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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 It was current when produced, but is no longer maintained and may be outdated. . Welcome VMAC. Comments by Stephen F. Sundlof, D.V.M., Ph.D.

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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 It was current when produced, but is no longer maintained and may be outdated.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. Welcome VMAC Comments by Stephen F. Sundlof, D.V.M., Ph.D. Director, Center for Veterinary Medicine U.S. Food and Drug Administration To the Veterinary Medicine Advisory Committee Rockville, Maryland November 4, 2003

  3. Chairman John Waddell Members Corrie Brown Arthur Craigmill Sherman (Skip) Jack Deborah T. Kochevar Alexander MacDonald John McGlone Lisa Nolan Mark Papich Marguerite Pappaioanou Anne M. Parkhurst Dennis P. Wages Richard R. Wood VMAC Members

  4. Animal Biotechnology • Three new technologies • gene therapy • transgenics • cloning – today’s topic • CVM’s primary focus for cloning – food safety • also significant – animal health

  5. Cloning Risk Assessment • Identify hazards and characterize risks • Part of larger process of developing policy • necessary before making decisions about managing risks

  6. Information for Risk Assessment • Effort builds on the recommendations of National Academy of Sciences • Concluded somatic cell nuclear transfer appeared to cause no food safety concerns • more data needed

  7. Publicly Available Information • Another goal today – present risk assessment information publicly • FDA promised at start that process would be transparent

  8. First Risk Assessment Question • Do the risks experienced by animals involved in the cloning process differ qualitatively from those experienced by animals undergoing other assisted reproductive technologies?

  9. Second Risk Assessment Question • Are the edible products derived from animal clones and their progeny as safe to eat as the edible products derived from their conventional counterparts?

  10. Our Initial Conclusions • Frequency of animal health problems higher in newborns • but type of problems were no different • Food from adult clones is as safe as food from conventional adult animals

  11. Questions for VMAC (1) Based on what we have presented, has the risk assessment adequately identified the hazards and characterized the risks relating to animal health?

  12. Questions for VMAC (2) Based on what we have presented, has the risk assessment adequately identified the hazards and characterized the risks relating to food consumption?

  13. Thank You • Your review is part of transparency we want to bring to initiative • Your expertise will help us be sure analysis is best possible

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