Food Emergency Response Network FERN Randal C Layton

Food Emergency Response Network (FERN) Randal C. Layton DVM, MS, COL (Ret), DACVPM Deputy Director-FERN USDA, FSIS, OPHS, FERN 4 Jun 08

Food Emergency Response Network (FERN) U. S. Dept of Agriculture/Food Safety Inspection Service Dept of Health & Human Services/Food & Drug Administration

FERN Mission & Objectives Mission - Integrate the nation’s food-testing laboratories for the detection of threat agents in food at the local, state, and federal levels. Comprehensive effort – chemical, biological, radiological disciplines involving full range of food commodities Objectives – Prevention – federal/state surveillance sampling programs – Preparedness – strengthening lab capabilities/capacities – Response – surge capacity – Recovery – provide assurance to the consumer

FERN Deliverables Proven capacity and capability Ability to rapidly respond to an incident Significant surge capacity Timely recovery from event Restore public confidence in food

FERN Deliverables Rapid response Surveillance testing (HSPD-9) Demonstrated competency Geographically distributed capability Communication/coordination

Response to Events Goal: 100, 000 bio samples/month 50, 000 chemical/rad samples/month Used anthrax event as benchmark Current capability varies with agent Very limited for some agents Delayed response/recovery times for some agents

Co-Chairs USDA/FDA Steering Committee Northeast Regional Coordination Center Jamaica, NY National Program Office USDA/FDA Southeast Regional Coordination Center Athens, GA Central Regional Coordination Center St Paul, MN FERN Support Programs Southwest Regional Coordination Center Denver, CO Pacific Regional Coordination Center Alameda, CA

FERN Members 145 Laboratories representing 50 States and Puerto Rico have satisfactorily completed FERN Laboratory Qualification Checklists. 30 Federal (HHS-FDA, [USDA-FSIS, APHIS, AMS], DOE, DHS, CBP, DOD) 104 State/territory 11 Local Disciplines – 98 Chemical; 114 Microbiological; 32 Radiological

Food Emergency Response Network Federal, State, and Local Laboratories = 138 Total Pacific Region (34) RCC: Alameda, CA Alaska (2) Arizona (2) California (15) Hawaii (2) Idaho (3) Montana (2) Nevada (1) Oregon (3) Washington (4) Northeast Region (13) RCC: Jamaica, NY (Temp located Rockville, MD) ▲-represents Regional Coordination Centers ▲ ▲ ▲ Southwest Region (27) RCC: Denver, CO Arkansas (2) Colorado (3) Iowa (4) Kansas (2) Missouri (3) Nebraska (1) New Mexico (1) Oklahoma (1) Texas (7) Utah (2) Wyoming (1) Connecticut (1) Maine (1) Massachusetts (3) New Hampshire (1) New York (5) Rhode Island (1) Vermont (1) Southeast Region (31) RCC: Athens, GA Alabama (2) Florida (7) Georgia (9) Louisiana (1) Mississippi (1) North Carolina (3) South Carolina (2) Puerto Rico (3) Tennessee (3) Central Region (40) RCC: St. Paul, MN Delaware (1) Illinois (4) Indiana (2) Kentucky (1) Maryland (6) Michigan (3) Minnesota (3) New Jersey (2) North Dakota (1) Ohio (3) Pennsylvania (5) South Dakota (2) Virginia (3) West Virginia (2) Wisconsin (2) 6/04/08

FERN Division-National Program Office Coordinates daily operation of FERN Manages FERN support programs Coordinates national lab emergency response Oversees RCC activities Provides training opportunities and outreach to FERN partner labs

FSIS/FERN Reorganization FERN Division Director Office Biological Food Defense and Emergency Response Branch National Program Office Dr Doug Abbott Steve Benson Dr Marcus Head BSL-3 high containment lab Regional Coordination Center Jamaica, NY Paul Morin Chemical Food Defense and Emergency Response Branch FERN Division Deputy Director Dr Randal Layton Victor Vega Regional Coordination Center Athens, GA Dr Tom Beacorn Glenn Tillman Regional Coordination Center St Paul, MN Dr Don Burr Kevin Vought Regional Coordination Center Denver, CO Natalie Courson Karen Kreuzer Mike Lankford Regional Coordination Center Alameda, CA Patricia Linden David Martin Tom Sidebottom

