Preventative Research

1. Preventative Research David J. Armstrong, Ph.D. National Center for Food Safety and Technology Associate Research Director Office of Plant & Dairy Foods & Beverages, Center for Food Safety and Applied Nutrition, FDA

2. Strategies for Critical Infrastructures • Awareness • Prevention • Preparedness • Response • Recovery

3. FDA’s Overall Food Security Strategy • Increased awareness through collection, analysis and dissemination of information, intelligence, and knowledge to reduce vulnerabilities • Develop preventionstrategies through capacity for rapid identification of a specific threat or attack • Develop effective protection strategies to shield the food supply • Develop capacity for rapid, coordinated response • Develop capacity for rapid, coordinated recovery

4. CFSAN Research Program Intramural Research Extramural Research Centers of Excellence

5. Food Security Research Needs • Knowledge of Agents • Behavior in foods – Development of preventative measures • Acid tolerance • Alkali tolerance • Heat stability • Resistance to dehydration • Resistance to hydration • Resistance to freezing • Resistance to proteolytic enzymes

6. Food Security Research Needs • Prevention/Shields • Inactivation/neutralization technologies • Security technologies • In-line sensors

7. FDA’s 10 Point Program for FDA Food Security • A stronger FDA • Strategic approach for imports • Bioterrorism Act Regulations • Industry Guidance and Prevention Measures

8. NCFST........ What is it? • Government/academia/industry consortium focused on food safety • Research facility for cooperative research on • - New processing & packaging technologies • - Modifications of traditional technologies • - HACCP controls • - Interventions • Source of training, education, and information Programs on food safety • Neutral forum for discussion of food safety issues and regulation

9. Why a Cooperative Food Safety Consortium?

10. To Enhance FDA Food Science Program Required: • Pilot Plant • Access to special laboratories e.g., BSL-3 facility for pathogen and packaging research • Access to specialized expertise • In public health emergency situations, immediate access to facilities and equipment to provide research support • Training facility for FDA, states, and others

11. Objectives of Cooperative Program • Address key public health issues • Establish scientific competencies in additional areas of actual or potential public health concern • Establish dialogue with representatives of industry and academia in important areas of food processing • Conduct collaborative studies with other units of the Center, industry, and academia • Transfer technology to FDA consumer safety officers, inspectors, and other public health authorities • Provide research support during emergencies

12. NCFST Mission “Foster scientific and technical exchange among the partners, leading to a better understanding of the science and engineering behind food safety decisions and to conduct research upon which future food safety decisions will be based.”

13. Current Collaborative Research Program • High priority food safety and security research • Intervention and prevention strategies • CT and BSL-3 pilot plant research • New technologies • Effectiveness of process/packaging parameters

16. NCFST Programs: Relation to FDA Programs Food Safety Issue Scientific discussion NCFST Programs Workshops, etc. Industry Interaction Research Training Guidance Policy Regulations Food Additive approvals Training Food Safety

17. Participants • FDA • Illinois Institute of Technology (IIT) • University of Illinois at Urbana-Champaign Food Science Department • State of Illinois • Industry Members

18. Preventative Research at the National Center for Food Safety and Technology

19. Ongoing Research

20. Ongoing Collaborative CT Projects at NCFST • Survival and growth of non-traditional pathogens in foods • Thermal resistance of microbial agents associated with bioterrorism • Evaluation of ELISA assay to detect botulinal toxin in foods

21. Survival and Growth of Non-Traditional Pathogens in Foods • Agents of study: non-sporeforming bacteria • Current work: Yersinia • Objective: Will the agent survive, grow, or die-off in the event of deliberate addition to foods? • Team: Tortorello, Stewart, Reineke, Swiech, Gendel

22. Benefits • New knowledge: little or no data exist on agent behavior in foods • Forensics support: may help to answer when? and where? in case investigation • Risk management: survivability data may support decision making about food safety

23. RESULTS • Yersinia grows poorly or dies in nutrient limited foods. • Yersinia containing all virulence genes die more quickly under nutrient-limiting conditions than cells without virulence genes.

24. NEXT STEPS • Continue long-term studies of Yersinia survival and virulence in nutrient-limiting foods and in shelf-stable milk • Develop studies in other shelf-stable beverages, e.g infant formula, juices, sports drinks, etc.

25. 2. Thermal Resistance of Non-Traditional Microbial Agents • Agents of study: C. botulinum neurotoxin • Current work: C. botulinum neuotoxin • Objective: Determine heat resistance in foods and the effects of pH, salt, etc. • Team: Skinner, Larkin, Reddy, Tetzloff, Chen, Gerdes,

26. Benefits • New knowledge: little or no data exist on thermal destruction kinetics of CT agents in food products • Risk Management: thermal kinetic data may support decision making

27. Future Research • Heat resistance studies for additional non-traditional agents

28. ELISA Assay for Botulinal Toxin in Foods • Agent of study: C. botulinum neurotoxin • Originally Initiated as NCFST Collaborative Project • Objective: Can ELISA Assays be Utilized to Detect Botulinal Toxin in Foods? • Project Team: Skinner, Chen, Larkin, Reddy, Ferreira

29. Future Research • Investigate food additives that may interfere with dig-ELISA performance • Results from Liberty Shield tests will be compiled from Moffett and ORA’s laboratories

30. New Research

31. New Collaborative CT Projectsat NCFST • Thermal/shear food processes that inactivate protein toxins • Decontamination of food processing facilities/equipment

32. Thermal/shear Food Processes • Many proteins can be denatured by mechanical action (egg white) • Food processes such as extrusion, foaming, homogenization etc. may partially inactivate toxins • Evaluate combination processes

33. Thermal/shear food processes • Toxins to be investigated: C. botulinum toxin, ricin, fungal toxins, and others where assays are available • Biochemical assays will be correlated with bioassays to verify loss of biological activity

34. Thermal/shear food processes • Food processes to be investigated: extrusion, homogenization, high-shear mixing, foaming and other shear/thermal processes

35. 2. Decontamination of food processing facilities/equipment • Rapid recovery after bioterrorism incident • Food would be discarded after incident, facilities and equipment would not • Need to know if currently used food sanitation techniques are effective against potent biological agents

36. 2. Decontamination of food processing facilities/equipment • Project will be coordinated with previous project – natural outcome of need to decontaminate processing equipment between experiments

37. BSL-3 Pilot Plant and Lab

38. NCFST Select Agent/BL-3 Pilot Plant and Laboratory • Unique capability within the U.S. • Will meet CDC Select Agent Requirements of the Patriot Act • Readily transfer select agents between pilot plant and laboratory • Stringent personal protection measures

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

40. BSL-3 Pilot Plant-Restricted Access

41. BSL-3 Pilot Plant

42. Laboratory Food Extruder

45. Hurdles

46. CT Research- Hurdles • Facilities • Security Upgrades • Laboratory Upgrades • Select Agent License • Security Audits • Personnel Background Checks • Mixed Industry Response