FDA食品防护法规宣讲（20171101）.pdfVIP

10/12/2017 Food Safety Modernization Act: Intentional Adulteration Rule 食品安全现代化法： 故意掺杂法规 U. S. Food and Drug Administration Food Defense and Emergency Coordination Staff Ryan Newkirk, PhD, MPH Background 背景 Mitigation Strategies to Protect Food Against Intentional Adulteration 保护食品防止被故意掺杂的缓解策略 • Proposed on December 24, 2013 • 2013 12 24 年 月 日发布草案 • Public comments: more than 200 for the original proposal • 200 征求意见：对最初草案有 多条意见 • Final rule: May 27, 2016 • 2016 5 27 年 月 日发布最终法规 What Does the IA Rule Do? IA法规的作用 • Establishes requirements to prevent or significantly minimize acts intended to cause wide-scale public health harm • 建立要求来预防或最大限度地减少那些引起广泛公众 健康危害的行为 • Uses a HACCP-type approach, with important differences from the Preventive Controls for Human Food rule • 使用HACCP模式的方法，与食品的预防控制措施法规 有重要差别 • Is risk-based and flexible • 是基于风险的和灵活的 1 10/12/2017 Who Is Covered by the IA Rule? IA 谁将适用于 法规？ • Facilities that manufacture, process, pack or hold human food • 生产、加工、包装和贮存食品的企业设施 • In general, facilities required to register with FDA under sec. 415 of the Food, Drug, and Cosmetic Act (FDC) Act 通常，《联邦食品、药品和化妆品法》第 节要求向 • 415 FDA注册的企业 – Not farms or retail food establishments 不是农场或零售食品的 企业 • Applies to domestic and im