Wendy Fanaselle MS, RS Food and Drug Administration Center for Food Safety and Applied Nutrition Division of Cooperative Programs Retail Food Protection.

Wendy Fanaselle MS, RS

Food and Drug Administration Center for Food Safety and Applied Nutrition

Division of Cooperative ProgramsRetail Food Protection Branch

Food SecurityFood Security

Information available on the Information available on the webweb::

Food safety and terrorismFood safety and terrorism: : www.cfsan.fda.Gov/~dms/fsterr.Htmlwww.cfsan.fda.Gov/~dms/fsterr.Html

BioterrorismBioterrorism: : www.fda.Gov/oc/opacom/hottopics/bioterroriswww.fda.Gov/oc/opacom/hottopics/bioterrorism.htmlm.html

www.www.foodsafetyfoodsafety..govgov: “Countering : “Countering Bioterrorism and other threats to Bioterrorism and other threats to the food supplythe food supply”: ”: www.foodsafety.Gov/~fsg/bioterr.htmlwww.foodsafety.Gov/~fsg/bioterr.html

Food SecurityFood SecurityPreventive Measures GuidancePreventive Measures Guidance

AIDAID to operators of food establishments to operators of food establishments Firms that produce, process, store, Firms that produce, process, store,

repack, relabel, distribute, or transport repack, relabel, distribute, or transport food or ingredientsfood or ingredients

Firms that prepare or distribute food at Firms that prepare or distribute food at retailretail

IDENTIFIESIDENTIFIES preventive measures to preventive measures to minimize the riskminimize the risk that food under their that food under their control will be subject to tampering or control will be subject to tampering or criminalcriminal or terrorist actionsor terrorist actions

www.cfsan.fda.gov/~dms/secguid.htmlwww.cfsan.fda.gov/~dms/secguid.html

Food SecurityFood SecurityPreventive Measures GuidancePreventive Measures Guidance

RECOMMENDSRECOMMENDS review of current review of current procedures and improvements as neededprocedures and improvements as needed

ENCOURAGESENCOURAGES the commitment of the commitment of management and employees to be management and employees to be successfulsuccessful

ACKNOWLEDGES ACKNOWLEDGES not all preventive not all preventive measures are appropriate for every measures are appropriate for every operationoperation

SUPPORTSSUPPORTS use of operational risk use of operational risk management to prioritize improvementsmanagement to prioritize improvements

Food Establishment OperationsFood Establishment OperationsManagement of Food SecurityManagement of Food Security

Security proceduresSecurity procedures• Assign responsibility to qualified Assign responsibility to qualified

individual(s)individual(s)• Encourage all staff to be alert Encourage all staff to be alert

Investigation of suspicious activityInvestigation of suspicious activity• Investigate suspicious activityInvestigate suspicious activity• Alert local law enforcementAlert local law enforcement

Food Establishment OperationsFood Establishment OperationsPhysical SecurityPhysical Security

Visitors Visitors • Observe incoming and outgoing vehiclesObserve incoming and outgoing vehicles• Restricted entryRestricted entry• Restrict access to food handling and Restrict access to food handling and

storage areas and locker roomsstorage areas and locker rooms• Ensure there is a valid reason for the visitEnsure there is a valid reason for the visit• Rules apply to everyoneRules apply to everyone

Food Establishment Operations Food Establishment Operations EmployeesEmployees

Pre-hiring screeningPre-hiring screening• Work referencesWork references• Check of immigration status Check of immigration status • Criminal background checksCriminal background checks• Apply to all employeesApply to all employees

Food Establishment Operations Food Establishment Operations EmployeesEmployees

TrainingTraining• Provide food security training to Provide food security training to

new employees new employees • Provide periodic reminders Provide periodic reminders • Ensure employee buy-inEnsure employee buy-in

Food Establishment Operations Food Establishment Operations Raw Materials and PackagingRaw Materials and Packaging

SuppliersSuppliers• Use known sourcesUse known sources• Ensure suppliers/transporters practice Ensure suppliers/transporters practice

security measures and audit for security measures and audit for compliancecompliance

