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Salmon

Salmon

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Published by: srust2792 on Sep 10, 2010
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10/31/2011

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BRIEFING PACKET
Food and Drug AdministrationCenter for Veterinary MedicineVeterinary Medicine Advisory CommitteeSeptember 20, 2010
 AquAdvantage Salmon
 
 
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PREFACE
 
 

 
VMAC Briefing PacketAquAdvantage Salmon
TABLE OF CONTENTS
I. BACKGROUND..............................................................................................................1A. Introduction.......................................................................................................................1B. Risk-Based Approach to Assessing Genetically Engineered (GE) Animals....................2C. Team-Based Review ........................................................................................................6D. Transparency and Public Participation.............................................................................6E. Summary...........................................................................................................................7II. PRODUCT DEFINITION................................................................................................8III. MOLECULAR CHARACTERIZATION OF THE CONSTRUCT.................................9A. Overview...........................................................................................................................9B. Evaluation.......................................................................................................................10C. Conclusions.....................................................................................................................13IV. MOLECULAR CHARACTERIZATION OF THE GE ANIMAL LINEAGE..............14A. Overview.........................................................................................................................14B. Evaluation.......................................................................................................................14C. Conclusion......................................................................................................................20V. PHENOTYPIC CHARACTERIZATION......................................................................21A. Overview.........................................................................................................................21B. Evaluation.......................................................................................................................22C. Addressing the Risk Questions.......................................................................................45D. Conclusions.....................................................................................................................46VI. GENOTYPIC AND PHENOTYPIC DURABILITY.....................................................48A. Overview.........................................................................................................................48B. Evaluation.......................................................................................................................49C. Conclusions.....................................................................................................................60VII. FOOD AND FEED SAFETY.........................................................................................61A. Overview.........................................................................................................................61B. Is AquAdvantage Salmon an Atlantic salmon?..............................................................63C. Hazard Characterization for Food Safety Determination ..............................................64D. Summary of the Characterization of Food Consumption Hazards...............................107E. Characterization and Summary of Food Consumption Risks.......................................108F. Uncertainties.................................................................................................................109G. Analytical Method for a Tolerance...............................................................................109iii

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