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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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The Boston Seafood Show

March 16, 2009

Presentation by:

CDR Domenic J. Veneziano,

Director, Division of Import Operations

Division of Import Operations & Policy

DIOP


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Overview of Presentation

  • Four Major Initiatives

  • Import Operations of Tomorrow

Division of Import Operations & Policy

DIOP


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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  • Out of Date Operations for Handling Imports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


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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


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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


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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


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    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


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    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


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    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


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    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)


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    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


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    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


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    Life – Cycle of an Imported Product

    • FDA Can Not Do It Alone!

    • Industry

    • Importers

    • Brokers

    • Congress

    • States


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