food security research: the race to protect the u.s. consumer

Food Security Food Security Research:Research:

The Race to Protect The Race to Protect the U.S. Consumerthe U.S. Consumer

A New Way of ThinkingA New Way of Thinking

Dealing with Dealing with intentional intentional contamination contamination requires requires consideration ofconsideration of New agentsNew agents New routes of New routes of

introductionintroduction

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Sound ScienceSound ScienceFood Safety ProgramsFood Safety Programs

Food Security Food Security EnhancementsEnhancements

Food Security ChallengeFood Security Challenge

Has required Has required FDA to rapidly FDA to rapidly enhance its enhance its capabilitiescapabilities

At the core is At the core is FDA’s strong FDA’s strong science basescience base

Four Primary Food Security Four Primary Food Security Research NeedsResearch Needs

Knowledge of AgentsKnowledge of Agents Oral pathogenicity and toxicityOral pathogenicity and toxicity

• Most information available is via Most information available is via inhalational route of exposureinhalational route of exposure

• Ingestion can increase or decrease Ingestion can increase or decrease potential toxicity/pathogenicitypotential toxicity/pathogenicity

• Matrix effects largely unknown Matrix effects largely unknown Behavior in foodsBehavior in foods


Prevention, Prevention, “Shields”“Shields” Inactivation - Inactivation -

neutralization neutralization technologiestechnologies

Security Security technologiestechnologies

In-line In-line sensorssensors


Response and Response and RecoveryRecovery Laboratory Laboratory

supportsupport Rapid Rapid

response response research team research team

Facility clean-Facility clean-upup

Detection MethodologyDetection Methodology Deployable, rapid field testsDeployable, rapid field tests Laboratory-based screening Laboratory-based screening

teststests Laboratory-based confirmatory Laboratory-based confirmatory

teststests ForensicsForensics Technology transferTechnology transfer Methods ValidationMethods Validation


Getting to Where We Want Getting to Where We Want to Beto Be

BasicBasicResearchResearch

Safe Safe ProductProducts, Sound s, Sound Policies Policies

and and GuidancGuidanc

ee

Getting to Where We Want Getting to Where We Want to Beto Be

FDA Translational FDA Translational ResearchResearch

BasicBasicResearchResearch

Safe Safe ProductProducts, Sound s, Sound Policies Policies

and and GuidancGuidanc

ee

IntramuralIntramuralResearchResearch

ExtramuralExtramuralResearchResearch

Centers ofCenters ofExcellenceExcellence

CFSAN Research ProgramCFSAN Research Program

$5M Supplement$5M Supplement

Provided us Provided us with additional with additional funds to get funds to get through the through the next lap of the next lap of the race to protect race to protect the food the food supplysupply

CFSAN Research ProgramCFSAN Research Program Within weeks of Within weeks of

the tragedy of the tragedy of 9/11, CFSAN 9/11, CFSAN redirected 30% of redirected 30% of its intramural its intramural research program research program and most of its and most of its extramural extramural program to food program to food securitysecurity

““Foods” Research ProgramFoods” Research Program Center for Food Safety and Applied Center for Food Safety and Applied

NutritionNutrition Center for Veterinary MedicineCenter for Veterinary Medicine

Feed SafetyFeed Safety Animal Health/ProtectionAnimal Health/Protection

Office of Regulatory AffairsOffice of Regulatory Affairs Detection method adaptationDetection method adaptation Methods validationMethods validation FERNFERN

National Center for Toxicological National Center for Toxicological ResearchResearch

““Foods” Research ProgramFoods” Research Program Center for Food Safety and Applied Center for Food Safety and Applied

NutritionNutrition Methods developmentMethods development Agent characterizationAgent characterization

• Pathogencity/toxicityPathogencity/toxicity• Behavior in foodsBehavior in foods

Intervention technologiesIntervention technologies Toxicity/PathogenicityToxicity/Pathogenicity

Attempted to enhance food safety Attempted to enhance food safety while advancing food securitywhile advancing food security

““Foods” Research ProgramFoods” Research Program

Leverage research Leverage research performed by medical, performed by medical, agricultural, and defense agricultural, and defense research agencies and the research agencies and the academic communityacademic community DHHS NIH and CDCDHHS NIH and CDC USDA ARS and CREESUSDA ARS and CREES DODDOD

