Transcript
Focus on Phase 2 FSMA Implementation
http://www.fda.gov/fsma
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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
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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Phase 2: Operations and Policy Working Together
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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 FSMA@fda.hhs.gov
Public Information Available
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Thank You For Your Attention!
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