Elements of Reform
Building a Modern Food Safety System
Caroline Smith DeWaal
Food Safety Director
Center for Science in
the Public Interest
May 19, 2008
What Congress Must Fix

Antiquated Food Laws, Some 100 Years Old


Laws Not Designed for Modern Hazards
Better Allocation of Resources
FDA regulated foods account for 67% of outbreaks
 FDA regulates 80 percent of food supply but receives less
than half the funding provided USDA
 FDA inspection workforce one-fourth the size of USDA’s
 FDA inspects little more than 1% of imported foods

What Congress Must Fix

Reactive Authority to Protect Food
Prevention missing from the legislation
 No minimum frequency for inspections
 Weak enforcement powers, like voluntary recall


Inadequate oversight of imported foods




More than 10 million line items
Imported food = 13% of average American’s diet
FDA rarely inspects foreign plants (96 in 2007)
Only 1.28% of imports inspected at border
Elements of Reform:
Process Controls

Proactive approach to prevent, eliminate
or reduce hazards.



Industry responsibilities clearly defined
Emphasis on prevention instead of
response.
Builds on existing industry practices
HACCP planning already in wide use
 Integrates this into system-wide approach

Elements of Reform:
Performance Standards

Science-based limits on the incidence or
levels of contamination set by FDA
Establishes targets process controls must
achieve
 Provides a basis for FDA monitoring (and if
necessary enforcement)
 Can be tailored for specific high-risk foods

Elements of Reform:
Inspections

FDA’s means for overseeing domestic and
imported food to assure compliance with food
laws




Registration (tells FDA who it must inspect)
Auditing of safety plans and plant physical structure
Regular inspections of all plants, more frequent
inspections of some plants based on risk
Access to records, sampling and testing are critical
elements
Elements of Reform:
Imports

New authorities FDA needs
Accreditation of foreign inspection authorities
 Certification foreign food meets U.S.
standards
 Importer accountable for assuring safety
 Inspection authority with power to refuse entry

Elements of Reform:
Research and Development

Public health assessment programs



Research



Improve identification and analysis of foodborne
illnesses
Develop preventive interventions
Design tests and techniques for detecting
contaminants and pathogens
Develop effective controls
Public Education and Advice


Educate public on safe food handling practices
Help health professionals improve diagnosis and
treatment/advise at-risk patients
Elements of Reform:
On Farm

Fresh fruits and vegetables are frequently linked
to outbreaks but FDA does not have specific
authority to set standards or inspect




Require growers and processors to have written food
safety plans
Provide specific criteria for farm practices and worker
sanitation
Require packages to be marked for farm-to-fork,
fork-to-farm traceability
Require audits of written plans at least once per
growing season
Elements of Reform:
Enforcement

Mandatory Recall


Traceback


Allow FDA to detain food that may be unsafe
Civil Penalties


Traceability an essential element to recalls
Detention


FDA needs authority to order recalls
Give FDA new authority to impose civil penalties
Whistleblower

Protect federal and private inspectors from being
harassed for doing their job
Comprehensive Food Safety Bills
How Key Measures Compare to CSPI’s Principles
Whistle-blower
Penalties
Detention
Trace-back
Recall
On Farm
Research and
Education
Imports
Inspections
Performance Standards
Process Controls
Enforcement
Discussion Draft - FDA Globalization Act
X X X X X X X
X X
Discussion Draft - Senator Kennedy
X X X X
X X
H.R. 1148/S. 654, Safe Food Act
X X X X X X X X X X X
H.R. 3624, Consumer Food Safety Act
X X X X X
H.R. 5904, Safe FEAST Act
X
X X
X X
X X X X X
X X
Key Bills:
FDA Globalization Act

What it gets right





Comprehensive – Requires domestic and foreign food to meet
all essential food safety elements
Excellent import section – accreditation and certification,
dedicated inspectors, importer accountability
Improves enforcement – mandatory recall, civil penalties, and
power to refuse imports and suspend unsafe plants
Adds resources to FDA inspection program
Areas needing improvement




