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 Antiquated Food Laws, Some 100 Years Old Laws Not Designed for Modern Hazards Laws Not Designed for Modern Hazards Better Allocation of Resources Better Allocation of Resources FDA regulated foods account for 67% of outbreaks 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 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 inspection workforce one-fourth the size of USDA’s FDA inspects little more than 1% of imported foods FDA inspects little more than 1% of imported foods

What Congress Must Fix Reactive Authority to Protect Food Reactive Authority to Protect Food Prevention missing from the legislation Prevention missing from the legislation No minimum frequency for inspections No minimum frequency for inspections Weak enforcement powers, like voluntary recall Weak enforcement powers, like voluntary recall Inadequate oversight of imported foods Inadequate oversight of imported foods More than 10 million line items More than 10 million line items Imported food = 13% of average American’s diet Imported food = 13% of average American’s diet FDA rarely inspects foreign plants (96 in 2007) FDA rarely inspects foreign plants (96 in 2007) Only 1.28% of imports inspected at border Only 1.28% of imports inspected at border

Elements of Reform: Process Controls Proactive approach to prevent, eliminate or reduce hazards. Proactive approach to prevent, eliminate or reduce hazards. Industry responsibilities clearly defined Industry responsibilities clearly defined Emphasis on prevention instead of response. Emphasis on prevention instead of response. Builds on existing industry practices Builds on existing industry practices HACCP planning already in wide use HACCP planning already in wide use Integrates this into system-wide approach Integrates this into system-wide approach

Elements of Reform: Performance Standards Science-based limits on the incidence or levels of contamination set by FDA Science-based limits on the incidence or levels of contamination set by FDA Establishes targets process controls must achieve Establishes targets process controls must achieve Provides a basis for FDA monitoring (and if necessary enforcement) Provides a basis for FDA monitoring (and if necessary enforcement) Can be tailored for specific high-risk foods 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 FDA’s means for overseeing domestic and imported food to assure compliance with food laws Registration (tells FDA who it must inspect) Registration (tells FDA who it must inspect) Auditing of safety plans and plant physical structure Auditing of safety plans and plant physical structure Regular inspections of all plants, more frequent inspections of some plants based on risk Regular inspections of all plants, more frequent inspections of some plants based on risk Access to records, sampling and testing are critical elements Access to records, sampling and testing are critical elements

Elements of Reform: Imports New authorities FDA needs New authorities FDA needs Accreditation of foreign inspection authorities Accreditation of foreign inspection authorities Certification foreign food meets U.S. standards Certification foreign food meets U.S. standards Importer accountable for assuring safety Importer accountable for assuring safety Inspection authority with power to refuse entry Inspection authority with power to refuse entry

Elements of Reform: Research and Development Public health assessment programs Public health assessment programs Improve identification and analysis of foodborne illnesses Improve identification and analysis of foodborne illnesses Develop preventive interventions Develop preventive interventions Research Research Design tests and techniques for detecting contaminants and pathogens Design tests and techniques for detecting contaminants and pathogens Develop effective controls Develop effective controls Public Education and Advice Public Education and Advice Educate public on safe food handling practices Educate public on safe food handling practices Help health professionals improve diagnosis and treatment/advise at-risk patients 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 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 Require growers and processors to have written food safety plans Provide specific criteria for farm practices and worker sanitation Provide specific criteria for farm practices and worker sanitation Require packages to be marked for farm-to-fork, fork-to-farm traceability Require packages to be marked for farm-to-fork, fork-to-farm traceability Require audits of written plans at least once per growing season Require audits of written plans at least once per growing season

Elements of Reform: Enforcement Mandatory Recall Mandatory Recall FDA needs authority to order recalls FDA needs authority to order recalls Traceback Traceback Traceability an essential element to recalls Traceability an essential element to recalls Detention Detention Allow FDA to detain food that may be unsafe Allow FDA to detain food that may be unsafe Civil Penalties Civil Penalties Give FDA new authority to impose civil penalties Give FDA new authority to impose civil penalties Whistleblower Whistleblower Protect federal and private inspectors from being harassed for doing their job Protect federal and private inspectors from being harassed for doing their job