News-FY 05/06/07/08 FDA Cooperative Agreements: 8 Chemistry Labs for FY 06 & 07 and 5 Radiological Labs for FY 07, Recruiting 3 additional Chem labs for FY 09 USDA Cooperative Agreements: 21 Micro Labs renewed for FY 08. Recruiting 4 additional labs for FY 09. FERN Personnel FTE Hiring's for FY 08: – – – USDA FERN NPO Staff (GS-13 [2]): Selected USDA FERN RCC (SE) (GS-13): Selected FDA FERN NPO Director (GS-14 Selected)

Regional Coordination FERN NPO has held 3 Regional Meetings in FY 04/05/07 and is having 1 National Meeting in Jul 08. Purpose: – Establish internal/external communication links within each FERN regional hub (i. e. , alert rosters, monthly conference calls) – Access lab capabilities, capacities, response times, training needs – Communicate FERN objective, policies and current activities – Enhance collaboration between FERN laboratories within a region (i. e. , training events, table-top exercises, DODNational Guard civil support teams [CST]) – Provide an opportunity for individual regions to tailor response plans (5 FSIS OFDER table top exercises in FY 06, 3 in FY 07 & 3 in FY 08)

Training Performed Developed a training plan which includes both web-based and faceto-face training on methods, BSL-3 level laboratories, etc. Since 2003, >300 participants have been trained from 50 states. Recent training done by FERN includes: – – – – – Shigella Training-Mar 07 (17 states) ELISA, ICP/MS Training-Feb 07 Micro threat agent Training-Feb 06 (18 states) BSL-3/threat agent Training-Jan 06 (18 states) 2 Chemistry Methods Training workshops-Aug 05 Radiological Workshop-Jul 05 Threat screening methods-Jul 05 Real time PCR training – April 2005 (18 states) Real time PCR training – August 2004 (35 Federal, state and local labs) Select agent training – Aug 2004 (13 International, Federal and state participants)

Training Performed FERN – Beta version of Web based training – Jun 07 FERN GC-MS Jun 07 at VA FERN Lab, Richmond, VA FERN LC-MS Jul 07 at FDA Forensic Chem Cntr, Cincinnati, Ohio FERN RT-PCR Jul 07 at FDA Reg Lab Irvine, CA FERN GC-MS Aug 07 at FDA Forensic Chem Cntr, Cincinnati, Ohio FERN ICP-MS Aug 07 at FDA Forensic Chem Cntr, Cincinnati, Ohio FERN Rad Workshop Aug 07, Winchester, MA FERN BSL-3 Web based course-Sept 07 M 1 M Bead. Retriever Nov 07, St. Paul, MN (10 states) M 1 M Bead. Retriever Dec 07, Athens, GA (10 states) FTIR Training Mar 08, Westmont IL (6 states) FERN BSL-3 Workshop May 08, Minneapolis, MN (8 states)

Training Planned FTIR Aug 08, Athens, GA (6 states)

Proficiency Testing (PT) Standard Operating Procedures developed by FERN sub -committee. 3 PTs in 2004 (1 Chem, 1 Rad & 1 joint PT with LRN) 3 PTs in 2005 (1 Rad, 2 Chem) 3 PTs in 2006 (2 joint Micro with LRN, 1 Rad) 5 PTs in CY 2007 (1 joint with USDA/FDA) 2 PTs in CY 2008 (51 and 66 FERN Labs)

FSIS SURVEILLANCE Testing § Over and beyond routine food safety analyses, FSIS Laboratories have performed almost 100, 000 analyses for 13 high consequence biological and chemical select/threat agents since 3/3/03. § Process is underway to include State and Local FERN lab in threat agent surveillance testing on FSIS regulated products.