CFSAN Intramural CFSAN Intramural Research ProgramResearch Program

Meeting Critical Laboratory Meeting Critical Laboratory Infrastructure Needs Infrastructure Needs

Training of research to work Training of research to work with non-traditional agentswith non-traditional agents

Upgrading of laboratory Upgrading of laboratory securitysecurity

Upgrading of critical Upgrading of critical instrumentationinstrumentation

Renovation of laboratories to Renovation of laboratories to perform BL-3 level researchperform BL-3 level research

Compliance with CDC and Compliance with CDC and APHIS Select Agent RegulationAPHIS Select Agent Regulation

CFSAN Microbiology CFSAN Microbiology Laboratories Laboratories First FDA First FDA

laboratory to join laboratory to join LRNLRN

Developed and Developed and disseminated disseminated methods for non-methods for non-traditional traditional pathogens in foodspathogens in foods

Trained LRN and Trained LRN and FERN members in FERN members in analysis of foodsanalysis of foods

Evaluation of Evaluation of methods in foods methods in foods

Evaluation of Detection Evaluation of Detection MethodsMethods

Kits developed Kits developed for clinical and for clinical and microbiological microbiological samples often do samples often do not work in foodsnot work in foods

Examining rapid Examining rapid methods for non-methods for non-traditional traditional agents for agents for applicabilityapplicability

Microbial ForensicsMicrobial Forensics Take advantage of Take advantage of

the evolution and the evolution and genetics of enteric genetics of enteric bacteria to be able bacteria to be able to uniquely to uniquely fingerprint fingerprint individual strainsindividual strains

Cooperating with Cooperating with the FBI, CIA, DHS, the FBI, CIA, DHS, and DTRAand DTRA

Microbial ForensicsMicrobial Forensics Single nucleotide Single nucleotide

polymorphisms polymorphisms (SNPs)(SNPs) DNA sequence DNA sequence

basedbased Assigns unknowns Assigns unknowns

into established into established clustersclusters

Reveals “siblings”Reveals “siblings”

Staphylococcus epidermisStaphylococcus epidermis detected on cantilevers after 1h detected on cantilevers after 1h

Development of In-line Development of In-line BiosensorsBiosensors

SampleSample

Hand-held AssayHand-held Assay ELISAELISA

-- ++ --++

AwaitAwaitResultsResultsOf ELISAOf ELISA

StopStopStart Mouse Start Mouse BioassayBioassayWithout Without Awaiting Awaiting Results of Results of ELISAELISA

Mouse BioassayMouse Bioassay

-- ++

Confirm usingConfirm usingMouse BioassayMouse Bioassay

Confirmed AssayConfirmed Assay

Clostridium botulinumClostridium botulinum Neurotoxin: Neurotoxin:Testing schemeTesting scheme

CT Research – Chemical Methods:CT Research – Chemical Methods:Basic Testing StrategyBasic Testing Strategy

Non-Laboratory Rapid Screening(ELISA, lateral flow, paper)

Laboratory Based Rapid Screening(GC/MS, LC/MS, Infra-red)

Unknown hazardUnknown hazard

CT Research – Chemical MethodsCT Research – Chemical MethodsMethod Development and Method Development and ImplementationImplementation

Forensic ChemistryForensic Chemistry Center - ORACenter - ORA

Integration intoIntegration into Field laboratoriesField laboratories

CFSAN Labs CFSAN Labs

DevelopmentDevelopment and Testingand Testing

Detection of RadionuclidesDetection of Radionuclides Winchester Winchester

Engineering Engineering and Analytical and Analytical Center:Center:

““Rapid Assay of Rapid Assay of 241241Am in Foods Am in Foods Using a High Using a High Purity Purity Germanium Germanium Well Gamma-Well Gamma-Ray Detector”Ray Detector”

HPGe Well DetectorHPGe Well Detector

Sample

HP

Ge D

ete

cto

rH

PG

e D

ete

cto

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HP

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Cross-Sectional View

Animal Feed SafetyAnimal Feed Safety Protection from BSE – PCR and Protection from BSE – PCR and

immunochemical methods to detect immunochemical methods to detect prohibited proteins in animal feedprohibited proteins in animal feed

Nationwide feed surveysNationwide feed surveys

Investigation of livestock feeds as a Investigation of livestock feeds as a means of dissemination of foodborne means of dissemination of foodborne pathogens, resistant organisms and pathogens, resistant organisms and possible chemical contaminants possible chemical contaminants (counter-terrorism)(counter-terrorism)

