Chapter I: Executive Summary
Cloning is the colloquial term used to describe the process of somatic cell nuclear transfer (SCNT) that falls on a continuum of assisted reproductive technologies (ARTs) currently used in agriculture. In this Risk Assessment, the Center for Veterinary Medicine (CVM or the Center) at the US Food and Drug Administration (FDA) presents a science-based review of the available information on cloning in species traditionally used for food (i.e., cattle, swine, sheep, and goats).
A. Overview
This Risk Assessment addresses SCNT technology, its impact on the health of animals involved in that process, and food consumption hazards that may arise in animal clones and their progeny[1] in the context of the use of ARTs in conventional animal agriculture. Chapter II is a summary of ARTs currently used in food animal breeding and a detailed explanation of SCNT. Chapter III describes the process of risk assessment, its application to animal cloning, and the nature of the hazards that may arise as the result of cloning. A synopsis of the processes involved in epigenetic reprogramming and their relevance to adverse outcomes noted in animals derived via SCNT and other ARTs is found in Chapter IV. Chapter V addresses potential health risks to animals involved in the process of cloning, including surrogate dams, clones, and their progeny. Chapter VI addresses potential food consumption risks that may result from edible products derived from animal clones or their progeny. Each chapter contains conclusions relevant to that subject; the Risk Assessment is summarized in Chapter VII, and our overall conclusions are presented there. In order to make this process as transparent as possible, all of our methodologies are presented in the text of the risk assessment; the information and data that CVM evaluated are publicly available, either in peer-reviewed publications, or in Appendices to this document. The process by which CVM drew its conclusions is presented in the Risk Assessment, along with explicit statements of potential bias and uncertainty. The document concludes with a complete bibliography, a glossary of terms, and appendices containing data and background information.
The Risk Assessment is the result of a qualitative analysis that identifies and characterizes the nature of hazards that may be introduced into animals as a result of cloning, and puts them in the context of other ARTs currently practiced in the United States. The strongest conclusions that
- ↑ For the purposes of this analysis, a clone is defined as an animal produced asexually from a single animal by somatic cell nuclear transfer. Clones are thus genetically identical to their nuclear donor animal. Progeny of clones have at least one animal clone as a parent (but could also result from mating two animal clones) and are produced by sexual reproduction. Clones of clones would be considered as clones (i.e., directly arising from an SCNT process).
Animal Cloning: A Risk Assessment
