1. Food Security Research: The Race to Protect the U.S. Consumer

2. A New Way of Thinking Dealing with intentional contamination requires consideration of Dealing with intentional contamination requires consideration of New agents New agents New routes of introduction New routes of introduction

3. ` Sound Science Food Safety Programs Food Security Enhancements Food Security Challenge Has required FDA to rapidly enhance its capabilities Has required FDA to rapidly enhance its capabilities At the core is FDA’s strong science base At the core is FDA’s strong science base

4. Four Primary Food Security Research Needs Knowledge of Agents Knowledge of Agents Oral pathogenicity and toxicity Oral pathogenicity and toxicity Most information available is via inhalational route of exposureMost information available is via inhalational route of exposure Ingestion can increase or decrease potential toxicity/pathogenicityIngestion can increase or decrease potential toxicity/pathogenicity Matrix effects largely unknownMatrix effects largely unknown Behavior in foods Behavior in foods

5. Four Primary Food Security Research Needs Prevention, “Shields” Prevention, “Shields” Inactivation - neutralization technologies Inactivation - neutralization technologies Security technologies Security technologies In-line sensors In-line sensors

6. Four Primary Food Security Research Needs Response and Recovery Response and Recovery Laboratory support Laboratory support Rapid response research team Rapid response research team Facility clean-up Facility clean-up

7. Detection Methodology Detection Methodology Deployable, rapid field tests Deployable, rapid field tests Laboratory-based screening tests Laboratory-based screening tests Laboratory-based confirmatory tests Laboratory-based confirmatory tests Forensics Forensics Technology transfer Technology transfer Methods Validation Methods Validation Four Primary Food Security Research Needs

8. Getting to Where We Want to Be BasicResearch Safe Products, Sound Policies and Guidance

9. Getting to Where We Want to Be FDA Translational Research BasicResearch Safe Products, Sound Policies and Guidance

10. IntramuralResearchExtramuralResearch Centers of Excellence CFSAN Research Program

11. $5M Supplement Provided us with additional funds to get through the next lap of the race to protect the food supply Provided us with additional funds to get through the next lap of the race to protect the food supply

12. CFSAN Research Program Within weeks of the tragedy of 9/11, CFSAN redirected 30% of its intramural research program and most of its extramural program to food security Within weeks of the tragedy of 9/11, CFSAN redirected 30% of its intramural research program and most of its extramural program to food security

13. “Foods” Research Program Center for Food Safety and Applied Nutrition Center for Food Safety and Applied Nutrition Center for Veterinary Medicine Center for Veterinary Medicine Feed Safety Feed Safety Animal Health/Protection Animal Health/Protection Office of Regulatory Affairs Office of Regulatory Affairs Detection method adaptation Detection method adaptation Methods validation Methods validation FERN FERN National Center for Toxicological Research National Center for Toxicological Research

14. “Foods” Research Program Center for Food Safety and Applied Nutrition Center for Food Safety and Applied Nutrition Methods development Methods development Agent characterization Agent characterization Pathogencity/toxicityPathogencity/toxicity Behavior in foodsBehavior in foods Intervention technologies Intervention technologies Toxicity/Pathogenicity Toxicity/Pathogenicity Attempted to enhance food safety while advancing food security Attempted to enhance food safety while advancing food security

15. “Foods” Research Program Leverage research performed by medical, agricultural, and defense research agencies and the academic community Leverage research performed by medical, agricultural, and defense research agencies and the academic community DHHS NIH and CDC DHHS NIH and CDC USDA ARS and CREES USDA ARS and CREES DOD DOD

16. CFSAN Intramural Research Program

17. Meeting Critical Laboratory Infrastructure Needs Training of research to work with non-traditional agents Training of research to work with non-traditional agents Upgrading of laboratory security Upgrading of laboratory security Upgrading of critical instrumentation Upgrading of critical instrumentation Renovation of laboratories to perform BL-3 level research Renovation of laboratories to perform BL-3 level research Compliance with CDC and APHIS Select Agent Regulation Compliance with CDC and APHIS Select Agent Regulation

18. CFSAN Microbiology Laboratories First FDA laboratory to join LRN First FDA laboratory to join LRN Developed and disseminated methods for non- traditional pathogens in foods Developed and disseminated methods for non- traditional pathogens in foods Trained LRN and FERN members in analysis of foods Trained LRN and FERN members in analysis of foods Evaluation of methods in foods Evaluation of methods in foods

19. Evaluation of Detection Methods Kits developed for clinical and microbiological samples often do not work in foods Kits developed for clinical and microbiological samples often do not work in foods Examining rapid methods for non- traditional agents for applicability Examining rapid methods for non- traditional agents for applicability

20. Microbial Forensics Take advantage of the evolution and genetics of enteric bacteria to be able to uniquely fingerprint individual strains Take advantage of the evolution and genetics of enteric bacteria to be able to uniquely fingerprint individual strains Cooperating with the FBI, CIA, DHS, and DTRA Cooperating with the FBI, CIA, DHS, and DTRA