FERN Surveillance Testing April 2004, 18 Federal and State laboratories received samples for Microbiological and Chemical analyses pilot program. – Practiced coordination and communication protocols – Evaluated sample preparation, transportation, receipt, and timeframes. – Method identification – Data entry in to e. LEXNET September 2004 with 40 participating Federal and State laboratories. – Assessed the effectiveness and capabilities of the FERN Chem/Micro and Rad laboratories October 2004 Food Security Surveillance Assignment-16 Federal Labs. May 2005 Water Security Assignment 13 Federal and State Laboratories

FERN Surveillance Testing cont. Mar 2006 -FDA Food Defense Assignment Pilot release (Micro/Chem) FDA labs & FDA Grant labs only July 2006 -FDA Food Defense Assignment (Micro/Chem)-full scale release to FERN Labs. Aug 2006 - FSIS FERN is implementing a pilot program to survey the USDA school lunch program for select agents. Pilot will include 4 FERN labs, more will join later with full program implementation. Mar 07 -FDA/FSIS joint food defense assignment involving FDA & FSIS field labs with state FERN labs. May 07 -FDA Food Defense-Melamine

FERN Methods Developed and Implemented: – – – 8 microbiological 22 chemical 1 radiological Method sub-committee - Method SOP developed detailing minimum standards, methods provide consistent repeatable results in food matrices Chemistry & Radiological Method Validation SOPcompleted FERN Methods are harmonized with LRN

USDA, FSIS, FERN Division Cooperative Agreements: Enhancement of Food Emergency Response Network Laboratory Testing Capability for Microbiological Threat Agents. FSIS FERN Division cooperative agreements are intended to target State, Local, and tribal FERN labs to augment microbiological threat agent testing capacities and expand the numbers of member laboratories able to perform threat agent testing for the network. 18 Cooperative Agreements-FY 05/06 17 Cooperative Agreements renewed for FY 07. 4 additional CAP selected for FY 08. 4 additional CAP recruited for FY 09.

Electronic Communication The data capture and exchange mechanism for the FERN is the Electronic Laboratory Exchange Network (e. LEXNET). FERN uses e. LEXNET for Collaboration & Data Sharing: – FERN National Program Offices share current information, meeting minutes, documentation, and guidance information – FERN Subcommittees conduct discussions, disseminate information, and develop documentation – FERN Methods Repository on e. LEXNET – 113 Lab Participants can review information on samples that have been submitted by e. LEXNET’s participating laboratories – FERN Proficiency & Surveillance Assignments: FERN related data can be captured and reported independently

FERN Web Database and Directory Project Carrie Rigdon, Ph. D UMN/MDA Postdoctorate & Food. SHIELD Coordinator

Food. SHIELD Web-based System - Unite the people-regulators, investigators, analysts: who protect the food supply and public health - Provide a tool to find & communicate w/people - Characterize the laboratories, divisions, & agencies: - Duties & responsibilities - Key personnel roles - Capacity & capabilities

www. foodshield. org

FERN Public Web Page www. fernlab. org

What’s on the FERN Public Page ? Basic FERN information – Mission of FERN – Organization – Regions NPO and RCC contact information Quick links to emergency and defense information

FERN Secure Site – Goals, Timeline Project Introduction: Aug. – Sept. 2007 – Introduce project at regional meetings – Solicit feedback from FERN staff and members

FERN Secure Site – Goals, Timeline Project Introduction: Aug. – Sept. 2007 – Introduce project at regional meetings – Solicit feedback from FERN staff and members Verification of Current Information: – Jan. 2008 – Enrollment onto secure site – Member laboratories verify their information online

FERN Secure Site – Goals, Timeline Project Introduction: Aug. – Sept. 2007 – Introduce project at regional meetings – Solicit feedback from FERN staff and members Verification of Current Information: Oct. – Nov. 2007 – Enrollment onto secure site – Member laboratories verify their information online Completion of Initial Data Collection: May 2008 – Finalize additional data fields and assign security – Upload completed data template from member labs – Activate database search/query function

Laboratory Networks Food Emergency Response Network (FERN) Laboratory Response Network (LRN) National Animal Health Laboratory Network (NAHLN) National Plant Diagnostic Network (NPDN) Environmental Network (e. LRN)

National Animal Health Laboratory Network (NAHLN) Pullman Puyallup Corvallis St. Paul Brookings Logan Davis Galesburg Manhattan Albuquerque Stillwater Pilot NAHLN (CSREES coop agreement) Exotic Newcastle Disease/Avian Influenza Scrapie/Chronic Wasting Disease Bovine Spongiform Encephalopathy Classic Swine Fever and Foot & Mouth Disease National Veterinary Services Laboratories College Station Trenton Plum Island Georgetown West Reynoldsburg Moorefield Lafayette Harrisonburg Salisbury Columbia Centralia Frankfort Raleigh Hopkinsville Little Rock Oakwood. Columbia Athens Amarillo Approved Laboratories 3/19/2018 Kennett Square Harrisburg Lincoln Ft. Collins Tucson Ithaca Storrs Lansing Ames Laramie Reno Madison Auburn Baton Jackson Rouge Tifton Kissimmee

