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

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