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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. Mission of FERN.

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food emergency response network fern fda science board advisory committee meeting november 6 2003

Food Emergency Response Network (FERN)FDA Science Board Advisory Committee MeetingNovember 6, 2003

Carl J. Sciacchitano

Office of Regulatory Affairs/Division of Field Science

mission of fern
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.
fern objectives
FERN Objectives
  • Prevention – federal/state surveillance sampling programs
  • Preparedness – strengthening lab capabilities/capacities
  • Response – surge capacity
  • Recovery – provide assurance to the consumer
directive from the interagency food working group
Directive from the Interagency Food Working Group
  • Build an integrated network of food testing laboratories
  • Cooperate with federal and state partners
  • Do it now!
food laboratories are mission critical resources
Food Laboratories are Mission-Critical Resources
  • Food Laboratories:
  • Environmental
  • Veterinary Diagnostic
  • Agricultural
  • Clinical
  • Federal

Proficiency

Testing

Method

Validation

Consumer

Complaints

Regulatory

Compliance

Routine

Surveillance

Training

CT

Surveillance

Outbreak

Investigation

Emergency

Response

fern structure
FERN Structure

Regional Coordination Centers

fern steering committee members

FERN Structure: Steering Committee

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 steering committee responsibilities

FERN Structure: Steering Committee

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 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

FERN National Operations Center - Responsibilities
fern support programs sub committees

FERN Structure: Support Programs

FERN Support Programs – Sub-committees
  • Training
  • Proficiency Testing
  • Method Development/Validation
  • Surveillance
  • Electronic communication
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)

Training Performed
regional coordination centers rccs overview

FERN Structure:Regional Coordination Centers (RCCs)

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
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

RCCs - Responsibilities
collection and storage of fern related data
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)
food laboratories and the national food safety and security system

Storage & transport

of raw commodities

Storage &

Transport

of products

Food service

& preparation

Agricultural

production

& processing

Wholesale &

retail distribution

Processing &

manufacturing

Consumption

Consumer Protection

Research

Education

Inspection

Activities

Firm and Product Registration

Clinical

Imports

Quality Assurance

CDC

EPA

FDA

DoD

DOT

Customs

Adverse Events

USDA

Federal

State

Local

Food Laboratories and the National Food Safety and Security System

Supporting Agencies and Systems

Public Health

Law Enforcement

Veterinary Diagnostic

Agriculture

Environmental

Food Testing Laboratories

elexnet overview
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
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 Data

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:

elexnet s gis reporting functions
eLEXNET’s GIS Reporting Functions

Report Parameters:

Salmonella

Cheese/Cheese Products

All Laboratories

All States

August 2002 to present

what s happening in your region
What’s Happening in your Region?

Listeria in the Central Region (Illinois, Indiana, Michigan, Minnesota, Wisconsin) in 2001

slide21
National Food Laboratory Directory: Map view results of State, Lab Function search (drill down to Florida)
an integrated national laboratory infrastructure
An Integrated National Laboratory Infrastructure

Laboratory Capability and Capacity Programs

National Animal Health Laboratory Network (NAHLN)

Food Emergency Response Network (FERN)

NAHLN IT System:

Animal Disease Test Results

eLEXNET:

Food Pathogen Test Results

Secure Data Exchange of Laboratory Test Results

HL7 Data Exchange

Methods Repository

Laboratory Directory

Shared System Modules

an integrated national laboratory infrastructure future
An Integrated National Laboratory Infrastructure, Future

Laboratory Capability and Capacity Programs

Environmental Programs

Other Lab Programs …

NAHLN

FERN

HL7 Data Exchange

Soil and Water Test Results

NAHLN IT System:

Animal Disease Test Results

eLEXNET:

Food Pathogen Test Results

Other Laboratory Test Results

Secure Data Exchange of Laboratory Test Results

Methods Repository

Laboratory Directory

Other Common Laboratory Functions …

Shared System Modules

next steps for fern
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