Food Security Research: The Race to Protect the U.S. Consumer

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Food Security ResearchThe Race to Protect the
U.S. Consumer
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A New Way of Thinking

• Dealing with intentional contamination requires
  consideration of
• New agents
• New routes of introduction

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Food Security Challenge

• Has required FDA to rapidly enhance its
  capabilities
• At the core is FDAs strong science base

Food Security Enhancements

Sound Science
Food Safety Programs
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Four Primary Food Security Research Needs

• Knowledge of Agents
• Oral pathogenicity and toxicity
• Most information available is via inhalational
  route of exposure
• Ingestion can increase or decrease potential
  toxicity/pathogenicity
• Matrix effects largely unknown
• Behavior in foods

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Four Primary Food Security Research Needs

• Prevention, Shields
• Inactivation - neutralization technologies
• Security technologies
• In-line sensors

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Four Primary Food Security Research Needs

• Response and Recovery
• Laboratory support
• Rapid response research team
• Facility clean-up

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Four Primary Food Security Research Needs

• Detection Methodology
• Deployable, rapid field tests
• Laboratory-based screening tests
• Laboratory-based confirmatory tests
• Forensics
• Technology transfer
• Methods Validation

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Getting to Where We Want to Be
Safe Products, Sound Policies and Guidance
Basic Research
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Getting to Where We Want to Be
FDA Translational Research
Safe Products, Sound Policies and Guidance
Basic Research
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CFSAN Research Program
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5M Supplement

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

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CFSAN Research Program

• Within weeks of the tragedy of 9/11, CFSAN
  redirected 30 of its intramural research program
  and most of its extramural program to food
  security

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Foods Research Program

• Center for Food Safety and Applied Nutrition
• Center for Veterinary Medicine
• Feed Safety
• Animal Health/Protection
• Office of Regulatory Affairs
• Detection method adaptation
• Methods validation
• FERN
• National Center for Toxicological Research

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Foods Research Program

• Center for Food Safety and Applied Nutrition
• Methods development
• Agent characterization
• Pathogencity/toxicity
• Behavior in foods
• Intervention technologies
• Toxicity/Pathogenicity
• Attempted to enhance food safety while advancing
  food security

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Foods Research Program

• Leverage research performed by medical,
  agricultural, and defense research agencies and
  the academic community
• DHHS NIH and CDC
• USDA ARS and CREES
• DOD

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CFSAN Intramural Research Program
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Meeting Critical Laboratory Infrastructure Needs

• Training of research to work with non-traditional
  agents
• Upgrading of laboratory security
• Upgrading of critical instrumentation
• Renovation of laboratories to perform BL-3 level
  research
• Compliance with CDC and APHIS Select Agent
  Regulation

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CFSAN Microbiology Laboratories

• First FDA laboratory to join LRN
• Developed and disseminated methods for
  non-traditional pathogens in foods
• Trained LRN and FERN members in analysis of foods
• Evaluation of methods in foods

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Evaluation of Detection Methods

• Kits developed for clinical and microbiological
  samples often do not work in foods
• Examining rapid methods for non-traditional
  agents for applicability

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Microbial Forensics

• Take advantage of the evolution and genetics of
  enteric bacteria to be able to uniquely
  fingerprint individual strains
• Cooperating with the FBI, CIA, DHS, and DTRA

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Microbial Forensics

• Single nucleotide polymorphisms (SNPs)
• DNA sequence based
• Assigns unknowns into established clusters
• Reveals siblings

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Development of In-line Biosensors
Staphylococcus epidermis detected on cantilevers
after 1h
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Clostridium botulinum Neurotoxin Testing scheme
Sample
Hand-held Assay
ELISA
-

Await Results Of ELISA
Start Mouse Bioassay Without Awaiting Results
of ELISA
Stop
Confirm using Mouse Bioassay
Mouse Bioassay
Confirmed Assay
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CT Research Chemical MethodsBasic Testing
Strategy
Unknown hazard
Non-Laboratory Rapid Screening (ELISA, lateral
flow, paper)
Laboratory Based Rapid Screening (GC/MS, LC/MS,
Infra-red)
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CT Research Chemical MethodsMethod Development
and Implementation
Development and Testing
Forensic Chemistry Center - ORA
CFSAN Labs
Integration into Field laboratories
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Detection of Radionuclides

• Winchester Engineering and Analytical Center
• Rapid Assay of 241Am in Foods Using a High
  Purity Germanium Well Gamma-Ray Detector

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Animal Feed Safety

• Protection from BSE PCR and immunochemical
  methods to detect prohibited proteins in animal
  feed
• Nationwide feed surveys
• Investigation of livestock feeds as a means of
  dissemination of foodborne pathogens, resistant
  organisms and possible chemical contaminants
  (counter-terrorism)

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Large Animal Research Facilities- Studies of
Animal Feeds
Dissemination of drugs and other products
in animal feeds
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Response National Laboratory Networks

• Laboratory Response Network
• Food Emergency Response Network
• Microorganisms
• Toxic chemicals
• Biologically derived toxins
• Radionuclides

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Centers of Excellence
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Centers of Excellence

• Collaborative research initiatives between
  industry, academia, and FDA
• NCFST
• JIFSAN
• NCNPR

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Centers of Excellence

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

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Collaborative CT Projectsat NCFST

• Thermal resistance of microbial agents associated
  with bioterrorism
• Survival and growth of non-traditional pathogens
  in foods
• Thermal/shear food processes that inactivate
  protein toxins
• Decontamination of food processing
  facilities/equipment

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NCFST Select Agent/BL-3 Pilot Plant and
Laboratory Design
Equipment Decontamination
Pilot Plant
LockerRoom
Laboratory
Personnel Decontamination
Air Lock
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Extramural Research Program
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Extramural Programs

• The challenges are too big and too important to
  try and do it alone
• Enlist
• Unique capabilities
• Unique expertise
• Unique facilities

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Extramural Grants

• Rapid Immunoassay Silver Application Test System
  Cornell University
• Development of Waveguide Immunoassay for Yersenia
  enterocolitica University of Georgia
• Rapid Screening of Foods for Toxins by
  TLC-Bioluminescence ChromaDex Inc.
• Development of a PCR Device for Pathogen
  Detection Cornell University
• Rapid Screening for Biological Toxins on a
  Microchip Naval Research Laboratory

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Collaborative Studies with Other Agencies

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

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Collaborative Studies with Other Agencies

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

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The Future

• Address priority agent/commodity combinations
• Detection methodology
• Agent characteristics
• Prevention/intervention technologies
• Rapid response and recovery capabilities
• Seek additional resources to accelerate progress

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The Future

• Keeping focused on the goal
• Completing as rapidly as possible the critical
  translational research that FDA needs to assure
  the security of the nations food supply