1. FSMA Implementation Where We’ve Been, Where We’re Going AND MFRPS March 10, 2015 Roberta F. Wagner, MS Deputy Director for Regulatory Affairs FDA/Center for Food Safety and Nutrition 1

2. Topics Guiding FSMA Implementation – Program Alignment Initiative – FSMA Operational Strategy FSMA Implementation in Phases Stakeholder Engagement Remains a Priority Impacts of FSMA on MFRPS President’s FY2016 Budget Proposal for FSMA Implementation 2

3. FDA’s Food/Feed Program Spans Two Directorates and Four Offices/Centers Office of the Commissioner Commissioner of Food and Drugs Dr. Margaret Hamburg, M.D. Directorate of Foods and Veterinary Medicine Deputy Commissioner Michael Taylor, J.D. Center for Food Safety and Applied Nutrition Director Susan T. Mayne, PhD. 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

4. FDA Program Alignment Initiative Program Alignment Initiative Announced in February 2014 Memo from the Commissioner – Vertically Integrated, Commodity Specific Programs – Specialization of Inspection/Compliance Staff, Regulatory Labs – Clear, Current, Consistently Applied Technical/Operational Policy – Clear Roles, Responsibilities, Streamlined Decision Making – Risk Based Allocation of Program Resources – Agreed Upon Performance/Public Health Metrics Program Alignment will set the Agency up for Successful FSMA Implementation 4

5. FDA’s FSMA Operational Strategy Provides a foundation for fully developing and implementing FSMA standards – Regulations, guidance, protocols Captures in broad, high-level terms our current thinking on strategy and guiding principles for the implementation of FSMA standards Made Public May 2014; View at fda.gov/fsma 5

6. FSMA Implementation is a Continuum Phase 1: Set standards – Develop regulations, guidance, protocols for new administrative enforcement tools Phase 2: Implement standards – Design strategies to implement standards – Fully develop and implement the standards Phase 3: Monitor, evaluate, refresh 6

7. Regulation ProposalFinal (consent decree) Preventive Controls (Human Food)* Jan 16, 2013Aug 30, 2015 Preventive Controls (Animal Food)* Oct 29, 2013Aug 30, 2015 Produce Safety*Jan 16, 2013Oct 31, 2015 Foreign Supplier Verification Program* Jul 29, 2013Oct 31, 2015 Third Party AccreditationJul 29, 2013Oct 31, 2015 Sanitary TransportFeb 5, 2014Mar 31, 2016 Intentional AdulterationDec 24, 2013May 31, 2016 * Supplemental proposals published September 2014 Phase 1: Standard Setting 7

8. Phase 2: Operations and Policy Working Together 8

9. Phase 2: Workgroups Charge Develop a framework and multi-year implementation plan for ensuring compliance with regulations: Education, outreach and technical assistance for industry – Alliances Training for regulators Data collection, analysis, updated IT Performance goals and metrics Inspections, compliance and enforcement 9

10. How FDA Will Operate Differently 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 10

11. Mar-Apr 2015 May-Jul 2015 Jul-Sept 2015 Oct-Dec 2015 Food Safety Culture Webinar – 3/19/2015 Develop & Deliver PC Rule Readiness Training Environmental Monitoring 5/21/2015 Supply Chain Management 6/18/2015 Technical Updates 1-hr Webinars Systems Thinking Negotiation / Persuasion Cooperative Inspections Applied Soft Skills PC Training Plan: FY15 PC Rule Readiness Plan & FY 15-18 PC Regulator Plan Deliver PC Regulator in FY2016-2018 Technical Knowledge Behavior & Systems Thinking Inspectional Skills & knowledge Allergens Controls 7/16/2015 FSPCA TTT for FDA Trainers FSPCA Course for FDA Staff Jan. 2016 thru Sept 2018 Technical Knowledge Inspection Skills & Knowledge Behavior & Systems Thinking FSPCA Training FDA TTT for FDA Trainers Develop PC Regulator Training in FY2015

12. 12

13. FY2015 PC Rule Readiness Training T PC Rule Readiness FSMA Chats – Typically Third Thursday of the Month – Speakers: Academia, Industry and Government – State Participation; Webinars Limited to 1000 Lines – Recordings of FSMA Chats posted on Food Shield & FDA Intranet Tentative Schedule – March 19: Food Safety Culture Series (5 Webinars) – May 21: Environmental Monitoring: Industry Best Practices – June 18: Supply Chain Management: Industry Best Practices – July 16: Minimizing Allergen Risks: Industry Best Practices 13

