The FDA Food Protection Plan and Others

Transcription

1 The FDA Food Protection Plan and Others Martine Hartogensis, DVM Center for Veterinary Medicine Deputy Director, Office of Surveillance and Compliance States Industry Relations Committee AAFCO Midyear Meeting Tuesday, January 29, 2008 San Antonio, Texas

2 Agenda The Charge to FDA Food Protection Plan *Core Elements & Principles * Import Safety Action Plan *Building Blocks & Principles FDA Amendments Act (FDAAA) *Animal Feed & Public Meeting China MOA Conclusions

3 The Charge to FDA Food Protection Plan (11/07) - Agency-wide focus on food and feed products Import Safety Action Plan (11/07) - Government-wide focus on all imported products FDAAA (9/07) - Agency-wide focus on medical and food products China MOA (12/11/07) - Country specific, focus on medical and food/feed products

4 Food Protection Plan

5 Core Elements Prevention Build safety in from the start Intervention Verify prevention and intervene when risks are identified Response Respond rapidly and appropriately

6 Cross-Cutting Cutting Principles Focus on risks over a product s life cycle from production to consumption Target resources to achieve maximum risk reduction Address both unintentional and deliberate contamination Use science and modern technology systems, including enhanced IT

7 Prevention Promote Increased Corporate Responsibility to Prevent Foodborne Illness FDA Actions: Analyze food import trend data & integrate it into risk-based inspection approaches that focus resources on greatest risk Focus foreign inspections on high-risk firms & products Improve FDA s s presence overseas Additional Legislative Authorities: Allow FDA to require preventive controls against intentional adulteration at points of high vulnerability in the food chain Authorize FDA to issue add l l preventive controls for high risk foods Require food facilities to renew registrations every 2 years and allow FDA to modify registration categories Categories to be tailored based on up-to to-date food safety information Ensures up-to to-date, accurate data from facilities

8 Intervention Focus Inspections & Sampling Based on Risk FDA Actions: Focus food & feed safety inspections & sampling based on risk Foodborne pathogen detection methods/tools capable of rapid detection of contaminants in foods Train FDA/states on new mfg. processes, as determined by risk-based needs assessment and modern inspection strategies Additional Legislative Authorities: Authorize FDA to accredit qualified 3 rd parties for voluntary food inspections Require re-inspection fees from facilities that fail to meet cgmps

9 Intervention Enhance Risk-Based Surveillance Improve FDA Actions: Enhance FDA s s ability to target imported foods for inspection based on risk Conduct foreign food & animal feed inspections more efficiently using tools designed to target high risk firms Use advanced screening technology at the border Data quality and handling capacity for food imports Enhance information sharing agreements with foreign countries Additional Legislative Authorities: Authorize FDA to require electronic import certificates for shipments of designated high risk products Provide parity between domestic and imported foods if inspection access is delayed, limited or denied

10 Intervention Improve the Detection of Food System Signals That Indicate Contamination FDA Actions: Deploy new rapid screening tools and methods to identify pathogens and other contaminants Improve FDA s s adverse event and consumer complaint reporting systems, including complaints made to food manufacturers and distributors Create a Reportable Food Registry for reports where there is a reasonable probability of serious harm or death to humans or animals Create an Early Warning Surveillance & Notification System to identify adulterated pet food products, outbreaks of pet illness

11 Response Improve Immediate Response FDA Actions: Enhance Emergency Operations Develop an Action Plan for more effective trace-back process improvements and technologies Increase collaboration with foreign, federal, state and local FDA partners, i.e. sources of contamination & corrective actions Work with CDC & other federal, state, local testing labs Additional Legislative Authorities: Mandatory recall authority Enhanced access to food records during emergencies

12 50 State Meeting Update Conference Call with FDA, HHS, State Departments Agriculture & Health We are in early stages of the 50 State Meeting on the Food Protection Plan Will be later in 2008 We will be keeping states informed on progress and scheduling Representatives from all states will be involved.

13 Import Safety Action Plan

14 Import Safety Action Plan (ISAP) Mirrors Food Protection Plan Involvement of 12 Federal Departments and Agencies - Led by HHS Secretary Leavitt Strategic Framework September 2007 Risk-Based, Life Cycle Approach Organizing Principles Prevention (with Verification) Intervention Response Action Plan November Broad Recommendations 50 Specific Action Steps Short and Long Term

15 Current Approach to Imports Mainly reactive Inspect < 1% of imports Import alerts based on laboratory / inspection documentation of a problem (feed) State results not routinely used to support an import alert Import alerts mainly product and manufacturer specific Coordination Hampered by lack of integrated IT systems

16 ISAP Building Blocks Advancing a Common Vision Increasing Accountability, Enforcement & Deterrence Focusing on Risks over the Life Cycle Building Interoperable Systems Fostering a Culture of Collaboration Promoting Technological Innovation and New Science

17 Food and Drug Administration Amendments Act of 2007

18 FDAAA Title X Food Safety Built into FPP Section 1002 Ensuring the Safety of Pet Food Section 1003 Ensuring Efficient and Effective Communications During a Recall Section 1004 State and Federal Cooperation Section 1005 Reportable Food Registry

19 FDAAA Title X, Section 1002 Within 2 years, FDA will issue new regulations to: * Establish ingredient standards, definitions, and processing standards for pet food [animal feed] * Update labeling standards for pet food to include nutritional and ingredient information

20 FDAAA Public Meeting Federal Register Notice published January 7, 2008 Rockville, MD area Docket opened to receive any comments before +/- after the meeting open to general public Docket No. 2007N ( /)

21 U.S. and China Memorandum of Agreement (MOA) Agreement on the Safety of Food and Feed Signed December 11, 2007 Key points New registration and certification requirements Greater information sharing Increased access to production facilities Greater regulatory cooperation (standards, capacity building) Implementation of agreement will begin with designated covered products LACF pet food/treats of animal or plant origin ingredients for food and feed (e.g( e.g,, wheat gluten) all aquaculture farming products except molluscan shellfish

22 Conclusions Significant overlap between FPP, ISAP, FDAAA, & China MOA Common theme of risk-based PIR and State Collaboration Communications & Technology = Large Components

23 The End!!