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U.S. Food and Drug Administration

U.S. Food and Drug Administration. Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

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U.S. Food and Drug Administration

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  1. U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

  2. Cloning of Animals with Known Genetic Merit - Risk Assessment Background John C. Matheson FDA, Center for Veterinary Medicine Rockville, Maryland

  3. Clones of Elite Animals “Just Clones” = Just Copies, Not Genetically Engineered

  4. Goals of the Animal Cloning Risk Analysis Process • Science-based Decisionmaking • Education about Cloning • Transparency of Decisionmaking Process • Establish a Basis for Risk Management Proportionate with Level of Risk

  5. Assessing Animal Clones - 2000-2004 • Meetings with Commercial and Academic Groups Conducting Cloning - 2000 cont. Encouraging Publication of Safety Data • Requested Temporary Halt to Introduction of Products from Clones into Food and Feed - CVM Update7/01 • Contracted for Review of Safety Issues by National Academies of Science - Delivered 09/02

  6. Assessing Animal Clones - 2000 - 2004 • Co-Sponsored w/ PIFB Public Meeting on Animal Cloning- 09/02, Report 06/03 • Preparing Risk Assessment for Animal Clones and Progeny - Final Stages • VMAC Public Meeting - Draft Exec. Summary and Preview RA Presentation • Release of Draft RA for Comment via CVM Website

  7. Definitions Somatic Cell Nuclear Transfer= the fusion of the nuclei (or entirety) of diploid donor cells with unfertilized, enucleated oöcytes. Clone = Animal resulting directly from SCNT (AC= Animal Clone) Clone Progeny = Any animal derived from sexual reproduction that has a clone as at least one parent. Specifically excludes clones of clones. (P= Progeny)

  8. Not = In general, clones and genetically engineered animals occupy different “risk spaces”. Clones v Genetically Engineered Animals

  9. Enucleation of oöcyte Insertion of donor cell Fusion Implantation from www.cyagra.com The Technology

  10. How was the animal produced? Somatic Cell Nuclear Transfer BNT Embryo Split Natural Service AI ± Frozen Semen in vitro Fertilization Data Review, Risk Analysis Develop Policy Products Enter Foodstream via Conventional Route(s) Animal Clone Risk Assessment: Technology Continuum

  11. Risk Assessment Presentations • Risk Assessment Methodology • Data Summaries • Animal Health Risk Conclusions • Food Consumption Risk Conclusions

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