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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

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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


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Strategies for Critical Infrastructures

  • Awareness

  • Prevention

  • Preparedness

  • Response

  • Recovery


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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


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CFSAN Research Program

Intramural

Research

Extramural

Research

Centers of

Excellence


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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


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Food Security Research Needs

  • Prevention/Shields

    • Inactivation/neutralization technologies

    • Security technologies

    • In-line sensors


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FDA’s 10 Point Program for FDA Food Security

  • A stronger FDA

  • Strategic approach for imports

  • Bioterrorism Act Regulations

  • Industry Guidance and Prevention Measures


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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



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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


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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


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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.”


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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


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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


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Participants

  • FDA

  • Illinois Institute of Technology (IIT)

  • University of Illinois at Urbana-Champaign Food Science Department

  • State of Illinois

  • Industry Members



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Ongoing Research and Technology


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Ongoing Collaborative CT Projects at NCFST and Technology

  • 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


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Survival and Growth of Non-Traditional Pathogens in Foods and Technology

  • 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


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Benefits and Technology

  • 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


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RESULTS and Technology

  • 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.


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NEXT STEPS and Technology

  • 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.


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2. Thermal Resistance of Non-Traditional Microbial Agents and Technology

  • 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,


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Benefits and Technology

  • 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


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Future Research and Technology

  • Heat resistance studies for additional non-traditional agents


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ELISA Assay for Botulinal Toxin and Technologyin 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


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Future Research and Technology

  • Investigate food additives that may interfere with dig-ELISA performance

  • Results from Liberty Shield tests will be compiled from Moffett and ORA’s laboratories


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New Research and Technology


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New Collaborative CT Projects and Technologyat NCFST

  • Thermal/shear food processes that inactivate protein toxins

  • Decontamination of food processing facilities/equipment


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Thermal/shear Food Processes and Technology

  • 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


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Thermal/shear food processes and Technology

  • 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


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Thermal/shear food processes and Technology

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


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2. Decontamination of food processing facilities/equipment and Technology

  • 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


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2. Decontamination of food processing facilities/equipment and Technology

  • Project will be coordinated with previous project – natural outcome of need to decontaminate processing equipment between experiments



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NCFST Select Agent/BL-3 and TechnologyPilot 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


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NCFST Select Agent/BL-3 and TechnologyPilot Plant and Laboratory Design

EquipmentDecontamination

Pilot Plant

LockerRoom

Laboratory

Personnel Decontamination

Air Lock


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BSL-3 Pilot Plant- and TechnologyRestricted Access


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BSL-3 Pilot Plant and Technology


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Laboratory Food Extruder and Technology


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Hurdles and Technology


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CT Research- Hurdles and Technology

  • Facilities

    • Security Upgrades

    • Laboratory Upgrades

  • Select Agent License

  • Security Audits

  • Personnel Background Checks

  • Mixed Industry Response


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