• Authenticate labeling and packaging Authenticate labeling and packaging configuration in advance of receipt of configuration in advance of receipt of shipmentshipment

Food Establishment Operations Food Establishment Operations Raw Materials and PackagingRaw Materials and Packaging

SuppliersSuppliers

• Inspect incoming Inspect incoming products for signs of tampering products for signs of tampering or counterfeiting or counterfeiting

• Report evidence of tampering or Report evidence of tampering or counterfeitingcounterfeiting

Food Establishment Operations Food Establishment Operations Raw Materials and PackagingRaw Materials and Packaging

SuppliersSuppliers• Reconcile the amount received with Reconcile the amount received with

the amount ordered and the amount the amount ordered and the amount invoiced invoiced

• Supervise off-loading Supervise off-loading of productsof products

Food Code Represents Food Code Represents

FDA’s Best Advice for:FDA’s Best Advice for:

Uniform system of Uniform system of regulation;regulation;

Safe food service Safe food service through researched through researched and recommended and recommended practices; practices;

Food is properly Food is properly protected, protected, unadulterated, and unadulterated, and honestly presented.honestly presented.

Intent of the Food CodeIntent of the Food Code

Provide guidance / tools to prevent Provide guidance / tools to prevent Foodborne illnessFoodborne illness

Uniform standardsUniform standards 3,000 local regulatory food agencies3,000 local regulatory food agencies

Implementation supported by Implementation supported by other program elementsother program elements

Major Food Safety Major Food Safety Subject AreasSubject Areas

PersonnelPersonnel

FoodFood

Equipment, facilities, related Equipment, facilities, related suppliessupplies

Compliance & enforcementCompliance & enforcement

5 Identified Major Risk 5 Identified Major Risk FactorsFactors

Poor personal hygienePoor personal hygiene Improper holding temperaturesImproper holding temperatures Inadequate cooking:Inadequate cooking:

Such as undercooking raw shell Such as undercooking raw shell eggs eggs

Contaminated equipmentContaminated equipment Food from unsafe sourcesFood from unsafe sources

Food Code Food Code 5 Key Interventions5 Key Interventions

1.1. Demonstration of knowledge Demonstration of knowledge

2.2. Employee health Employee health

3.3. Time / temperature Time / temperature

4.4. Hands a vehicle of Hands a vehicle of

contaminationcontamination

5.5. Consumer advisory Consumer advisory

CDC Estimated Data on CDC Estimated Data on Foodborne Disease in the Foodborne Disease in the United StatesUnited States

0%10%20%30%40%50%60%70%80%

Deaths

Bacteria

Parasites

Viruses

5000 deaths 5000 deaths 325,000 325,000

hospitalizationshospitalizations 76 million 76 million

gastrointestinal gastrointestinal illnessesillnesses

CDC Estimated Food-CDC Estimated Food-related Deaths: related Deaths: 55 Pathogens Pathogens = 90% of Total= 90% of Total

0%

5%

10%

15%

20%

25%

30%

35%

Est. Food-Related Deaths

Salmonella

Listeria

Toxoplasma

Norwalk-likevirusesCampylobacter

E.coli 0157:H7

CDC Estimated % of Total CDC Estimated % of Total Foodborne Illnesses, Foodborne Illnesses, Hospitalizations, and DeathsHospitalizations, and Deaths

0

10

20

30

40

50

60

70

% TotalFBI

% TotalHospital

% TotalDeaths

Salmonella

Listeria

Toxoplasma

Norwalk-likevirusesCampylobacter

E.coli 0157:H7

Specific Product Specific Product ConcernsConcernsSpecific Product Specific Product ConcernsConcerns

EggsEggs

JuiceJuice

ProduceProduce

Imported Imported foodsfoods

Imported FoodsImported FoodsImported FoodsImported Foods

1/2 of all fish & shellfish imported1/2 of all fish & shellfish imported

1/3 of all fresh fruit 1/3 of all fresh fruit

12% of all vegetables 12% of all vegetables

GAO study: only 1.7% of 2.7 million GAO study: only 1.7% of 2.7 million shipments are inspected by FDAshipments are inspected by FDA

