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1、Focus on Prevention FDA Food Safety Modernization Act,Agenda,The public health imperative Why is the law needed? Provisions of the law, focus on prevention Implementation timeline and plans,Why is the law needed?,Foodborne illness is a significant burden About 48 million (1 in 6 Americans) get sick
2、each year 128,000 are hospitalized 3,000 die Food supply more high-tech and complex 15 percent of U.S. food supply is imported More foods in the marketplace New hazards in foods not previously seen,Main Themes of the Legislation,Prevention: The Cornerstone,Comprehensive preventive controls for human
3、 and animal food facilities Prevention is not new, but Congress has given FDA explicit authority to use the tool more broadly Strengthens for prevention Produce safety standards Intentional adulteration standards Transportation,General Approach to Preventive Controls,5. Review & Adjust,1. Identify H
4、azard,2. Understand Cause,3. Implement Preventive Controls,4. Monitor Effectiveness,4. Monitor Effectiveness,Prevention Standards Mandates,Sec. 103. Hazard analysis and risk-based preventive controls Requires human and animal food facilities to: Evaluate hazards that could affect food safety; Identi
5、fy and implement preventive controls to prevent hazards; Monitor controls and maintain monitoring records; and Conduct verification activities.,Modified Requirements for Qualified Facilities (Section 103),Facility is exempt if: Defined as very small business; OR The facility has a limited annual mon
6、etary value of sales,Modified Requirements for Qualified Facilities (Section 103),Limited annual monetary value of sales is defined as: During the last 3 years, sales were less than $500,000; AND Sales to “Qualified End Users“ exceed sales to others,Examples of Compliance with Prevention Standards,S
7、anitation Training for supervisors and employees Environmental controls and monitoring Food allergen controls Recall contingency plan Good Manufacturing Practices (GMPs) Supplier verification activities,Prevention Standards Mandates,Sec. 105. Standards for Produce Safety Establish science-based, min
8、imum standards for the safe production and harvesting of fruits and vegetables Applies to raw agricultural commodities for which FDA determines that such standards minimize the risk of serious adverse health consequences or death.,Exemption for Direct Farm Marketing (Sec. 105),Farms exempt if: Durin
9、g the last 3 years, sales were less than $500,000 and Majority of product is distributed directly to consumers or farmers markets and restaurants either intrastate or within a 275-mile radius,Intentional Contamination,Sec. 106. Protection against Intentional Adulteration Issue final rule and guidanc
10、e to protect against the intentional adulteration of food Conduct vulnerability assessments of the food supply and determine mitigation strategies Sec. 108 Prepare a National Agriculture and Food Defense Strategy with USDA, and DHS,Prevention Standards Mandates,Sec. 111. Sanitary Transportation of F
11、ood Addresses implementation of the Sanitary Food Transportation Act of 2005, which requires persons engaged in food transportation to use sanitary transportation practices to ensure that food is not transported under conditions that may render it adulterated.,Prevention in Imports,Sec. 301 Foreign
12、Supplier Verification Program (FSVP) Requires importers to conduct risk-based foreign supplier verification activities to verify that food imported into the United States is not adulterated and that it was produced in compliance with FDAs preventive controls requirements and produce safety standards
13、 Sec. 307. Third Party Auditor Accreditation Can be used by importers for supplier verification under FSVP,Implementation Approach,Items are prioritized based on public health protection Engage with stakeholders to help determine reasonable and practical ways to implement preventive control provisio
14、ns Implementation progress at http:/www.fda.gov/fsma,Prevention Projects Completed (as of October 2011),Public Meeting on Preventive Controls for Facilities (4/20/11) Preventive Controls for Registered Human Food and Animal Food/Feed Facilities Docket FDA-2011-N-0238 (5/23/11) Tours of farms and foo
15、d/facilities,Outreach Recent,Farm tour at Milk Pail Farm,Outreach,Upcoming public meetings on preventive controls and produce safety when proposals are issued Numerous listening sessions, meetings, presentations FSMA web page has subscription service for immediate updates,Rulemaking Process,FDA prop
16、oses a regulation Draft rules are published on http:/www.regulations.gov Time is allowed for public comment, and FDA is required to consider comments during the rulemaking process Regulation is revised and final rule is issued,Rulemaking Process,After a final rule is published, it may have an effect
17、ive date in the future FDA issues guidance documents Check http:/www.fda.gov/fsma to find out what is open for comment,Snapshot of FSMA homepage elements at: http:/www.fda.gov/fsma,For More Information,Web site is at: http:/www.fda.gov/fsma Subscription feature available Send questions to FSMAfda.hhs.gov,