Food Safety RegulationFood Safety Regulationin the United Statesin the United States

Caroline Smith DeWaalCaroline Smith DeWaalFood Safety DirectorFood Safety DirectorCenter for Science in Center for Science in the Public Interestthe Public Interest

Seattle, WashingtonSeattle, WashingtonApril 11, 2008April 11, 2008

What is the Center for What is the Center for Science in the Public Science in the Public

Interest(CSPI)?Interest(CSPI)? A nonprofit health advocacy and A nonprofit health advocacy and

education organization, focusing on:education organization, focusing on: Food safetyFood safety NutritionNutrition Alcohol issuesAlcohol issues

Supported principally by 900,000 Supported principally by 900,000 subscribers to subscribers to Nutrition Action Nutrition Action HealthLetter HealthLetter and by foundation grants. and by foundation grants.

We accept no government or industry We accept no government or industry funding.funding.

FoodborneFoodborne Illness Illness The CDC estimates that foodborne diseases The CDC estimates that foodborne diseases

affect 76 million Americans annuallyaffect 76 million Americans annually An estimated 5,000 Americans die from An estimated 5,000 Americans die from

foodborne diseases and another 325,000 foodborne diseases and another 325,000 people are hospitalized each yearpeople are hospitalized each year

The worst cases of foodborne illness occur The worst cases of foodborne illness occur in the most vulnerable: in the most vulnerable: the old, the young, and the old, the young, and those with weakened immune systemsthose with weakened immune systems

History of History of Outbreak Outbreak Alert!Alert!

CSPI started collecting CSPI started collecting data on food-borne illness data on food-borne illness outbreaks in 1997 and outbreaks in 1997 and organized it by regulatory organized it by regulatory agencyagency

The data was not The data was not available from CDC available from CDC without a FOIA; however, without a FOIA; however, with our continued with our continued requests, CDC started requests, CDC started posting yearly line posting yearly line listings on the internetlistings on the internet

Starting in 1999, we Starting in 1999, we publish annually our publish annually our outbreaks organized by outbreaks organized by food category and by food category and by regulatory agency.regulatory agency.

Number of Outbreaks by Food, Number of Outbreaks by Food, 1990-20051990-2005

Source: Outbreak Alert! Center for Science in the Public Interest, 2007

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Complex System of LawsComplex 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 Laws100 Years of Food Laws Pure Food and Drug Act-1906Pure Food and Drug Act-1906 Federal Meat Inspection Act-1907Federal Meat Inspection Act-1907 Food, Drug, and Cosmetic Act-1938Food, Drug, and Cosmetic Act-1938 Public Health Service Act-1944Public Health Service Act-1944 Poultry Products Inspection Act-1957Poultry 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-1990Sanitary Food Transportation Act-1990 Food Quality Protection Act-1996 Food Quality Protection Act-1996 Bioterrorism Act-2002Bioterrorism Act-2002 Food Allergen Labeling and Consumer Protection Act-2004Food Allergen Labeling and Consumer Protection Act-2004 Food and Drug Administration Amendments Act-2007Food and Drug Administration Amendments Act-2007

Food RegulationFood Regulation12 Agencies; 35 Statutes12 Agencies; 35 Statutes

The National Academy of Sciences The National Academy of Sciences identified multiple agencies administering identified multiple agencies administering numerous food-related statutes resulting numerous food-related statutes resulting in:in:

An absence of focused leadershipAn absence of focused leadership Lack of a common missionLack of a common mission Inadequate emphasis on surveillanceInadequate emphasis on surveillance Lack of nationwide adherence to Lack of nationwide adherence to

appropriate minimum standardsappropriate minimum standards

Two Major Food Safety Two Major Food Safety AgenciesAgencies

Food and Drug Administration (HHS)Food and Drug Administration (HHS) Responsible for 80% of food supply (Fruit, vegetables, Responsible for 80% of food supply (Fruit, vegetables,

processed foods, seafood, etc.)processed foods, seafood, etc.) Fewer than 2,000 inspectorsFewer than 2,000 inspectors More than 136,000 domestic establishmentsMore 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 inspectorsMore than 7,300 inspectors 6,200 federally inspected establishments6,200 federally inspected establishments Daily and Continuous InspectionsDaily and Continuous Inspections

Food-Related Outbreaks by Food-Related Outbreaks by Government Agency 1990-Government Agency 1990-

20052005

Yearly Trends in Outbreaks

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Ten Other AgenciesTen Other Agencies Centers for Disease ControlCenters for Disease Control

Foodborne Illness SurveillanceFoodborne Illness Surveillance Environmental Protection AgencyEnvironmental Protection Agency

Pesticide Residue LevelsPesticide Residue Levels Animal Plant Health Inspection ServiceAnimal Plant Health Inspection Service

Controls Outbreaks of Animal and Plant DiseasesControls Outbreaks of Animal and Plant Diseases Grain Inspection, Packers and Stockyards AdministrationGrain Inspection, Packers and Stockyards Administration

Quality and Inspection Standards for GrainsQuality and Inspection Standards for Grains Agricultural Marketing ServiceAgricultural Marketing Service

Egg Quality and Marketing ProgramEgg Quality and Marketing Program Agricultural Research ServiceAgricultural Research Service

Food Safety ResearchFood Safety Research National Agricultural Statistics ServiceNational Agricultural Statistics Service

Statistical Data on Agricultural Chemical UsageStatistical Data on Agricultural Chemical Usage Cooperative State Research, Education and Extension ServiceCooperative State Research, Education and Extension Service

