food emergency response network (fern) fda science board advisory committee meeting november 6, 2003...
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Food Emergency Response Network
(FERN)
FDA Science Board Advisory Committee Meeting
November 6, 2003
Carl J. Sciacchitano
Office of Regulatory Affairs/Division of Field Science
2
Mission of FERN
Integrate the nation’s food-testing laboratories for the detection of threat agents in food at the local, state, and federal levels.
Detection of biological, chemical and radiological agents.
3
FERN Objectives
Prevention – federal/state surveillance sampling programs
Preparedness – strengthening lab capabilities/capacities
Response – surge capacity
Recovery – provide assurance to the consumer
4
Directive from the Interagency Food Working Group
Build an integrated network of food testing laboratories
Cooperate with federal and state partners
Do it now!
5
Food Laboratories are Mission-Critical Resources
OutbreakOutbreakInvestigationInvestigation
RoutineRoutineSurveillanceSurveillance
RegulatoryRegulatoryComplianceCompliance
MethodMethodValidationValidation
EmergencyEmergencyResponseResponse
TrainingTraining
Food Laboratories:• Environmental• Veterinary
Diagnostic• Agricultural• Clinical• Federal
ConsumerConsumerComplaintsComplaints
CTCTSurveillanceSurveillance
ProficiencyProficiencyTestingTesting
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FERN Structure
Regional Coordination
Centers
FERN Steering CommitteeFERN Steering Committee
FERN National Operations Center(FERN Support Programs)
FERN National Operations Center(FERN Support Programs)
SoutheastSoutheast SouthwestSouthwest NortheastNortheast NorthwestNorthwest CentralCentral
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FERN Steering Committee Members
Federal
HHS, FDA-ORA, FDA-CFSAN, CDC
USDA-FSIS, USDA-APHIS, USDA-AMS, USDA-GIPSA,
US Customs, DoD, FBI, EPA
State
Agriculture
Public Health
Veterinary Diagnostic
FERN Structure: Steering Committee
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FERN Steering Committee Responsibilities
Develop FERN guidelines, policies and procedures
Coordinate, integrate and develop national resources to support FERN
Oversee FERN National Operations Center
Provide guidance to FERN Support Programs
FERN Structure: Steering Committee
9
FERN National Operations Center - Responsibilities
Responsible for day to day operation of FERN
Operated by full time staff
Reports to FERN Steering Committee
Oversee implementation of policies/procedures
Coordinate Regional Coordination Center (RCC) activities
Manage and coordinate FERN Support Programs
Coordinate meetings of FERN components
Coordinate communications
Evaluate needs/capabilities
Develop/propose budget to Steering Committee
Conduct exercises
Coordinate emergency response
FERN Structure: National Operations Center
10
FERN Support Programs – Sub-committees
Training
Proficiency Testing
Method Development/Validation
Surveillance
Electronic communication
FERN Structure: Support Programs
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Training Performed
BSL-3 Rapid ID Methods for the Detection of B. anthracis, October 2002
BSL-3 Food Enrichment Techniques for the Detection of B. anthracis, October 2002
Food Sample Preparation and Organism Enrichment Methods for BSL-3 Labs, December 2002-16 state participants
BSL-3 Rapid ID Methods and Food Enrichment Techniques for the Detection of B. anthracis, January 2003-6 state participants
BSL-3 Yersinia pestis, Francisella tularensis, and B. anthracis training course, February 2003
BSL-3 Rapid ID and food Enrichment Techniques for the Detection of B. anthracis Train the Trainer course, May 2003
Clostridium botulinum toxin training collaborations with the ORA U, CFSAN Staff College, and the CDC-May and July 2003 (32 state and federal participants)
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Regional Coordination Centers (RCCs) - Overview
Consists of representatives from laboratory communities
Staffed by FDA, USDA, and others?
