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 It was current when produced, but is no longer maintained and may be outdated.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 DecisionmakingScience-based Decisionmaking Education about CloningEducation about Cloning Transparency of Decisionmaking ProcessTransparency of Decisionmaking Process Establish a Basis for Risk Management Proportionate with Level of RiskEstablish 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 DataMeetings 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 Update7/01Requested 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 09/02Contracted 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 06/03Co-Sponsored w/ PIFB Public Meeting on Animal Cloning- 09/02, Report 06/03 Preparing Risk Assessment for Animal Clones and Progeny - Final StagesPreparing Risk Assessment for Animal Clones and Progeny - Final Stages VMAC Public Meeting - Draft Exec. Summary and Preview RA PresentationVMAC Public Meeting - Draft Exec. Summary and Preview RA Presentation Release of Draft RA for Comment via CVM WebsiteRelease 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. In general, clones and genetically engineered animals occupy different “risk spaces”. Not = Clones v Genetically Engineered Animals

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

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

11. Risk Assessment Presentations Risk Assessment MethodologyRisk Assessment Methodology Data SummariesData Summaries Animal Health Risk ConclusionsAnimal Health Risk Conclusions Food Consumption Risk ConclusionsFood Consumption Risk Conclusions