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

Strategies for Critical Infrastructures Awareness Prevention Preparedness Response Recovery

FDA’s Overall Food Security Strategy Increased awareness through collection, analysis and dissemination of information, intelligence, and knowledge to reduce vulnerabilities Develop prevention strategies 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

IntramuralResearchExtramuralResearch Centers of Excellence CFSAN Research Program

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

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

FDA’s 10 Point Program for FDA Food Security 1. A stronger FDA 2. Strategic approach for imports 3. Bioterrorism Act Regulations 4. Industry Guidance and Prevention Measures

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

Why a Cooperative Food Safety Consortium?

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

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

“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.” NCFST Mission

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

Food Safety Issue Research Training GuidancePolicyRegulations Food Additive approvalsTraining Food Safety Scientific discussion NCFST Programs: Relation to FDA Programs NCFST Programs Workshops, etc. Industry Interaction

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

Preventative Research at the National Center for Food Safety and Technology

Ongoing Research

Ongoing Collaborative CT Projects at NCFST 1. Survival and growth of non-traditional pathogens in foods 2. Thermal resistance of microbial agents associated with bioterrorism 3. Evaluation of ELISA assay to detect botulinal toxin in foods

1.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

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

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.

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.

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,

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

Future Research Heat resistance studies for additional non- traditional agents

3.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

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

New Research

New Collaborative CT Projects at NCFST 1. Thermal/shear food processes that inactivate protein toxins 2. Decontamination of food processing facilities/equipment

1.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

1.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

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

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

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

BSL-3 Pilot Plant and Lab

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

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

BSL-3 Pilot Plant- Restricted Access

BSL-3 Pilot Plant

Laboratory Food Extruder

Hurdles

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