FDA - Introduction

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Information about FDA - Introduction

Published on March 6, 2009

Author: Andrew.Smale

Source: authorstream.com

OVERVIEW OFFDA’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 Food Safety is an Important Public Health Issue : 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 FDA’s Mission : 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 Legal Authority : 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) Legal Authority : 5 Legal Authority Infant Formula Act (1980) Nutrition Labeling and Education Act (1990) Dietary Supplement Health and Education Act (1994) Bioterrorism Act (2002) How it Works: Rule-making Process and Enforcement Strategy : 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 Important Aspects of the U.S. System : 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 U.S. Federal Partners for the Food Safety System : 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) Department of Health and Human Services -- Secretary : 9 Department of Health and Human Services -- Secretary Center for Biologics, Evaluation, and Research FDA – Acting Commissioner, Frank Torti Office of Science and Health Coordination Office of External Relations Center for Devices and Radiological Health Office of Policy Center for Food Safety and Applied Nutrition National Center for Toxicological Research Center for Veterinary Medicine Center for Drug Evaluation and Research Office of Regulatory Affairs Office of Legislation Office of Combination Products Center for Food Safety and Applied Nutrition (CFSAN) Mission : 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 Slide 11: 11 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 CFSAN Organization Major CFSAN Programs : 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 Major CFSAN Programs : 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 Slide 14: 14 OFFICE OF REGULATORY AFFAIRS 190 OFFICES NORTHEAST PACIFIC CENTRAL SOUTHEAST SOUTHWEST REGIONAL OFFICES - 5 DISTRICT OFFICES - 20 RESIDENT INSPECTION POSTS - 140 OCI FIELD OFFICES - 6 OCI RESIDENT OFFICES - 6 OCI DOMICILES - 13 CA NV WA MT OR ID AL HI AZ UT WY CO NM TX OK AR MO IA NE KS TN NC GA AL MS LA FL SC PR ME VT NY NH MA CT RI MN WI IL MI IN OH PA WV KY VA NJ ND SD MD DE VI Slide 15: 15 OFFICE OF REGULATORY AFFAIRS 13 FIELD LABORATORIES ORALABSCurr.PPT 5 MULTI-PURPOSE LABS 8 ORA LABS SEATTLE SAN FRANCISCO LOS ANGELES ` DENVER KANSAS CITY JEFFERSON DETROIT FORENSIC CHEMISTRY CENTER PHILADELPHIA NEW YORK WINCHESTER ATLANTA SAN JUAN Role of the States : 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 Bioterrorism Act Regulations : 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 FDA-regulated Food Imports : 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 IMPORT LINES HISTORY : 19 IMPORT LINES HISTORY 11.4 MILLION 1176 FTES Food Protection Plan : 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 Food Protection Plan : 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 Action Plan for Import Safety : 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 Action Plan for Import Safety : 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 FDA Beyond Our Borders : 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…. Food Defense Approach : 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) New Food Defense Programs : 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 Technical Assistance Activities : 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 How to Export Food to the U.S. : 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” For More Information on FDA : 29 For More Information on FDA www.cfsan.fda.gov Robin.woo@fda/hhs.gov

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