Mini Session: Risk Management & Communication

February 13, 2019
3:30 pm  -  5:30 pm

Moderator: John Balog, RBP, U.S. Food and Drug Administration, Silver Spring, MD

3:30 – 4:00 pm

Food Defense Authorities and Response (PDF, 3MB)

LeeAnne Jackson, PhD, U.S. Food and Drug Administration, College Park, MD

4:00 – 4:30 pm

Community Outreach Risks (PDF, 29MB)

Connie Holubar, MBA, University of Texas Medical Branch, Galveston, TX

4:30 – 5:30 pm
Gene Editing/Gene Therapy and Dealing with Regulatory Pathways

4:30 – 4:45pm

Federal Roles for Products of Biotechnology & USDA’s Plan Biotechnology Program (PDF, 796KB)

Biotechnology Regulatory Service (BRS)—U.S. Department of Agriculture
Michael Firko, PhD, U.S. Department of Agriculture, Riverdale, MD

4:45 – 5:00 pm

FDA Regulation of Animals with Intentionally Altered Genomic DNA (PDF, 3MB)

Center for Veterinary Medicine (CVM)—U.S. Food and Drug Administration
Laura Epstein, U.S. Food and Drug Administration, Rockville, MD

5:00 – 5:15 pm

Regulatory Pathway for Replicating Recombinant Veterinary Biologics (PDF, 424KB)

Center for Veterinary Biologics (CVB)—U.S. Department of Agriculture
Paul Hauer, DVM, PhD, U.S. Department of Agriculture—APHIS, Ames, IA

5:15 – 5:30 pm
Question and Answer


After completing this session, participants will be able to:

  • Identify the risks of community outreach
  • Restate the ways of engaging with regulatory institutions regarding gene editing and gene therapy
  • Define food defense

Session Category :  2019  Symposium Program  Wednesday