Elements of ReformBuilding a Modern Food Safety System

Caroline Smith DeWaalCaroline Smith DeWaal

Food Safety DirectorFood Safety DirectorCenter for Science in Center for Science in

the Public Interestthe Public Interest

May 19, 2008May 19, 2008

What Congress Must Fix

Antiquated Food Laws, Some 100 Years OldAntiquated Food Laws, Some 100 Years Old Laws Not Designed for Modern HazardsLaws Not Designed for Modern Hazards

Better Allocation of ResourcesBetter Allocation of Resources FDA regulated foods account for 67% of outbreaksFDA regulated foods account for 67% of outbreaks FDA regulates 80 percent of food supply but receives less FDA regulates 80 percent of food supply but receives less

than half the funding provided USDAthan half the funding provided USDA FDA inspection workforce one-fourth the size of USDA’sFDA 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 FoodReactive Authority to Protect Food Prevention missing from the legislationPrevention missing from the legislation No minimum frequency for inspectionsNo minimum frequency for inspections Weak enforcement powers, like voluntary recallWeak enforcement powers, like voluntary recall

Inadequate oversight of imported foodsInadequate oversight of imported foods More than 10 million line itemsMore than 10 million line items Imported food = 13% of average American’s dietImported 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 borderOnly 1.28% of imports inspected at border

Elements of Reform:

Process Controls

Proactive approach to prevent, eliminate Proactive approach to prevent, eliminate or reduce hazards.or reduce hazards. Industry responsibilities clearly definedIndustry responsibilities clearly defined

Emphasis on prevention instead of Emphasis on prevention instead of response.response.

Builds on existing industry practicesBuilds on existing industry practices HACCP planning already in wide useHACCP planning already in wide use Integrates this into system-wide approachIntegrates this into system-wide approach

Elements of Reform:

Performance Standards

Science-based limits on the incidence or Science-based limits on the incidence or levels of contamination set by FDAlevels of contamination set by FDA Establishes targets process controls must Establishes targets process controls must

achieveachieve Provides a basis for FDA monitoring (and if Provides a basis for FDA monitoring (and if

necessary enforcement)necessary enforcement) Can be tailored for specific high-risk foodsCan be tailored for specific high-risk foods

Elements of Reform:

Inspections FDA’s means for overseeing domestic and FDA’s means for overseeing domestic and

imported food to assure compliance with food imported food to assure compliance with food lawslaws Registration (tells FDA who it must inspect)Registration (tells FDA who it must inspect) Auditing of safety plans and plant physical structureAuditing of safety plans and plant physical structure Regular inspections of all plants, more frequent Regular inspections of all plants, more frequent

inspections of some plants based on riskinspections of some plants based on risk Access to records, sampling and testing are critical Access to records, sampling and testing are critical

elementselements

Elements of Reform:

Imports

New authorities FDA needsNew authorities FDA needs Accreditation of foreign inspection authoritiesAccreditation of foreign inspection authorities Certification foreign food meets U.S. Certification foreign food meets U.S.

standardsstandards Importer accountable for assuring safetyImporter accountable for assuring safety Inspection authority with power to refuse entryInspection authority with power to refuse entry

Elements of Reform:

Research and Development Public health assessment programsPublic health assessment programs

Improve identification and analysis of foodborne Improve identification and analysis of foodborne illnessesillnesses

Develop preventive interventionsDevelop preventive interventions ResearchResearch

Design tests and techniques for detecting Design tests and techniques for detecting contaminants and pathogenscontaminants and pathogens

Develop effective controlsDevelop effective controls Public Education and AdvicePublic Education and Advice

Educate public on safe food handling practicesEducate public on safe food handling practices Help health professionals improve diagnosis and Help health professionals improve diagnosis and

treatment/advise at-risk patientstreatment/advise at-risk patients

Elements of Reform:

On Farm

Fresh fruits and vegetables are frequently linked Fresh fruits and vegetables are frequently linked to outbreaks but FDA does not have specific to outbreaks but FDA does not have specific authority to set standards or inspectauthority to set standards or inspect Require growers and processors to have written food Require growers and processors to have written food

safety planssafety plans Provide specific criteria for farm practices and worker Provide specific criteria for farm practices and worker

sanitationsanitation Require packages to be marked for farm-to-fork, Require packages to be marked for farm-to-fork,

fork-to-farm traceabilityfork-to-farm traceability Require audits of written plans at least once per Require audits of written plans at least once per

growing seasongrowing season

Elements of Reform:

Enforcement

Mandatory RecallMandatory Recall FDA needs authority to order recallsFDA needs authority to order recalls

TracebackTraceback Traceability an essential element to recallsTraceability an essential element to recalls

