Focus on Phase 2 FSMA Implementation

2 Topics Guiding FSMA Implementation −Program Alignment Initiative −FSMA Operational Strategy FSMA Implementation in Phases Focus on FSMA Phase 2

Collaboration within FDA’s Food Program Office of the Commissioner Acting Commissioner of Food and Drugs Stephen Ostroff, M.D. Directorate of Foods and Veterinary Medicine Deputy Commissioner Michael Taylor, J.D. Center for Food Safety and Applied Nutrition Director Susan Mayne, Ph.D. Center for Veterinary Medicine Director Bernadette Dunham, D.V.M., Ph.D. Directorate of Global Regulatory Operations and Policy Deputy Commissioner Howard Sklamberg, J.D. Office of Regulatory Affairs Associate Commissioner Melinda Plaisier Office of International Programs Associate Commissioner Mary Lou Valdez

Program Alignment Program Alignment Initiative Announced in February 2014 Memo by Commissioner −Vertically integrated, commodity-based programs −Specialization of inspection/compliance staff, regulatory labs −Clear, current, consistently applied policy −Roles, responsibilities, streamlined decision-making −Risk-based allocation of program resources −Agreed-upon performance/public health metrics Result: Successful FSMA Implementation 4

FSMA Operational Strategy Foundation for Developing and Implementing FSMA Standards −Regulations, guidance, protocols Captures in Broad, High-Level Terms Our Current Thinking on Strategy and Guiding Principles for Implementation Made public May 2014 −View at 5

FSMA Implementation as a Continuum Phase 1: Set Standards −Regulations, guidance, policy Phase 2: Planning/Implementation −Design strategies and begin implementation to gain/maintain industry compliance with FSMA rules Phase 3: Implementation, Monitor, Evaluate, Refresh 6

Transition to Phase 2: Planning/Implementation Phase 1 Teams Continue Rulemaking, Guidance and Policy Work until Completed Concurrently, Phase 2 Structure Established/Work Initiated −Design strategies/frameworks and develop operational plans for gaining and maintaining industry compliance with the foundational FSMA rules 7

Phase 2: Operations and Policy Working Together 8

FDA Strategic Program Planning Focus on Steps Steps 9

Phase 2: Workgroup Charge Multi-Year Plan Industry Education, Outreach, Technical Assistance Training for Regulators Inspections, Compliance and Enforcement Data Collection, Analysis, Updated Information Technology (IT) Performance Goals and Metrics 10

12 Phase 2 Guiding Principles FDA Will Speak With One Voice Inspection, Compliance Functions Specialized Investigators and Subject Matter Experts Work Together to Drive Correction of Problems Invest in Regulator Training to Promote Consistent Inspections, Decision Making

13 Phase 2 Guiding Principles Robust Data Integration, Analysis and Information Sharing Work Closely With Government Counterparts and Other Food Safety System Stakeholders Public Health Metrics

14 Phase 2 Guiding Principles Education Before Regulation Facilitate Industry Implementation of Modern, Preventive Practices Through: −Commodity and sector-specific guidance −Education, outreach and technical assistance −Regulatory incentives for compliance

15 Phase 2 Guiding Principles Approach to Operational Activities Improved Risk-Based Work Planning Through Targeted Data Collection and More Timely Data Analysis and Program Evaluation Targeted, Risk-Based Inspection models Range of Inspection, Sampling, Testing, Data Collection Activities

16 Stakeholder Engagement Transparency Remains a Priority Next Phase: Inclusive/Coalition Approach −Engage FDA employees, key partners, the public to determine ways to implement provisions before rules become final Future: Partnerships/Collaboration Key −Establish mechanisms through partnerships and collaboration to foster industry understanding of final rules/guidance and to encourage firms to comply and initiate any corrections on their own

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