14. FY2015 PC Rules Regulator Training FY2015: Develop PC Rule Regulatory Curriculum Centrally State Involvement; PFP to Provide State Representatives FY2015 – FY2016: Complete Pre-requisite Training/FSPCA Industry Training FY2016: Deliver PC Rule Regulatory Training/Training Hubs What: Human Food: GMPs/PC; Animal Food: GMPs Followed by PC? How: TTT/Training Cadre; Criteria for Inclusion; Pre-requisite Training; Periodic “Evaluation” of Trainers Who: Federal/State Investigators/Inspectors/Food Safety Staff Performing Food Inspections in FDA/States Under Contract Where: Nationwide Based on Location of Large Firms 14

16. How FDA Will Operate Differently Robust data integration, analysis and information sharing Public health metrics Work closely with government counterparts and other food safety system stakeholders 16

17. How FDA Will Operate Differently 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 17

18. How FDA Will Operate Differently Approach to Operational Activities Targeted, risk-based inspection models Wider range of inspection, sampling, testing and data collection activities Improved risk-based work planning through targeted data collection and more timely data analysis and program evaluation 18

19. PC Rule Inspection “Concepts” PC Inspection Program “Must Haves” – Federal/State Food Safety Staff Train Together – Multi-Year Work Planning Prioritization/Planning – Integrated Strategy for Federal/State Inspections – Integrated Data Collection Strategy/Structured Data – Explicit Compliance Strategy; Agreement on Critical/Non-Critical Deviations Dynamic” Inspection Approach – Timely Follow Up to Critical Deviations Tiered PC Inspections for Large Facilities – Not One Size Fits All – Adequacy of Food Safety Plan; Implementation of Plan – Review of Corporate Programs; Implementation at Facility Level Focus on Gaining Industry Compliance – “Incentives” for Compliance – Better Tracking/Reporting of Corrective Actions – Investigators Kept Abreast of Industry Best Practices 19

20. 20

21. FSMA Integrated Master Schedule Is a living document and is regularly updated and maintained Provides an integrated view to support effective planning, monitoring, and control of implementation progress Identifies key milestones, deliverables, and dependencies Helps connect tasks to activities to costs and enables data-driven trade-off decisions Consists of data consolidated from supporting schedules Enables FDA to organize and manage plans and schedules comprehensively and consistently across FSMA Identifies issues and risks Is a communications tool Integrated with FSMA Decision Tracker and Work Group Milestone Timelines Posted on FDA’s FSMA Program Management SharePoint Site 21

23. FSMA and Regulatory Laboratories Detection and Surveillance Sec. 202. Laboratory Accreditation** Sec. 203. Integrated Consortium of Laboratory Networks Sec. 205. Surveillance 23

24. Why Sample/Test Food Under FSMA Surveillance Risk based targeting of operational resources Emerging issues Baseline/prevalence data for risk analysis/policy decisions Verification (Emphasis Under FSMA) Environmental sampling programs are robust Preventive controls/mitigation strategies/corrective actions effective Import controls are effective: FSVP, Third Party Accreditation, VQIP, Import Certification, Systems Recognition Compliance (Public Health Focus Under FSMA) Support removal of adulterated/misbranded foods from market Environmental assessments / root cause(s) of contamination events/foodborne outbreaks Enforcement actions, including import actions 24

25. FSMA Stakeholder Engagement Transparency Remains a Priority Next Phase: Inclusive/Coalition Approach – Engage FDA employees, key partners, and the public to help determine ways to implement provisions and concepts before rules become final. Future: Partnerships/Collaboration Key – Establish mechanisms, including working with multiple partners, to foster industry understanding of final rules/guidance and encourage firms to comply and initiate any corrections on their own. 25

26. MFRPS and FSMA Standard 1: Regulatory Foundation Standard 2: Training Program Standard 3: Inspection Program Standard 4: Inspection Audit Program Standard 5: Food Related Illness, Outbreaks and Response Standard 6: Compliance and Enforcement Program Standard 7: Industry and Community Relations Standard 8: Program Resources Standard 9: Program Assessment Standard 10: Laboratory Support 26

27. President’s FY2016 Budget Proposal An increase of 109.5 million requested in the President’s budget for FSMA implementation FDA plans to continue to make improvements in the following areas: – Inspection Modernization and Training 25 million – National Integrated Food Safety System 32 million – Industry Education and Technical Assistance 11.5 million – Technical Staffing and Guidance Development at FDA 4 million – Modernized Import Safety Programs/System 25.5 million – Risk Analytics and Evaluation 4.5 million And ** 7 million for necessary infrastructure costs 27

28. Thank You For You Attention! Questions??? Feel free to contact me at: roberta.wagner@fda.hhs.gov 28