DetentionDetention Allow FDA to detain food that may be unsafeAllow FDA to detain food that may be unsafe

Civil PenaltiesCivil Penalties Give FDA new authority to impose civil penaltiesGive FDA new authority to impose civil penalties

WhistleblowerWhistleblower Protect federal and private inspectors from being Protect federal and private inspectors from being

harassed for doing their job harassed for doing their job

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Discussion Draft - FDA Globalization ActDiscussion Draft - FDA Globalization Act XX XX XX XX XX XX XX XX XXDiscussion Draft - Senator KennedyDiscussion Draft - Senator Kennedy XX XX XX XX XX XX XX XXH.R. 1148/S. 654, Safe Food ActH.R. 1148/S. 654, Safe Food Act XX XX XX XX XX XX XX XX XX XX XXH.R. 3624, Consumer Food Safety ActH.R. 3624, Consumer Food Safety Act XX XX XX XX XX XX XX XX XX XXH.R. 5904, Safe FEAST ActH.R. 5904, Safe FEAST Act XX XX XX XX XX

Comprehensive Food Safety BillsHow Key Measures Compare to CSPI’s Principles

Key Bills:Key Bills:

FDA Globalization ActFDA Globalization Act What it gets rightWhat it gets right

Comprehensive – Requires domestic and foreign food to meet Comprehensive – Requires domestic and foreign food to meet all essential food safety elementsall essential food safety elements

Excellent import section – accreditation and certification, Excellent import section – accreditation and certification, dedicated inspectors, importer accountabilitydedicated inspectors, importer accountability

Improves enforcement – mandatory recall, civil penalties, and Improves enforcement – mandatory recall, civil penalties, and power to refuse imports and suspend unsafe plantspower to refuse imports and suspend unsafe plants

Adds resources to FDA inspection programAdds resources to FDA inspection program Areas needing improvementAreas needing improvement

More frequent inspectionsMore frequent inspections Sliding scale registration feesSliding scale registration fees Stronger on-farm provisionsStronger on-farm provisions Phase in mandatory certificationPhase in mandatory certification

Key Bills:Key Bills:

Senate Discussion DraftSenate Discussion Draft What it gets rightWhat it gets right

Comprehensive – Requires domestic and foreign food to meet Comprehensive – Requires domestic and foreign food to meet all essential food safety elements (Strong section on all essential food safety elements (Strong section on performance standards)performance standards)

Import section – Certification, importer accountability, refused Import section – Certification, importer accountability, refused entry stamp (prevents port shopping)entry stamp (prevents port shopping)

Improves enforcement – Mandatory recall, targeted civil Improves enforcement – Mandatory recall, targeted civil penalties, detention of unsafe food, power to suspend unsafe penalties, detention of unsafe food, power to suspend unsafe plants, enhances authority to inspect records in emergenciesplants, enhances authority to inspect records in emergencies

Improves state notification requirementsImproves state notification requirements Provides resources to FDAProvides resources to FDA

Areas needing improvementAreas needing improvement Add accreditation system to support certification programAdd accreditation system to support certification program Provide broader mandatory recall authorityProvide broader mandatory recall authority Phase in mandatory certificationPhase in mandatory certification

Key Bills:Key Bills:

Safe FEAST ActSafe FEAST Act What it gets rightWhat it gets right

Preventive measures – Requires process controls, provides for biennial Preventive measures – Requires process controls, provides for biennial registration and inspections (with more frequent inspections based on registration and inspections (with more frequent inspections based on risk)risk)

On farm – Strong section requiring standards for fresh produceOn farm – Strong section requiring standards for fresh produce Imports – Certification, importer accountability, inspection based on risk Imports – Certification, importer accountability, inspection based on risk

profile of food, capacity building in foreign countriesprofile of food, capacity building in foreign countries Enforcement – Mandatory recall, enhanced authority to inspect records Enforcement – Mandatory recall, enhanced authority to inspect records

in emergenciesin emergencies

Areas needing improvementAreas needing improvement Clarify responsibilities in process controls sectionClarify responsibilities in process controls section Strengthen FDA oversight, tighten prohibited acts to make them Strengthen FDA oversight, tighten prohibited acts to make them

enforceableenforceable Add performance standard sectionAdd performance standard section Add civil penalties, detention and research sectionsAdd civil penalties, detention and research sections Provide more resources for inspectionsProvide more resources for inspections

The Record for Action:The Record for Action:

Senate HearingsSenate Hearings Appropriations Subcommittee on Agriculture, Rural Appropriations Subcommittee on Agriculture, Rural

Development, Food and Drug Administration, and Development, Food and Drug Administration, and Related Agencies -- Field Hearing to Discuss Food Related Agencies -- Field Hearing to Discuss Food Safety, March 12, 2007.*Safety, March 12, 2007.*

