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

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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

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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

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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