U.S. Food and Drug Administration
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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 It was current when produced, but is no longer maintained and may be outdated.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. 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 It was current when produced, but is no longer maintained and may be outdated. - PowerPoint PPT Presentation
Transcript of U.S. Food and Drug Administration
U.S. Food and Drug Administration
Notice: Archived DocumentThe 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 It was current when produced, but is no longer maintained and may be outdated.
Cloning of Animals with Cloning of Animals with Known Genetic Merit - Known Genetic Merit - Risk Assessment BackgroundRisk Assessment Background
John C. MathesonJohn C. Matheson
FDA, Center for Veterinary MedicineFDA, Center for Veterinary Medicine
Rockville, MarylandRockville, Maryland
Clones of Elite AnimalsClones of Elite Animals
“Just Clones” = Just Copies, Not Genetically Engineered
Goals of the Animal Cloning Risk Goals of the Animal Cloning Risk Analysis ProcessAnalysis Process
• Science-based DecisionmakingScience-based Decisionmaking
• Education about CloningEducation about Cloning
• Transparency of Decisionmaking ProcessTransparency of Decisionmaking Process
• Establish a Basis for Risk Management Establish a Basis for Risk Management Proportionate with Level of RiskProportionate with Level of Risk
Assessing Animal Clones - 2000-2004Assessing Animal Clones - 2000-2004
• Meetings with Commercial and Academic Meetings with Commercial and Academic Groups Groups Conducting Cloning - 2000 cont. Conducting Cloning - 2000 cont. Encouraging Encouraging Publication of Safety DataPublication of Safety Data
• Requested Temporary Halt to Introduction of Requested Temporary Halt to Introduction of Products from Clones into Food and Feed - Products from Clones into Food and Feed - CVM CVM Update7/01Update7/01
• Contracted for Review of Safety Issues by Contracted for Review of Safety Issues by National National Academies of Science - Academies of Science - Delivered 09/02Delivered 09/02
Assessing Animal Clones - 2000 - 2004Assessing Animal Clones - 2000 - 2004
• Co-Sponsored w/ PIFB Public Meeting on Co-Sponsored w/ PIFB Public Meeting on Animal Cloning- 09/02, Report 06/03Animal Cloning- 09/02, Report 06/03
• Preparing Risk Assessment for Animal Preparing Risk Assessment for Animal Clones and Progeny - Final StagesClones and Progeny - Final Stages
• VMAC Public Meeting - Draft Exec. VMAC Public Meeting - Draft Exec. Summary and Preview RA PresentationSummary and Preview RA Presentation
• Release of Draft RA for Comment via CVM Release of Draft RA for Comment via CVM WebsiteWebsite
DefinitionsDefinitionsSomatic Cell Nuclear TransferSomatic Cell Nuclear Transfer= the fusion of the = the fusion of the nuclei (or entirety) of diploid donor cells with nuclei (or entirety) of diploid donor cells with unfertilized, enucleated oöcytes.unfertilized, enucleated oöcytes.
Clone Clone = Animal resulting directly from SCNT (AC= = Animal resulting directly from SCNT (AC= Animal Clone)Animal Clone)
Clone ProgenyClone Progeny = Any animal derived from sexual = Any animal derived from sexual reproduction that has a clone as at least one parent. reproduction that has a clone as at least one parent. Specifically excludes clones of clones. (P= Progeny)Specifically excludes clones of clones. (P= Progeny)
In general, clones and genetically engineered animals occupy different “risk spaces”.
Not =
Clones v Genetically Engineered Clones v Genetically Engineered AnimalsAnimals
Enucleation of oöcyte
Insertion of donor cell
Fusion
Implantation
from www.cyagra.com
The TechnologyThe Technology
Data Review,Risk Analysis
DevelopPolicy
Data Review,Risk Analysis
DevelopPolicy
How was the animal produced?How was the animal produced?
NaturalServiceNaturalService
AI ±FrozenSemen
AI ±FrozenSemen
in vitroFertilization
in vitroFertilization
EmbryoSplit
EmbryoSplit
SomaticCell
NuclearTransfer
SomaticCell
NuclearTransfer
Products EnterProducts EnterFoodstreamFoodstream
viaviaConventionalConventional
Route(s)Route(s)
Products EnterProducts EnterFoodstreamFoodstream
viaviaConventionalConventional
Route(s)Route(s)
BNTBNT
Animal Clone Risk Assessment: Animal Clone Risk Assessment: Technology ContinuumTechnology Continuum
Risk Assessment PresentationsRisk Assessment Presentations
• Risk Assessment MethodologyRisk Assessment Methodology
• Data SummariesData Summaries
• Animal Health Risk ConclusionsAnimal Health Risk Conclusions
• Food Consumption Risk ConclusionsFood Consumption Risk Conclusions
