1. , 2003 Overview of FDA’s Food Security Program Joseph A. Levitt Director, Center for Food Safety and Applied Nutrition November 6, 2003

2. Main Messages ●We need to be prepared. ●While we are much better prepared than we were 2 years ago, we have a very long way to go. ●We have a blueprint on how to get there.

3. July 23, 2003 Progress Report Principles ●Food security and safety are integrated goals. ●The food safety and security system is comprehensive. ●The food safety and security system is built on a solid foundation of national partnership. ●Americans must have confidence in the U.S. government.

4. July 23, 2003 Progress Report Strategic Categories ●Awareness ●Prevention ●Preparedness ●Response ●Recovery

5. July 23, 2003 Progress Report 10 Operational Categories ●Stronger FDA – New Staff

6. July 23, 2003 Progress Report 10 Operational Categories ●Stronger FDA – New Staff ●Imports – Strategic Approach

7. July 23, 2003 Progress Report 10 Operational Categories ●Stronger FDA – New Staff ●Imports – Strategic Approach ●Bioterrorism Act Regulations

8. Registration ●Will facilitate timely notification and response in the event of a food safety threat ●Interim Final Rule (IFR) Published October 10, 2003 (68 FR 58894) ●Effective Date: December 12, 2003 ●Applies to most domestic and foreign facilities ●Registration system is operational now; electronic registration encouraged ●Registration is one-time, not annual; no fee ●Help is available at 800-216-7331 or furls@fda.gov ●See 21 CFR 170.3 for Food Product Categories

9. Prior Notice of Food Imports ●Requires advance notice of shipments of human and animal food being imported into the U.S. ●Interim Final Rule (IFR) Published October 10, 2003 (68 FR 58974) ●Effective Date: December 12, 2003 ●In Collaboration with Customs and Border Protection (CBP) ●Notices must be submitted electronically; most notices can come in through the existing CBP system ●Excludes food for personal use, food made at home for a gift and products regulated exclusively by USDA

10. July 23, 2003 Progress Report 10 Operational Categories ●Stronger FDA – New Staff ●Imports – Strategic Approach ●Bioterrorism Act Regulations ●Industry Guidance and Preventive Measures

11. July 23, 2003 Progress Report 10 Operational Categories ●Stronger FDA – New Staff ●Imports – Strategic Approach ●Bioterrorism Act Regulations ●Industry Guidance and Preventive Measures ●Vulnerability and Threat Assessments

12. July 23, 2003 Progress Report 10 Operational Categories ●Stronger FDA – New Staff ●Imports – Strategic Approach ●Bioterrorism Act Regulations ●Industry Guidance and Preventive Measures ●Vulnerability and Threat Assessments ●Operation Liberty Shield

13. July 23, 2003 Progress Report 10 Operational Categories ●Stronger FDA – New Staff ●Imports – Strategic Approach ●Bioterrorism Act Regulations ●Industry Guidance and Preventive Measures ●Vulnerability and Threat Assessments ●Operation Liberty Shield ●Emergency Preparedness and Response

14. July 23, 2003 Progress Report 10 Operational Categories ●Stronger FDA – New Staff ●Imports – Strategic Approach ●Bioterrorism Act Regulations ●Industry Guidance and Preventive Measures ●Vulnerability and Threat Assessments ●Operation Liberty Shield ●Emergency Preparedness and Response ●Laboratory Enhancements

15. July 23, 2003 Progress Report 10 Operational Categories ●Stronger FDA – New Staff ●Imports – Strategic Approach ●Bioterrorism Act Regulations ●Industry Guidance and Preventive Measures ●Vulnerability and Threat Assessments ●Operation Liberty Shield ●Emergency Preparedness and Response ●Laboratory Enhancements ●Research

16. July 23, 2003 Progress Report 10 Operational Categories ●Stronger FDA – New Staff ●Imports – Strategic Approach ●Bioterrorism Act Regulations ●Industry Guidance and Preventive Measures ●Vulnerability and Threat Assessments ●Operation Liberty Shield ●Emergency Preparedness and Response ●Laboratory Enhancements ●Research ●Interagency and International Communications and Collaboration

17. Reducing Overall Risk from Terrorist Attacks on Food Supply 200120032007 Prevention Food Testing Inspections Intelligence Registration and Prior Notice Preparedness Inactivation Technologies In-line Detection Technologies Security Response Lab Capacity Emergency Response Highest Risk (Severity x Probability) High Risk Medium Risk Low Risk

18. Today’s Speakers Threat/Vulnerability Assessments Robert Brackett, Ph.D. Food Security Research Needs, Priorities, Resources, and Challenges Robert Buchanan, Ph.D. Prevention Research David Armstrong, Ph.D. Food Security Research at the National Center for Toxicological Research Daniel Casciano, Ph.D. Animal Feed Safety System (AFSS), BSE and Food Security Research at the Center for Veterinary Medicine Linda Youngman, MS, Ph.D. Food Emergency Response Network Carl Sciacchitano Facilitating Biologics Product Development to Address Threats to Food Security Jesse Goodman, M.D., Ph.D. Medical Counter Measures Diane Murphy, M.D.

19. Conclusion ●We need to be prepared. ●While we are much better prepared than we were 2 years ago, we have a very long way to go. ●We have a blueprint on how to get there.