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

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 • New agents • New routes of introduction

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

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

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

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

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

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

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

10. Intramural Research Extramural Research 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

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

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

14. “Foods” Research Program • Center for Food Safety and Applied Nutrition • Methods development • Agent characterization • Pathogencity/toxicity • Behavior in foods • Intervention technologies • Toxicity/Pathogenicity • 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 • DHHS NIH and CDC • USDA ARS and CREES • DOD

16. CFSAN Intramural Research Program

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

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

19. Evaluation of Detection Methods • Kits developed for clinical and microbiological samples often do not work in foods • 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 • Cooperating with the FBI, CIA, DHS, and DTRA

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

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

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

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

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

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

27. Animal Feed Safety • Protection from BSE – PCR and immunochemical methods to detect prohibited proteins in animal feed • Nationwide feed surveys • 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 • Food Emergency Response Network • Microorganisms • Toxic chemicals • Biologically derived toxins • Radionuclides

30. Centers of Excellence

31. Centers of Excellence • Collaborative research initiatives between industry, academia, and FDA • NCFST • JIFSAN • 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

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

34. NCFST Select Agent/BL-3 Pilot Plant and Laboratory Design EquipmentDecontamination Pilot Plant LockerRoom Laboratory Personnel Decontamination Air Lock

35. Extramural Research Program

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

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

38. Collaborative Studies with Other Agencies • 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: 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 • Detection methodology • Agent characteristics • Prevention/intervention technologies • Rapid response and recovery capabilities • Seek additional resources to accelerate progress

41. The Future • 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