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!