Virginia's FDA FERN Cooperative Agreement Proposal

<p>Abstract: The Division of Consolidated Laboratory Services (DCLS) serves the Commonwealth of Virginia as the State Laboratory providing analytical testing in support of foodborne disease surveillance outbreak response and large-scale food emergency testing in coordination with State analytical requirements. DCLS continues to use both state funds and FERN FDA Microbiological Cooperative Agreement (U18 FD003814) funding to strengthen and improve our capability and capacity to rapidly and accurately identify microbiological contaminants in food. Over the past three years, FDA FERN funding has enabled DCLS to participate in all offered surveillance assignments, proficiency testing, method evaluation studies and to learn and exercise the use of standardized analytical worksheets and electronic result reporting in collaboration with FERN .Continued support for personnel, equipment and reagents is necessary for DCLS to continue our full participation and support of these initiatives and to continue to strengthen our food testing program. This proposal identifies core yet critical resources necessary for DCLS maintain and strengthen our current capability and capacity to rapidly and accurately respond to issues of food safety and food security. Scientific personnel supported through FDA FERN Cooperative Agreement funding have invested hundreds of hours in training, competency assessments and establishing proficiencies in FDA standardized methods and instrumentation. Additionally, instrumentation has been maintained and supplies stocked in order to assure a ready state of preparedness. With 2012-2013 funding, DCLS proposes to continue to support the salaries of three FERN FDA scientists dedicated to FERN laboratory testing initiatives and to support emergency outbreak and surge testing needs. DCLS agrees to actively participate in all offered surveillance assignments, proficiency testing exercises and special projects as offered by the FERN NPO. DCLS will continue to collaborate with FDA subject matter expert to evaluate novel analytical methodologies to support and expand existing FERN methods in order to improve sensitivity and specificity of pathogen detection and recovery. In the event of a large-scale microbiological contamination event affecting foods, DCLS commits to assisting the other cooperative agreement laboratories with performing selected microbiological analyses of domestic and imported food samples collected and supplied by the FDA or other government agencies through FDA. DCLS will perform standardized methods and generate quality controlled and assured analytical data in compliance with regulatory requirements as requested by FDA NPO. DCLS will also engage in studies aimed at the method development, validation and matrix extension of methods as directed by the FERN NPO. Additionally, DCLS will provide all analytical data for potential regulatory action to FERN NPO as instructed using standardized analytical worksheets and reporting methods</p>.