Presentation on theme: "The Food Emergency Response Network (FERN) Integrating the Nation’s Food Testing Laboratories for Emergency Response CAPT Michael A. McLaughlin, PhD,"— Presentation transcript:
1 The Food Emergency Response Network (FERN) Integrating the Nation’s Food Testing Laboratories for Emergency Response CAPT Michael A. McLaughlin, PhD, FDA/ORA LCDR Ruiqing Pamboukian, PhD, FDA/ORA June 21, 2012
2 Mission of FERNIntegrate the nation’s multilevel food-testing laboratories to detect, identify, respond to and recover from a bioterrorism or public health emergency/outbreak involving the food supplyFERN is a comprehensive entity that operates at local, state, & federal levels to target threat agents in food, including biological, chemical, & radiochemical agents. FERN is jointly managed by both DHHS, FDA and USDA, FSIS.The need for networks that could integrate local, state and federal levels to respond to a bioterrorism or other emergency became a high priority following 2001, and Homeland Security Presidential Directives directly relevant to the mission of FERN were issued starting in 2003, culminating in the issuance of HSPD-9 in January HSPD-9 established a national policy to defend the agriculture and food system against terrorist attacks, major disasters, and other emergencies, including the need to develop surveillance and monitoring systems, tracking systems, a national response plan, and Nation-wide laboratory networks for food, veterinary, plant health and water quality that integrate existing federal and state laboratory resources, are interconnected, and utilize standardized diagnostic protocols and procedures.Of note, FERN was started to address exclusively bioterrorism threats, but over time has evolved to address other agents that pose a public health threat.Mission Expansion:Transition from exclusively bioterrorism to inclusion of food safetyUtilization of FERN cooperative agreement labsIntegrated Food/Feed Safety System
3 FERN ObjectivesDetection: identification of biological, chemical, and radiological threat agentsPrevention: operate targeted federal/state surveillance sampling programsPreparedness: strengthen laboratory capacities and capabilitiesResponse: provide large-scale laboratory testing capacityRecovery: provide public assurance of food safety following an emergencyFERN focuses on 5 objectives: Detection, prevention, preparedness, response and recovery. These objectives give the foundation for FERN’s Support Programs, which we will cover in detail a few slides from now. The take away message of these objectives is that FERN looks to increase the capabilities and capacities of all FERN member laboratories in support of early detection and efficient, effective, comprehensive response to any food-related incident involving a microbiological, chemical or radiochemical agent, either bioterrorism or public health in nature.
4 Laboratory Makeup 169 Laboratories Affiliations: 39 Federal 113 State 17 LocalDisciplines:133 Microbiological111 Chemistry36 RadiologicalLab Testing Types:115 Food Safety (Outbreak)90 Food Safety (Regulatory/Routine)40 Agricultural Input22 Veterinary Diagnostic102 Environmental58 ClinicalAs of April 24, 2012, 169 labs in 50 states and Puerto Rico have been accepted into the FERN. Breakdowns of participating FERN laboratories are as follows:
5 FERN Organizational Chart NortheastRegionalCoordinationCenterGA & NYCentralMN & WISouthwestCO &MOSoutheastGAFERNSupportProgramsNationalProgramOfficeUSDA/ FDAMD & GAPacificGA & CAFERN is organized into a National Program Office, which coordinates the FERN Support Programs, as well as 5 Regional Coordination Centers, which are located in various states across the nation. Both the NPO and RCC are staffed with both FDA and FSIS staff. The FDA NPO is located in Rockville, MD, and the FSIS NPO is located in Athens, GA. The locations of the RCCs are listed by the states that Regional Coordinators reside in. Both NPO and RCC Staff are involved in the administration of FERN Program Areas. Five RCCs are located throughout the U.S., one in each region, and are staffed by FDA and FSIS personnel
