U.S. Food and Drug Administration...

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1 American Society for Quality American Society for Quality Food, Drug, and Cosmetic Division Food, Drug, and Cosmetic Division Fall Midwest Fall Midwest Conference Conference Scott MacIntire Scott MacIntire District Director, Chicago, IL District Director, Chicago, IL Office of Regulatory Affairs Office of Regulatory Affairs Food and Drug Administration Food and Drug Administration U.S. Food and Drug Administration UPDATE U.S. Food and Drug Administration UPDATE FDA Strategic Plan FDA Strategic Plan Efficient Risk Management Efficient Risk Management -- -- Searching for new and better Searching for new and better ways to reduce risks to public health ways to reduce risks to public health Better Informed Consumers Better Informed Consumers -- -- Helping consumers get truthful Helping consumers get truthful information about products they use so they can make informed information about products they use so they can make informed decisions decisions Patient and Consumer Safety Patient and Consumer Safety -- -- Preventing adverse events Preventing adverse events involving FDA involving FDA-regulated products regulated products Counterterrorism Counterterrorism -- -- Responding quickly to terrorist acts and Responding quickly to terrorist acts and enhancing food security enhancing food security A Strong FDA A Strong FDA -- -- Maintaining a strong science base to support FDA's Maintaining a strong science base to support FDA's risk management responsibilities. risk management responsibilities.

Transcript of U.S. Food and Drug Administration...

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American Society for QualityAmerican Society for Quality

Food, Drug, and Cosmetic DivisionFood, Drug, and Cosmetic Division

Fall Midwest Fall Midwest ConferenceConference

Scott MacIntireScott MacIntire

District Director, Chicago, ILDistrict Director, Chicago, IL

Office of Regulatory AffairsOffice of Regulatory Affairs

Food and Drug AdministrationFood and Drug Administration

U.S. Food and Drug Administration UPDATEU.S. Food and Drug Administration UPDATE

FDA Strategic PlanFDA Strategic Plan

Efficient Risk ManagementEfficient Risk Management ---- Searching for new and better Searching for new and better

ways to reduce risks to public healthways to reduce risks to public health

Better Informed ConsumersBetter Informed Consumers ---- Helping consumers get truthful Helping consumers get truthful

information about products they use so they can make informed information about products they use so they can make informed

decisionsdecisions

Patient and Consumer SafetyPatient and Consumer Safety ---- Preventing adverse events Preventing adverse events

involving FDAinvolving FDA--regulated productsregulated products

CounterterrorismCounterterrorism ---- Responding quickly to terrorist acts and Responding quickly to terrorist acts and

enhancing food securityenhancing food security

A Strong FDAA Strong FDA ---- Maintaining a strong science base to support FDA's Maintaining a strong science base to support FDA's

risk management responsibilities.risk management responsibilities.

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Laws Enforced by FDALaws Enforced by FDA

1906 1906 –– Federal Food, Drug, & Cosmetic Federal Food, Drug, & Cosmetic

Act Act prohibits interstate commerce in prohibits interstate commerce in

misbranded and adulterated foods, drinks and misbranded and adulterated foods, drinks and

drugs (1938 et al). drugs (1938 et al).

(1906 (1906 -- MEAT INSPECTION ACTMEAT INSPECTION ACT enforced by USDA, passed the enforced by USDA, passed the

same day) same day)

Celebrating 100 Years of Public ServiceCelebrating 100 Years of Public Service

Laws Enforced by FDALaws Enforced by FDA

Additional Laws:Additional Laws:

�� 1997 Modernization Act1997 Modernization Act

�� Administrative Procedures ActAdministrative Procedures Act

�� Animal Drug User Fee Act of 2003Animal Drug User Fee Act of 2003

�� Best Pharmaceuticals for Children ActBest Pharmaceuticals for Children Act

�� Bioterrorism Act of 2002Bioterrorism Act of 2002

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Laws Enforced by FDALaws Enforced by FDA

