FSMA：FDA实现并保持企业符合新法规要求的战略.pptVIP

FSMA Implementation实施食品安全现代化法FDA’s Strategies for Gaining and Maintaining Industry Compliance with the New RulesFDA实现并保持企业符合新法规要求的战略 China FSMA Outreach April 19, 2016 中国FSMA宣贯 · 2016年4月19日 1 Steven M. Solomon, DVM, MPHDeputy Associate Commissioner for Regulatory Affairs 史蒂夫·所罗门 FDA负责监管事务副助理局长 FSMA Implementation “A Continuum”实施FSMA – “一个连续过程” Phase 1: Set Standards 第一阶段：建立标准 Develop regulations, guidance, policy 制定法规，指南，政策 Phase 2: Design Strategies to Promote and Oversee Industry Compliance 第二阶段：设计促进和监督企业合规的战略 Identify performance metrics to measure success 确定衡量成效的评价标准 Phase 3: Implement, Monitor, Evaluate, Refresh 第三阶段：实施，监督，评估，更新 Transition strategies and performance metrics from design to operational, evaluate success 从设计到实施过程中的过渡策略及成效评价标准，进行成效评价 2 FDA’s Food/Feed ProgramSpans Two Directorates and Four Offices/Centers FDA的食品/饲料项目涉及两个领导和四个办公室/中心 Office of the Commissioner Commissioner of Food and Drugs FDA局长办公室 Dr. Robert Califf, M.D. Directorate of Foods and Veterinary Medicine Deputy Commissioner 负责食品和兽医药的副局长 Michael Taylor, J.D. Stephen Ostroff, M.D. (6/1/16) Center for Food Safety and Applied Nutrition 食品安全与应用营养中心 Director Susan T. Mayne, PhD. Center for Veterinary Medicine 兽医药中心 Director Bernadette Dunham, D.V.M., Ph.D. Directorate of Global Regulatory Operations and Policy Deputy Commissioner 负责全球监管运营和政策的副局长 Howard Sklamberg, J.D. Office of Regulatory Affairs 监管事务办公室 Associate Commissioner Melinda Plaisier Office of International Programs 国际项目办公室 Associate Commissioner Mary Lou Valdez 3 Phase 1: Standard Setting第一阶段：建立标准 Supplemental proposals published September 2014 补充草案于2014年9月发布 ◊Final rule publication date最终法规发布日期 Regulation 法规 Proposal 草案 Final 最终法规 (consent decree) Preventive Controls (Human Food)* 预防性控制措施（人类食品） Jan 16, 2013 Aug 30, 2015 Sept 17, 2015◊ Preventive Controls (Animal Food)* 预防性控制措施（动物食品） Oct 29, 2013 Aug 30, 2015 Sept 17, 2015◊ Produce Safety* 果蔬安全 Jan 16, 2013 Oct 31, 2015 Nov 27, 2015◊ Foreig