6 FERN Support Programs Method Development & Validation Training Program FERN Methods Coordination Committee (MCC) is the reviewing and approval body for FERN MethodsFERN Methods have been evaluated and shared with CDC/LRN, and harmonized with other lab networksWork continues on method development, validation, and harmonization in all analytical areasTraining ProgramOver 600 people trained from all 50 states6 Training Centers throughout the countrySelect agent training; Rapid detection methodology trainingUtilization of web-based training coursesProficiency Testing/Readiness ProgramJoint PT exercises with LRN, ICLN conducted when possibleAim for quarterly PT offeringsFERN has several Program Areas, which are functional for all 3 analytical disciplinesThe First is Method Development and Validation. The FERN Methods Coordination Committee, staffed by NPO, RCC and member laboratory personnel, is responsible for generating Method Validation and Submission guidelines, determining method priorities for the FERN, soliciting method submissions from member labs, and reviewing and approving submissions as FERN methods. FERN also participates in method harmonization workgroups with other laboratory networks and programs, such as the LRN.The Training program offers courses through both the FDA training program and FSIS training centers, which are co-located with member laboratories and funded through Cooperative Agreements. There are a wide variety of training courses offered. The focus is on FERN methodology, but basic micro and other general courses are also offered.The Proficiency testing program is administered through the Institute for Food Safety & Health (IFSH), a joint initiative between FDA CFSAN and the Illinois Institute of Technology, which is funded through a FSIS Cooperative Agreement. The FERN aims to offer quarterly micro PTs and at least 3 chemistry PTs a year. Radiochemical PTs are offered, but are more sporadic. FERN alternates between food safety and food defense analytes, and also rotates the choice of matrices based on current events and risk assessments.The FERN also manages a FERN Storeroom, housed in Laurel, MD, as well as a Radiological Storeroom, housed in Winchester, MA. The FERN Storeroom stocks reagents, kits and supplies in support of many FERN Support Programs, such as the ones listed on this slide.
7 FERN Support Programs Surveillance Programs Assessing and demonstrating the effectiveness and capabilities of FERNTesting operating mechanism and protocols of FERNDemonstrating coordinated communication and data reportingElectronic communications and collaborationData capture & exchange mechanism for FERN is the Electronic Laboratory Exchange Network (eLEXNET)FERN Website contains public information, member directory as well as laboratory capability & assessment information (LabDIR)In the past, FERN has participated in Surveillance Assignments when available. For instance, FERN labs have participated in food defense assignments for the Republican and Democratic National Conventions of 2008 and the Inauguration in 2009, and FERN continually looks for other surveillance assignment opportunities. More recently, FERN has written surveillance activities into some of their cooperative agreements with member laboratories, and we expect that trend to continue.Lastly, FERN coordinates electronic communications through two separate systems: eLEXNET and the FERN website. eLEXNET acts as the analytical data and official document repository for the FERN, while the FERN Website contains a public site and database of laboratory capability and capacity data, called LabDIR. The FERN Website also contains registration modules for trainings, meetings and PTs.
8 FERN Cooperative Agreements A transfer of money, property, services or anything of value to recipients to accomplish a public purpose of support or stimulation.Requests For Applications – through Federal RegisterFERN currently has cooperative agreements in all three disciplines:MicrobiologyChemistryRadiologicalState laboratories, geographically dispersed.Cooperative Agreements are used to award funds to state member laboratories. Funds usually support procurement of equipment and dedicated personnel, as well as projects covered under the cooperative agreement. Requests For Applications are issued through the Federal Register. FERN currently has cooperative agreements in all three disciplines.
9 FERN Cooperative Agreement Labs Serve as “go to” labs for emergency response. These are basically “on retainer”.The FY12 Cooperative Agreement Program (CAP) funds cover:25 State Laboratories (USDA/FSIS CAP)Method development/validationIncrease capability/capacity (micro and chem focus)Training Centers3 Cooperative Agreements (USDA/FSIS CAP)Development & support of the FERN WebsitePT Program & Post-Training Check SamplesPlanning & hosting Annual FERN National Training ConferenceCooperative agreements are awarded through both FDA and FSIS. FERN Cooperative Agreements are focused on method development and validation, as well as increasing national capability and capacity, and serving as ‘go to’ labs during FERN Activations and incident response. With the advent of FDA micro Cooperative agreements in 2010, the FERN CAP program expanded into preparation of laboratories to participate in federal assignments (both emergency response and surveillance), with the goal of acceptance of state data by FDA for regulatory action. This project is still in progress.
