FDA FERN Cooperative Agreement Continuation Program (U18) RFA-FD-15-019 Proposal Abstract The Washington State Department of Agriculture (WSDA) Microbiology Laboratory is eager to continue as an FDA FERN-funded microbiology laboratory, as well as continue as an active participant in the creation of the nations? Integrated Food Safety System. The WSDA Microbiology Laboratory seeks five years of funding through the FDA FERN Cooperative Agreement Program for a total of $1,199,824. The Microbiology Laboratory currently participates in three food testing programs: WSDA state-directed Food Safety program, and Animal Feed program, and the FDA-FERN Microbiological Cooperative Agreement Program. Accomplishments and attributes The WSDA Microbiology Laboratory: ? Conducts an average of 15,000 individual tests on over 6,000 food, feed, environmental and dairy samples under our state directed food safety program. ? Is eligible to apply for this Cooperative Agreement Program since we currently receive funding under the FDA FERN MCAP. The WSDA Microbiology Laboratory has proven itself a successful partner under the 2009-2012 & 2012-2015 FDA FERN Microbiological Cooperative Agreements, having completed all assignments successfully and on-time. Our Laboratory?s FERN-Microbiologist took a leading role in research projects under the agreement in the past several years. ? Has a long-standing relationship with WSDA Food Safety Program?s samplers. For over fifteen years these samplers have demonstrated competence in aseptic sampling techniques and adherence to the strict sampling guidelines of USDA AMS-MDP Project. ? Microbiologists are knowledgeable and experienced in multiple food matrices, pathogens, toxins and various testing environments. ? Provides testing support under WSDA?s FDA-funded Rapid Response Team Cooperative Agreement and has responded to many Washington State food poisoning cases: Salmonella from Trader Joe?s Peanut Butter, environmental samples from a custom meat slaughtering facility, and Listeria monocytogenes found in Snoqualmie Gourmet Ice Cream to name a few recent incidents. FDA-FERN MCAP was instrumental in these efforts. ? Has the necessary space to continue supporting the additional work associated with this project. If funded, we propose to continue supporting a microbiologist dedicated to meeting the requirements of this Cooperative Agreement. ? Is located in a strategic geographic area of the United States. Washington State is home to several major international shipping ports, through which nearly $15.1 billion in food and agricultural products were exported in 2013. The Port of Seattle, the state?s largest city and port, is the gateway port for all Asian and Canadian trade. ? Has a mission statement which fits well with this project mission-: ?to serve the people of Washington by supporting the agricultural community and promoting consumer and environmental protection?. ? Has been accredited to ISO/IEC 17025:2005 since 2011 If our FERN proposal is accepted, we are willing AND able to address all three project areas incorporated in this Cooperative Agreement: 1. Participate in FDA/FERN sample analysis 2. Provide analytical data for potential regulatory utilization 3. Participate in small-scale method development, method validation and matrix extension work as determined by FERN NPO Using the following three key techniques defined in this Cooperative Agreement: 1. Various standardized cultural and biochemical analytical methods 2. Various standardized serological analytical methods 3. Various standardized molecular analytical methods for the detection and identification of food-borne pathogens.
FDA FERN Cooperative Agreement Continuation Program (U18) RFA-FD-15-019 Project Narrative The Washington State Department of Agriculture (WSDA) Microbiology Laboratory has a history of demonstrated success as a FDA-FERN MCAP Laboratory since 2009. As an MCAP member, WSDA Microbiology Laboratory actively participates in all activities associated with the Cooperative Agreement: teleconferences, proficiency sample testing, training seminars, FERN conferences, teleconferences, group testing assignments as well as additional novel experiments requested of our laboratory by FERN. As an ISO17025:2005 accredited laboratory, we have a quality management system in place with dedicated quality assurance staff, a safety officer and procedures in place to assure good laboratory practices. We have laboratory facilities to assure the proper environment for advanced instrumentation in addition to secure sample custody and laboratory space. As a current FERN laboratory, the WSDA Microbiology Laboratory is applying for the cooperative agreement titled: FDA FERN Cooperative Agreement Continuation Program (U18), announcement RFA-FD-15-019, with anticipation of funding for 2015-2020. Project Narrative Track 1 - Microbiology: The WSDA Microbiology Laboratory is willing and able to participate in the following 3 project areas: 1. The use of various standardized cultural and biochemical analytical methods for the detection and identification of pathogens in food. The WSDA Microbiology Laboratory shall participate in Food and Drug Administration (FDA) FERN sample analysis for surveillance assignments, food emergency outbreak testing and ensure large-scale food emergency event surge capacity by using various standardized cultural and biochemical analytical methods for the detection and identification of pathogens in food. Currently, our laboratory is participating in the 2014-2015 Avocado assignment, using standardized cultural/biochemical methods. 2. The use of various standardized serological analytical methods for the detection and identification of pathogens in food. The WSDA Microbiology Laboratory shall participate in FDA FERN sample analysis for surveillance assignments, food emergency outbreak testing and ensure large-scale food emergency event surge capacity by using various standardized serological analytical methods for the detection and identification of pathogens in food. The WSDA Microbiology Laboratory has trained staff and equipment to perform serological analysis for Listeria monocytogenes (Poly O, Type 1 and Type 4), Escherichia coli O157:H7 (O157 and H7), and E. coli STEC Big Six (all six O types). 3. The use of various standardized molecular analytical methods for the detection and identification of pathogens in food. The WSDA Microbiology Laboratory shall participate in FDA FERN sample analysis for surveillance assignments, food emergency outbreak testing and ensure large-scale food emergency event surge capacity by using various standardized molecular analytical methods for the detection and identification of pathogens in food. The WSDA Microbiology LaboratoryRRT Group conducts rapid detection (PCR) of most food borne pathogens including E. coli O157:H7, Salmonella spp., L. monocytogenes, Shigella spp., Shiga Toxin I and Shiga Toxin II E. coli, and Campylobacter jejuni. Additional testing includes biological and chemical toxins detection, DNA subtyping using Pulsed Field Gel Electrophoresis (PFGE) for quality control and submission into PulseNet for outbreak investigation, a free service covered by an inter-agency memo within the State of Washington. We project to use multiple funding sources to purchase whole genome sequencing instrumentation within the next two years. We also propose to improve and expand the capabilities of existing FERN methodologies as well as develop new methodologies as needed during this grant cycle. In conclusion, the Washington State Department of Agriculture Microbiology Laboratory wishes to continue as a FDA-funded FERN-MCAP Laboratory. We have met all Program requirements and will strive to meet these requirements in the future. Our Laboratory and Department has gained immensely from participating in the first and second grant cycles of MCAP funding, and we look forward to continued participation and the associated challenges and rewards.