More frequent inspections
Sliding scale registration fees
Stronger on-farm provisions
Phase in mandatory certification
Key Bills:
Senate Discussion Draft

What it gets right






Comprehensive – Requires domestic and foreign food to meet
all essential food safety elements (Strong section on
performance standards)
Import section – Certification, importer accountability, refused
entry stamp (prevents port shopping)
Improves enforcement – Mandatory recall, targeted civil
penalties, detention of unsafe food, power to suspend unsafe
plants, enhances authority to inspect records in emergencies
Improves state notification requirements
Provides resources to FDA
Areas needing improvement



Add accreditation system to support certification program
Provide broader mandatory recall authority
Phase in mandatory certification
Key Bills:
Safe FEAST Act

What it gets right





Preventive measures – Requires process controls, provides for biennial
registration and inspections (with more frequent inspections based on
risk)
On farm – Strong section requiring standards for fresh produce
Imports – Certification, importer accountability, inspection based on risk
profile of food, capacity building in foreign countries
Enforcement – Mandatory recall, enhanced authority to inspect records
in emergencies
Areas needing improvement





Clarify responsibilities in process controls section
Strengthen FDA oversight, tighten prohibited acts to make them
enforceable
Add performance standard section
Add civil penalties, detention and research sections
Provide more resources for inspections
The Record for Action:
Senate Hearings




Appropriations Subcommittee on Agriculture, Rural
Development, Food and Drug Administration, and
Related Agencies -- Field Hearing to Discuss Food
Safety, March 12, 2007.*
Commerce, Science and Transportation -- Safety of
Chinese Imports: Oversight and Analysis of the Federal
Response, July 18, 2007.*
Health, Education, Labor, and Pensions -- Developing a
Comprehensive Response to Food Safety, Dec. 4,
2007.*
Health, Education, Labor, and Pensions -- Restoring
FDA's Ability to Keep America's Families Safe, April 24,
2008.
* Center for Science in the Public Interest testified at this Hearing.
The Record for Action:
House E&C Hearings







Oversight and Investigations -- Diminished Capacity: Can the FDA
Assure the Safety and Security of the Nation’s Food Supply? – Part
I, April 24, 2007.
Oversight and Investigations -- Diminished Capacity: Can the FDA
Assure the Safety and Security of Our Nation’s Food Supply? – Part
2, July 17, 2007.*
Health -- H.R. 3610, the Food and Drug Import Safety Act, Sept. 26,
2007.*
Oversight and Investigations -- Diminished Capacity: Can the FDA
Assure the Safety and Security of Our Nation’s Food Supply? – Part
III, Oct. 11, 2007.
Oversight and Investigations -- Contaminated Food: Private Sector
Accountability, Feb. 26, 2008.
Oversight and Investigations -- Regulatory Failure: Must America
Live with Unsafe Food?, March 12, 2008.
Health -- Discussion Draft of the ‘Food and Drug Administration
Globalization Act’ Legislation: Food Provisions, April 24, 2008.*
* Center for Science in the Public Interest testified at this Hearing.
The Record for Action:
Other House Hearings




Agriculture Committee -- Review the impact of Imported
Contaminated Food and Feed Ingredients and of Recent Food
Safety Emergencies on Food Safety and Animal Health Systems,
May 9, 2007.
Agriculture Subcommittee on Horticulture and Organic Agriculture -Review of Industry Response to the Safety of Fresh and Fresh Cut
Produce, May 15, 2007.*
Appropriations Subcommittee on Agriculture, Rural Development,
Food and Drug Administration, and Related Agencies -- Ensuring
the Safety of Imported Foods: What Can the FDA and U.S.
Businesses Do Differently to Improve the Safety of Foods Imported
into the U.S., September 25, 2007.*
Ways and Means Subcommittee on Oversight, and Subcommittee
on Trade -- Joint Hearing on Import Safety, October 4, 2007.
* Center for Science in the Public Interest testified at this Hearing.
Questions?
Contact Information:
Caroline Smith DeWaal
Food Safety Director
CSPI
csmithdewaal@cspinet.org
(202) 777-8366