Preventive Controls for Human Food – FDA Presentation
Preventive Controls for Human Food
Final Rule
美国食品安全现代化法
食品预防控制最终法规
6th Annual Global Food Safety Summit January 8, 2016
Patrick Bowen 伯乐
Assistant Country Director 美国FDA驻华办公室
China Office, U.S. FDA 助理主任
What are the elements of the Preventive Controls Rule for Human Food?
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food 食品现行GMP，危害分析，以及基于风险的预防控制
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> 8,000 Public Comments 8000条公众意见
> 1,300 Public Comments
>1300条公众意见
Final Rule September 9, 2015 最终法规
Three Key Area Addressed 涉及三个关键领域
Food Safety Plan – Hazard Analysis
食品安全计划—危害分析
What hazards may be associated with my product? 我的产品可能会伴随那些危害？
…severity of illness/injury?
严重的疾病/损伤？
…effect of formulation and processing?
配方和加工的影响？
Is my product exempt from this Section of FSMA? 我的产品是否从美国食品安全 现代化法这些要求豁免？
Hazard Analysis and Risk-Based Preventive Controls
危害分析和基 于风险的预防 控制
Food Safety Plan – Preventive Controls
食品安全计划—预防控制
Does my plan include…
我的计划是否包含…
…process controls?
工艺控制？
…food allergen controls?
食品过敏源控制？
…supply-chain controls?
供应链控制？
…a recall plan?
召回计划？
Food Safety Plan – Monitoring, Corrective Actions, &
Verification
食品安全计划 – 监控，纠正运动及验证
Maintain written procedures to include… 保留书面程序，其内容包含…
…frequency for monitoring controls
…监控频率
…identification of issues and corrective actions made
…问题的识别及采取的纠正行动
Food Safety Plan – Monitoring, Corrective Actions, &
Verification
食品安全计划 – 监控，纠正运动及验证
Maintain written procedures to include… 保留书面程序，其内容包含…
…validation of controls by monitoring, calibrating instruments, testing/environmental monitoring, & records review
…通过监控，计量仪器仪表，环境
监控及测试，记录审核来确认相 关的控制措施
Reanalyze your Plan regularly!
定期对计划重新分析!
Updated Current Good Manufacturing Practices
现行良好制造操作（cGMP)的更新
What has changed 有哪些变化?
- Protection against allergen cross-contact
防止过敏源交叉接触
- Certain provisions containing recommendations have been deleted
有些含有推荐内容的部分已删除
- Previously nonbinding provisions are now binding
之前是非强制要求的变成强制要求了
– Necessary employee education, training, and/or experience
必要的员工教育培训及经验
Supplier Verification Activities 供应商验证工作
What actions do I take for Supplier Verification?
我对供应商进行哪些验证工作？
On-site
实地现场
Sampling/Testing
取样/检测
Record Review
文件核查
When must I comply and what guidance is planned?
Compliance Dates for Businesses 企业合规的限期
Very small businesses (less than $1 million in annual food sales): Three years (except for certain records).
微型企业 (年度食品销售少于100万美元): 三年(某些记录除外）
Businesses subject to the Pasteurized Milk Ordinance: Three years
受巴式杀菌乳品条例监管的企业：三年
Small businesses (a business with fewer than 500 full-time equivalent employees): Two years 小型企业(少于500全职雇员的企业): 两年
All other businesses: One year
所有其他企业： 一年
Separate compliance dates have been established for the supply-chain program
应链计划合规的不同期限
Planned Guidances 已在计划中的指南文件
Hazard analysis and preventive controls
危害分析和预防控制
Environmental monitoring
环境监控
Food allergen controls
食物过敏源控制
Validation of process controls
过程控制的确认
A Small Entity Compliance Guide
小企业合规指南
Training and Technical Assistance 培训和技术支持
Food Safety Technical Assistance Network
Where may I obtain more information?
For More Information 如需更多信息
Web site 网站: http://www.fda.gov/fsma
Subscription feature available 可使用网页上的订阅功能
To contact FDA about FSMA and find the new online form for submitting questions: 联系FDA查询食品安全现代化法及在线查找新版查询表格：
http://www.fda.gov/Food/GuidanceRegulation/ FSMA/ucm459719.htm
Upcoming FSMA Outreach Sessions:
Beijing and Guangzhou the week of April 17th, 2016
Featuring:
Mr. Michael Taylor, J.D.
FDA Deputy Commissioner for Foods and Veterinary Medicine
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