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U.S. Department of Health and Human Services

Advisory Committees

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Agenda for the AquAdvantage Salmon Veterinary Medicine Advisory Committee Meeting

September 19-20, 2010

Sunday, September 19, 2010 -- Orientation

This session will provide a broad overview of the issues with which the Committee should be familiar prior to considering the specific issues of the AquAdvantage salmon. Ample opportunity for questions and answers from Committee members will be provided. Opportunities for clarifying questions and answers will also be provided to the public.

1:00 - 1:20Welcome

Bernadette Dunham, DVM, PhD
Director, Center for Veterinary Medicine

1:20 - 1:40The Role of the Committee Member

Aleta Sindelar
VMAC Executive Secretary

1:40 - 2:00Genetic Engineering for Animals 101

Larisa Rudenko, PhD, DABT
Animal Biotechnology Interdisciplinary Group

2:00 - 2:20New Animal Drug Approval Process Applied to GE Animals

Laura Epstein, JD
Office of Chief Counsel

2:20 – 2:40National Environmental Policy Act (NEPA)
Eric Silberhorn, PhD, DABT
Animal Biotechnology Interdisciplinary Group
2:40 – 3:00Break    
3:00 – 3:20Overview of Hierarchical Risk-Based Review Process;
Weight of Evidence Approaches; Team-Based Peer Review

Larisa Rudenko, PhD, DABT


3:20 – 4:20Guidance 187 Recommendations for Data Presentation

ABIG Scientific Experts

4:20 – 4:30Deliberative Process

Aleta Sindelar

4:30 - 5:30Questions and Answers from VMAC to Agency Experts  


Animal Biotechnology Interdisciplinary Group (ABIG) Scientific Experts:
Jay Cormier, JD, PhD
Evgenij Evdokimov, PhD
Kevin Greenlees, PhD, DABT
Barry Hooberman, PhD, DABT
Jeffery Jones, DVM, PhD
Kathleen Jones, PhD
Donald Prater, DVM
Larisa Rudenko, PhD, DABT
Eric Silberhorn, PhD, DABT


Monday, September 20, 2010

8:00Welcome and Ground RulesAleta Sindelar
8:15Opening Remarks from CVM Center DirectorBernadette Dunham, DVM, PhD
8:25Opening Remarks from CFSANMichael Landa, JD
8:35Remarks from ONADESteven Vaughn, DVM
8:45State of World FisheriesYonathan Zohar, PhD, Director and Professor
Center of Marine Biotechnology, University of Maryland
9:25Atlantic Salmon and Risk Issues Associated with FishEric Hallerman, PhD
Professor of Fisheries and Wildlife
Department Head, Virginia Tech
10:00AnnouncementsAleta Sindelar
10:45AquaBounty TechnologiesRon Stotish, PhD, CEO
11:00Regulation of GE Animals at FDALarisa Rudenko, PhD, DABT
11:20Molecular Characterizations of AquAdvantage SalmonJeff Jones, DVM, PhD
11:40Phenotypic Characterization of AquAdvantage SalmonDonald Prater, DVM
12:00AnnouncementsAleta Sindelar
1:15Food/Feed Safety Assessment of AquAdvantage SalmonKevin Greenlees, PhD, DABT
Kathleen Jones, PhD
1:35Environmental Assessment for AquAdvantage SalmonEric Silberhorn, PhD, DABT
1:55Claim ValidationEvgenij Evdokimov, PhD
2:05Durability Plan; Post Market RequirementsJay Cormier, JD, PhD
Barry Hooberman, PhD, DABT
2:45Public Comments to the VMAC  
4:30Charge to VMAC; Questions of Clarification from VMAC to any PresentersLarisa Rudenko, PhD, DABT
4:45Discussion and VMAC OpinionDr. David Senior, VMAC Chair
6:00AdjournmentAleta Sindelar