�� Congressional Reports Elimination Act of 1982Congressional Reports Elimination Act of 1982�� Controlled Substances ActControlled Substances Act�� Controlled Substances Import and Export ActControlled Substances Import and Export Act�� Delegations of Authority to the Commissioner of Food Delegations of Authority to the Commissioner of Food and Drugsand Drugs

�� Department of Education Organization ActDepartment of Education Organization Act�� Dietary Supplement Health and Education Act of Dietary Supplement Health and Education Act of 19941994

�� Egg Products Inspection ActEgg Products Inspection Act�� Fair Packaging and Labeling ActFair Packaging and Labeling Act�� Federal Advisory Committee ActFederal Advisory Committee Act�� Federal Advisory Committee AmendmentsFederal Advisory Committee Amendments

Laws Enforced by FDALaws Enforced by FDA

�� Federal AntiFederal Anti--Tampering ActTampering Act�� Federal Fines and Sentencing LawsFederal Fines and Sentencing Laws�� Federal Import Milk ActFederal Import Milk Act�� Federal Meat Inspections ActFederal Meat Inspections Act�� Federal Trade Commission ActFederal Trade Commission Act�� Filled Milk ActFilled Milk Act�� Food Quality Protection Act of 1996Food Quality Protection Act of 1996�� Foods and DrugsFoods and Drugs�� GATT Uruguay Round Patent ProvisionsGATT Uruguay Round Patent Provisions

Laws Enforced by FDALaws Enforced by FDA

�� Generic Animal Drug and Patent Term Restoration Generic Animal Drug and Patent Term Restoration Act of 1988 (Summary)Act of 1988 (Summary)

�� Government in the Sunshine ActGovernment in the Sunshine Act�� Laws Delegating Authority Laws Delegating Authority ---- PatentsPatents�� Lead Based Paint Poisoning Prevention ActLead Based Paint Poisoning Prevention Act�� Mammography Quality Standards Act (MQSA)Mammography Quality Standards Act (MQSA)�� Medical Device User Fee and Modernization Act Medical Device User Fee and Modernization Act (MDUFMA) of 2002(MDUFMA) of 2002

�� Miscellaneous Provisions Relating to Orphan DrugsMiscellaneous Provisions Relating to Orphan Drugs�� The National Environmental Policy Act of 1969The National Environmental Policy Act of 1969�� Pediatric Research Equity Act of 2003Pediatric Research Equity Act of 2003�� Poultry Products Inspection ActPoultry Products Inspection Act

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Laws Enforced by FDALaws Enforced by FDA

�� Prescription Drug User Fee ActPrescription Drug User Fee Act

�� Project Project BioShieldBioShield Act of 2004Act of 2004

�� Public Health Service ActPublic Health Service Act

�� Reorganization Plan 1Reorganization Plan 1

�� Sanitary Food Transportation ActSanitary Food Transportation Act

�� Sentencing GuidelinesSentencing Guidelines

�� Tea Importation Act Tea Importation Act The Tea Importation Act was The Tea Importation Act was

repealed in 1996 by repealed in 1996 by Public Law 104Public Law 104--128128

�� Trademark Act of 1946Trademark Act of 1946

FDA Centers & FDA FieldFDA Centers & FDA Field

Commissioner

FOODS DRUGS DEVICE VET BIOLOGIC

ORA (FIELD)

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FDA’s Central RegionFDA’s Central Region

Central Region’s District OfficesCentral Region’s District Offices

�� Baltimore District (MD, VA, WV, DC)Baltimore District (MD, VA, WV, DC)

�� Chicago District (IL)Chicago District (IL)

�� Cincinnati District (OH, KY)Cincinnati District (OH, KY)

�� Detroit District (MI, IN)Detroit District (MI, IN)

�� Minneapolis District (MN, WI, ND, SD)Minneapolis District (MN, WI, ND, SD)

�� New Jersey District (NJ)New Jersey District (NJ)

�� Philadelphia District (PA, DE)Philadelphia District (PA, DE)