21. Microbial Forensics Single nucleotide polymorphisms (SNPs) Single nucleotide polymorphisms (SNPs) DNA sequence based DNA sequence based Assigns unknowns into established clusters Assigns unknowns into established clusters Reveals “siblings” Reveals “siblings”

22. Staphylococcus epidermis detected on cantilevers after 1h Development of In-line Biosensors

23. Sample Hand-held Assay ELISA - + - + AwaitResults Of ELISA Stop Start Mouse Bioassay Without Awaiting Results of ELISA Mouse Bioassay -+ Confirm using Mouse Bioassay Confirmed Assay Clostridium botulinum Neurotoxin: Testing scheme

24. CT Research – Chemical Methods: Basic Testing Strategy Non-Laboratory Rapid Screening (ELISA, lateral flow, paper) Laboratory Based Rapid Screening (GC/MS, LC/MS, Infra-red) Unknown hazard

25. CT Research – Chemical Methods Method Development and Implementation Forensic Chemistry Center - ORA Center - ORA Integration into Field laboratories Field laboratories CFSAN Labs Development and Testing and Testing

26. Detection of Radionuclides Winchester Engineering and Analytical Center: Winchester Engineering and Analytical Center: “Rapid Assay of 241 Am in Foods Using a High Purity Germanium Well Gamma-Ray Detector” HPGe Well Detector Sample HPGe Detector Cross-Sectional View

27. Animal Feed Safety Protection from BSE – PCR and immunochemical methods to detect prohibited proteins in animal feed Protection from BSE – PCR and immunochemical methods to detect prohibited proteins in animal feed Nationwide feed surveys Nationwide feed surveys Investigation of livestock feeds as a means of dissemination of foodborne pathogens, resistant organisms and possible chemical contaminants (counter- terrorism) Investigation of livestock feeds as a means of dissemination of foodborne pathogens, resistant organisms and possible chemical contaminants (counter- terrorism)

28. Large Animal Research Facilities - Studies of Animal Feeds Dissemination of drugs and other products in animal feeds

29. Response – National Laboratory Networks Laboratory Response Network Laboratory Response Network Food Emergency Response Network Food Emergency Response Network Microorganisms Microorganisms Toxic chemicals Toxic chemicals Biologically derived toxins Biologically derived toxins Radionuclides Radionuclides

30. Centers of Excellence

31. Collaborative research initiatives between industry, academia, and FDA Collaborative research initiatives between industry, academia, and FDA NCFST NCFST JIFSAN JIFSAN NCNPR NCNPR

32. Centers of Excellence The majority of our prevention technology and recovery research being conducted at the National Center for Food Safety and Technology The majority of our prevention technology and recovery research being conducted at the National Center for Food Safety and Technology

33. Collaborative CT Projects at NCFST Thermal resistance of microbial agents associated with bioterrorism Thermal resistance of microbial agents associated with bioterrorism Survival and growth of non- traditional pathogens in foods Survival and growth of non- traditional pathogens in foods Thermal/shear food processes that inactivate protein toxins Thermal/shear food processes that inactivate protein toxins Decontamination of food processing facilities/equipment Decontamination of food processing facilities/equipment

34. Pilot Plant Locker Room Laboratory Equipment Decontamination Personnel Decontamination Air Lock NCFST Select Agent/BL-3 Pilot Plant and Laboratory Design

35. Extramural Research Program

36. Extramural Programs The challenges are too big and too important to try and do it alone The challenges are too big and too important to try and do it alone Enlist Enlist Unique capabilities Unique capabilities Unique expertise Unique expertise Unique facilities Unique facilities

37. Extramural Grants Rapid Immunoassay Silver Application Test System – Cornell University Rapid Immunoassay Silver Application Test System – Cornell University Development of Waveguide Immunoassay for Yersenia enterocolitica – University of Georgia Development of Waveguide Immunoassay for Yersenia enterocolitica – University of Georgia Rapid Screening of Foods for Toxins by TLC- Bioluminescence – ChromaDex Inc. Rapid Screening of Foods for Toxins by TLC- Bioluminescence – ChromaDex Inc. Development of a PCR Device for Pathogen Detection – Cornell University Development of a PCR Device for Pathogen Detection – Cornell University Rapid Screening for Biological Toxins on a Microchip – Naval Research Laboratory Rapid Screening for Biological Toxins on a Microchip – Naval Research Laboratory

38. Collaborative Studies with Other Agencies Example: Example: Working with NIH to determine means for neutralizing pathogenic microorganisms and biologically derived toxins in various foods

39. Collaborative Studies with Other Agencies Example: Example: Working with DOD to acquire better information on the oral dose-response relationships for non- traditional pathogens

40. The Future Address priority agent/commodity combinations Address priority agent/commodity combinations Detection methodology Detection methodology Agent characteristics Agent characteristics Prevention/intervention technologies Prevention/intervention technologies Rapid response and recovery capabilities Rapid response and recovery capabilities Seek additional resources to accelerate progress Seek additional resources to accelerate progress

41. The Future Keeping focused on the goal: Keeping focused on the goal: Completing as rapidly as possible the critical translational research that FDA needs to assure the security of the nation’s food supply