FSMA Human Foods Preventive Controls Implementation Expansion Supplement to RFA-FD-18-001

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To help pave the way to a more integrated food safety system (IFSS) in furtherance of public health - and for the important sector of our economy in Wisconsin and nationwide that is manufactured food - Wisconsin's Department of Agriculture, Trade and Consumer Protection (DATCP) is requesting funding to develop and support implementation of the Preventive Controls for Human Food (PCHF) Rule in our state, and to more broadly attain the goals of the PCHF's “parent” legislation FSMA. In order to do so, Wisconsin has identified the need to enhance our information technology (IT) infrastructure. While Wisconsin has other areas with PCHF Rule conformance enhancement potential, our primary goals is to put in place a system that allows us to conduct and report about inspections, PCHF inspections in particular, more efficiently, more timely, and with less possibility of avoidable error. Based on experience, this will require better IT hardware and software for use by Wisconsin's manufactured food staff. The improvements we can make using such IT tools will allow us to do better workplanning and more transparent information sharing with our partners at the FDA. Wisconsin has come to recognize that the matter of state compatibility with the leading edge data platforms of the FDA would bolster better PCHF Rule implementation in our state and tie it into other programmatic areas. This recognition follows Wisconsin's work as one of the first states in the nation to pilot submission of non-contract inspection (NCI) information to the FDA for some of our state manufactured food facilities, and our similarly pioneering work helping to conduct user acceptance testing on NCI data for the FDA's Office of Regulatory Affairs Partners Portal. Around the time of Wisconsin's assistance with these projects, DATCP staff also spoke with a colleague in Florida whose state program has embraced the FDA's National Food Safety Data Exchange (NFSDX) platform, and with personnel in the FDA's Office of Regulatory Affairs. Such conversations, when combined with our other efforts, have helped make us believers in information technology solutions of the future and NFSDX in particular. Our proposed future- minded solutions (such as better hardware, i.e., durable IT goods) would almost by definition be sustainable beyond the end of the project period and thus help us carry our efforts into the future both for our own benefit and for that of the FDA and its vision of an IFSS.