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OFFICE OF REGULATORY AFFAIRS190 OFFICES IN FY 2005

NORTHEASTPACIFIC CENTRAL

SOUTHEAST

SOUTHWEST03-04

Division of Planning, Evaluation, & Mgmt

ORA Offices.ppt

REGIONAL OFFICES - 5DISTRICT OFFICES - 20RESIDENT INSPECTION POSTS - 140OCI FIELD OFFICES - 6OCI RESIDENT OFFICES - 6OCI DOMICILES - 13

CA

NV

WA

MT

OR

ID

AK

HI

AZ

UT

WY

CO

NM

TX

OK AR

MO

IANE

KS

TN NC

GAALMS

LA

FL

SC

PR

MEVT

NY

NH

MA

CTRI

MN

WI

IL

MI

INOH

PA

WV

KYVA

NJ

ND

SD

MDDE

VI

Responsibilities of Regional OfficeResponsibilities of Regional Office

�� Manage the RegionManage the Region

�� Cooperative ProgramsCooperative Programs

�� MilkMilk

�� Retail FoodRetail Food

�� ShellfishShellfish

�� Radiological HealthRadiological Health

Responsibilities of District OfficeResponsibilities of District Office

Regulatory Activities:Regulatory Activities:�� Inspections Inspections –– Domestic and ForeignDomestic and Foreign

�� InvestigationsInvestigations

�� Sample collections Sample collections –– Domestic and ImportDomestic and Import

�� Sample analysis Sample analysis

�� Field Exams Field Exams –– Domestic and ImportDomestic and Import

�� Consumer ComplaintsConsumer Complaints

�� RecallsRecalls

�� Compliance activities (seizure, injunction, prosecution)Compliance activities (seizure, injunction, prosecution)

�� Public AffairsPublic Affairs

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Food Safety is a Compelling and Food Safety is a Compelling and

Real Public Health ProblemReal Public Health Problem

�� 76 Million Foodborne Illnesses76 Million Foodborne Illnesses

�� 325,000 Hospitalizations325,000 Hospitalizations

�� 5,000 Deaths5,000 Deaths

EACH YEAR in the US:

55%

6%

21%

7%

11%

Foods Biologics Human Drugs Animal Drugs Devices

Allotment of FTEsAllotment of FTEs

in all Regions in all Regions -- FY05FY05

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FDA History of Food Safety and FDA History of Food Safety and

Nutritional QualityNutritional Quality

�� Early 1900’s Early 1900’s –– Food Sanitation/Consumer Food Sanitation/Consumer DeceptionDeception

�� 1950’s 1950’s –– Pesticides and food additivesPesticides and food additives

�� 1970’s 1970’s –– Botulism in canned foodBotulism in canned food

�� 1980’s 1980’s –– Food tamperingFood tampering

�� 1990’s 1990’s –– Nutrition LabelingNutrition Labeling

Food Safety TodayFood Safety Today

Food Safety and SecurityFood Safety and Security

`

Sound Science

Food Safety Programs

Food Security

Enhancements

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PartnershipsPartnerships

�� Build on a solid Build on a solid

foundation of a national foundation of a national

partnership with other partnership with other

entities involved in food entities involved in food

safety and security.safety and security.

FDA Strategic Action PlanFDA Strategic Action Plan

�� Five StrategiesFive Strategies

�� Enabling Technology Development and Enabling Technology Development and

InnovationInnovation

�� Improving Patient and Consumer Protection Improving Patient and Consumer Protection

�� Protecting the Homeland Protecting the Homeland -- Counterterrorism Counterterrorism

�� Improving Manufacturing Practices Improving Manufacturing Practices

�� Improving FDA’s Business Practices Improving FDA’s Business Practices

FDA Strategic Action PlanFDA Strategic Action Plan

�� Protecting the Homeland Protecting the Homeland -- CounterterrorismCounterterrorism

�� We have developed crisis management plans We have developed crisis management plans and have strengthened our readiness by and have strengthened our readiness by partnering with state and federal agencies in partnering with state and federal agencies in conducting emergency response exercises that conducting emergency response exercises that simulate chemical, biological, and radiological simulate chemical, biological, and radiological events.events.

