Description
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR), in collaboration with Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM), is announcing the availability of cooperative agreements to be awarded under a Limited Competition. Only States with current FDA Food Safety contracts (providing funding to State agency food protection regulatory programs) are eligible for these 3-year cooperative agreements. The agreements include one year of funding with up to two years of additional funding, to be awarded non-competitively dependant on performance and funds availability. The agreements will require the development and maintenance of Food Protection Rapid Response teams, encompassing both food and feed protection programs, through processes to enhance and build the existing infrastructures of State food protection programs.The goal of FDAs ORA Cooperative Agreement Program is to enhance, complement, develop, and improve States' regulatory and surveillance protection programs for manufactured foods. This will be accomplished through the provision of funding for program assessment, additional equipment, supplies, funding for personnel, and training (including ICS, rapid response team development and coordination, and exercises). This also will require extensive cooperation and coordination with: FDA District Offices to minimize duplication of inspections; an FDA contractor (the Western Institute for Food Safety and Security (WIFSS)) to develop Rapid Response Teams (RRTs); and other FDA program offices.These cooperative agreements are intended to develop, implement, and exercise an all-hazards food and foodborne illness RRT concept within food protection programs. RRTs in conjunction with other food and feed agencies within State programs, other State RRTs, FDA District Offices, and State Emergency Operations Centers (EOC) -- will respond (using expandable ICS protocols and structures as needed) to all-hazards food incidents in the farm-to-table continuum. The infrastructure necessary to develop and sustain an RRT is established using the FDA Manufactured Food Regulatory Program Standards (MFRPS) to assess and continually improve the infrastructure and equivalence of the State food regulatory program. State food program enhancements will also include the incorporation of the FDA Food Protection Plan ("FPP") to implement a strategy of prevention, intervention, and response to build safety into every step of the food supply chain. The cooperative agreements will provide funding for additional personnel, equipment, supplies, and training to support activities related to the FDA MFRPS and the RRT concept.Under the cooperative agreement, the State would assess and implement a continuous program improvement/enhancement strategy (strategic plan) using the FDA Manufactured Food Regulatory Program Standards (MFRPS) and, in addition, develop, train, and implement under Standard #5 a foodborne illness rapid response team that incorporates Incident Command System (ICS) concepts and other conceptual elements outlined in this Program Announcement (PA). Standard #5 applies to the surveillance, investigation, response, and subsequent review of alleged food-related incidents and emergencies, either unintentional or deliberate, that may result in illness, injury, or outbreaks. Post-assessment, these funds should be used to enhance or establish systems to:a. Use epidemiological information supplied by local, State, or Federal agencies to detect incidents or outbreaks of foodborne illness or injury;b. Investigate reports of illness, injury, and suspected outbreaks;c. Correlate and analyze data;d. Disseminate public information effectively;e. Distribute outbreak reports and surveillance summaries to relevant agencies;f. Disseminate current guidance to industry on food defense;g. Provide guidance for immediate notification of law enforcement agencies when intentional food contamination or terrorism is suspected or threatened; andh. Collaborate as necessary with FDA and other Federal authorities under conditions of increased threat of intentional contamination.The goal of developing and sustaining an RRT is in concert with long term goals to: enhance the food inspection and foodborne illness response programs; increase the programs' ability to inspect and obtain compliance for firms in their jurisdiction involved in the processing, manufacturing, distribution, transportation, and warehousing of food; and verify compliance with State laws and regulations, good manufacturing practices, food defense, and other food protection requirements in support of the State program and the FDA Food Protection Plan (FPP), Action Plan for Import Safety (ISAP), and the Food and Drug Administration Amendments Act of 2007 (FDAAA).Funds may be used to increase State personnel to support the RRT, team coordinators, technical experts, and epidemiologist team members. Funds may also be used for supplies, training, and equipment for inspections and rapid response, including investigational, GPS interface, communication, and laboratory. The goal of enhancing State food programs is to ensure that the necessary infrastructure is available to support RRTs along with the States' regulatory and food protection responsibilities for inspection and oversight of food processing, manufacture, distribution, transportation, and warehousing. Finally, these Support Project funds are intended to supplement, not replace, State funding for program improvement and activities. States funded under these cooperative agreements will be required to provide the previous and subsequent years of State funding to demonstrate that these funds have not replaced State allocations for the food protection program.