1. Food Safety – Challenges, Problems, and Opportunities By Thomas J. Billy, President International Food Safety Consulting, LLC Former Senior U.S. Food Safety Official and Chairperson, Codex Alimentarius Commission

2. A Risk Manager’s View §Director, FDA’s Office of Seafood §Administrator, FSIS §Chairman, Codex Alimentarius Commission

3. Two Mental Models §A Food Production / Supply Model §A Food Safety Control Model

4. Food Production/Supply Model Production Imports of Raw Ingredients Processing Product Exports Product Imports Distribution Food Service Retail

5. Food Safety Control Model Food Law(s) RISK MANAGEMENT RISK ASSESSMENT Regulations/Decrees Prior Approvals/MRLs Inspections Sampling/Testing Recalls Enforcement RISK COMMUNICATION

6. FDA Seafood HACCP Rule §NAS Report – Seafood Safety (1991) §National Committee on Microbiological Criteria for Foods §CDC l Food Net Pilot l National Estimates of Foodborne Illness §HACCP Rule l GMPs l HACCP Plans §Hazards and Controls Guide

7. FSIS: Pathogen Reduction/HACCP Rule §NAS Reports, 1985 and 1987 §National Committee on Microbiological Criteria for Foods §FSIS National Product Surveys §CDC l Food Net / Pulse Net l National Estimates of Foodborne Illness §Pathogen Reduction / HACCP Rule l SSOPs l Establishment HACCP Plan(s) l Salmonella Performance Standards l HACCP Models / Guides l Phase-in Strategy

8. Codex Alimentarius Commission §Role, Approach, and Focus §A Strategic Framework l Role of Science l Risk Analysis Paradigm Risk Management Risk Assessment Risk Communication §A New Expert Group – JEMRA

9. Codex Produces: General or Working Principles (Policy advice); MRLs (Maximum Residue Limits) for food additives (683), pesticide residues (2,579), veterinary drugs (377), and contaminants (14); Commodity Standards (202); Codes of Practice (43); and Recommendations (Scientific advice and guidance)

10. Food Safety Recommendations and Opportunities §Treat food safety as a farm/vessel to table system-wide issue §Make risk-based prevention of food safety problems the central focus of industry and consumers §Gain acceptance that the primary duty for prevention falls on industry §Focus regulatory priorities on setting and enforcing standards that make the food industry accountable for performance §Strengthen mandates and tools for food safety and security to assure it is a science-driven and risk-based approach

11. Thomas J. Billy, President International Food Safety Consulting, LLC 4802 Chevy Chase Blvd. Chevy Chase, MD 20815, USA tombilly@comcast.net Tel: + 1 202-251-0218 Fax: + 1 301-951-8833