FDA_FERN Cooperative Agreement Program

This application is submitted on behalf of the Ohio Department of Agriculture Consumer Protection Laboratory (ODA‐CPL) for the continuation of the FDA Chemistry and Microbiology Cooperative Agreements for the enhancement of Food Emergency Response Network (FERN) Laboratory Testing Capability and Capacity. The application covers FERN Microbiological (Track 1) and FERN Chemical (Track 2) Applications. The FERN Microbiological Application addresses the following three areas: 1) the use of various standardized cultural and biochemical analytical methods for the detection and identification of pathogens in food, 2) the use of various standardized serological analytical methods for the detection and identification of pathogens in food, and 3) the use of various standardized molecular analytical methods for the detection and identification of pathogens in food. The FERN Chemical Application addresses the following four areas: 1) the use of Gas Chromatography‐Mass Spectrometry (GC‐MS) analysis for the screening and identification of poisons, toxic substances, and unknown compounds in foods, 2) the use of Liquid Chromatography‐ Mass Spectrometry (LC‐MS) analysis for the screening and identification of poisons, toxic substances, and unknown compounds in food, 3) the use of Inductively Coupled Plasma‐Mass Spectrometry (ICP‐MS) analysis for the screening and identification of heavy metals and toxic elements in foods, and 4) the use of Enzyme‐Linked Immunosorbent Assay (ELISA) and other antibody‐based analyses for the screening and identification of unknown toxins in foods. Mr. Yamir Rosa and Mr. Jason Kong will serve as the principal investigators for Microbiological and Chemical applications, respectively. They will have responsibility for project management including organizing and assigning the team of analysts to ensure rapid sample analysis, reviewing supply purchases, and preparing project status reports as required by FERN NPO. They will also have the responsibility of providing technical oversight including method validation, reviewing standard operating procedures, approving protocol or methodology changes and providing problem‐solving expertise. Dr. Mohammed Amin will approve the protocol SOPs for compliance with Quality Management practices and will review data as appropriate. Dr. Byrum provides budgetary and facility oversight for the work performed under this agreement. Mr. Tan provides advisory and administrative support for the LC‐MS activities performed under this agreement. Dr. Tanieka Motley, Mr. Randy Wilson, and Ms. Christie Lightner will be functioning as the primary chemists for GC‐MS, LC‐MS, and ICP‐MS, respectively while Mr. David Williams, Dr. Saber Ahmed, and Ms. Duanita Booker will function as back‐ups for GS‐MS, LC‐MS, and ICP‐MS, respectively. Any of these chemists can be assigned to perform ELISA tests. Ms. Christina Reed and Ms. Angela Barlowe will serve as the primary and secondary microbiologist, respectively. The Quality Manual (ISO 17025 accredited) and management practices provide a high level of confidence in the reliability of results for all existing programs. The laboratory has a proven ability to perform large numbers of chemical and microbiological analyses with excellent turn‐around‐time for reporting results. The ODA‐CPL has a history of active participation in national food safety surveillance programs and in the investigation of significant chemical and microbiological emergencies in the United States. The ODA‐CPL laboratories have an excellent inventory of relevant instruments and equipment that could also be utilized during food emergency conditions or in the case of large scale testing needs.