Minnesota Department of Agriculture FDA FERN Cooperative Agreement Continuation Program (U18) FERN Chemical and Microbiological Laboratories Abstract for RFA-FD-15-019 ABSTRACT The Minnesota Department of Agriculture (MDA) Laboratory Services Division is submitting an application for consideration under the FDA FERN Cooperative Agreement Continuation Program (U18), FERN Chemical and Microbiological Laboratories, as announced in RFD-FD-15-019. Facility Name and Address: Most Responsible Individual: Minnesota Department of Agriculture Gary Horvath, Laboratory Director Laboratory Services Division Phone: 651-201-6563 601 Robert Street North St. Paul, MN 55155 PD/PI: Main Phone: 651-201-6010 Michelle Campbell, Chemistry Section Manager Main Fax: 651-201-6106 Phone: 651-201-6575 The MDA Laboratory has been a FERN microbiology and chemistry laboratory since 2004. The MDA Laboratory is well-positioned to carry out the goals of the FDA FERN cooperative agreement program in terms of the experience and expertise of its staff, facilities, equipment, food test capabilities, laboratory quality management system, and through its on-going participation in FERN training, surveillance, proficiency testing, and cooperative agreement programs activities. A Research Strategy with supporting documentation is submitted in the application package addressing the 2 items listed below. 1. Key project areas outlined in the program announcement include: Microbiology - Track 1 ? Use of various standardized cultural and biochemical analytical methods for the detection and identification of pathogens in food; ? Use of various standardized serological analytical methods for the detection and identification of pathogens in food; and ? Use of various standardized molecular analytical methods for the detection and identification of pathogens in food. Chemistry - Track 2 ? Use of Gas Chromatograph ? Mass Spectrometry (GC-MS) analysis for the screening and identification of poisons, toxic substances, and unknown compounds in foods; ? Use of Liquid Chromatograph ? Mass Spectrometry (LC-MS) analysis for the screening and identification of poisons, toxic substances, and unknown compounds in foods; ? Use of Inductively Coupled Plasma ? Mass Spectrometry for the screening and identification of heavy metals ands toxic elements in food; and ? Use of Enzyme-Linked Immunosorbent Assay (ELISA) and other antibody-based analysis for the screening and identification of unknown toxins in foods. 2. Specific issues addressed in the Research Strategy and Related Other Project Information portion of the announcement include: ? Laboratory Facilities and Other Resources ? Laboratory Personnel Qualifications ? Laboratory Management Practices ? Laboratory Expertise in Analyzing Foods for Unknown Contaminants ? Equipment ? Budget Projection ? Sample Analysis Commitment ? Ability and willingness to perform data entry into eLEXNET ? Ability and willingness to inform the FERN NPO immediately upon detecting a positive sample The research strategy and associated documentation responds to each item outlined above, and demonstrates how the MDA Laboratory will contribute toward meeting the objectives of the FDA FERN Cooperative Agreement Continuation Program (U18) for FERN Chemical and Microbiological Laboratories. The expected benefit of this cooperative agreement to FDA FERN is to leverage the considerable experience and expertise of the MDA staff, and the significant laboratory facilities and equipment resources available to FERN through MDA. The MDA Laboratory staff will be able to carry out FERN surveillance assignments, outbreak and surge capacity response, proficiency tests, as well as, perform method development, validation and enhancement activities for chemical contaminants and microbiological organisms in a variety of food matrices. 1
Minnesota Department of Agriculture FDA FERN Cooperative Agreement Continuation Project (U18) FERN Chemical and Microbiological Laboratories Project Narrative for RFA-FD-15-019 PROJECT NARRATIVE In accordance with the instructions provided in the RFA-FD-15-019 announcement, the MDA Laboratory's Research Strategy is submitted as one attachment, not to exceed 30 pages, under the Research Strategy in the Research Plan Attachments of the PHS 398 Research Plan document. 1