Process Controls Performance Standards Inspections Imports Research and Education On Farm Enforcement Recall Trace-back Detention Penalties Whistle-blower Discussion Draft - FDA Globalization Act XXXXXXXXX Discussion Draft - Senator Kennedy XXXXXXXX H.R. 1148/S. 654, Safe Food Act XXXXXXXXXXX H.R. 3624, Consumer Food Safety Act XXXXXXXXXX H.R. 5904, Safe FEAST Act XXXXX Comprehensive Food Safety Bills How Key Measures Compare to CSPI’s Principles

Key Bills: FDA Globalization Act What it gets right What it gets right Comprehensive – Requires domestic and foreign food to meet all essential food safety elements Comprehensive – Requires domestic and foreign food to meet all essential food safety elements Excellent import section – accreditation and certification, dedicated inspectors, importer accountability 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 Improves enforcement – mandatory recall, civil penalties, and power to refuse imports and suspend unsafe plants Adds resources to FDA inspection program Adds resources to FDA inspection program Areas needing improvement Areas needing improvement More frequent inspections More frequent inspections Sliding scale registration fees Sliding scale registration fees Stronger on-farm provisions Stronger on-farm provisions Phase in mandatory certification Phase in mandatory certification

Key Bills: Senate Discussion Draft What it gets right What it gets right Comprehensive – Requires domestic and foreign food to meet all essential food safety elements (Strong section on performance standards) 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) 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 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 Improves state notification requirements Provides resources to FDA Provides resources to FDA Areas needing improvement Areas needing improvement Add accreditation system to support certification program Add accreditation system to support certification program Provide broader mandatory recall authority Provide broader mandatory recall authority Phase in mandatory certification Phase in mandatory certification

Key Bills: Safe FEAST Act What it gets right What it gets right Preventive measures – Requires process controls, provides for biennial registration and inspections (with more frequent inspections based on risk) 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 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 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 Enforcement – Mandatory recall, enhanced authority to inspect records in emergencies Areas needing improvement Areas needing improvement Clarify responsibilities in process controls section Clarify responsibilities in process controls section Strengthen FDA oversight, tighten prohibited acts to make them enforceable Strengthen FDA oversight, tighten prohibited acts to make them enforceable Add performance standard section Add performance standard section Add civil penalties, detention and research sections Add civil penalties, detention and research sections Provide more resources for inspections 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.* 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.* 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 -- Developing a Comprehensive Response to Food Safety, Dec. 4, 2007.* Health, Education, Labor, and Pensions -- Health, Education, Labor, and Pensions -- Restoring FDA's Ability to Keep America's Families Safe, April 24, * 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, Oversight and Investigations -- Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation’s Food Supply? – Part I, April 24, Oversight and Investigations -- Diminished Capacity: Can the FDA Assure the Safety and Security of Our Nation’s Food Supply? – Part 2, July 17, 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.* 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, Oversight and Investigations -- Diminished Capacity: Can the FDA Assure the Safety and Security of Our Nation’s Food Supply? – Part III, Oct. 11, Oversight and Investigations -- Contaminated Food: Private Sector Accountability, Feb. 26, Oversight and Investigations -- Contaminated Food: Private Sector Accountability, Feb. 26, Oversight and Investigations -- Regulatory Failure: Must America Live with Unsafe Food?, March 12, Oversight and Investigations -- Regulatory Failure: Must America Live with Unsafe Food?, March 12, Health -- Discussion Draft of the ‘Food and Drug Administration Globalization Act’ Legislation: Food Provisions, April 24, 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, 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, Agriculture Subcommittee on Horticulture and Organic Agriculture -- Review of Industry Response to the Safety of Fresh and Fresh Cut Produce, May 15, 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.* 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, Ways and Means Subcommittee on Oversight, and Subcommittee on Trade -- Joint Hearing on Import Safety, October 4, * Center for Science in the Public Interest testified at this Hearing.

Questions? Contact Information: Caroline Smith DeWaal Food Safety Director CSPI (202)