OVERVIEW OF FDA’S ROLE IN THE U.S. FOOD SAFETY SYSTEM

1. OVERVIEW OFFDA’S ROLE IN THE U.S.FOOD SAFETY SYSTEM Dr. Robin Woo Center for Food Safety and Applied Nutrition Food and Drug Administration Department of Health and Human Services February 2009 For the Egyptian Delegation

2. Food Safety is an Important Public Health Issue • Each year in the U.S. there are • 76 million foodborne illnesses • 325,000 hospitalizations • 5,000 deaths

3. FDA’s Mission • Protect public health by assuring the safety and efficacy of • human drugs • biological products • medical devices and products that emit radiation • animal feed and veterinary drugs • food and cosmetics • Advance public health by facilitating innovations that make medicines and foods more effective, safer and more affordable • Provide the public with accurate, science-based information on medicines and foods

4. Legal Authority • Federal Food and Drug Act (1906) • Federal Food, Drug, and Cosmetic Act (amended 1938) • Federal Import Milk Act (1927) • Public Health Service Act (1944) • Fair Packaging and Labeling Act (1966)

5. Legal Authority • Infant Formula Act (1980) • Nutrition Labeling and Education Act (1990) • Dietary Supplement Health and Education Act (1994) • Bioterrorism Act (2002)

6. How it Works: Rule-making Process and Enforcement Strategy • Public demands action • Congress enacts general law • FDA proposes science-based regulations to put the law into effect • Regulations are notified, finalized and published in 21 Code of Federal Regulations (CFR) • FDA assures compliance by enforcement and inspections that are targeted by risk assessment • Industry has the ultimate responsibility to produce safe foods

7. Important Aspects of the U.S. System • FDA regulates interstate commerce • Transparency • Same standards for domestic and international • Science-based regulations • Consistency and predictability of implementation

8. U.S. Federal Partners for the Food Safety System Department of Health and Human Services (HHS) • Food and Drug Administration (FDA) • Centers for Disease Control and Prevention (CDC) Department of Agriculture (USDA) • Food Safety and Inspection Service (FSIS) • Animal and Plant Health Inspection Service (APHIS) • Foreign Agricultural Service (FAS) Environmental Protection Agency (EPA) Bureau of Customs and Border Protection (CBP) Alcohol and Tobacco Tax and Trade Bureau (TTB)

9. Department of Health and Human Services -- Secretary FDA – Acting Commissioner, Frank Torti Office of Science and Health Coordination Center for Drug Evaluation and Research Office of Regulatory Affairs Office of Policy Center for Biologics, Evaluation, and Research Office of Combination Products Office of External Relations Center for Devices and Radiological Health National Center for Toxicological Research Center for Veterinary Medicine Office of Legislation Center for Food Safety and Applied Nutrition

10. Center for Food Safety and Applied Nutrition (CFSAN) Mission • Protect public health by making sure the nation's food and cosmetics are safe, secure, sanitary, wholesome and properly labeled. • “Food” means 80% of the U.S. food supply, excluding meat, poultry and processed eggs which are regulated by USDA-FSIS

11. CFSAN Organization Office the Center Director (Science, International) Office Food Safety Office of Food Defense, Communication and Emergency Response Office of Cosmetics and Colors Office of Food Additive Safety Office of Nutrition, Labeling and Dietary Supplements Office of Regulations, Policy and Social Sciences Office of Applied Research and Safety Assessment Office of Regulatory Science Office of Compliance Office of Management Systems

12. Major CFSAN Programs • Contaminants (chemicals, toxins, pathogens, filth) • Dietary supplements, infant formulas and medical foods • Nutrition and allergen labeling • Food additives and colors, biotechnology • Food and supplement processing GMPs • Food defense

13. Major CFSAN Programs Seafood and juice HACCP programs Low Acid Canned Food/Acidified Food (LACF) process registration Post-market surveillance and compliance International food standards and trade obligations (Codex, WTO) Technical cooperation and assistance Risk analysis and public outreach

14. OFFICE OF REGULATORY AFFAIRS 190 OFFICES NORTHEAST AL PACIFIC CENTRAL NH ME VT ND MN WA MA NY WI SD MT RI MI CT OR NJ PA ID OH MD IN DE IL WV VA KY NV CA WY IA NE TN NC AZ SC UT GA AL CO KS MS MO HI PR LA OK AR NM VI REGIONAL OFFICES - 5 DISTRICT OFFICES - 20 RESIDENT INSPECTION POSTS - 140 OCI FIELD OFFICES - 6 OCI RESIDENT OFFICES - 6 OCI DOMICILES - 13 FL TX SOUTHEAST SOUTHWEST

