Transcript Prior Notice Center

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
Division of Import Operations & Policy
DIOP
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 Out of Date Operations for Handling Imports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
 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)
Intervention
Response
Import Safety Action Plan

Six building blocks
1.
2.
3.
4.
5.
6.

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
 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
 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
 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
PREVENTION
•Legislative changes
•Mandatory Certification
•Increased enforcement
•Beyond Our Borders
•Facility Verification Program
•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)
Life –Cycle of an Imported Product
INTERVENTION
•Increased enforcement
•Product Risk Assessments
•Laboratory results: Elexnet
•Increased Staff
•Domestic Inspections
•Importer history
•Develop rapid test kits
•Adverse Advents
•Voluntary Programs
•Use of State Data
•IT Improvements
•Legislative changes
•Historical examination results
•GIPs
•Import Alerts
•Recall Data
•Private Laboratory Guidance
•Expand laboratory capacity
•Collaboration with other Federal Agencies
•Collaboration with industry to develop new methods
•PREDICT
•Investigational tools
Life – Cycle of an Imported Product
RESPONSE
•Legislative changes
•Rapid Response Teams
•IT Improvements
•Collaboration with State Agencies
•Collaboration with other Federal Agencies
•Traceability Technologies
Life – Cycle of an Imported Product
 FDA Can Not Do It Alone!
Industry
Importers
Brokers
Congress
States