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

1. Food Emergency Response Network (FERN)FDA Science Board Advisory Committee MeetingNovember 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 • 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

6. FERN Structure Regional Coordination Centers

7. 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

8. 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

9. 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

10. FERN Structure: Support Programs FERN Support Programs – Sub-committees • Training • Proficiency Testing • Method Development/Validation • Surveillance • Electronic communication

11. 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

12. 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

13. 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

14. 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)

15. 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

16. 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

17. 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:

18. eLEXNET’s GIS Reporting Functions Report Parameters: Salmonella Cheese/Cheese Products All Laboratories All States August 2002 to present

19. What’s Happening in your Region? Listeria in the Central Region (Illinois, Indiana, Michigan, Minnesota, Wisconsin) in 2001

20. National Food Laboratory Directory

21. National Food Laboratory Directory: Map view results of State, Lab Function search (drill down to Florida)

22. 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

23. 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

24. 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