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

爱荷华大学国家卫生实验室支持 FDA 的食品防护和监测

• 批准号: 10448313
• 负责人: Dustin May
• 金额: $ 39.28万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10448313
• 关键词: Food; Defense; Surveillance; Support; FDA

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.

项目摘要/摘要 - 总体： 在州卫生实验室（SHL）内开发和维持的食品安全文化 在爱荷华大学是一项高质量的基于绩效的努力，可改善公共卫生，保护 消费者并促进准备。国家卫生实验室一直从事维护 自2013年9月以来，实验室中的质量系统符合ISO/IEC 17025 AIHA实验室的认证是专门为食品范围提供的，包括提供资源 - 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/代理标准。该总体应用的目的是：1）确保实验室能力 食物分析，2）在紧急情况和紧急情况/爆发中加强和增强食物反应， 3）增强当前验证并有可能开发新的分析方法。 SHL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 自从 2000年代初。 SHL拥有全部必需的和补充资源，以全面延续爱荷华州的食品计划 除了FDA ISO 17025和FDA FERN计划的末尾。 SHL在两个实验室中进行食物操作 位置。在实验室的位置是BSL2和BSL3套件，生物安全柜和通风罩。仪器 包括ICPM，LCMSM，GCMSMS，IC，比例计数器，液体闪烁计数器，Alpha和 伽马光谱仪，热循环器和大量支撑设备。 aiha食品计划证书， 这些位置的独特范围，工业卫生和环境铅是当前的。 SHL被认可 俄勒冈州的国家环境实验室认证计划（NELAP） 认证权限。 SHL得到了内部开发和维护的LIM支持。质量管理 系统已经到位，并受到质量管理计划的指导。在质量系统中合并的是 文档控制系统（IPASSPORT），一个不合格事件（NCE）协议和内部时间表 审核。安全是通过大量培训和教育要求来解决的。有改进 提出的新应用程序包括扩展的放射化学能力快速α-发射机 屏幕，化学方面扩展的能力，用于分析果汁和其他含糖产品并应用 SHL的微生物学验证了内部环形孢子RT PCR分析，以产生监视。在未来的几年中 SHL微生物学计划验证肉毒杆菌毒素的内皮ep-MS程序以取代停产 ELISA毒素套件，尤其是小鼠测定法。此外，Covid-19对食物和食物的影响 表面是病毒学测试中的关键新兴研究领域，需要开发此目标 相对较快。 SHL具有为该科学以及所有其他的专业知识，资源和设施 提出的项目不仅将是SHL和爱荷华州的收益，还将成为FDA和FERN网络。