Food Defense and Surveillance in Support of the FDA by the State Hygienic Laboratory at the University of Iowa

项目摘要/摘要--总体： 在国家卫生实验室(SHL)内发展和保持的食品安全文化 在爱荷华大学的是一项高质量的、基于绩效的努力，旨在增强公共健康，保护 消费者，并促进备灾。国家卫生实验室一直致力于维护 自2013年9月以来，实验室的质量体系符合国际标准化组织/国际电工委员会17025标准，并保持 AIHA实验室认证通过提供资源，包括系统， 设备和人员-确保遵守严格的QA/QC协议和适当的认证 权威/机构标准。这一总体应用的目标是：1)确保实验室能力 食品分析，2)加强和加强在紧急和紧急情况/疫情中的食品反应， 3)加强目前已被验证的分析方法，并有可能开发新的分析方法。SHL的管理和 支持食品安全的技术人员在公共卫生实验室拥有丰富的经验。SHL化学家 微生物学家已经对监测、暴发和检查样本进行了食品分析 21世纪初。Shl拥有在爱荷华州全面继续实施食品计划所需的所有必要和补充资源。 超过FDA国际标准化组织17025和FDA蕨类计划的结束。卫生福利局局长在两个实验室进行食物操作 地点。实验室内有BSL2和BSL3套房、生物安全柜和通风柜。仪器仪表 包括ICPMS、LCMSM、GCMSM、IC、比例计数器、液体闪烁计数器、阿尔法和 伽马能谱仪、热循环仪和实质性支持设备。Aiha计划食品证书， 这些地区目前有独特的范围、工业卫生和环境铅。Shl获得以下认证 俄勒冈州监督的国家环境实验室认可计划(NELAP) 认证机构。SHL由内部开发和维护的LIMS提供支持。A质量管理 体系是否到位，并以质量管理计划为指导。包含在质量体系中的是 文件控制系统(IPassport)、不合格事件(NCE)协议和内部 审计。通过大量的培训和教育要求来解决安全问题。有改进的地方 以及提出的新应用，包括扩展用于快速阿尔法发射体的放射化学能力 果汁及其他糖类产品的化学分析筛选及应用 Shl的微生物学验证了环孢子菌的内部RT-PCR检测方法，以产生监测。在未来的几年里， SHL微生物公司计划验证Endoep-MS程序以取代已停产的肉毒杆菌毒素 酶联免疫吸附试验毒素试剂盒，特别是小鼠试验。此外，新冠肺炎对食品和食品的影响 表面是病毒学测试中一个关键的新兴研究领域，需要为此目标而发展 相对较快。Shl拥有专业知识、资源和设施，可以为该科学以及其他所有科学做出贡献。 被提议的项目不仅将使SHL和爱荷华州受益，而且还将使FDA和FERN网络受益。

Project Summary/Abstract - Overall: The culture of food safety that has been developed and sustained within the State Hygienic Laboratory (SHL) at the University of Iowa is a high-quality, performance-based effort that enhances public health, protects consumers, and promotes preparedness. The State Hygienic Laboratory has been engaged in maintaining quality systems in the laboratory in compliance with ISO/IEC 17025 since September 2013 and maintains AIHA Laboratory Accreditation specifically for the food scope by providing the resources - including systems, equipment, and personnel - to ensure adherence to rigorous QA/QC protocols and appropriate accrediting authority/agency standards. The aims of this overall application are to: 1) ensure laboratory capacity for the analysis of foods, 2) strengthen and enhance food response in urgent and emergency situations/outbreaks, and 3) enhance currently validated and potentially develop new analytical methods. The SHL management and technical staff supporting food safety have substantial experience in the public health laboratory. SHL chemists and microbiologists have performed food analysis for surveillance, outbreak and inspection samples since the early 2000s. SHL has all required and supplemental resources for full continuation of the food program in Iowa beyond the end of the FDA ISO 17025 and FDA FERN programs. SHL performs food operations in two lab locations. Within lab locations are BSL2 and BSL3 suites, biosafety cabinets, and fume hoods. Instrumentation includes ICPMS, LCMSMS, GCMSMS, IC, proportional counters, liquid scintillation counters, alpha and gamma spectrometers, thermocyclers, and substantial support equipment. AIHA program certificates for food, unique scopes, industrial hygiene and environmental lead are current for these locations. SHL is accredited by the National Environmental Laboratory Accreditation Program (NELAP) with oversight from the Oregon accrediting authority. SHL is supported by a LIMS developed and maintained in-house. A quality management system is in place and guided by the Quality Management Plan. Incorporated in the quality systems are a document control system (iPassport), a non-conforming event (NCE) protocol and a schedule of internal audits. Safety is addressed through substantial training and education requirements. There are improvements and new applications proposed that include expanded capability in Radiochemistry for rapid alpha-emitter screen, expanded capability in Chemistry for the analysis of juice and other sugary products and applying SHL's Microbiology validated in-house Cyclospora RT PCR assay to produce surveillance. In future years, SHL Microbiology plans to validate Endopep-MS procedure for C. botulinum toxin to replace discontinued ELISA toxin kits and particularly the mouse assay. In addition, the implications of COVID-19 on food and food surfaces is a critical emerging research area in virology testing that will need development for this aim relatively soon. SHL has the expertise, resources and facilities to contribute to that science, as well as all other projects that are proposed that will not only be a benefit SHL and Iowa, but also the FDA and FERN networks.