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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:

Food safety

Nutrition

Alcohol issues

Supported principally by 900,000 subscribers to

Nutrition Action HealthLetter and by foundation grants.

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

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.

Number of Outbreaks by Food,

1990-2005

1200

1000

800

600

400

200

0

Se af oo d lti

-I ng re di en t

Mu

Pro du ce

Po ul try

Be ef

Eg gs

Bo th

Po rk

D ai ry

Lu nch eo n ad s/

Ba ke ry

Be ve ra ge s

Bre

G ame

Outbreaks Illnesses

40000

35000

30000

25000

20000

15000

10000

5000

0

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

Federal Meat Inspection Act-1907

Food, Drug, and Cosmetic Act-1938

Public Health Service Act-1944

Poultry Products Inspection Act-1957

Egg Products Inspection Act-1970

Infant Formula Act-1980

Sanitary Food Transportation Act-1990

Food Quality Protection Act-1996

Bioterrorism Act-2002

Food Allergen Labeling and Consumer Protection Act-2004

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

Lack of a common mission

Inadequate emphasis on surveillance

Lack of nationwide adherence to appropriate minimum standards

Two Major Food Safety Agencies

 Food and Drug Administration (HHS)

 Responsible for 80% of food supply (Fruit, vegetables, processed foods, seafood, etc.)

Fewer than 2,000 inspectors

More than 136,000 domestic establishments

Random Inspections (frequency as little as once every 10 years)

 Food Safety Inspection Service (USDA)

 Responsible for 20% of food supply (Meat, Poultry Eggs)

More than 7,300 inspectors

6,200 federally inspected establishments

Daily and Continuous Inspections

Food-Related Outbreaks by

Government Agency 1990-2005

Yearly Trends in Outbreaks

400

350

300

250

200

FDA Outbreaks

USDA Oubreaks

150

100

50

0

19

90

19

91

19

92

19

93

19

94

19

95

19

96

19

97

19

98

19

99

20

00

20

01

20

02

20

03

20

04

20

05

Ten Other Agencies

Centers for Disease Control

 Foodborne Illness Surveillance

Environmental Protection Agency

 Pesticide Residue Levels

Animal Plant Health Inspection Service

 Controls Outbreaks of Animal and Plant Diseases

Grain Inspection, Packers and Stockyards Administration

 Quality and Inspection Standards for Grains

Agricultural Marketing Service

 Egg Quality and Marketing Program

Agricultural Research Service

 Food Safety Research

National Agricultural Statistics Service

 Statistical Data on Agricultural Chemical Usage

Cooperative State Research, Education and Extension Service

 University-based Food Safety Research & Education

National Marine Fisheries Service

 NOAA Seafood Inspection Program

Department of Homeland Security

 Coordination of Food Security Activities

Overlapping Responsibilities

Four Agencies Performing Similar Roles

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

USDA FDA

EPA NMFS

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 Decisionmaking

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 2007.

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

dropping from 56% in 2004

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

Enforcement

Food Safety Legislation

In the 110 th Congress

S. 654/H.R. 1148, Safe Food Act

H.R. 3624, Consumer Food Safety Act

H.R. 3610, Food & Drug Import Safety Act

S. 1776, Imported Food Security Act

S. 1274/H.R. 2108, Human & Pet Food Safety Act

S. 2077, Fresh Produce Safety Act

H.R. 3484, SAFER Meat, Poultry, & Food Act

H.R. 3485, TRACE Act

H.R. 2997, Assured Food Safety Act

S. 2081, Food & Product Responsibility Act

H.R. 3937, Food Import Safety Act

S. 1292, Meat & Poultry Products Traceability & Safety Act

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Questions?

Caroline Smith DeWaal

Food Safety Director

Center for Science in the Public Interest

Washington, DC phone (202) 777-8366 e-mail cdewaal@cspinet.org

On the internet: www.cspinet.org

www.safefoodinternational.org

To search our Outbreak Alert database: http://www.cspinet.org/foodsafety/

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