Elements of Reform Building a Modern Food Safety System

1. Elements of ReformBuilding a Modern Food Safety System Caroline Smith DeWaal Food Safety Director Center for Science in the Public Interest May 19, 2008

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. Comprehensive Food Safety Bills How Key Measures Compare to CSPI’s Principles

12. 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

13. 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

14. 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

15. 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.

16. 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.

17. 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.

18. Questions? Contact Information: Caroline Smith DeWaal Food Safety Director CSPI csmithdewaal@cspinet.org (202) 777-8366