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The Boston Seafood Show
March 16, 2009
Presentation by:CDR Domenic J. Veneziano,
Director, Division of Import Operations
DIOPDivision of Import Operations & Policy
Overview of Presentation
Four Major Initiatives
Import Operations of Tomorrow
Division of Import Operations & Policy
DIOP
Import Challenges
GlobalizationConsumers/behaviorAdvanced TechnologyEconomyOut of Date Operations for Handling ImportsResourcesCounterterrorism Responsibilities Information Technology (IT)
Division of Import Operations & Policy
DIOP
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
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)InterventionResponse
Import Safety Action Plan
Six building blocks
1. Advance a Common Vision2. Increase Accountability, Enforcement, and Deterrence3. Focus on Risk over the Life-Cycle of an Imported Product4. Build Interoperable Systems5. Foster a Culture of Collaboration6. Promote Innovative Technologies and New Science
Action Plan – November 2007
14 Broad Recommendations 50 Specific Action Steps
– Short and Long Term
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
Three core elements: Prevention Intervention Response
Under each element Key steps
• FDA actions• Legislative proposals
Approach 38 FDA Administrative Actions 10 Legislative Proposals
Food Protection Plan
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
Life –Cycle of an Imported Product
• Beyond Our Borders
• Third Party Certification
• Facility Verification Program
• FDA Foreign Inspections• Foreign Governments
MOAs
PREVENTION
• Dedicated Foreign Cadre
• Development of Standards
• IT Improvements
• Voluntary Programs
• Legislative changes
• Good Importer Practices (GIPs)
• Increased enforcement
• Mandatory Certification
• Unique Identifier for firms
Life –Cycle of an Imported Product
• Domestic Inspections
• Use of State Data
• Recall Data
• Adverse Advents
• Historical examination results
• Product Risk Assessments
• Importer history
• Voluntary Programs
• Laboratory results: Elexnet
INTERVENTION
• Increased Staff
• IT Improvements
• Collaboration with other Federal Agencies
• Legislative changes
• Import Alerts
• Increased enforcement
• Investigational tools
• Expand laboratory capacity
• Develop rapid test kits
• GIPs
• Collaboration with industry to develop new methods
• PREDICT
• Private Laboratory Guidance
Life – Cycle of an Imported Product
RESPONSE
• Legislative changes
• Rapid Response Teams
• IT Improvements
• Traceability Technologies
• Collaboration with other Federal Agencies
• Collaboration with State Agencies
Life – Cycle of an Imported Product
FDA Can Not Do It Alone!
IndustryImportersBrokersCongressStates