USDA: National Plant Diagnostics Network (NPDN) Network NAPIS database (Purdue Univ. ) Michigan State University Regional Plant Diagnostics Ctr. Cornell University Animal-Satellite Regional Plant Diagnostics Ctr. * * University of Florida Regional Plant Diagnostics Ctr. UC Davis Regional Plant Diagnostics Ctr. Animal-Core Kansas State University Regional Plant Diagnostic Ctr. Texas Tech University Plant Diagnostic Support * November 5, 2004

Environmental Laboratory Response Network (e. LRN) Laboratories with Capabilities to Analyze Environmental Samples for Chemical Warfare Agents Key Commercial Laboratories 8 Federal Laboratories 4 Total Laboratories 12 Laboratories included based on survey responses to EPA’s Compendium of Environmental Testing Laboratories, as well as laboratories who are authorized under Army Regulation 50 -6 Chemical Surety to possess neat or dilute standards for chemical warfare agents. However, since several of these laboratories did not respond to the survey, the scope of their capabilities and capacities is not known. Locations displayed do not include seven Department of Defense facilities in the continental United States where chemical warfare agents are disposed of and stored. Interim Draft - Do not cite, for official use only. July 2005

Environmental Laboratory Response Network (e. LRN) Major Laboratories with Capabilities for Analyzing Environmental Samples for Radiochemical-nuclear Agents Key State/Local Laboratories 2 Commercial Laboratories 16 U. S. EPA laboratories 2 Federal Laboratories 9 Total Laboratories 29 Laboratories included based on survey responses to EPA’s Compendium of Environmental Testing Laboratories, as well as eight Department of Energy National Laboratories. Interim Draft - Do not cite, for official use only. July 2005

Recent FERN Activities Spinach outbreak - EHEC – Method development/validation – Storeroom participation Pet food contamination – Melamine – Chemists get to be involved – Method development/validation Food defense assignments – FDSA and PSA

Spinach Outbreak For the spinach outbreak, the FERN was activated in the following capacities: – – FERN storeroom Technical guidance Methodology FERN monitoring to determine need for surge capacity. FERN method experts and CDC/LRN finalized a harmonized EHEC method Method was approved by FERN MCC and NPO and posted on e. LEXNET for use by labs

Pet Food Contamination FERN was activated – RCC’s contact labs: capabilty and capacity Forensic Chemistry Center, states, and USDA developed methods Eight Chemistry Cooperative Agreement labs tested imported and domestic protein sources (China) FERN Storeroom supplied standards FERN NPO acted as a clearing house of information: – – Method expertise Daily calls for method development 50 state calls Laboratory calls

Priority: Leveraging Identify existing labs that are willing to assist with method validation activities Identify subject matter experts to assist with methods and technical issues Identify current laboratory capabilities and capacities and any gaps that need to be addressed Attend organizational meetings in regions Participate in emergency response and/or table top exercises

Next steps for FERN Establish criteria for FERN Activation and national emergency response coordination Communicate FERN objectives, policies and current activities with ICLN & other networks Enhance collaboration among FERN labs within a region, i. e. tailored response plans Expand FERN capacity and capability Leverage existing resources, responsibilities, and roles to maximize cost effectiveness Continue to align FERN with a risk-based approach

A more secure Dawn!

POCs USDA-FSIS-OPHS FERN Director: Doug Abbott, Ph. D 706 -546 -3578 douglas. abbott@fsis. usda. gov USDA-FSIS-OPHS FERN Deputy Director: Randy Layton, DVM 706 -546 -3572 randal. layton@fsis. usda. gov USDA-FSIS-OPHS FERN NPO Chief: Steve Benson 706 -546 -3564 steve. benson@fsis. usda. gov DHHS-FDA-ORA Field Science Division Director: Carl Sciacchitano 301 -827 -1232 carl. sciacchitano@fda. hhs. gov DHHS-FDA-ORA: FERN Director Tim Mc. Grath 301 -827 -1028 timothy. mcgrath@fda. gov

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