VIII – Air Cargo Americas International Congress and Exhibition

1. VIII – Air Cargo AmericasInternational Congress and Exhibition Food and Drug Administration – Florida District – Import Operations Branch Ted Ogdahl March 2, 2006

2. U.S. Statutes • Food, Drug and Cosmetic Act 1938 • Bioterrorism Act 2002 • FDA 100th Birthday 2006

3. Prior Notice Submission • No more than 5 days prior • Road (truck) – 2 hours • Rail & Air – 4 hours • Water – 8 hours • Mail – before food is sent • Electronic submission only • Confirmation numbers

4. Prior Notice Contact • www.fda.gov or www.fda.access.gov • Brokers -- over 85% • Questions by phone (English is mostly spoken) – outside U.S. 301-575-0156 fax 301-210 0247

5. Registration – BT Act 2002 • Registration is in addition to other requirements such as for LACF/Acidified Foods and Seafood HACCP. • Manufacturers/processors, packers, storage operations must register • Not to register food contact surfaces or pesticides

6. Operational & Administrative System for Import Support OASIS

7. Entry Review - How Decisions are Made • OASIS • Import Alerts/FIARS • First Level of Review • Compliance Review Imports R’ Us @ Import.com

8. FDA Options • May Proceed. • Conduct field examination. • Collect sample. • Detain based on document review or DWPE (Detention without physical examination).

9. Compliance Options • Release • Detention • Refusal • Release - Import for Export Intention declared.

10. Detention • 10 day response period, minimum. • Detention without physical examination (DWPE). • Private Laboratories.

11. Refusal • Redeliver to Customs • Importer’s options • Destruction (Customs Form 3499) • Exportation (Customs Form 7512)

12. Perishable Samples – FDA Lab. • After collecting samples, the samples are shipped to FDA Southeast Regional Laboratory, Atlanta, Georgia (SER) • Overnight shipments • SER conducts analysis and provides the results in OASIS • Chain of Custody is recorded

13. Exam or Sample Timeframes • Samples for pesticide analysis: 24-48 hours • Samples for microbiological analysis: 2 weeks average • Importer makes a business decision – a violation may result in bond liquidation by customs • Sample collected after release may result in a recall procedure • Violation results in an addition to the Import Alert List • Detention and Refusal Process followed

14. Field Exam/Label Exam • Field Exam conducted on the spot • Label exam conducted on the spot with further examination by an FDA Compliance Officer • Detention Period is the time for a reconditioning proposal (Form 766) • Ask for an extension of detention if needed

15. FDA Notice of Action • OASIS sends an electronic notification to the broker • Detention and Refusal Notice of Actions are mailed to the Broker and Importer • Contact Persons name is on the Notice of Action with phone, fax, and e-mail • Take action on the Detention

16. Process • Reconditioning Proposals During Detention • FDA will hear the Importer during Detention – Give explanations • After Refusal Destruction or Re-Export are the Importer’s Options • Petition CBP after Refusal

17. FDA Miami Imports • FDA • Florida District Import Operations Branch • 66011 NW 25 Street, Suite 241 • Miami, Florida, 33122 • USA • www.fda.gov

18. After Refusal • Customs redelivery/FDA refusal • CUSTOMS CASES • Bond liquidation cases; 3 x value • Informal entries vs. formal entries • Petitions to CBP – mitigation • CBP and FDA working as a team

19. FDA enforcement • Introduction of adulterated – misbranded FDA regulated products into domestic commerce • Influencing voluntary recalls • FDA seizure – USDOJ • FDA injunction – USDOJ • FDA Criminal prosecution – OCI • “May proceed” overturn – 30 days

20. Miami FDA Problems • Pathogens in cheese • Pathogens in seafood • Pesticides in fresh produce • Antibiotics in seafood • Antibiotics in honey • Import Alert guidance • Getting off and Import Alert