FDA SEATTLE DISTRICT REGULATORY UPDATE

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1 FDA SEATTLE DISTRICT REGULATORY UPDATE SEAFOOD PRODUCTS ASSOCIATION PROCESSORS WORKSHOP SEATTLE, WASHINGTON MARCH 10, 2015 MIRIAM R. BURBACH SEATTLE DISTRICT DIRECTOR 1

2 FDA SEATTLE DISTRICT REGULATORY UPDATES FSMA Operational Strategy FDA Seattle District staffing updates Pacific Regional NW Laboratory staffing updates Salmon Control Plan Regulatory Compliance Year in review 2

3 FSMA: Where We ve Been and Where We re Going SEAFOOD PRODUCTS ASSOCIATION PROCESSORS WORKSHOP SEATTLE, WASHINGTON MARCH 10, 2015 MIRIAM R. BURBACH SEATTLE DISTRICT DIRECTOR

4 Presentation Overview 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 Engagement along the way 4

5 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. View at fda.gov/fsma 5

6 Phase 1: Standard Setting Regulation Proposal Final (consent decree) Preventive Controls (Human Food)* Preventive Controls (Animal Food)* Jan 16, 2013 Aug 30, 2015 Oct 29, 2013 Aug 30, 2015 Produce Safety* Jan 16, 2013 Oct 31, 2015 Foreign Supplier Verification Program* Jul 29, 2013 Oct 31, 2015 Third Party Accreditation Jul 29, 2013 Oct 31, 2015 Sanitary Transport Feb 5, 2014 Mar 31, 2016 Intentional Adulteration Dec 24, 2013 May 31, 2016 *Supplemental proposals published September

7 Rule Compliance Dates by Business Size 2014 Dec Aug 30 Oct Produce Safety Preventive Controls Human Preventive Controls Animal FSVP Suppl. Prop. Final Large Small V. Small Water

8 Compliance Dates by Business Size Rule Intentional Adulteration Oct 31 Mar 31 May Sanitary Transport 3 rd Party Cert. Final Large Small V. Small

Phase 2: Operations and Policy Working Together High-level FDA Oversight FVM Governance Board FVM Executive Council Internal Advisory Team Steering Committee

9 Phase 2: Operations and Policy Working Together High-level FDA Oversight FVM Governance Board FVM Executive Council Internal Advisory Team Steering Committee Intentional Adulteration Import Controls Preventive Controls Human Food Animal Food Produce Safety ORA, CFSAN, CVM and State representation. Sanitary Transportation

10 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 10

11 How FDA Will Operate Differently FDA will speak with one voice Inspection, compliance functions specialized Invest in regulator training to promote consistent inspections, decision making Investigators and subject matter experts work together to drive correction of problems 11

12 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 12

13 Educate Before and While We Regulate Facilitate industry implementation of modern, preventive practices through: Commodity and sector-specific guidance Education, outreach and technical assistance Regulatory incentives for compliance 13

14 Company s Food Safety Culture Guides FDA Approach Targeted, risk-based inspection models Wider range of inspection, sampling, testing and data collection activities Improve risk-based work planning through targeted data collection and more timely data analysis and program evaluation 14

15 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. 15

Public Information Available Web site: http://www.fda.

16 Public Information Available Web site: Subscription feature available Send questions to 16

17 FSMA Questions

18 Regulatory Updates FDA Seattle District staffing updates Pacific Regional Laboratory staffing updates Salmon Control Plan Regulatory Compliance Year in review 18

19 INDUSTRY COMPLIANCE The Year in Review 19

20 QUESTIONS THANK YOU

Update on FSMA Implementation. Rebecca Buckner May 24, 2016

Update on FSMA Implementation. Rebecca Buckner May 24, 2016 Update on FSMA Implementation Rebecca Buckner May 24, 2016 Presentation Overview FSMA Implementation Rulemaking and Industry Guidance - Focus on the Preventive Controls Rules FSMA Implementation Guiding