Transcript Title
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 Improve identification and analysis of foodborne illnesses Develop preventive interventions Research 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 FDA needs authority to order recalls Traceback Traceability an essential element to recalls Detention Allow FDA to detain food that may be unsafe Civil Penalties 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
Enforcement
Discussion Draft - FDA Globalization Act Discussion Draft - Senator Kennedy H.R. 1148/S. 654, Safe Food Act H.R. 3624, Consumer Food Safety Act H.R. 5904, Safe FEAST Act
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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 risk) – Requires process controls, provides for biennial registration and inspections (with more frequent inspections based on 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 [email protected]
(202) 777-8366