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

项目概要/摘要-总体： 在国家卫生实验室（SHL）内发展和维持的食品安全文化 在爱荷华州大学是一个高质量的，基于性能的努力，提高公共卫生，保护 消费者，并促进准备。国家卫生实验室一直致力于维护 自2013年9月起，实验室的质量体系符合ISO/IEC 17025，并保持 AIHA实验室认证专门为食品范围提供的资源-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。这一全面应用的目的是：1）确保实验室能力， 2）加强和提高紧急情况/疫情中的粮食应对措施， 和3）增强目前已验证的分析方法并可能开发新的分析方法。SHL管理层和 支援食物安全的技术人员在公共卫生化验所有丰富经验。SHL化学家 和微生物学家进行了食品分析的监测，爆发和检查样本，因为 2000年代初SHL拥有在爱荷华州继续开展食品项目所需的所有补充资源 FDA ISO 17025和FDA FERN计划结束后。SHL在两个实验室进行食品操作 地点实验室内设有BSL 2和BSL 3套间、生物安全柜和通风柜。仪表 包括ICPMS、LCMSMS、GCMSMS、IC、比例计数器、液体闪烁计数器、α和 伽马能谱仪热循环仪和大量的辅助设备AIHA食品计划证书， 独特的范围，工业卫生和环境的铅目前为这些地点。SHL是由 国家环境实验室认证计划（NEOLS），由俄勒冈州监督 授权。SHL由内部开发和维护的LIMS提供支持。质量管理 质量管理体系已到位，并由质量管理计划指导。质量体系中包含了 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。进行了改进 和新的应用建议，包括扩大能力，在放射化学快速α发射 筛选，扩大了果汁和其他含糖产品的化学分析能力， SHL的微生物学验证了内部环孢子虫RT PCR检测，以进行监测。在未来几年， SHL Microbiology计划验证C.肉毒杆菌毒素取代 ELISA毒素试剂盒，特别是小鼠试验。此外，COVID-19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，需要为此目的进行开发 相对快。SHL拥有专业知识，资源和设施，为科学做出贡献，以及所有其他 提出的项目不仅有利于SHL和爱荷华州，而且有利于FDA和FERN网络。

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.