Overview of FDA

1
Overview of FDAs Food Security Program Joseph
A. LevittDirector, Center for Food Safety and
Applied NutritionNovember 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_at_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

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Reducing Overall Risk from Terrorist Attacks on Food Supply Reducing Overall Risk from Terrorist Attacks on Food Supply Reducing Overall Risk from Terrorist Attacks on Food Supply Reducing Overall Risk from Terrorist Attacks on Food Supply
  2001 2003 2007
Prevention Prevention Prevention Prevention
Food Testing      
Inspections      
Intelligence      
Registration and Prior Notice      
Preparedness Preparedness Preparedness Preparedness
Inactivation Technologies      
In-line Detection Technologies      
Security      
Response Response Response Response
Lab Capacity      
Emergency Response      
Highest Risk (Severity x Probability)
Medium Risk
High Risk
Low Risk
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• Todays 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

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.