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

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Presentation on theme: "The Boston Seafood Show March 16, 2009 Presentation by: CDR Domenic J. Veneziano, Director, Division of Import Operations DIOP Division of Import Operations."— Presentation transcript:

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

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3 Import Challenges  Globalization  Consumers/behavior  Advanced Technology  Economy  Out of Date Operations for Handling Imports  Resources  Counterterrorism Responsibilities  Information Technology (IT) Division of Import Operations & Policy DIOP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 – 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 1.Advance a Common Vision 2.Increase Accountability, Enforcement, and Deterrence 3.Focus on Risk over the Life-Cycle of an Imported Product 4.Build Interoperable Systems 5.Foster a Culture of Collaboration 6.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  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

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 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

11 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

12 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

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


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