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An Update on FDA’s FSMA Implementation Strategy and Progress

An Update on FDA’s FSMA Implementation Strategy and Progress. November, 2013. Implementation Strategy. Implementation critical to achieve goals New public health/prevention framework for FDA inspections Work with multiple partners to leverage resources, ensure voluntary compliance

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An Update on FDA’s FSMA Implementation Strategy and Progress

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  1. An Update on FDA’s FSMA Implementation Strategy and Progress November, 2013

  2. Implementation Strategy • Implementation critical to achieve goals • New public health/prevention framework for FDA inspections • Work with multiple partners to leverage resources, ensure voluntary compliance • Change resource planning and deployment strategies to achieve better public health outcomes

  3. Operational Approach • FSMA Operations Team (FOT), with Steering Committee, and three new workgroups formed: • Preventive Controls (human and animal food) • Produce Safety • Import Controls (each workgroup includes at least one representative from a state agency)

  4. Ingredients for Success • Strengthen state partnerships • Build on Partnership for Food Protection (PFP) work to date • Leverage resources and efforts of new and existing partnerships • Develop risk-based metrics aligned with the public health/prevention framework

  5. Next Steps • Work with multiple partners to foster understanding, ensure voluntary compliance • Link risk-based priority setting with actual budget planning and execution • Expand skills and capacities of FDA’s scientific, technical and operational staff

  6. Summary • FDA has already invested enormous effort in implementation • There is still much to do • Many people across FDA still working on guidance, proposals yet to be released • Need the active and positive engagement of stakeholders in the process

  7. Questions?

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