FDA FERN Cooperative Agreement Continuation Program (U18): Minnesota Department of Agriculture

明尼苏达州农业部 FDA蕨类合作协议延续计划(U18) 蕨类化学和微生物实验室 RFA-FD-15-019摘要 摘要 明尼苏达州农业部(MDA)实验室服务部正在提交一份申请，根据 FDA蕨类合作协议延续计划(U18)，蕨类化学和微生物实验室，如#年宣布的 RFD-FD-15-019。 设施名称和地址：最负责任的个人： 明尼苏达州农业部，实验室主任加里·霍瓦斯 实验室服务部电话：651-201-6563 罗伯特北街601号 明尼苏达州圣保罗，55155 PD/PI： 主电话：651-201-6010，化学科经理米歇尔·坎贝尔 主要传真：651-201-6106电话：651-201-6575 自2004年以来，丙二醛实验室一直是蕨类微生物和化学实验室。丙二醛实验室处于有利地位， 落实FDA蕨类合作协议计划的目标，包括其员工、设施、 设备、食品检测能力、实验室质量管理体系，并通过持续参与蕨类培训， 监督、能力测试和合作协议计划活动。 研究战略和支持文件在应用程序包中提交，涉及列出的两个项目 下面。 1.计划公告中列出的主要项目领域包括： 微生物学--第1轨 ·使用各种标准化培养和生化分析方法检测和鉴定#年的病原体 食物； ·使用各种标准化的血清学分析方法检测和鉴定食品中的病原体；以及 ·使用各种标准化的分子分析方法来检测和鉴定食品中的病原体。 化学--第二轨 ·使用气相色谱-质谱仪(GC-MS)分析来筛选和鉴定有毒、有毒物质 食品中的物质和未知化合物； ·使用液-质联用(LC-MS)分析来筛选和鉴定有毒、有毒物质 食品中的物质和未知化合物； ·使用电感耦合等离子体质谱对重金属和有毒物质进行筛选和鉴定 食物中的元素；以及 ·使用酶联免疫吸附分析(ELISA)和其他以抗体为基础的分析进行筛选和鉴定 食物中的未知毒素。 2.公告的研究战略和相关其他项目信息部分涉及的具体问题 包括： ·实验室设施和其他资源 ·实验室人员资格 ·实验室管理做法 ·分析食品中未知污染物的实验室专业知识 ·设备 ·预算预测 ·样本分析承诺 ·将数据输入eLEXNET的能力和意愿 ·有能力和意愿在检测到阳性样本后立即通知蕨类NPO 研究策略和相关文档对上面概述的每一项做出了响应，并演示了MDA如何 实验室将为实现FDA蕨类合作协议延续计划(U18)的目标做出贡献 蕨类化学和微生物实验室。这项合作协议对FDA Fern的预期好处是利用 MDA工作人员的丰富经验和专业知识，以及可用的重要实验室设施和设备资源 蕨类植物通过丙二醛。MDA实验室工作人员将能够执行蕨类监测任务、疫情暴发和激增能力 对化学污染物进行响应、熟练程度测试以及进行方法开发、验证和增强活动 以及各种食品基质中的微生物。 1

Minnesota Department of Agriculture FDA FERN Cooperative Agreement Continuation Program (U18) FERN Chemical and Microbiological Laboratories Abstract for RFA-FD-15-019 ABSTRACT The Minnesota Department of Agriculture (MDA) Laboratory Services Division is submitting an application for consideration under the FDA FERN Cooperative Agreement Continuation Program (U18), FERN Chemical and Microbiological Laboratories, as announced in RFD-FD-15-019. Facility Name and Address: Most Responsible Individual: Minnesota Department of Agriculture Gary Horvath, Laboratory Director Laboratory Services Division Phone: 651-201-6563 601 Robert Street North St. Paul, MN 55155 PD/PI: Main Phone: 651-201-6010 Michelle Campbell, Chemistry Section Manager Main Fax: 651-201-6106 Phone: 651-201-6575 The MDA Laboratory has been a FERN microbiology and chemistry laboratory since 2004. The MDA Laboratory is well-positioned to carry out the goals of the FDA FERN cooperative agreement program in terms of the experience and expertise of its staff, facilities, equipment, food test capabilities, laboratory quality management system, and through its on-going participation in FERN training, surveillance, proficiency testing, and cooperative agreement programs activities. A Research Strategy with supporting documentation is submitted in the application package addressing the 2 items listed below. 1. Key project areas outlined in the program announcement include: Microbiology - Track 1 • Use of various standardized cultural and biochemical analytical methods for the detection and identification of pathogens in food; • Use of various standardized serological analytical methods for the detection and identification of pathogens in food; and • Use of various standardized molecular analytical methods for the detection and identification of pathogens in food. Chemistry - Track 2 • Use of Gas Chromatograph – Mass Spectrometry (GC-MS) analysis for the screening and identification of poisons, toxic substances, and unknown compounds in foods; • Use of Liquid Chromatograph – Mass Spectrometry (LC-MS) analysis for the screening and identification of poisons, toxic substances, and unknown compounds in foods; • Use of Inductively Coupled Plasma – Mass Spectrometry for the screening and identification of heavy metals ands toxic elements in food; and • Use of Enzyme-Linked Immunosorbent Assay (ELISA) and other antibody-based analysis for the screening and identification of unknown toxins in foods. 2. Specific issues addressed in the Research Strategy and Related Other Project Information portion of the announcement include: • Laboratory Facilities and Other Resources • Laboratory Personnel Qualifications • Laboratory Management Practices • Laboratory Expertise in Analyzing Foods for Unknown Contaminants • Equipment • Budget Projection • Sample Analysis Commitment • Ability and willingness to perform data entry into eLEXNET • Ability and willingness to inform the FERN NPO immediately upon detecting a positive sample The research strategy and associated documentation responds to each item outlined above, and demonstrates how the MDA Laboratory will contribute toward meeting the objectives of the FDA FERN Cooperative Agreement Continuation Program (U18) for FERN Chemical and Microbiological Laboratories. The expected benefit of this cooperative agreement to FDA FERN is to leverage the considerable experience and expertise of the MDA staff, and the significant laboratory facilities and equipment resources available to FERN through MDA. The MDA Laboratory staff will be able to carry out FERN surveillance assignments, outbreak and surge capacity response, proficiency tests, as well as, perform method development, validation and enhancement activities for chemical contaminants and microbiological organisms in a variety of food matrices. 1