10 FERN Cooperative Agreement Labs (cont.) 15 State Microbiology Laboratories (FDA CAP)Analyze samples for FDA/FERN (e.g. surveillance/emergency)Some method development/validation work14 State Chemistry Laboratories (FDA CAP)PT’s, surveillance, emergencies (Melamine, Oil Spill)5 State Radiochemistry Laboratories (FDA CAP)PTs, surveillance, emergencies
11 FDA Microbiology Cooperative Agreement Program (MCAP) Provide large-scale sample analysesOutbreaksSurveillance assignmentsSurge capacityUniformity of results – data acceptanceCommon analytical platforms and methodsTraining and proficiency testingBuilding Quality SystemLaboratory Accreditation (ISO/IEC:17025)Model for Integrated Food/Feed Safety System (IFSS) and Partnership for Food Protection (PFP)One Mission - One ProgramState lab data utilizationNational standardsNational work plan
12 FDA Microbiology Cooperative Agreement Program (MCAP) -Continued Recent AccomplishmentsMethod Development/validationMulti-lab Validation (MLV) for extraction and qPCR of E. coli O157:H7 in ABI 7500 Fast systemMLV for Listeria spp. and L. Monocytogenes qPCR (ABI 7500 Fast)MLV for Salmonella qPCR (ABI 7500 Fast)Vibrio qPCR MLV for isolates (BAX)Participated Surveillance Program2011 Produce Surveillance collaborated with USDA Microbiological Data Program (MDP)2012 Democratic and Republican Convention Political AssignmentB
13 FDA Chemistry Cooperative Agreement Program Recent AccomplishmentsSurveillance assignment for Arsenic in various fruit juices (total and speciation analyses). 4 labs for total As analysis and 2 for speciation.Tested FDA regulatory samples from juice import bulletin for arsenic (FDA lab was overbooked)Labs participate in a PT program which have/will include testing for As and ricin in foods.2012 Democratic and Republican Convention Political Assignment
14 FERN Laboratory Response Examples of recent events where FERN member laboratories have assistedE. coli O157:H7 in spinach, 2006Salmonella in peppers, 2008Melamine in pet food and infant formula,Salmonella in peanut butter, 2009Deepwater Horizon Oil Spill, 2010Radiological Crisis in Japan, 2011Arsenic Testing in Rice and Juices, 2012FERN has activated incident response activities 5 times since its inception. In the next slides, we will review some of the large scale FERN Incident Responses. During any given Incident, FERN can perform a variety of roles, from providing technical guidance and reagents to directing sample collection and analysis by member laboratories.
15 Examples of FERN Laboratory Response Salmonella saintpaul Outbreak response activities (Summer, 2008)FERN was activated in response to this outbreak 12 FERN Microbiology Labs tested 290 pepper/cilantro/basil samples collected by the states in a FDA coordinated effortFERN testing augmented and complemented concurrent FDA testing efforts (~550 samples)In 2008, FERN was activated in response to the Salmonella outbreak in peppers (originally thought to be tomatoes). In this instance, FERN laboratories became part of a FDA assignment, where states with FDA collection contracts collected samples and sent them to FERN labs for analysis. FERN labs analyzed 290 pepper/cilantro and basil samples.
