Improving the Capability of Maryland State Public Health Food Testing Laboratory

项目总结 食品防务和食品安全是食品药品监督管理局的核心职能。 这些活动与保护国家的粮食供应不受故意 缓和或无意污染，并帮助食品加工者了解如何以及在哪里 食品供应可能受到污染。如果听之任之，食品污染可能会导致大规模 疾病或死亡，或产生毁灭性的经济影响，或精神焦虑(消费者恐惧， 恐慌和对美国食品供应的信心丧失)。食品防务和安全不仅是 在公共卫生方面很重要，但具有重大的经济价值和对食品的影响 行业，从而对美国经济的影响。在这种徒劳的情况下，马里兰州面临着巨大的挑战 在城乡环境和活动密切结合的情况下进行粮食保护。 国家防备的一个主要缺陷是缺乏一个全面的国家 统一的国家食品检测认证能力和识别所需的能力， 对食品的化学和微生物污染进行筛查和监测，以供监测； 恐怖主义，或紧急情况。 实验室管理局食品检测实验室是该州的主要服务机构 代表世界卫生组织进行化学和微生物食品/饲料分析实验室 马里兰州制定了食品监管计划。为了更好地解决这些实验室 和基础设施挑战，实验室管理局将使用该合作 同意：(1)制定、建立和实施符合管理要求的质量体系 和2005年国际标准化组织/国际电工委员会17025版的技术要求，目标是实现实验室 认证；(2)参加能力测试研究；(3)建立和维护员工队伍 培训、通信系统和IT管理；以及(4)进行差距分析和 申请资金以获得和获得所需的资源，以获得和保持ISO17025 化学和微生物检测方面的认证。这些努力将导致国家 协调执行的测试和生成的数据，以支持马里兰州制造 食品监管计划。此外，它还将为马里兰州提供监控 过去有污染问题历史的某些进口和国产食品 或者涉及到国家和民族的安全担忧。随后的监视 该计划还将有助于保持确保激增所需的计划熟练程度和效率 在疾病暴发或实际紧急情况下的能力和适当的反应。 实验室管理局进一步建议开发和维护这一计划 根据时间表，将采购QA技术人员、外部咨询、设备、 供应；开发和验证方法；培训和评估工作人员以进行认证；申请和 获得国际标准化组织17025认证；参与和维护PT计划；参与规定的 演练/桌面演习，计划和进行监视监控；发展通信 与授权者和利益相关者一起构建，并改进访问、管理和安全 信息技术。 实验室管理局建议在第一年实施这一项目，并建立一个 申请的联邦预算为300,000美元，并以预计总额进一步运作该项目 第2至第5年的预算为1 200 000美元。

PROJECT SUMMARY Food defense and food safety are core functions of the Food and Drug Administration. These activities are associated with protecting the nation's food supply from intentional tempering or unintentional contamination and to help food processors understand how and where food supplies could be contaminated. If left unabated, food contamination could cause massive illness or death, or produce devastating economic impacts, or mental anxiety (consumer fear, panic, and loss of confidence in the US food supply). Food defense and safety is not only important in terms of public health but has significant economic value and impact on food industries and thus on the US economy. In this vain, Maryland presents significant challenges for food protection with an intimate mix of urban and rural environments and activities. A major gap in the Nation's preparedness is the lack of a comprehensive nationally harmonized State-based food testing accreditation capability and capacity needed to identify, screen, and monitor chemical and microbiological contamination of foods for surveillance, terrorism, or emergencies. The Laboratories Administration food testing laboratory is the state's primary servicing laboratory for conducting chemical and microbiological food/feed analyses on behalf of the Maryland State manufactured food regulatory programs. To better address these laboratory and infrastructure challenges, the Laboratories Administration will use this Cooperative Agreement to: (1) develop, establish, and implement a quality system that meets the management and technical requirements of ISO/IEC 17025:2005 with the goal of achieving laboratory accreditation; (2) participate in proficiency testing studies; (3) establish and maintain staff training, communication systems, and IT management; and (4) conduct gap analysis and request funding to obtain and acquire needed resources to obtain and maintain ISO17025 accreditation in chemistry and microbiology testing. These efforts will lead to national harmonization of tests performed and data generated to support Maryland State manufactured food regulatory programs. Additionally, it will provide Maryland with the ability to monitor certain imported and domestic food products that have a history of past contamination problems or that involve security concerns for the State and the nation. The subsequent surveillance program will also help maintain program proficiency and efficiency needed to ensure surge capacity and an adequate response during a disease outbreak or an actual emergency. The Laboratories Administration further proposes to develop and maintain this program under a timetable that would procure QA technical staff, outside consultation, equipment, supplies; develop and validate methods; train and evaluate staff for accreditation; apply and obtain ISO 17025 accreditation; participate in and maintain PT program; participate in prescribed drills/table top exercises, plan and conduct surveillance monitoring; develop communications architecture with grantor and stakeholders, and improve access, management, and security of information technology. The Laboratories Administration proposes to carry out this project in Year 1 with a requested federal budget of $300,000 and to further operate this project with a projected total budget of $1,200,000 for Years 2 through 5.