fsma focus on implementation 2015
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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 CommissionerActing Commissioner of Food
and DrugsStephen Ostroff, M.D.
Directorate of Foods and Veterinary MedicineDeputy CommissionerMichael Taylor, J.D.
Center for Food Safety and Applied Nutrition
DirectorSusan Mayne, Ph.D.
Center for Veterinary Medicine
DirectorBernadette Dunham,
D.V.M., Ph.D.
Directorate of Global Regulatory Operations and
PolicyDeputy CommissionerHoward Sklamberg, J.D.
Office of Regulatory Affairs
Associate CommissionerMelinda Plaisier
Office of International Programs
Associate CommissionerMary 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
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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 http://www.fda.gov/fsma
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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
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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
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FDA Strategic Program Planning
Focus on Steps 1-3 5 Steps
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Implementation Process
Update Strategic Planning Materials
Develop Strategic Goals
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Develop Strategic
Framework
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Conduct Evaluation & Strategic Refresh
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Develop Performance Measures
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Monitor Implementation
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Planning Process
Monitoring and Evaluating Process
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
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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
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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
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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
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Phase 2 Guiding PrinciplesApproach 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
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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
• Web site: http://www.fda.gov/fsma • Subscription feature available• Send questions to [email protected]
Public Information Available
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