University-based Food Safety Research & EducationUniversity-based Food Safety Research & Education National Marine Fisheries ServiceNational Marine Fisheries Service

NOAA Seafood Inspection ProgramNOAA Seafood Inspection Program Department of Homeland SecurityDepartment of Homeland Security

Coordination of Food Security ActivitiesCoordination of Food Security Activities

Overlapping Overlapping ResponsibilitiesResponsibilities

Four Agencies Performing Similar RolesFour Agencies Performing Similar RolesUSDAUSDA FDAFDA EPAEPA NMFSNMFS

Inspection of Domestic Food FacilitiesInspection of Domestic Food Facilities

Inspection of Foreign Food FacilitiesInspection of Foreign Food Facilities

Inspection at PortsInspection at Ports

Laboratory Analysis for ContaminationLaboratory Analysis for Contamination

Research on Pathogen ReductionResearch on Pathogen Reduction

Research on Foodborne ContaminantsResearch on Foodborne Contaminants

Risk Assessments of ContaminantsRisk Assessments of Contaminants

Public Education and OutreachPublic Education and Outreach

Development of Guidance for IndustryDevelopment of Guidance for Industry

International HarmonizationInternational Harmonization

Surveillance/MonitoringSurveillance/Monitoring

Rule Development & PromulgationRule Development & Promulgation

Piecemeal EvolutionPiecemeal EvolutionIn Need of Revolution?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 1998 National Academy of Sciences Study Found Poorly Sciences Study Found Poorly Integrated Decision-makingIntegrated Decision-making

““With so many agencies involved in food With so many agencies involved in food safety, decisions and priorities often safety, decisions and priorities often focus on specific issues rather than focus on specific issues rather than strategies . . .. The system that has strategies . . .. The system that has evolved in the federal government for evolved in the federal government for regulating food safety is complex, regulating food safety is complex, fragmented, and cumbersome.”fragmented, and cumbersome.”

National Research Council, Ensuring Safe Food From Production to Consumption, National Research Council, Ensuring Safe Food From Production to Consumption, 19981998

2007 Findings of 2007 Findings of FDA’s Science BoardFDA’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. 2007National Science Board, FDA Science and Mission at Risk, Nov. 2007

2007 “High Risk” 2007 “High Risk” Designation by the GAODesignation 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 confidenceConsumer confidence

The Food Marketing Institute annual The Food Marketing Institute annual survey found that overall confidence in the survey found that overall confidence in the safety of food safety of food dropped from 82% in dropped from 82% in 2006 to 66% in 2007. 2006 to 66% in 2007.

A survey of consumer confidence in FDA A survey of consumer confidence in FDA has also showed huge declines – has also showed huge declines – dropping dropping from 56% in 2004 to 36% in 2006.from 56% in 2004 to 36% in 2006.

In July, In July, 83 percent of shoppers voiced 83 percent of shoppers voiced concernconcern about food from China, and 61 about food from China, and 61 percent about food from Mexico.percent about food from Mexico.

Building a Modern Food Safety System: CSPI White

PaperCSPI has written a blue print for FDA reform for CSPI has written a blue print for FDA reform for

Congress:Congress: Preventive Process Controls and Performance Preventive Process Controls and Performance

StandardsStandards Inspections and State/Federal CooperationInspections and State/Federal Cooperation Food ImportsFood Imports Research and EducationResearch and Education On-Farm Food SafetyOn-Farm Food Safety Enforcement AuthorityEnforcement Authority

http://www.cspinet.org/new/pdf/fswhitepaper.pdfhttp://www.cspinet.org/new/pdf/fswhitepaper.pdf

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S. 654/H.R. 1148, Safe Food ActS. 654/H.R. 1148, Safe Food Act XX XX XX XX XX XX XX XX XX XX XXH.R. 3624, Consumer Food Safety ActH.R. 3624, Consumer Food Safety Act XX XX XX XX XX XX XX XX XX XXH.R. 3610, Food & Drug Import Safety ActH.R. 3610, Food & Drug Import Safety Act XX XX XX XX XXS. 1776, Imported Food Security ActS. 1776, Imported Food Security Act XX XX XXS. 1274/H.R. 2108, Human & Pet Food Safety S. 1274/H.R. 2108, Human & Pet Food Safety

ActAct XX XX XX

S. 2077, Fresh Produce Safety ActS. 2077, Fresh Produce Safety Act XX XX XX XX XXH.R. 3484, SAFER Meat, Poultry, & Food ActH.R. 3484, SAFER Meat, Poultry, & Food Act XX XXH.R. 3485, TRACE ActH.R. 3485, TRACE Act XXH.R. 2997, Assured Food Safety ActH.R. 2997, Assured Food Safety Act XX XX XXS. 2081, Food & Product Responsibility ActS. 2081, Food & Product Responsibility Act XXH.R. 3937, Food Import Safety ActH.R. 3937, Food Import Safety Act XX XXS. 1292, Meat & Poultry Products Traceability S. 1292, Meat & Poultry Products Traceability

& Safety Act& Safety Act XX

Food Safety LegislationIn the 110th Congress

Questions?Questions?Caroline Smith DeWaalFood Safety DirectorCenter for Science in the Public

InterestWashington, DC phone (202) 777-8366e-mail cdewaal@cspinet.orgOn the internet:www.cspinet.orgwww.safefoodinternational.org

To search our Outbreak Alert To search our Outbreak Alert database:database:

http://www.cspinet.org/foodsafety/http://www.cspinet.org/foodsafety/