The Boston Seafood Show March 16, 2009 Presentation by: CDR Domenic J. Veneziano , Director, Division of Import Operat

1. The Boston Seafood Show March 16, 2009 Presentation by: CDR Domenic J. Veneziano, Director, Division of Import Operations Division of Import Operations & Policy DIOP

2. Overview of Presentation • Four Major Initiatives • Import Operations of Tomorrow Division of Import Operations & Policy DIOP

3. Import Challenges • Globalization • Consumers/behavior • Advanced Technology • Economy • Out of Date Operations for Handling Imports • Resources • Counterterrorism Responsibilities • Information Technology (IT) Division of Import Operations & Policy DIOP

4. Four Major Initiatives • Import Safety Action Plan (ISAP) • Food and Drug Amendments Act (FDAAA) • Food Protection Plan (FPP) • ORA’s Revitalization Plan Division of Import Operations & Policy DIOP

5. Import Safety Action Plan • Executive Order 13439 – July 2007 • Involvement of 12 Federal Departments and Agencies - Led by HHS Secretary Leavitt • The Import Safety Action Plan follows the organizing principles identified in the Strategic Framework – September 2007: • Prevention (with Verification) • Intervention • Response

6. Import Safety Action Plan • Six building blocks • Advance a Common Vision • Increase Accountability, Enforcement, and Deterrence • Focus on Risk over the Life-Cycle of an Imported Product • Build Interoperable Systems • Foster a Culture of Collaboration • Promote Innovative Technologies and New Science • Action Plan – November 2007 • 14 Broad Recommendations • 50 Specific Action Steps • Short and Long Term

7. The Food Protection Plan • In May 2007, the Secretary of HHS and the Commissioner of Food and Drugs charged FDA with developing a comprehensive, integrated Food Protection Plan • Food for people and animals • Domestic and imported • Food safety and food defense

8. Food Protection Plan • Three core elements: • Prevention • Intervention • Response • Under each element • Key steps • FDA actions • Legislative proposals • Approach • 38 FDA Administrative Actions • 10 Legislative Proposals

9. Import Operations of Tomorrow • The Goal is to focus on the life-cycle of an imported product and make risk-base decisions to target those products that are of the highest risk to Public Health

10. Life –Cycle of an Imported Product • PREVENTION • Legislative changes • Beyond Our Borders • Mandatory Certification • Facility Verification Program • Increased enforcement • FDA Foreign Inspections • Development of Standards • Foreign Governments MOAs • Third Party Certification • IT Improvements • Voluntary Programs • Unique Identifier for firms • Dedicated Foreign Cadre • Good Importer Practices (GIPs)

11. Life –Cycle of an Imported Product • INTERVENTION • Increased Staff • Product Risk Assessments • Increased enforcement • Laboratory results: Elexnet • Domestic Inspections • Importerhistory • Develop rapid test kits • Voluntary Programs • Adverse Advents • Use of State Data • IT Improvements • Legislative changes • Import Alerts • Historical examination results • Recall Data • GIPs • Private Laboratory Guidance • Expand laboratory capacity • Collaboration with other Federal Agencies • Investigational tools • Collaboration with industry to develop new methods • PREDICT

12. Life – Cycle of an Imported Product • RESPONSE • Collaboration with State Agencies • Legislative changes • Collaboration with other Federal Agencies • Rapid Response Teams • Traceability Technologies • IT Improvements

13. Life – Cycle of an Imported Product • FDA Can Not Do It Alone! • Industry • Importers • Brokers • Congress • States