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FDA Strategic Plan and HSPDFDA Strategic Plan and HSPD--99

Go Hand and Hand

HSPDHSPD--99

�� Establishes national policy to defend Establishes national policy to defend

the agriculture and food system the agriculture and food system

against terrorist attacks, major against terrorist attacks, major

disasters and other emergencies.disasters and other emergencies.

Bioterrorism Act 2002Bioterrorism Act 2002

�� Directed FDA to take aggressive steps Directed FDA to take aggressive steps

to protect the public health from to protect the public health from

deliberate and accidental deliberate and accidental

contamination of our food supply.contamination of our food supply.

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Final RulesFinal Rules

1. Registration of Food Facilities1. Registration of Food Facilities

�� Requires all foreign and domestic facilities Requires all foreign and domestic facilities

that manufacture, process, pack or hold that manufacture, process, pack or hold

food for human or animal consumption in food for human or animal consumption in

the United States to register with FDA.the United States to register with FDA.

Interim Final RulesInterim Final Rules

2. Prior Notice of Imported Foods2. Prior Notice of Imported Foods

�� Requires food importers to provide FDA Requires food importers to provide FDA

with prior notice of human or animal with prior notice of human or animal

food shipments imported or offered for food shipments imported or offered for

import.import.

New Final RuleNew Final Rule

3. Administrative Detention3. Administrative Detention

�� FDA may detain an article of food on FDA may detain an article of food on the strength of credible evidence or the strength of credible evidence or information resulting from an information resulting from an inspection, examination, or inspection, examination, or investigationinvestigation

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New Final RuleNew Final Rule

4. Establishment and Maintenance of 4. Establishment and Maintenance of

RecordsRecords

�� Identify immediate previous source and Identify immediate previous source and

immediate subsequent recipients of foodimmediate subsequent recipients of food

Monitoring and SurveillanceMonitoring and Surveillance

�� Methods Methods –– developing and validating developing and validating

methods that can be used to detect, methods that can be used to detect,

enumerate and identify potential nonenumerate and identify potential non--

traditional agents that may threaten the food traditional agents that may threaten the food

supply.supply.

FOOD/AGENT SCENARIOSFOOD/AGENT SCENARIOS

�� Assess risk for specific productAssess risk for specific product--agentagent--activity activity

combinations covering harvest, production combinations covering harvest, production

and delivery and delivery -- farm to table:farm to table:

�� Farm/dairy farm/orchard/apiary/fishing vesselFarm/dairy farm/orchard/apiary/fishing vessel

�� Bulk transportationBulk transportation

�� Manufacturing (including packing houses)Manufacturing (including packing houses)

�� Finished product transportationFinished product transportation

�� WarehousingWarehousing

�� Retail/food serviceRetail/food service

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Vulnerability AssessmentVulnerability Assessment

�� Evaluating the public health consequences of Evaluating the public health consequences of

a range of producta range of product--agent scenarios agent scenarios

associated with potential tampering, associated with potential tampering,

criminal, malicious, or terrorist activity.criminal, malicious, or terrorist activity.

�� Implement “shields” for protecting those Implement “shields” for protecting those

identified food/agent combinations.identified food/agent combinations.

ResearchResearch

�� Assessing the abilities of nonAssessing the abilities of non--traditional traditional

microbial pathogens to survive and grow in microbial pathogens to survive and grow in

foods during processing and storage, or the foods during processing and storage, or the

stability and activity of chemical agents while stability and activity of chemical agents while

present in foods, and the potential for their present in foods, and the potential for their

inactivation during food processing.inactivation during food processing.

FY 05 Food Security AssignmentFY 05 Food Security Assignment

�� Exercise the planning and implementation Exercise the planning and implementation

for responding to a period of increased for responding to a period of increased

food security risk and identify gaps in the food security risk and identify gaps in the

systemsystem..

�� Deter intentional contamination of food Deter intentional contamination of food

through heightened and targeted through heightened and targeted

preventative activities.preventative activities.

