FDA食品防护法规宣讲PPT(20171101)

• 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 (FD&C) Act • 通常，《联邦食品、药品和化妆品法》第415节要求向
appropriate method to conduct a vulnerability assessment • 关键活动类别被认为是一种评估薄弱环节的 适当方法
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Food Defense Plan – Mitigation Strategies 食品防护计划 – 缓解策略
• 工厂必须有书面程序，包括他们对缓解策略监控执 行的频率（适用于缓解策略本身的性质）
• Monitoring must be documented in records subject to verification
• 监控工作必须记录下来以备验证
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 imported food • 对美国国内企业和海外企业同样适用 • Some exemptions and modified requirements apply • 有一些豁免情况和变更要求
business, of eggs (in-shell, other than RACs) or certain types of game meats, if such activities are the only activities conducted by the business subject to section 418 of the FD&C Act • 小型或微型企业在农场进行特殊食品的生产、加工、包装或贮存，特殊食品包 括带壳蛋（不是RACs）或野味。这类FD&C法第418节规定的企业所开展的活动 只限这些。
– 食品平均年销售额小于1千万美元，包括市场食品销售额和已经 生产、加工、包装或贮存的未销售的食品的市场价值
• VSBs are required to provide for official review, upon request, documentation sufficient to show that the facility qualifies for this exemption
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
• Measures to ensure significant vulnerabilities at actionable process steps are significantly minimized or prevented
• 确保可采取措施的步骤中的重要薄弱环节都最大程度地 减少或被预防
• Is risk-based and flexible • 是基于风险的和灵活的
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Who Is Covered by the IA Rule? 谁将适用于IA法规？
• Facilities that manufacture, process, pack or hold human food
• 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
Exemptions 豁免
• Very small businesses* 微型企业* • Holding of food, except holding of food in liquid storage tanks • 储藏食品的企业，液体储藏罐的食品储藏企业除外 • Packing, repacking, labeling, or relabeling of food where the container that directly
product – 破坏分子成功污染产品的可能性
Food Defense Plan – Vulnerability Assessment 食品防护计划 – 评估薄弱环节
• Must consider the possibility of an inside attacker
• 必须考虑内部有破坏分子的可能性 • Outcome of assessment must be written • 评估结果必须书面记录下来 • Key Activity Types are considered an
• Training 培训
Food Defense Plan – Vulnerability Assessment 食品防护计划 – 评估薄弱环节
• Identification of those points at highest risk, i.e., actionable process steps
contacts the food remains intact • 包装、再包装、贴标或重贴标签等企业，其不直接接触食品的容器进行任何改
变 • Activities of a farm subject to the Produce Safety Rule • 在果蔬安全法规中的农场进行的操作 • Manufacturing, processing, packing, or holding food for animals • 生产、加工、包装、或贮存动物食品的企业 • Alcoholic beverages at certain facilities (under specified conditions) • 符合特定条件的酒精饮料企业 • On-farm manufacturing/processing, packing, or holding by a small or very small
施 • Food defense verification 食品防护验证
− as appropriate to ensure the proper implementation of the mitigation strategies, taking into account the nature of the mitigation strategy and its role in the facility’s food defense system
• 如果被要求，则VSBs需要提供官方审核文件，充分显示其企业设施 符合豁免条件
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What Is Required? 有哪些要求？
• Food defense plan 食品防护计划
– Vulnerability assessment 评估薄弱环节 – Mitigation strategies 缓解策略 – Procedures for food defense monitoring – 食品防护监控程序 – Food defense corrective action procedures – 食品防护整改程序 – Food defense verification procedures – 食品防护验证程序 – Records记录
− 为了确保正确的执行了缓解策略，需要考虑缓解策 略的性质及其对工厂食品防护体系的作用
Food Defense Plan – Food Defense Monitoring
食品防护计划 – 食品防护监控
• Facility must have written procedures, including the frequency they are to be performed, for monitoring the mitigation strategies (as appropriate to the nature of the mitigation strategies)
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年12月24日发布草案 • Public comments: more than 200 for the original
proposal • 征求意见：对最初草案有200多条意见 • Final rule: May 27, 2016 • 2016年5月27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
• 必须包括书面的解释如何有策略地减少薄弱环节
Food Defense Plan – Mitigation Strategy Management Components
食品防护计划 – 缓解策略管理内容