Highly Susceptible Highly Susceptible PopulationPopulation

JuiceJuice SproutSprout

ss EggsEggs

Microbiological Hazards Microbiological Hazards Fresh Fruits and Fresh Fruits and VegetablesVegetables

Microbiological Hazards Microbiological Hazards Fresh Fruits and Fresh Fruits and VegetablesVegetables E.coli 0157: H7E.coli 0157: H7

CyslosporaCyslospora

SalmonellaSalmonella

Salmonella Salmonella & E. coli& E. coli

Lettuce in Lettuce in CaliforniaCalifornia

Guatemalan Guatemalan raspberriesraspberries

Mexican Mexican cantaloupescantaloupes

Alfalfa sprouts / Alfalfa sprouts / NetherlandsNetherlands

Juice Microbiological Juice Microbiological HazardsHazardsJuice Microbiological Juice Microbiological HazardsHazards E. coli 0157:H7E. coli 0157:H7

Salmonella spp.Salmonella spp.

CrytosporidiumCrytosporidium

1996: Apple juice1996: Apple juice 66 ill & 1 death66 ill & 1 death

Unpasteurized Unpasteurized orange juiceorange juice

Apple ciderApple cider

Juice Microbiological Juice Microbiological HazardsHazardsJuice Microbiological Juice Microbiological HazardsHazards

BacillusBacillus

Vibrio choleraVibrio cholera

Orange juiceOrange juice

Frozen coconut Frozen coconut milkmilk MarylandMaryland

EggsEggsEggsEggs

Salmonella stereotype Salmonella stereotype EnteritidisEnteritidis

65 Billion eggs produced 65 Billion eggs produced annuallyannually 1% Contain SE1% Contain SE 10.2 Million servings contain SE10.2 Million servings contain SE Pooling eggs increases SEPooling eggs increases SE

Eggs – Salmonella Eggs – Salmonella EnteritidisEnteritidisEggs – Salmonella Eggs – Salmonella EnteritidisEnteritidis

2.4 million persons exposed / 2.4 million persons exposed / yearyear

661,000 see physician661,000 see physician

390 die from SE390 die from SE

Highly Susceptible Highly Susceptible PopulationsPopulationsHighly Susceptible Highly Susceptible PopulationsPopulations

HSP are 10 fold more susceptible to SEHSP are 10 fold more susceptible to SE

Pooling eggs = highest incidence of SEPooling eggs = highest incidence of SE

Most SE outbreaks occur in institutionsMost SE outbreaks occur in institutions Nursing homesNursing homes

Part 3-8 Specialized Part 3-8 Specialized Topics Topics

Highly susceptible populations:Highly susceptible populations:

Use of pasteurized packaged juice Use of pasteurized packaged juice requiredrequired

Raw seed sprouts prohibitedRaw seed sprouts prohibited Use of pasteurized eggsUse of pasteurized eggs Allowance for restricted use of shell Allowance for restricted use of shell

eggseggs Time as a public health control Time as a public health control

prohibitedprohibited

FOOD SECURITYFOOD SECURITYPREVENTIVE MEASURES GUIDANCEPREVENTIVE MEASURES GUIDANCE

Emergency Point of ContactEmergency Point of Contact

FDA 24 hour contact: (301) 443-1240 FDA 24 hour contact: (301) 443-1240

OrOr

LOCAL FDA District Office: listed atLOCAL FDA District Office: listed at

FDA’s website (FDA’s website (www.fda.govwww.fda.gov))

For Further For Further

InformationInformation ... ... Center for Food Safety Center for Food Safety

& Applied Nutrition& Applied Nutrition

Division of Cooperative ProgramsDivision of Cooperative Programs

Retail Food Protection TeamRetail Food Protection Team

5100 Paintbranch Parkway (HFS-5100 Paintbranch Parkway (HFS-627)627)

College Park, MD 20740College Park, MD 20740

WWW.CFSAN.FDA.GovWWW.CFSAN.FDA.Gov