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FY 05 Food Security AssignmentFY 05 Food Security Assignment

�� Identify foods of concern using ORMIdentify foods of concern using ORM�� Raw milkRaw milk

�� Fruit and vegetable juiceFruit and vegetable juice

�� Spring and mineral waterSpring and mineral water

�� Liquid and powdered infant formulaLiquid and powdered infant formula

�� Fresh leaf and stem vegetablesFresh leaf and stem vegetables

�� Inspect firms processing that foodInspect firms processing that food

�� Take samplesTake samples

FY 05 Food Security AssignmentFY 05 Food Security Assignment

�� Ship and test samplesShip and test samples

�� Chemical CT agents (e.g. CN)Chemical CT agents (e.g. CN)

�� Microbiological CT agents (e.g. Microbiological CT agents (e.g. BotBot toxin)toxin)

�� Test infrastructure for handling presumptive Test infrastructure for handling presumptive

and confirmed positives.and confirmed positives.

FY 06 Strategic Partnership Program FY 06 Strategic Partnership Program

AgroterrorismAgroterrorism (SPPA) Initiative(SPPA) Initiative

�� Joint effort to assess and identify vulnerabilities in the Joint effort to assess and identify vulnerabilities in the agricultural and food sectorsagricultural and food sectors

�� FDA, FBI, USDA and DHS will collaborate with states FDA, FBI, USDA and DHS will collaborate with states

and private industry to protect the nation’s food and private industry to protect the nation’s food

supply from terrorist threatssupply from terrorist threats

�� Focus from farmFocus from farm--toto--tabletable

�� Goal Goal -- SPPA intends to provide government and SPPA intends to provide government and

private industry the tools to refine its efforts and to private industry the tools to refine its efforts and to seek better technology or steps to protect the food seek better technology or steps to protect the food

and agriculture infrastructure with research and and agriculture infrastructure with research and

developmentdevelopment

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CT Guidance for IndustryCT Guidance for Industry

1.1. RETAIL FOOD STORES AND FOOD SERVICE RETAIL FOOD STORES AND FOOD SERVICE ESTABLISHMENTSESTABLISHMENTS

2.2. FOOD PRODUCERS, PROCESSORS, AND FOOD PRODUCERS, PROCESSORS, AND TRANSPORTERSTRANSPORTERS

3.3. IMPORTERS AND FILERSIMPORTERS AND FILERS

4.4. COSMETICS PROCESSORS AND TRANSPORTERSCOSMETICS PROCESSORS AND TRANSPORTERS

5.5. MILK PROGRAMMILK PROGRAM

“Firewalls” Against BSE “Firewalls” Against BSE

TransmissionTransmission

�� Joint USDA FSIS, USDA APHIS, FDA notice asks for Joint USDA FSIS, USDA APHIS, FDA notice asks for public comment on additional preventive actions public comment on additional preventive actions

being considered on BSEbeing considered on BSE

�� An interim final FDA rule prohibits use of certain An interim final FDA rule prohibits use of certain

cattlecattle--derived materials in human food, dietary derived materials in human food, dietary

supplements, and cosmeticssupplements, and cosmetics

�� Proposed FDA rule on recordkeeping for the interim Proposed FDA rule on recordkeeping for the interim

final rule relating to this ban final rule relating to this ban

IMPORTSIMPORTS

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Growth of Imported FDA Growth of Imported FDA

Regulated EntriesRegulated Entries

0

1

2

3

4

5

6

7

8

9

10

11

12

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

IMPORT LIN

ES

(MIL

LIO

NS)

IMPORT LINE DATA SOURCES:

1986 - 1993: CENSUS

1994 - 1996: U.S. CUSTOMS

1997 - 2004: FDA OASIS

What types of goods are imported?What types of goods are imported?

