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

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

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slide1
The Boston Seafood Show

March 16, 2009

Presentation by:

CDR Domenic J. Veneziano,

Director, Division of Import Operations

Division of Import Operations & Policy

DIOP

overview of presentation
Overview of Presentation
  • Four Major Initiatives
  • Import Operations of Tomorrow

Division of Import Operations & Policy

DIOP

import challenges
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  • Out of Date Operations for Handling Imports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

four major initiatives
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
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
import safety action plan6
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
the food protection plan
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
food protection plan
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
import operations of tomorrow
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
slide10

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)
slide11

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
slide12

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
life cycle of an imported product
Life – Cycle of an Imported Product
  • FDA Can Not Do It Alone!
  • Industry
  • Importers
  • Brokers
  • Congress
  • States
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