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
Four Primary Food Security Four Primary Food Security Research NeedsResearch Needs
Prevention, Prevention, “Shields”“Shields” Inactivation - Inactivation -
neutralization neutralization technologiestechnologies
Security Security technologiestechnologies
In-line In-line sensorssensors
Four Primary Food Security Four Primary Food Security Research NeedsResearch Needs
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
Four Primary Food Security Four Primary Food Security Research NeedsResearch Needs
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
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PG
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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
Centers of ExcellenceCenters of Excellence
Collaborative Collaborative research research initiatives initiatives between between industry, industry, academia, and academia, and FDAFDA NCFSTNCFST JIFSANJIFSAN NCNPRNCNPR
Centers of ExcellenceCenters of Excellence
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