15. OFFICE OF REGULATORY AFFAIRS 13 FIELD LABORATORIES WINCHESTER SEATTLE DETROIT NEW YORK PHILADELPHIA FORENSIC CHEMISTRY CENTER SAN FRANCISCO KANSAS CITY LOS ANGELES DENVER ATLANTA JEFFERSON SAN JUAN 5 MULTI-PURPOSE LABS ` 8 ORA LABS ORALABSCurr.PPT

16. Role of the States • State Departments of Agriculture and Health • Contract with FDA to inspect and certify domestic food facilities • Food Emergency Response Network (FERN) with 120 federal and state laboratories • Intrastate commerce • Restaurants, grocery stores, and other retail food establishments, dairy farms and milk processing plants at state or local level

17. Bioterrorism Act Regulations • Took effect December 12, 2003 • FDA and Border Patrol/Customs collaboration • Facility Registration • Domestic and foreign facilities engaged in manufacturing, processing, packing and holding of food (total = 367,600) • Prior Notification of imported foods • 2 hours by land • 4 hours by air • 8 hours by sea

18. FDA-regulated Food Imports • 216,825 Foreign facilities are registered • 504 Egyptian facilities are registered • 11 million CFSAN-regulated import lines • 5,595 lines from Egypt (in 2005) • Enter through 90+ international ports

19. IMPORT LINES HISTORY 11.4 MILLION 1176 FTES

20. Food Protection Plan • To meet these challenges, for domestic and imported food safety • Prevent foodborne contamination • Increase corporate responsibility • Identify vulnerabilities, assess risks • Expand and use effective mitigation measures • Intervene at critical points in the food supply chain • Focus inspections, surveillance and sampling based on risk • Improve contamination detection systems • Respond rapidly to minimize harm • Improve immediate response • Improve risk communication to public, industry, others

21. Food Protection Plan • 38 FDA administrative actions • 10 Legislative proposals • Accreditation of third parties to perform food inspections • Export certification for designated high risk products • Refusal of admission if inspection access is denied • Authority for mandatory recalls

22. Action Plan for Import Safety • 14 broad recommendations, for all FDA-regulated products • Create new and stronger safety standards • Verify compliance of foreign producers through certification • Promote good importer practices • Strengthen penalties and enforcement actions • Make product safety important in diplomacy; increase technical assistance • Harmonize procedures for imports • Single interface for import data

23. Action Plan for Import Safety • Interactive import safety information network • Expand lab capacity; more rapid tests • Strengthen protection of intellectual property • More effective recalls • Maximize federal-state collaboration • Expedite consumer notification of recalls • Expand trace-back technologies

24. FDA Beyond Our Borders • Increase FDA’s international presence • China (Beijing -- Shanghai, Guangzhou) • India (New Delhi -- Mumbai) • Latin American Region (Costa Rica – Chile, Mexico in process) • European Region (Brussels-- EMEA, EFSA) • Future plans….

25. Food Defense Approach • Detect and identify harmful organisms and toxins in food (Awareness) • Train industry and state officials on “CARVER” vulnerability assessments (Prevention) • Criticality • Accessibility • Recuperability • Vulnerability • Effect • Reconcilability • Develop effective strategies to protect the food supply from terrorist threats (Protection)

26. New Food Defense Programs • ALERT raises awareness of state and local government agency and industry representatives • Assure, Look, Employees, Reports, Threat • FIRST for employees • Follow, Inspect, Recognize, Secure, Tell

27. Technical Assistance Activities • FDA Experts • Retired Experts (FDA Alumni Association) • Regulatory consults for food safety authorities • Food labeling seminars • Regional food processing institute • International Visitors’ Program • Over 150 delegations of 600 visitors from government, industry and academia each year • Educational videoconferences, DVDs, website • Long term laboratory international research fellows

28. How to Export Food to the U.S. • Register facility with FDA • Register process for canning/aseptic packaging of Low Acid/Acidified Canned Foods (LACF) • Use good practices in food production • Agricultural • Aquacultural • Manufacturing • HACCP • Assure that the product is safe, wholesome, sanitary, properly packaged and labeled • Give “Prior Notice”

29. For More Information on FDA • www.cfsan.fda.gov • Robin.woo@fda/hhs.gov