Possibility of “virtual hubs”
Two RCCs initially; five RCCs total
FERN Structure:Regional Coordination Centers (RCCs)
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RCCs - Responsibilities
Identify volunteer laboratories
Determine capabilities and needs of laboratories
Ensure adequate screening, confirmatory and forensic capacity
Coordinate response of laboratories during an emergency
Coordinate surveillance sampling programs
Communicate with Operations Center
Coordinate with FERN support programs
Provide quality assurance oversight
Identify needs and convey to Operations Center
Conduct exercises and coordinate reporting of results
Coordinate with key non-laboratory stakeholders
FERN Structure: RCCs
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Collection and Storage of FERN Related Data
We must find a way to store and maintain data from this project including:
Surveillance sample analysis results
Proficiency sample analysis results
Results from any samples collected during an actual bioterrorism event
The data capture mechanism for the FERN is the Electronic Laboratory Exchange Network (eLEXNET)
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Food Laboratories and the National Food Safety and Security System
Agricultural production & processing
Storage & transport of raw commodities
Processing &manufacturing
Storage & Transport of products
Consumption
Food service & preparation
Wholesale & retail distribution
Su
pp
ort
ing
Ag
enci
es
and
Sys
tem
s
Food Testing Laboratories
Federal
State
Local
EPAUSDA
CustomsCDC
FDA
DoD
Public Health
Agriculture Environmental
Law Enforcement
DOT
Veterinary Diagnostic
Inspection
Imports
Act
ivit
ies Research Education
Adverse Events
Firm and Product
Registration
Quality Assurance
Clinical
Consumer Protection
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eLEXNET Overview
What is it?
An integrated, secure system designed for multiple government agencies involved in food safety activities
The necessary infrastructure for an early warning system that identifies potentially hazardous foods and enables health officials to assess risks and analyze trends
Who is participating?
Federal laboratories (USDA/FSIS, FDA, Department of Defense-VETCOM)
State Public Health, Agriculture and Veterinary Diagnostic Laboratories
Local Laboratories
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eLEXNET Data
Aflatoxin B1, B2
Listeria spp.
Bacillus cereus
Salmonella spp.
Lasalocid
Vibrio fluvialis
Campylobacter spp.
Campylobacter jejuni
Decoquinate
Listeria monocytogenes
from over 55 food testing laboratories, including FDA, USDA, DoD VETCOM, as well as state agriculture, environmental, and public health …
and more than 40 product industry categories: Cheese/cheese products, Fishery/seafood products, Fruit/fruit products …
and over 16,500 imported products tested.
Staphylococcus aureus
Shigella spp.
Sulfathiazole
Vibrio parahaemolyticus
Escherichia coli (Typical)
Escherichia coli, Enterohemorrhagic (EHEC)
Penicillin G Procaine
Penicillin G Benzathine
Chlortetracycline
eLEXNET provides states with unprecedented, free access to food testing data from USDA, FDA, DoD, and state and local laboratories.
Over 160,000 sample test records are in eLEXNET:
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eLEXNET’s GIS Reporting Functions
Report Parameters:
Salmonella
Cheese/Cheese Products
All Laboratories
All States
August 2002 to present
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What’s Happening in your Region?
Listeria in the Central Region (Illinois, Indiana, Michigan, Minnesota, Wisconsin) in 2001
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National Food Laboratory Directory: Map view results of State, Lab Function search (drill down to Florida)
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An Integrated National Laboratory Infrastructure
NAHLN IT System:
Animal Disease Test Results
eLEXNET:
Food Pathogen Test Results
National Animal Health Laboratory Network (NAHLN)
Food Emergency Response Network (FERN)
Laboratory Capability
and Capacity Programs
Secure Data Exchange of Laboratory
Test Results
Shared System Modules
Methods Repository
Laboratory Directory
HL7 Data Exchange
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An Integrated National Laboratory Infrastructure, Future
NAHLN IT System:
Animal Disease Test Results
eLEXNET:
Food Pathogen Test Results
NAHLN FERN
Laboratory Capability
and Capacity Programs
Secure Data Exchange of Laboratory
Test Results
Shared System Modules
Methods Repository
Laboratory Directory
HL7 Data Exchange
Environmental Programs
Other Lab Programs …
Other Common Laboratory
Functions …
Other Laboratory
Test Results
Soil and Water Test Results
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Next Steps for FERN
Resources
Expand FERN Capacity/Capability
Continue to communicate/collaborate with other networks
Continue Sub-Committee Activities
Develop food surveillance/proficiency sampling programs Develop validated biological, chemical, and radiological methods for food Develop and prioritize training plans eLEXNET expansion