / Q000235:genetics; D014481:United States; D014486:United States Food and Drug Administration