Preventive Controls Phase 2 Workgroup 1

Results Oriented Management (ROM) Defines high level and supporting results to ensure we perform activities that have a direct or causal relationship with achieving those results Identifies metrics to monitor the progress of goals FDA wants to achieve –Tracking trends –Making appropriate adjustments 2

Metrics Four criteria used to select a good metric: −Direct: Measure of the result −Objective: Stated in a way that is measurable, precise and unambiguous −Practical: Data for the indicator can be collected in a reliable, timely and cost-effective manner. −Adequate: Set of measures for any particular result is sufficient to understand whether progress is being made toward the achievement of the goal. 4

Guidance FDA will develop and make available guidance documents to help industry and food/feed safety staff identify significant hazards and develop preventive control strategies 5

Technical Assistance Launch an internal technical assistance network that involves all food safety staff to help ensure consistent implementation in the field Supplement the internal technical assistance network by identifying Subject Matter Experts to help mentor food safety staff 6

Training Food Safety Preventive Controls Alliance (FSPCA): Develop and deliver basic preventive controls training to show industry and regulatory staff how to develop a Food Safety Plan that would be acceptable to FDA FDA: Develop and deliver a training curriculum for regulatory staff on how to assess a facility against the requirements of the preventive controls rule. 7

Training Overlay large, small and very small facility inventory and rollout training according to compliance dates. 8

FSMA Training Work Group Formed in January 2015 to plan preventive controls (PC) regulator training for food and feed safety staff Development and delivery model to include curricula developers, Train the Trainers (TTT), and Instructor Cadre –Will consist of experts from ORA, CFSAN, CVM, and States 9

FSMA Training Work Group New training needed: −Food Safety Preventive Controls Alliance Core Curriculum (prerequisite) −Good Manufacturing Practices (updated regulations) overview for human and new for animal food (Subpart B of PC rules) −Preventive Controls (Subpart C of PC rules) −FDA’s Food Hazards and Controls Guide for Human and Animal Food 11

Inspection Approach Need to consider staggered compliance timeframe Not a “one size fits all” approach Two-tier approach –Adequacy first, then implementation Feasibility study or pilot (corporate vs facility) 12

Inspection Reporting System Streamline IT inspection reporting system to capture structured data and track corrective action 13

Compliance Rank violations based on regulatory requirement AND public health impact (e.g., critical, major, minor) Regulatory strategy that is dynamic, i.e., different violations trigger different regulatory response, different industry timeframes for corrective action, and different timeframes for FDA or state verification Build in industry incentives for prompt and adequate corrective action 14

Challenges Food Facility Establishment Inventory Information Technology Improving communication with stakeholders Change in Culture 15

Breakout Sessions Session 1 Discussions −Technical assistance and outreach −Tools for developing Food Safety Plan Session 2 Discussions −Challenges to inspection and compliance −Incentives for compliance −Inspection approaches 16