Food Safety Modernization Act

Transcription

1 Overview FDA Food Safety Modernization Act Presented to ASTHO: State Environmental Health Directors Group Guy F. Delius, R.S. FDA-DFSR September 21, 2011

2 Food Safety Modernization Act I thank the President and members of Congress for recognizing that the burden that foodborne illness places on the American people is too great, and for taking this action. Margaret A. Hamburg, M.D., Commissioner of Food and Drugs

3 Agenda The public health imperative Why is the law needed? Provisions of the law and their significance Implementation

4 The Public Health Imperative Foodborne illness is a significant burden About 48 million (1 in 6 Americans) get sick each year 128,000 are hospitalized 3,000 die Immune-compromised individuals more susceptible Infants and children, pregnant women, older individuals, those on chemotherapy Foodborne illness is not just a stomach ache it can cause life-long chronic disease Arthritis, kidney failure

5 Why is the law needed? Globalization 15 percent of U.S. food supply is imported Food supply more high-tech and complex More foods in the marketplace New hazards in foods not previously seen Shifting demographics Growing population (about 30%) of individuals are especially at risk for foodborne illness

6 What s so historic about the law? Involves creation of a new food safety system Broad prevention mandate and accountability New system of import oversight Emphasizes partnerships Emphasizes farm-to-table responsibility Developed through broad coalition

7 Main Themes of the Legislation Prevention Standards Enhanced Partnerships Inspections, Compliance, and Response Import Safety

8 Prevention: The cornerstone Comprehensive preventive controls for food and feed facilities Prevention is not new, but Congress has given FDA explicit authority to use the tool more broadly Strengthens accountability for prevention Produce safety standards Intentional adulteration standards Transportation

9 Inspection, Compliance, and Mandated inspection frequency Response More inspections, but with preventive controls in place, we can consider new ways to inspect New tools Mandatory recall Expanded records access Expanded administrative detention Suspension of registration Enhanced product tracing Third party laboratory testing

10 Import Safety: Most groundbreaking shift Importers now responsible for ensuring that their foreign suppliers have adequate preventive controls in place FDA can rely on third parties to certify that foreign food facilities meet U.S. requirements Can require mandatory certification for high-risk foods Voluntary qualified importer program--expedited review Can deny entry if FDA access for inspection is denied Requires food from abroad to be as safe as domestic

11 Enhanced Partnerships: Vital to Success Reliance on inspections by other agencies that meet standards State/local and international capacity building Improve foodborne illness surveillance National agriculture and food defense strategy Consortium of laboratory networks Easier for consumers to find recall information

12 Implementation Approach Implementation already underway Coalition needed Transparency a priority Focus on public health protection Engage with stakeholders to help determine reasonable and practical ways to implement provisions

13 Implementation Executive Committee Strategic Communications & Outreach Team Sharon Natanblut Prevention Standards Don Kraemer Inspection & Compliance Barbara Cassens Imports David Elder Federal/State Integration Joe Reardon Fees David Wardrop Reports & Studies David Dorsey Produce Safety Regulation Produce Safety Guidance Preventive Controls Regulation Preventive Controls Guidance Mandatory Recall / Recall Communication s Administrative Enforcement Tools Registration Frequency of Inspection Importer Verification & VQIP Import Certification Accredited Third- Party Certification Lab Accreditation & Integrated Consortium / FERN Operational Partnership Capacity Building Training Inspection & Auditor Fees Reports to Congress/ Studies Safe Food Transport Food Defense Manner of Inspection / Food Safety Plan Review Tracing International Capacity Building Comparability Contaminants RFR Improvements Task A: Prior Notice

14 Section 205(c)1 Team Anita MacMullan: Capacity Building Lead Guy Delius and Shuen Chai are Deliverable Co-Leads

15 Section 205 (c) 1 (C) Improving Food Safety and Defense Capacity at the State and Local Level. (1) In General: The Secretary shall develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies in order to achieve the following goals.

16 Section 205 (c) 1 (Subgroup A) Improve FBIO Response/ Containment (Subgroup B) Accelerate FBIO Surveillance & Investigations-more standardized outbreak interviews (Subgroup C) Strengthen Capacity of State and Local Agencies: Inspections & Enforce Safety Standards (Subgroup D) Improve Effectiveness of Fed-State-Local Partnerships/Coordinate Resources & Reduce FBI (Subgroup E) Share Information in a timely manner among Public Health/Food Regulatory/Industry/Health Care/Public

17 205(c)1 Structure

18 Teamwork

19 Teamwork

20 Partners Reaching out to many entities for expertise and partnering to ensure broad scope development. CDC: ASTHO: AFDO: AFFCO: NEHA: Partnership for Food Protection (PFP) group leads for (Emergency Response, National Standards, Policies and Procedures-IT)

21 Partners FDA CFSAN: FDA CVM: APHL: FDA DFSR: State/Local Representatives:

22 Section 205 (c) 1 Sub Group Leads Sub Group A: Darby Greco Sub Group B: Andy Maccabe and Dr. Stephanie Mayfield Sub Group C: Doug Saunders Sub Group D: Wendy Campbell Sub Group E: Communications/IT-Open

23 ASTHO Representation Abraham Kulungara (ASTHO Liaison) Subgroup (D) Representative Cliff Mitchell of Maryland Subgroup (E) Representative Suzanne Condon of Massachusetts

24 Early Goals and Successes Develop an Internal Strategy document: Completed Develop an internal Structure document: Completed Held conference calls with PFP and other stakeholders: Completed Developed Dynamic Team Membership: Completed Good working relationship and overlap with CDC to ensure coverage but minimize duplication (205(c)1 and 205(b). Ongoing Initiated Monthly Group calls: Completed-Ongoing Developed Sub Group Structure with Sub Group Leads Identified: Completed Drafted Concept Papers for sections (A-D): Completed-Ongoing

25 Our Forward Goals Monthly update status calls for large group. Sub Group leads working with their respective groups, feeding input into the large group. Use Concept Papers as a foundation platform Identifying and researching best practices, developing new strategies. Target the end of November to have draft conceptual recommendation documents from Sub Groups for review. Target end of 2011 calendar year to have a foundational template-platform for each Sub Group. Waterfall Point : Target by January 2012 to have Sub Groups finalized consensus strategy/goals and path forward timeline. Provide recommendations to improve the food safety system(s)

26 But, many challenges Enormous workload 50 new rules, guidance documents, reports in 3 years Tight deadlines Changes won t appear overnight Building new system will be a long-range process Resources

27 Implementation Progress (as of Aug. 1, 2011) Updated list and more information can be found at Fees (107) New dietary ingredients ( sec.113) Anti-smuggled food strategy (sec. 201) Registration of Food Facilities (sec. 103) Prior Notice of imported food shipments (sec. 304) Administrative detention of food (sec, 207) Consumer-friendly web search for recalls (sec. 205) Guidance to Seafood Industry on food safety hazards (sec. 103)

28 Outreach Public Meetings Preventive Controls Inspection and Compliance Comparability and Import Practices Imports Numerous listening sessions, meetings, presentations FSMA web page has subscription service for immediate updates.

29 Rulemaking Process Rulemaking is open and public. Draft rules are published on Time is allowed for public comment, and FDA is required to consider significant comments during the rulemaking process. Check to find out what is open for comment.

30 Snapshot of FSMA homepage elements at:

31 For more information Web site is at: Subscription feature available Send questions to

32 Division of Federal State Relations Parklawn Drive, ELEM- 3033, Rockville, MD DFSR Website: (240)