16 Examples of FERN Laboratory Response Salmonella Typhimurium in Peanut Butter691 illnesses in 46 statesUse of state analytical data for outbreak/epi determinationsFERN labs utilized for a state-driven initiative to test manufacturing plant after clean up
17 Examples of FERN Laboratory Response Melamine Outbreak response activitiesFERN Chemistry Cooperative Agreement Program labs analyzed over 200 samples of protein products in 2007FERN Chemistry laboratories participated in the #09-06 CFSAN Melamine Import Assignment ( ), assisting FDA in the analysis of milk and protein samplesAnalyzed 340 samples, or ~20% of the total sample collection to dateWere a key factor in clearing an FDA sample backlog, which arose due to very high collection ratesMelamine was a multi-headed emergency. First, FERN chemistry CAP labs analyzed over 200 samples during the pet food crisis in FERN also developed methodology and approved it as an emergency use FERN method during this incident.Melamine reappeared in infant formula in 2008, and FERN labs were called upon again to analyze some 340 samples, which were part of an FDA assignment that created a huge sample backlog in the FDA laboratories.
18 Examples of FERN Laboratory Response PAH analysis for Deepwater Horizon Oil Spill (Summer, 2010)FERN was activated in response to this emergency.Chemistry CAP laboratories stood up for NOAA (GCMS) and Alternative (LCF) Methodologies2 FERN Chemistry CAP Labs (MN Dept of Ag and CT Agricultural Experiment Station) assisted FDA FCC in validation/development of Alternative LCF PAH method.FERN provided surge capacity testing to augment and complement concurrent FDA testing efforts for Reopening of State Waters for shrimp, crab, finfish and oysters, as well as baseline sample testing.Most recently, FERN participated in the Deepwater Horizon Oil Spill response. Chemistry CAP laboratories were responsible for analyzing the seafood samples collected as part of the reopening of state waters protocol. Labs also analyzed baseline samples collected before the oil spill. This response also involved method development and validation on the fly, and FERN labs were a critical component of this initiative. FERN labs used both the NOAA method and the LC-Fluorescence screen method to analyze the oil spill samples.
19 ICLN Organizational Structure FERN Interaction with other National Laboratory Network Through the Integrated Consortium of Laboratory Networks (ICLN)ICLN Organizational Structureas outlinedby MOAJoint Leadership Council (JLC)(Assistant Secretary Level)DHS ChairTETechnical ExpertsNetwork Coordinating Group (NCG)DHS ChairExec SecDHSThe Joint Leadership Council provides overall leadership for the ICLN, while the Network Coordination Group, consisting of leadership from each of the member networks, as well as the Joint Leadership Council, provides direct oversight of all 5 member networks: LRN, NAHLN, NPDN, FERN and ERLN. The Subgroups mentioned on the previous call are staffed by representatives from all member networks.LRNLaboratory Response NetworkNAHLNNational Animal Health Laboratory NetworkNPDNNational Plant Diagnostic NetworkFERNFood Emergency Response NetworkERLNEnvironmental Laboratory Network19
20 Next steps for FERNContinue to improve FERN Activation and National emergency response coordination protocolsCommunicate FERN objectives, policies and current activities with ICLN & other networksEnhance collaboration among FERN labs within a region, i.e. tailored response plansExpand FERN capacity and capabilityLeverage existing resources, responsibilities, and roles to maximize cost effectivenessContinue to align FERN with a risk-based approachFSMA National Surveillance program (under development)FERN is still a young network, and we have lots of growth to accomplish. On our to do list is establishment of standardized criteria and SOPs for FERN Activation and Incident Response activities, as well as development of SOPs for all FERN Programs, to facilitate communication and documentation of FERN work processes and accomplishments. ICLN- Integrated Consortium of Laboratory NetworksAs always, FERN is continually looking to bolster member lab capacities and capabilities, and leverage existing resources to maximize cost effectiveness and personnel/laboratory resources.
21 Acknowledgements -FERN National Program Office (NPO) FDA FERN NPO:Timothy McGrathCAPT Palmer OrlandiTara DoranCAPT Michael McLaughlinHitelia CastellanosDean TurcoSusanne BrookLCDR Ruiqing Pamboukian
22 USDA/FSIS FERN NPO: Randy Layton Ronald Blakely Robert Philip Kevin VoughtOye AdeyemoFrankie BeacornTom BeacornSteve Benson Brown, ElseDavis, GeneHead, MarcusHutchins, JanJohnson, LyndaJones, Jim Mayer, GabrieleRussell, KellySprague, GrisselleCampbell, Mark