10%

20%

2%

<1%

2%

65%

Devices and Rad Health

Foods

Biologics

Animal Drugs and Feed

Human Drugs

Cosm

etics

Size of International MarketSize of International Market

�� 224 countries exporting FDA regulated goods 224 countries exporting FDA regulated goods

�� 221,100 foreign manufacturers221,100 foreign manufacturers

�� 196,224 Shippers196,224 Shippers

�� 127,896 importers of record127,896 importers of record

�� 3,700 active OASIS filers3,700 active OASIS filers

�� 134,433 consignees (includes overlap)134,433 consignees (includes overlap)

Source : OASIS (2004)Source : OASIS (2004)

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Predictive RiskPredictive Risk--based Evaluation & Demonstrative Import Compliance Trackingbased Evaluation & Demonstrative Import Compliance Tracking

The Automated RiskThe Automated Risk--based Import based Import

Entry Examination SystemEntry Examination System

“PREDICT”“PREDICT”

What is What is PREDICT ?PREDICT ?

An automated screening system that:An automated screening system that:

•• Associates disparate data to reveal “risk Associates disparate data to reveal “risk

statements” about specific importsstatements” about specific imports

•• Is selfIs self--learning learning ---- “rules evolve with “rules evolve with

experience” experience”

•• Augments FDA scienceAugments FDA science--based risk based risk

decisionsdecisions

PREDICTPREDICT

Algorithms

Decision

Support

Internal FDA

Data(OASIS, ORADDS,

FACTS, MARCS, …)

External

Regulatory Data (Prior Notice,

Customs, USDA, …)

Supply Chain

Data (Transactional,

Transportation,

Business Practices, …)

Exogenous

Data (Political Risk,

Disease, Weather,

Intelligence, …)

Data Merge

“PREDICT”“PREDICT”Components of Components of PREDICTPREDICT

Disparate Data

Sources Science-based Risk Analysis

Shipment-specific

Output Reporting

Defined by broad

sets of data and

advanced analysis

methods, each

shipment has a

snowflake-like

uniqueness

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FERNFERN

�� Food Emergency Response Network Food Emergency Response Network ––

nationwide network of Federal and State nationwide network of Federal and State

laboratories capable of testing the safety of laboratories capable of testing the safety of

thousands of food samples and enabling us thousands of food samples and enabling us

to respond to a terrorist attack.to respond to a terrorist attack.

eLEXNET: eLEXNET: What is it?What is it?

�� An integrated, secure An integrated, secure

system designed for system designed for

multiple government multiple government

agencies involved in agencies involved in

food safety activitiesfood safety activities

�� The necessary The necessary

infrastructure for an infrastructure for an

early warning system early warning system

that identifies potentially that identifies potentially

hazardous foods and hazardous foods and

enables health officials enables health officials

to assess risks and to assess risks and

analyze trendsanalyze trends

eLEXNET’s GIS Reporting FunctionseLEXNET’s GIS Reporting Functions

Report Parameters:

Salmonella

Cheese/Cheese Products

All Laboratories

All States

August 2002 to present

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FDA Retail Food Program FDA Retail Food Program

�� Federal, State, Local Federal, State, Local Gov’tGov’t and Industryand Industry

�� One of several Cooperative ProgramsOne of several Cooperative Programs

�� Program is in FDA Regional OfficesProgram is in FDA Regional Offices

�� Field Retail Food SpecialistsField Retail Food Specialists

“Measuring the Effectiveness of the Nation’sFood Service and Retail Food Protection System”

�� Randomly Selected:Randomly Selected:

�� DelisDelis

�� Full service restaurantsFull service restaurants

�� Fast food restaurantsFast food restaurants

�� Schools Schools

�� Nursing homesNursing homes

�� HospitalsHospitals

“Measuring the Effectiveness of the Nation’sFood Service and Retail Food Protection System”

�� Risk FactorsRisk Factors

�� Food from unsafe sourcesFood from unsafe sources

�� Inadequate cookingInadequate cooking

�� Improper holding temperatures Improper holding temperatures

�� Contaminated equipment andContaminated equipment and

�� Poor personal hygienePoor personal hygiene

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“Measuring the Effectiveness of the Nation’sFood Service and Retail Food Protection System”

�� Food Code public health interventions:Food Code public health interventions:

�� Demonstration of KnowledgeDemonstration of Knowledge

�� Employee health controlsEmployee health controls

�� Controlling hands as a vehicle of contamination Controlling hands as a vehicle of contamination

(No bare hand contact with ready to eat food)(No bare hand contact with ready to eat food)