Large Animal Research Large Animal Research FacilitiesFacilities- Studies of Animal Feeds- Studies of Animal Feeds

Dissemination of Dissemination of drugs and otherdrugs and otherproducts inproducts inanimal feedsanimal feeds

Response – National Response – National Laboratory NetworksLaboratory Networks

Laboratory Laboratory Response NetworkResponse Network

Food Emergency Food Emergency Response NetworkResponse Network MicroorganismsMicroorganisms Toxic chemicalsToxic chemicals Biologically Biologically

derived toxinsderived toxins RadionuclidesRadionuclides

Centers of ExcellenceCenters of Excellence


Collaborative Collaborative research research initiatives initiatives between between industry, industry, academia, and academia, and FDAFDA NCFSTNCFST JIFSANJIFSAN NCNPRNCNPR


The majority of The majority of our prevention our prevention technology and technology and recovery recovery research being research being conducted at the conducted at the National Center National Center for Food Safety for Food Safety and Technologyand Technology

Collaborative CT ProjectsCollaborative CT Projectsat NCFSTat NCFST

Thermal resistance of microbial Thermal resistance of microbial agents associated with agents associated with bioterrorismbioterrorism

Survival and growth of non-Survival and growth of non-traditional pathogens in foodstraditional pathogens in foods

Thermal/shear food processes Thermal/shear food processes that inactivate protein toxinsthat inactivate protein toxins

Decontamination of food Decontamination of food processing facilities/equipmentprocessing facilities/equipment

Pilot Plant

LockerRoomLaboratory

Equipment Decontamination

Personnel Decontamination

Air Lock

NCFST Select Agent/BL-3 NCFST Select Agent/BL-3 Pilot Plant and Laboratory DesignPilot Plant and Laboratory Design

Extramural Research Extramural Research ProgramProgram

Extramural ProgramsExtramural Programs

The challenges The challenges are too big and are too big and too important to too important to try and do it try and do it alonealone

Enlist Enlist Unique Unique

capabilitiescapabilities Unique expertiseUnique expertise Unique facilitiesUnique facilities

Extramural GrantsExtramural Grants Rapid Immunoassay Silver Application Test Rapid Immunoassay Silver Application Test

System – Cornell UniversitySystem – Cornell University Development of Waveguide Immunoassay Development of Waveguide Immunoassay

for for Yersenia enterocolitica Yersenia enterocolitica – University of – University of GeorgiaGeorgia

Rapid Screening of Foods for Toxins by TLC-Rapid Screening of Foods for Toxins by TLC-Bioluminescence – ChromaDex Inc.Bioluminescence – ChromaDex Inc.

Development of a PCR Device for Pathogen Development of a PCR Device for Pathogen Detection – Cornell UniversityDetection – Cornell University

Rapid Screening for Biological Toxins on a Rapid Screening for Biological Toxins on a Microchip – Naval Research Laboratory Microchip – Naval Research Laboratory

Collaborative Studies with Other Collaborative Studies with Other AgenciesAgencies

Example:Example: Working with NIH to Working with NIH to determine means for determine means for neutralizing pathogenic neutralizing pathogenic microorganisms and microorganisms and biologically derived toxins in biologically derived toxins in various foodsvarious foods

Collaborative Studies with Other Collaborative Studies with Other AgenciesAgencies

Example:Example:

Working with DOD to Working with DOD to acquire better acquire better information on the oral information on the oral dose-response dose-response relationships for non-relationships for non-traditional pathogenstraditional pathogens

The FutureThe Future Address priority agent/commodity Address priority agent/commodity

combinationscombinations Detection methodologyDetection methodology Agent characteristicsAgent characteristics Prevention/intervention technologiesPrevention/intervention technologies Rapid response and recovery capabilities Rapid response and recovery capabilities

Seek additional resources to Seek additional resources to accelerate progressaccelerate progress

The FutureThe Future Keeping focused Keeping focused

on the goal:on the goal:Completing as rapidly Completing as rapidly

as possible the as possible the critical translational critical translational research that FDA research that FDA needs to assure the needs to assure the security of the security of the nation’s food supplynation’s food supply

food security research: the race to protect the u.s. consumer

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