FDA CVM GFI #179 Use of Animal Clones and Clone Progeny for Human Food and Animal Feed

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CVM GFI #179 Use of Animal Clones and Clone Progeny for Human Food and Animal Feed[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于United States。

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Use of Animal Clones and Clone Progeny for Human Food and Animal Feed This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. Introduction FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required. FDA’s Center for Veterinary Medicine (CVM) recently completed a risk assessment 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 II. Background In July 2001, FDA’s Center for Veterinary Medicine (CVM) issued an Update on Livestock Cloning (available at http://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm130

770.htm ) and proceeded to work with stakeholders to assess potential risks presented by cloning food-producing animals. CVM also requested that companies voluntarily refrain from introducing meat or milk from animal clones or their progeny into the human or animal food supply pending completion of the risk assessment process.

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