�� Time and temperature parameters for Time and temperature parameters for

controlling pathogens andcontrolling pathogens and

�� Consumer advisoriesConsumer advisories

Voluntary National Retail FoodVoluntary National Retail Food

Regulatory Program StandardsRegulatory Program Standards

1. 1. Regulatory Foundation Regulatory Foundation

2. 2. Trained Regulatory StaffTrained Regulatory Staff

3. 3. Inspection Program Based on HACCP Inspection Program Based on HACCP PrinciplesPrinciples

4. 4. Uniform Inspection ProgramUniform Inspection Program

5. 5. Food borne Illness Investigation and Food borne Illness Investigation and ResponseResponse

6. 6. Compliance and EnforcementCompliance and Enforcement

7. 7. Industry and Community RelationsIndustry and Community Relations

8. 8. Program Support and ResourcesProgram Support and Resources

9. 9. Program AssessmentProgram Assessment

CURRENT ENROLLMENTCURRENT ENROLLMENT

�� NationallyNationally –– >118>118 State, local State, local

and tribal jurisdictions are and tribal jurisdictions are

enrolledenrolled

WE WANT YOU!WE WANT YOU!

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RETAIL FOODRETAIL FOOD PROGRAM PROGRAM

RESOURCE DISKRESOURCE DISK

�� PROGRAM STANDARDSPROGRAM STANDARDS

�� FOOD CODE & supplementFOOD CODE & supplement

�� HACCP GUIDESHACCP GUIDES

�� BASELINE DATABASEBASELINE DATABASE

�� STANDARDIZATIONSTANDARDIZATION

�� MANY OTHERSMANY OTHERS

IT’S HERE!!!IT’S HERE!!!

1 COPY FOR EVERY RETAIL FOOD PROGRAM

Eureka! DiskEureka! Disk

�� Free Subscription Free Subscription

�� Over 700 Subscribers!Over 700 Subscribers!

�� ORA’s Eureka DatabaseORA’s Eureka Database

�� Over 12,000 DocumentsOver 12,000 Documents

�� 1,800 Graphics1,800 Graphics

�� A Great Resource!A Great Resource!

�� Use on a Stand Alone or Use on a Stand Alone or LAN ServerLAN Server

New Format (WebNew Format (Web--CD) Technology!CD) Technology!

Eureka! DiskEureka! Disk

�� FDA regulatory references in electronic format :FDA regulatory references in electronic format :

�� Federal Food Drug and Cosmetic ActFederal Food Drug and Cosmetic Act

�� Title 21 CFRTitle 21 CFR

�� Compliance Policy GuidesCompliance Policy Guides

�� Enforcement ReportsEnforcement Reports

�� Talk PapersTalk Papers

�� Import AlertsImport Alerts

�� Investigations Operations Manual, Regulatory Investigations Operations Manual, Regulatory Procedures ManualProcedures Manual

�� Food CodeFood Code

�� Compliance ProgramsCompliance Programs

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Eureka! DiskEureka! Disk

�� Not available to the publicNot available to the public�� Available to state and local agencies Available to state and local agencies �� Disk is not releasable under FOI Disk is not releasable under FOI

Disks available from:Disks available from:

FDA Division of Federal-State Relations

Call: 301Call: 301--827827--6906 6906

Email: [email protected]: [email protected]

Revitalizing the Nutrition Revitalizing the Nutrition

ProgramProgram

Improving NutritionImproving Nutrition

�� Better InformationBetter Information

�� Consumer Health Information for Better Nutrition Consumer Health Information for Better Nutrition

InitiativeInitiative

�� Supporting ConsumersSupporting Consumers

�� Obesity Working GroupObesity Working Group

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24

ClosingClosingWorking together we will rise Working together we will rise

to the challenge of making to the challenge of making

sure Americans continue to sure Americans continue to

enjoy a safe food supply and enjoy a safe food supply and

medical products.medical products.

CONTACTCONTACT

SCOTT J. SCOTT J. MacINTIREMacINTIRE

[email protected]@FDA.HHS.GOV

312312--596596--42004200