Food Safety Regulation in the United States Caroline Smith DeWaal Food Safety Director Center for Science in the Public Interest Seattle, Washington April 11, 2008

What is the Center for Science in the Public Interest(CSPI)? A nonprofit health advocacy and education organization, focusing on: A nonprofit health advocacy and education organization, focusing on: Food safety Food safety Nutrition Nutrition Alcohol issues Alcohol issues Supported principally by 900,000 subscribers to Nutrition Action HealthLetter and by foundation grants. Supported principally by 900,000 subscribers to Nutrition Action HealthLetter and by foundation grants. We accept no government or industry funding. We accept no government or industry funding.

Foodborne Illness  The CDC estimates that foodborne diseases affect 76 million Americans annually  An estimated 5,000 Americans die from foodborne diseases and another 325,000 people are hospitalized each year  The worst cases of foodborne illness occur in the most vulnerable: the old, the young, and those with weakened immune systems

History of Outbreak Alert! CSPI started collecting data on food-borne illness outbreaks in 1997 and organized it by regulatory agency CSPI started collecting data on food-borne illness outbreaks in 1997 and organized it by regulatory agency The data was not available from CDC without a FOIA; however, with our continued requests, CDC started posting yearly line listings on the internet The data was not available from CDC without a FOIA; however, with our continued requests, CDC started posting yearly line listings on the internet Starting in 1999, we publish annually our outbreaks organized by food category and by regulatory agency. Starting in 1999, we publish annually our outbreaks organized by food category and by regulatory agency.

Number of Outbreaks by Food, Source: Outbreak Alert! Center for Science in the Public Interest, 2007

Complex System of Laws “ The safety and quality of the U.S. food supply is governed by a highly complex system stemming from 30 principal laws related to food safety” GAO, Steps Should be Taken to Reduce Overlapping Inspections and Related Activities, May 17, 2005

100 Years of Food Laws Pure Food and Drug Act-1906 Pure Food and Drug Act-1906 Federal Meat Inspection Act-1907 Federal Meat Inspection Act-1907 Food, Drug, and Cosmetic Act-1938 Food, Drug, and Cosmetic Act-1938 Public Health Service Act-1944 Public Health Service Act-1944 Poultry Products Inspection Act-1957 Poultry Products Inspection Act-1957 Egg Products Inspection Act-1970 Egg Products Inspection Act-1970 Infant Formula Act-1980 Infant Formula Act-1980 Sanitary Food Transportation Act-1990 Sanitary Food Transportation Act-1990 Food Quality Protection Act-1996 Food Quality Protection Act-1996 Bioterrorism Act-2002 Bioterrorism Act-2002 Food Allergen Labeling and Consumer Protection Act-2004 Food Allergen Labeling and Consumer Protection Act-2004 Food and Drug Administration Amendments Act-2007 Food and Drug Administration Amendments Act-2007

Food Regulation 12 Agencies; 35 Statutes The National Academy of Sciences identified multiple agencies administering numerous food-related statutes resulting in: An absence of focused leadership An absence of focused leadership Lack of a common mission Lack of a common mission Inadequate emphasis on surveillance Inadequate emphasis on surveillance Lack of nationwide adherence to appropriate minimum standards Lack of nationwide adherence to appropriate minimum standards

Two Major Food Safety Agencies Food and Drug Administration (HHS) Food and Drug Administration (HHS) Responsible for 80% of food supply (Fruit, vegetables, processed foods, seafood, etc.) Responsible for 80% of food supply (Fruit, vegetables, processed foods, seafood, etc.) Fewer than 2,000 inspectors Fewer than 2,000 inspectors More than 136,000 domestic establishments More than 136,000 domestic establishments Random Inspections (frequency as little as once every 10 years) Random Inspections (frequency as little as once every 10 years) Food Safety Inspection Service (USDA) Food Safety Inspection Service (USDA) Responsible for 20% of food supply (Meat, Poultry Eggs) Responsible for 20% of food supply (Meat, Poultry Eggs) More than 7,300 inspectors More than 7,300 inspectors 6,200 federally inspected establishments 6,200 federally inspected establishments Daily and Continuous Inspections Daily and Continuous Inspections