Commerce, Science and Transportation -- Safety of Commerce, Science and Transportation -- Safety of Chinese Imports: Oversight and Analysis of the Federal Chinese Imports: Oversight and Analysis of the Federal Response, July 18, 2007.*Response, July 18, 2007.*

Health, Education, Labor, and Pensions -- Developing a Health, Education, Labor, and Pensions -- Developing a Comprehensive Response to Food Safety, Dec. 4, Comprehensive Response to Food Safety, Dec. 4, 2007.*2007.*

Health, Education, Labor, and Pensions -- 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.* Center for Science in the Public Interest testified at this Hearing.

The Record for Action:The Record for Action:

House E&C HearingsHouse E&C Hearings Oversight and Investigations -- Diminished Capacity: Can the FDA Oversight and Investigations -- Diminished Capacity: Can the FDA

Assure the Safety and Security of the Nation’s Food Supply? – Part Assure the Safety and Security of the Nation’s Food Supply? – Part I, April 24, 2007.I, April 24, 2007.

Oversight and Investigations -- Diminished Capacity: Can the FDA Oversight and Investigations -- Diminished Capacity: Can the FDA Assure the Safety and Security of Our Nation’s Food Supply? – Part Assure the Safety and Security of Our Nation’s Food Supply? – Part 2, July 17, 2007.*2, July 17, 2007.*

Health -- H.R. 3610, the Food and Drug Import Safety Act, Sept. 26, Health -- H.R. 3610, the Food and Drug Import Safety Act, Sept. 26, 2007.*2007.*

Oversight and Investigations -- Diminished Capacity: Can the FDA Oversight and Investigations -- Diminished Capacity: Can the FDA Assure the Safety and Security of Our Nation’s Food Supply? – Part Assure the Safety and Security of Our Nation’s Food Supply? – Part III, Oct. 11, 2007.III, Oct. 11, 2007.

Oversight and Investigations -- Contaminated Food: Private Sector Oversight and Investigations -- Contaminated Food: Private Sector Accountability, Feb. 26, 2008.Accountability, Feb. 26, 2008.

Oversight and Investigations -- Regulatory Failure: Must America Oversight and Investigations -- Regulatory Failure: Must America Live with Unsafe Food?, March 12, 2008.Live with Unsafe Food?, March 12, 2008.

Health -- Discussion Draft of the ‘Food and Drug Administration Health -- Discussion Draft of the ‘Food and Drug Administration Globalization Act’ Legislation: Food Provisions, April 24, 2008.*Globalization Act’ Legislation: Food Provisions, April 24, 2008.*

* Center for Science in the Public Interest testified at this Hearing.* Center for Science in the Public Interest testified at this Hearing.

The Record for Action:The Record for Action:

Other House HearingsOther House Hearings Agriculture Committee -- Review the impact of Imported Agriculture Committee -- Review the impact of Imported

Contaminated Food and Feed Ingredients and of Recent Food Contaminated Food and Feed Ingredients and of Recent Food Safety Emergencies on Food Safety and Animal Health Systems, Safety Emergencies on Food Safety and Animal Health Systems, May 9, 2007.May 9, 2007.

Agriculture Subcommittee on Horticulture and Organic Agriculture -- Agriculture Subcommittee on Horticulture and Organic Agriculture -- Review of Industry Response to the Safety of Fresh and Fresh Cut Review of Industry Response to the Safety of Fresh and Fresh Cut Produce, May 15, 2007.*Produce, May 15, 2007.*

Appropriations Subcommittee on Agriculture, Rural Development, Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies -- Ensuring Food and Drug Administration, and Related Agencies -- Ensuring the Safety of Imported Foods: What Can the FDA and U.S. the Safety of Imported Foods: What Can the FDA and U.S. Businesses Do Differently to Improve the Safety of Foods Imported Businesses Do Differently to Improve the Safety of Foods Imported into the U.S., September 25, 2007.*into the U.S., September 25, 2007.*

Ways and Means Subcommittee on Oversight, and Subcommittee Ways and Means Subcommittee on Oversight, and Subcommittee on Trade -- Joint Hearing on Import Safety, October 4, 2007.on Trade -- Joint Hearing on Import Safety, October 4, 2007.

* Center for Science in the Public Interest testified at this Hearing.* Center for Science in the Public Interest testified at this Hearing.

Questions?

Contact Information:Contact Information:

Caroline Smith DeWaalCaroline Smith DeWaalFood Safety DirectorFood Safety Director

CSPICSPI

csmithdewaal@cspinet.orgcsmithdewaal@cspinet.org(202) 777-8366(202) 777-8366