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

FSMA Human Foods Preventive Controls Implementation Expansion Supplement to RFA-FD-18-001
FSMA 人类食品预防控制实施扩展对 RFA-FD-18-001 的补充
批准号:
10175799
负责人:
Troy S Sprecker
金额:
$14.51万
依托单位国家:
美国
项目类别:
财政年份:
2018
资助国家:
美国
项目状态:
已结题
起止时间:
2018-09-01 至 2021-06-30

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项目成果

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中文摘要
翻译
为建立一个更加综合的食品安全体系铺平道路, 健康-和我们的经济在威斯康星州和全国的重要部门, 制造食品-威斯康星州的农业,贸易和消费者保护部 (DATCP)正在申请资金,以制定和支持实施预防性 控制人类食品(PCHF)规则在我们的国家,并更广泛地实现的目标, PCHF的"母"立法FSMA。 为了做到这一点,威斯康星州已确定需要加强我们的信息技术(IT) 基础设施演进虽然威斯康星州有其他地区与PCHF规则一致性增强 我们的主要目标是建立一个系统,使我们能够进行和报告 检查,特别是PCHF检查,更有效,更及时, 可避免的错误的可能性。根据经验,这将需要更好的IT硬件, 供威斯康星州的食品加工人员使用的软件。我们可以利用 这些信息技术工具将使我们能够更好地进行工作规划,并实现更透明的信息共享 我们在食品药品管理局的合作伙伴威斯康星州已经认识到 与FDA前沿数据平台的兼容性将支持更好的PCHF规则 在我们的国家实施,并将其纳入其他方案领域。 这一认可是在威斯康星州作为全国首批试点州之一的工作之后做出的 向FDA提交我们州部分地区的非合同检查(NCI)信息 制造食品设施,以及我们类似的开创性工作,帮助用户 FDA法规事务办公室合作伙伴门户网站的NCI数据验收测试。 大约在威斯康星州协助这些项目的时候,DATCP的工作人员还与一位 我在佛罗里达的一位同事,他的州项目已经接受了FDA的国家食品安全数据 交易所(NFSDX)平台,并与FDA法规事务办公室的工作人员。 这样的对话,当与我们的其他努力相结合时,有助于使我们相信 未来的信息技术解决方案,特别是NFSDX。我们的未来- 有意识的解决方案(例如更好的硬件,即,耐用IT产品)几乎可以定义为 项目结束后的可持续性,从而帮助我们将我们的努力带入未来 这既是为了我们自己的利益,也是为了FDA及其IFSS愿景的利益。
英文摘要
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.
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