Food-Related Outbreaks by Government Agency

Ten Other Agencies Centers for Disease Control Centers for Disease Control Foodborne Illness Surveillance Foodborne Illness Surveillance Environmental Protection Agency Environmental Protection Agency Pesticide Residue Levels Pesticide Residue Levels Animal Plant Health Inspection Service Animal Plant Health Inspection Service Controls Outbreaks of Animal and Plant Diseases Controls Outbreaks of Animal and Plant Diseases Grain Inspection, Packers and Stockyards Administration Grain Inspection, Packers and Stockyards Administration Quality and Inspection Standards for Grains Quality and Inspection Standards for Grains Agricultural Marketing Service Agricultural Marketing Service Egg Quality and Marketing Program Egg Quality and Marketing Program Agricultural Research Service Agricultural Research Service Food Safety Research Food Safety Research National Agricultural Statistics Service National Agricultural Statistics Service Statistical Data on Agricultural Chemical Usage Statistical Data on Agricultural Chemical Usage Cooperative State Research, Education and Extension Service Cooperative State Research, Education and Extension Service University-based Food Safety Research & Education University-based Food Safety Research & Education National Marine Fisheries Service National Marine Fisheries Service NOAA Seafood Inspection Program NOAA Seafood Inspection Program Department of Homeland Security Department of Homeland Security Coordination of Food Security Activities Coordination of Food Security Activities

Overlapping Responsibilities Four Agencies Performing Similar Roles USDAFDAEPANMFS Inspection of Domestic Food Facilities  Inspection of Foreign Food Facilities  Inspection at Ports  Laboratory Analysis for Contamination  Research on Pathogen Reduction  Research on Foodborne Contaminants  Risk Assessments of Contaminants  Public Education and Outreach  Development of Guidance for Industry  International Harmonization  Surveillance/Monitoring Rule Development & Promulgation 

Piecemeal Evolution In Need of Revolution? “The federal regulatory system for food safety, like many others in the federal government, evolved piecemeal, typically in response to particular health threats or economic crises. GAO, Federal Oversight of Food Safety, April 24, 2007

1998 National Academy of Sciences Study Found Poorly Integrated Decision- making “ With so many agencies involved in food safety, decisions and priorities often focus on specific issues rather than strategies.... The system that has evolved in the federal government for regulating food safety is complex, fragmented, and cumbersome.” National Research Council, Ensuring Safe Food From Production to Consumption, 1998

2007 Findings of FDA’s Science Board “The FDA does not have the capacity to ensure the safety of food for the nation: “There is an appallingly low inspection rate: the FDA cannot sufficiently monitor either the tremendous volume of products manufactured domestically or the exponential growth of imports.” National Science Board, FDA Science and Mission at Risk, Nov. 2007

2007 “High Risk” Designation by the GAO “We have added food safety to our list of programs needing urgent attention and transformation to ensure our government functions in the most economical, efficient and effective manner possible... An accidental or deliberate contamination of food or the introduction of a disease to livestock, poultry or crops could undermine consumer confidence in the safety of the U.S. food supply...”, GAO, High-Risk Designation Can Bring Needed Attention to Fragmented System, February 8, 2007

Consumer confidence The Food Marketing Institute annual survey found that overall confidence in the safety of food dropped from 82% in 2006 to 66% in The Food Marketing Institute annual survey found that overall confidence in the safety of food dropped from 82% in 2006 to 66% in A survey of consumer confidence in FDA has also showed huge declines – dropping from 56% in 2004 to 36% in A survey of consumer confidence in FDA has also showed huge declines – dropping from 56% in 2004 to 36% in In July, 83 percent of shoppers voiced concern about food from China, and 61 percent about food from Mexico. In July, 83 percent of shoppers voiced concern about food from China, and 61 percent about food from Mexico.

Building a Modern Food Safety System: CSPI White Paper CSPI has written a blue print for FDA reform for Congress:  Preventive Process Controls and Performance Standards  Inspections and State/Federal Cooperation  Food Imports  Research and Education  On-Farm Food Safety  Enforcement Authority

Process Controls Performance Standards InspectionsImports Research and Education On Farm Enforcement RecallTracebackDetentionPenaltiesWhistle-blower S. 654/H.R. 1148, Safe Food Act XXXXXXXXXXX H.R. 3624, Consumer Food Safety Act XXXXXXXXXX H.R. 3610, Food & Drug Import Safety Act XXXXX S. 1776, Imported Food Security Act XXX S. 1274/H.R. 2108, Human & Pet Food Safety Act XXX S. 2077, Fresh Produce Safety Act XXXXX H.R. 3484, SAFER Meat, Poultry, & Food Act XX H.R. 3485, TRACE Act X H.R. 2997, Assured Food Safety Act XXX S. 2081, Food & Product Responsibility Act X H.R. 3937, Food Import Safety Act XX S. 1292, Meat & Poultry Products Traceability & Safety Act X Food Safety Legislation In the 110 th Congress

Questions? Caroline Smith DeWaal Food Safety Director Center for Science in the Public Interest Washington, DC phone (202) On the internet: To search our Outbreak Alert database: