AFDO Annual Meeting Presented by: Barbara Cassens, Jeff Farrar June, 2013

1. Building a Fully Integrated Food Safety System (IFSS)Utilizing the Partnership for Food Protection (PFP) AFDO Annual Meeting Presented by: Barbara Cassens, Jeff Farrar June, 2013

2. Topics • IFSS & PFP Defined • Historical Background: IFSS/PFP • Recent FDA Actions to Support Building an IFSS • Staff Additions/Integration from Within • FDA IFSS Taskforce Action Plan • FSMA & Building an IFSS • Current State of the PFP • Relevant PFP Accomplishments & Outputs from Related Efforts that Support Building an IFSS

3. Integrated Food Safety System (IFSS) Definition: An IFSS is a systematic collaboration and coordination of local, state, and federal food and feed safety regulatory programs, resources, and authorities to protect public health. Vision: Public health & regulatory partners work collaboratively across all jurisdictions to provide comprehensive, coordinated coverage of the food supply from farm to table to prevent foodborne illness in humans and animals.

4. IFSS Vision Achieved, in part, by: • Establishing and implementing national standards to ensure consistency across all jurisdictions; • Developing training & certification programs to establish a highly skilled workforce across all jurisdictions & levels of government; • Implementing IFSS foundational elements including: • joint work planning including inventory sharing • joint inspections where appropriate • joint enforcement and compliance teams • joint after action reviews of significant events • joint responses to significant events • immediate notification of egregious conditions • Identifying mechanisms and processes, both legal & technological, to share information, & where appropriate, use data from regulatory partners to support enforcement actions; • Ensuring food laboratory accreditation and providing food laboratory best practices to ensure consistent, high quality data;

5. Historical Background: IFSS & PFP • Since the 1990s and before, Federal, state, territorial, tribal & local agencies have worked together to address pieces of an integrated food safety system. • 1998:First 50-State Workshop held, in part, due to the launch of the National Food Safety Initiative that included a comprehensive approach to food safety; success in moving integration forward followed, but faltered after a few years w/o adequate federal infrastructure & funding support for the effort.

6. Historical Background: IFSS & PFP • 2008:FDA held its second 50-State Workshop titled Gateway to Food Protection • Reenergized integration efforts to address challenges of growing global food supply • FDA established PFP to bring together regulatory and public health partners to develop an IFSS • PFP Coordinating Committee: Established to advise FDA on IFSS infrastructure needs & to suggest strategies & tools for integration; set goals & provided oversight to PFP Workgroups • PFP Workgroups: Created by PFP Coordinating Committee to work on projects focused on IT, training, emergency response, risk-based work planning & development of PETNet (target completion August 2010).

7. Historical Background: IFSS & PFP • 2009: • White House Food Safety Working Group Key Findings Report: IFSS priority recommendation; recommends unified IC structure & adequate provisions for sharing data in an emergency • FDA drafts an IFSS vision paper, supported by PFP • 2010: • Administration supports IFSS in 2010 budget; $14.6 million to build FDA infrastructure for an IFSS • Third 50-State Workshop; FDA commits to continued PFP IFSS support • 2011: • PFP work underscored by passage of FSMA; mandates an IFSS • 2012: • Fourth 50-State Workshop • New PFP Governance Committee created; PFP Workgroups redefined

8. Internal FDA Action to Support Building an IFSS & the PFP Organization Changes/Staff Additions Implementation of Integrated Task Force Action Plan

9. FDA Support for an IFSS • Office of Foods and Veterinary Medicine (OFVM) Changes • Added Director of Intergovernmental Affairs & Partnerships • Office of Regulatory Affairs (ORA) Changes • Created Office of Partnerships • Added Senior Advisor for Fed-State Relations • Added District State Liaisons; • Added District Emergency Response Coordinators • New PFP Governance structure and Governance Council contains Senior Leaders from Across FDA’s Foods Program    • Add dedicated project managers for PFP WGs from across FDA’s Foods Programs 

10. FDA’s Integrated Food Safety Taskforce • Commissioner charged Deputy Commissioners for Foods & Global Regulatory Operations & Policy to establish a high-level Integration Task Force to oversee the development & implementation of new strategies & action plans to achieve full partnership with state/local agencies • Co-chaired by Joe Reardon, ORA & Jeff Farrar, OFVM • Members include Senior Officials from • ORA • CFSAN • CVM • State/local leaders involved in the PFP

11. FDA’s Integrated Food Safety Taskforce • Charge: Identify & address enhancements needed w/in FDA to ensure full adoption of an IFSS; immediate priority given to addressing the following: • Strengths/weaknesses of Fed-State partnership, perspectives of officials from FDA & state/local agencies • Current FDA policies & practices fostering/impeding development of a full partnership • Specific actions FDA leadership can take to institutionalize communication & operational practices required to achieve full partnership • Deliverable: Action Plan

12. FSMA & Building an IFSSMain Themes of the Legislation Prevention Inspections, Compliance, & Response Enhanced Partnerships Import Safety

13. IFSS Related FSMA Sections • Section 201: Targeting of Inspection Resources for Domestic Facilities • Section 205: Surveillance • Section 209: Improving the Training of State, Local, Territorial, & Tribal Food Safety Officers • Section 210: Enhancing Food Safety

14. FSMA Section 201: Targeting of Inspection Resources for Domestic Facilities • Sec 201 (a) Establishes the Domestic Inspection Frequency Mandate • Sec 201 (a)(2)(E) Reliance on Federal, State or Local Inspections • “In meeting the inspection requirements under 201 for domestic facilities the FDA may rely on inspections conducted by other Federal, State or local agencies under interagency agreement, contract, MOU or other obligation.” • States currently conduct 50% of federal registered food facility inspections reported each year under contract

15. FSMA Section 201: Targeting of Inspection Resources for Domestic Facilities – cont. • Role of MFRPS and AFRPS • Provide uniformity and consistency among Federal & State Inspection Programs • Need to clarify process for providing feedback to FDA on MFRPS and AFRPS standards • FDA Established Independent Audit Group • Ensures uniform implementation of Program Standards

16. FSMA Section 205: Surveillance • 205(c)(1): Improving State/Local Food Safety/Defense Capacity FDA to develop/implement strategies to leverage/enhance food safety & defense capacities of state /local agencies to: • Improve emergency response & containment; • Strengthen capacity of state/local agencies to conduct inspections & enforce safety standards; • Improve effectiveness of fed/state/locals to coordinate food safety & defense resources & reduce foodborne illness; • Share information among public health/regulatory partners/public in a timely manner • 205(c)(2): Review of State/Local Capacities & Needs for Enhancement Staffing levels & expertise available to perform food safety & defense functions; laboratory capacity to support surveillance, outbreak response, inspection, & enforcement; information systems & ability to share data

17. FSMA Section 209: Improving the Training of State, Local, Territorial & Tribal Officers • Requires FDA to set standards & administer training/education programs for fed/state/local food safety officials relating to the regulatory responsibilities & policies established under FSMA/FD&C Act • Includes programs for: scientific training & training on sampling, laboratory analysis/methodology, inspections, specialization relative to inspections, best practices & building enforcement actions • Training can assure consistency & equivalencyamong fed/state/local programs

18. FSMA Section 210: Enhancing Food Safety • Authorizes FDA to make grants to eligible entities to: • Conduct inspections & investigations • Train to FDA standards for inspections/investigations of food & retail facilities • Build food safety capacity of the laboratories • Build infrastructure & capacity of food safety programs to meet standards • Permits FDA to provide funds to eligible entities (state/local/territorial/tribal) for direct investment into their food safety infrastructure; monies that can improve upon the current capabilities and capacities of these entities

19. Partnership for Food Protection What is it and what is the current state?

20. Partnership for Food Protection A collaboration between federal, state, and local public health and regulatory agencies working together to ensure food safety. PFP is comprised of a Governing Council, a Coordinating Committee, and various workgroups who help achieve an IFSS.

21. PFP Governing Council Representatives FDAState and Local Barbara Cassens (ORA) Pat Kennelly (CA) Jeff Farrar (OFVM) Claudia Coles (WA) Tracey Forfa (CVM) Brian Collins (Plano, TX) Roberta Wagner (CFSAN) Adam London (Kent County, MI) Mel Plaisier (ORA) Dan Rice (NY) Bob Waltz (IN)

22. Current State of the PFP • August 2012 50-State Workshop in Nashville, TN • 217 attendess • 6 Federal agencies • 47 States • 20 Local Jurisdictions • 3 Territories • 8 Associations • Reviewed PFP Accomplishments • Developed next steps/projects to address the critical needs of an IFSS.

23. How do the PFP and IFSS relate to the Implementation of FSMA? • The good news is the at many of the PFP and IFSS initiatives are directly tied to the goals and outcomes set out in FSMA. • More work remains to ensure that we identify the most critical gaps in the IFSS and direct our PFP efforts to filling those gaps.

24. Thank You for Your Attention We Welcome Your Questions, Comments & Suggestions