Advancing the Minnesota Department of Agriculture's conformance with the Animal Feed Regulatory Program Standards

项目摘要 明尼苏达州农业部正在根据FDA拨款机会RFA-FD-15-寻求资金- 021，实施动物饲料监管计划标准(AFRPS)(U18)。食品与药品 美国食品和药物管理局(FDA)、监管事务办公室(ORA)、伙伴关系办公室(OP)宣布 在对国家动物饲料监管的有限竞争下，最高可获得12,600,000美元 程序。这一FOA的预期成果是推动国家综合饲料安全的努力 通过实施和推进饲料管理程序标准来建立体系 (AFRPS)由国家饲料监管计划实施。 AFRPS允许通过建立统一的基础来开发基于风险的饲料安全计划 衡量和改进美国国家饲料监管计划的绩效。通过 实现并维持这些计划的实施标准，联邦和州计划可以更好地 指导他们的监管活动，以减少可归因于动物饲料安全危害的食源性疾病 饲料/供应设施。因此，美国动物饲料供应的安全和保障 将会有所改善。 AFRPS由十一(11)个标准组成，这些标准为以下关键要素奠定了基础 作为评估和改进国家饲料方案组成部分的客观框架。这些元素 涵盖国家饲料计划的监管基础、培训、检查计划、审计、饲料相关 疾病或死亡和紧急反应、执行方案、外展活动、预算和规划、 实验室服务、抽样计划、评估和改进标准的执行。 明尼苏达州农业部(MDA)乳制品和食品检验部(DFID)商业 饲料单位(CFU)对明尼苏达州约1900家饲料企业发放许可证并进行检查。CFU已经 同时负责零售和人工饲料，并有(20)名与饲料相关的员工 活动，其中(9)项专门用于实地考察。 作为申请的一部分，明尼苏达州农业部将保持全面的战略 该计划概述了在#年底前实现显著符合AFRPS所需的里程碑和目标 第四年的授权期。本申请还描述了标准操作程序(SOP)的创建 和标准增强项目(SEP)，将作为其他机构和司法管辖区的资源 试图符合这些标准。 丙二醛实验室服务司包括在这项资金申请中，并继续致力于 与丙二醛饲料计划官员和FDA合作保护国家动物饲料的安全 通过一个全国性的综合饲料安全系统，提供和改善公众健康。实验室 通过实现、保持和扩大其ISO17025认证范围来支持这一目标 代表国家饲料监管计划和AFRPS对饲料进行微生物和化学分析。 共享实验室的高质量、有效和可辩护的结果有助于及早识别和 对饲料中的掺杂物、污染物、毒素等作出监管反应，减少食源性疾病 饲料中含有安全隐患的动物饲料。因此，美国的安全和保障 动物饲料供应将有所改善。 在这份合作协议提案中，MDA实验室确定了其满足所有资格的能力 要求。此外，我们还证明了该实验室能够很好地实现该计划 在RFA-FD-15-021中确定的实验室设施和设备、组织、人员方面的目标 资质、运营支持、管理实践、饲料检测能力和实验室质量 管理系统。

Project Abstract The Minnesota Department of Agriculture is seeking funding under the FDA grant opportunity RFA-FD-15- 021, Implementation of the Animal Feed Regulatory Program Standards (AFRPS) (U18). The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP) announced the availability of up to $12,600,000 to be awarded under limited competition to State animal feed regulatory programs. The intended outcome of this FOA is to advance efforts for a nationally integrated feed safety system through the implementation and advancement of the Animal Feed Regulatory Program Standards (AFRPS) by State feed regulatory programs. The AFRPS allows for the development of risk-based feed safety programs by establishing a uniform basis for measuring and improving the performance of State feed regulatory programs in the United States. By achieving and sustaining implementation of these programs standards, Federal and State programs can better direct their regulatory activities toward reducing foodborne illness attributed to feed safety hazards in animal feed materials/supply facilities. Consequently, the safety and security of the United States animal feed supply will improve. The AFRPS is comprised of eleven (11) standards which establish the foundation for the critical elements that serve as an objective framework to evaluate and improve components of a State feed program. These elements cover the State feed programs regulatory foundation, training, inspection program, auditing, feed-related illness or death and emergency response, enforcement program, outreach activities, budget and planning, laboratory services, sampling program, and assessment and improvement standard implementation. The Minnesota Department of Agriculture (MDA) Dairy and Food Inspection Division (DFID) Commercial Feed Unit (CFU) licenses and inspects approximately 1,900 feed establishments in Minnesota. The CFU has both responsibility for both retail and manufactured feed and has a staff complement of (20) for feed related activities, with (9) devoted to field inspection. The Minnesota Department of Agriculture, as part of the application, will maintain a comprehensive strategic plan that outlines the milestones and goals needed to gain significant conformance to the AFRPS by the end of the Year 4 grant period. This application also describes the creation of Standard Operating Procedures (SOPs) and Standard Enhancement Projects (SEPs) that will serve as a resource to other agencies and jurisdictions attempting to conform to these standards. The MDA Laboratory Services Division is included in this request for funding and remains committed to working with the MDA Feed Program officials and the FDA to protect the safety of the nation's animal feed supply and to enhance public health through a nationally integrated feed safety system. The laboratory supports this goal by achieving, maintaining and expanding its ISO17025 scope of accreditation in performing microbiological and chemical analyses of feed on behalf of the State's feed regulatory program and the AFRPS. Sharing the laboratory's high-quality, valid, and defensible results promotes the early identification and regulatory response to feed adulterants, contaminants, toxins, etc. and reduces the foodborne illness attributed to feed safety hazards in animal feed material. Consequently, the safety and security of the United States animal feed supply will improve. In this cooperative agreement proposal, the MDA Laboratory establishes its ability to meet all eligibility requirements. Furthermore, we demonstrate that the laboratory is well-positioned to achieve the program objectives identified in RFA-FD-15-021 in terms of laboratory facilities and equipment, organization, personnel qualifications, operational support, management practices, feed testing capabilities, and the laboratory quality management system.