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FDA Foods Program Update

FDA Foods Program Update. Comments by Michael M. Landa Acting Director, Center for Food Safety and Applied Nutrition JIFSAN Advisory Council Business Meeting Greenbelt, MD April 28, 2011. FDA Food Safety Modernization Act. Main Themes of the Legislation. Prevention.

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FDA Foods Program Update

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  1. FDA Foods Program Update Comments by Michael M. Landa Acting Director, Center for Food Safety and Applied Nutrition JIFSAN Advisory Council Business Meeting Greenbelt, MD April 28, 2011

  2. FDA Food Safety Modernization Act

  3. Main Themes of the Legislation Prevention Enhanced Partnerships Inspections, Compliance, and Response Import Safety

  4. Prevention: Cornerstone of the Legislation Comprehensive preventive controls for food facilities Prevention is not new, but Congress has given FDA explicit authority to use the tool more broadly Strengthens accountability for prevention Produce safety standards Intentional adulteration standards

  5. Inspection, Compliance, and Response Mandated inspection frequency Considering new ways to inspect New tools Mandatory recall Expanded records access Expanded administrative detention Suspension of registration Enhanced product tracing Third party laboratory testing

  6. Import Safety: Most Groundbreaking Shift Importers now responsible for ensuring that their foreign suppliers have adequate preventive controls in place FDA can rely on third parties to certify that foreign food facilities meet U.S. requirements Can require mandatory certification for high-risk foods Voluntary qualified importer program--expedited review Can deny entry if FDA access for inspection is denied Requires food from abroad to be as safe as domestic

  7. Partnerships Centers of Excellence -- Institute for Food Safety and Health (formerly National Center for Food Safety and Technology) -- Joint Institute for Food Safety and Nutrition -- National Center for Natural Products Research -- Western Center for Food Safety International Food Protection Training Institute Asia Pacific Economic Cooperation (APEC)/Partnership Training Institute Network (PTIN) Steering Committee

  8. Enhanced Partnerships: Vital to Success Reliance on inspections by other agencies that meet standards State/local and international capacity building Improve foodborne illness surveillance National agriculture and food defense strategy Consortium of laboratory networks Easier to find recall information

  9. Implementation: FDA is Prepared Experience in preventive controls Implementation process in place Much work already underway

  10. But, Many Challenges Enormous workload 50 new rules, guidance documents, reports in 3 years Tight deadlines Changes won’t appear overnight Building new system will be a long-range process Resources

  11. Implementation Approach Coalition needed Transparency a priority Focus on public health protection Engage with stakeholders to help determine reasonable and practical ways to do so

  12. Priorities Prevention Mandatory preventive controls for facilities (FR 18 months) Produce safety standards (FR 2 years) Intentional contamination (FR 18 months) Inspection, Compliance, and Response Administrative detention (IFR 120 days) Recall (Upon enactment) Suspension of registration (180 days) Imports Foreign supplier verification program (Guidance and FR 1 year) Accredited third-party certification program (FR 2 years) Mandatory certification for high risk foods (Upon enactment)

  13. Public Meetings on FSMA

  14. Public Meetings on FSMA Imports (3/29) Comparability of Food Safety Systems (3/30 – 3/31) Preventive Controls (4/20) Inspections and Compliance (TBD)

  15. For More Information www.fda.gov www.foodsafety.gov

  16. Nutrition Activities

  17. Nutrition Activities Proposed rule on menu and vending machine labeling Publish a proposed rule for manufacturers that choose to put dietary guidance statements on packaged food products Publish a proposed rule to modernize the Nutrition Facts label Initiate a process to support reduction of sodium in foods Develop an evidence-based approach for nutrition labeling on front of packages that consumers will notice, understand and use

  18. Coordinated Outbreak Response Team

  19. Coordinated Outbreak and Response Team (CORE) Will be led by a Chief Medical Officer/National Outbreak Director Dr. Susan Lance is heading the program on an interim basis Goal is to strengthen and streamline FDA's approach to identifying, investigating, and responding to foodborne disease outbreaks, and to analyze and address the root causes of those outbreaks to prevent future outbreaks

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