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 

Proposed Rule January 16, 2013 法规草案

> 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

Posted in NEWS.

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