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<strong>Overview</strong> <strong>of</strong> FDA’s <strong>Food</strong><strong>Defense</strong> <strong>Activities</strong>January 26, 2012LeeAnne Jackson, Ph.D.Center for <strong>Food</strong> Safety <strong>and</strong> Applied Nutrition<strong>Food</strong> <strong>and</strong> <strong>Drug</strong> AdministrationDefinitions• <strong>Food</strong> defense – the protection <strong>of</strong> food productsfrom intentional adulteration by biological,chemical, physical or radiological agents• <strong>Food</strong> safety - the protection <strong>of</strong> food productsfrom unintentional contamination• <strong>Food</strong> security - having enough food <strong>of</strong> sufficientnutritional quality to sustain yourself1


International <strong>Food</strong> <strong>Defense</strong> <strong>Activities</strong>• APEC <strong>Food</strong> <strong>Defense</strong> Pilot Program– Thail<strong>and</strong>, Peru, Vietnam, Philippines– 3 phases• Assessment/Relationship Building• Train the Trainer/Awareness Workshops• Individual food defense plan development• Regional Awareness Workshops– Latin America– Caribbean– China– MexicoFuture International <strong>Food</strong><strong>Defense</strong> <strong>Activities</strong>• 2012-13 <strong>Food</strong> <strong>Defense</strong> Roadshows– India– Middle East <strong>and</strong> North Africa– Latin America2


<strong>Food</strong> Safety Modernization ActIntentional Adulteration Provisions• Section 103 - Hazard Analysis <strong>and</strong> Risk-Based Preventive Controls– “...hazards that occur naturally or may be intentionallyintroduced.”– “…identify <strong>and</strong> evaluate hazards that may beintentionally introduced, including by acts <strong>of</strong>terrorism…”• Section 105 – St<strong>and</strong>ards for Produce Safety– “…consider hazards …. that may be intentionallyintroduced, including by acts <strong>of</strong> terrorism…”<strong>Food</strong> Safety Modernization ActIntentional Adulteration Provisions• Section 106 – Protection Against IntentionalAdulteration– Determinations – vulnerability assessment, economic assessment,science-based mitigation strategies– Regulations• Assess individual implementation requirements for mitigation strategies• Specify appropriate science-based mitigation strategies– Regulation Applicability – foods with a high risk <strong>of</strong> intentionalcontamination (exception – farms, but does apply to milk)– Guidance Documents – model assessment, example <strong>of</strong> mitigationstrategies, examples <strong>of</strong> situations where mitigation strategies areappropriate3


<strong>Food</strong> Safety Modernization ActIntentional Adulteration Provisions• Section 208 – Decontamination <strong>and</strong>Disposal St<strong>and</strong>ards <strong>and</strong> Plans– Development <strong>of</strong> Model Plans• Section 301 – Foreign SupplierVerification Program• Evaluate the potential risk for intentionaladulteration <strong>of</strong> the food<strong>Food</strong> <strong>Defense</strong> Tools4


Tools• Guidance Documents• CARVER + Shock• <strong>Food</strong> <strong>Defense</strong> Mitigations Database• FDA’s <strong>Food</strong> Related EmergencyExercise Bundle (FREE-B)<strong>Food</strong> <strong>Defense</strong> GuidanceDocuments• Guidance documents– <strong>Food</strong> Producers, Processors <strong>and</strong>Transporters– Dairy Farms, Bulk Milk Transport,Processors– Retail <strong>Food</strong> Stores <strong>and</strong> <strong>Food</strong> Service– Importers <strong>and</strong> Filers– Cosmetics Processors <strong>and</strong> Transporters5


Appendix V: <strong>Food</strong> <strong>Defense</strong> SelfAssessment Tool• Downloadable PDF file format• Preventative measure captured as astatement• Same topics reflected in text document• Yes/No/Not Applicable/Don’t Know choices• Assessment Tool--No Score<strong>Food</strong> <strong>Defense</strong> Self Assessment Tool• Appendix to the guidance documents– Checklist mechanism by which a firm isguided through assessing the security<strong>of</strong> a facility– Once complete the information can beused to develop a <strong>Food</strong> <strong>Defense</strong> Plan6


7CARVER + Shock S<strong>of</strong>tware• Breaks a food systeminto nodes in the farm totable continuum• Assesses each node toprioritize those mostvulnerable• Identifies mitigations toreduce vulnerability<strong>Food</strong> <strong>Defense</strong> MitigationStrategies Database• Released in March 2011• Contains a range <strong>of</strong> preventive measures for industry toconsider• Searchable• Focuses on manufacturers, processors, distributors, <strong>and</strong>retail/food service• Contains roughly 60 production steps (nodes)• Mitigations compiled from:– Guidance Documents– Open Literature– Industry Inputwww.fda.gov/fooddefense


8<strong>Food</strong> Related EmergencyExercise Bundle (FREE-B)• Released in August 2011.• Provide jurisdictions (Federal, State, <strong>and</strong> local) with avariety <strong>of</strong> options to test <strong>and</strong> improve their capabilities torespond to human or animal health emergencies.• 5 scenarios in the set are designed so that jurisdictionscan conduct them with a minimal amount <strong>of</strong> effort <strong>and</strong>editing.• Each scenario is st<strong>and</strong>-alone. Collaboration <strong>and</strong>partnering between government <strong>and</strong> private sector iskey.Raising <strong>Food</strong> <strong>Defense</strong>Awareness


ALERTHow do I ALERT the operators <strong>of</strong> theestablishments to make them more aware<strong>of</strong> <strong>Food</strong> <strong>Defense</strong> issues?17FDA’s ALERT Initiative• Intended to raise awareness <strong>of</strong> fooddefense• Applies to all aspects <strong>of</strong> the farm-totablecontinuum• Identifies 5 key food defense points:• Assure• Look• Employees• Report• Threat9


FDA’s ALERT InitiativeSee WWW.FDA.GOV/FOODDEFENSE for more informationFDA’s ALERT InitiativeALERT materials are available in PDF <strong>and</strong>multiple languages• Wallet Card: English, Chinese, French,Korean, Portuguese, Spanish, Vietnamese• Brochure: English, Chinese, French, Korean,Portuguese, Spanish, Vietnamese• Poster: English, French, Portuguese,Spanish2010


11WEB-BASED TRAININGAVAILABLE IN ENGLISH & SPANISHEmployees FIRST22


Employees FIRST• Follow company fooddefense plan <strong>and</strong>procedures.• Inspect your work area<strong>and</strong> surroundingsareas.• Recognize anything out<strong>of</strong> the ordinary.• Secure all ingredients,supplies <strong>and</strong> finishedproduct.• Tell management if younotice anything unusualor suspicious.FIRST Employees <strong>Food</strong> <strong>Defense</strong>Awareness Training• Training Kit for management toincorporate into company’s food defensetraining program for first-line employees• 10 - 15 minute video• Use images to re-enforce key message• Currently available in Chinese, English,French, Korean, Japanese, Portuguese,<strong>and</strong> Spanish.12


13Questions????LeeAnne.Jackson@fda.hhs.gov240-402-1593


<strong>Food</strong> <strong>Defense</strong> HistoryShaun KennedyDirector, National Center for <strong>Food</strong> Protection <strong>and</strong><strong>Defense</strong>Assistant Pr<strong>of</strong>essor, Veterinary Population Medicine,University <strong>of</strong> MinnesotaThe <strong>Food</strong> <strong>and</strong> <strong>Drug</strong> <strong>Law</strong> Institute<strong>Food</strong> Week26 January 2012©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.<strong>Food</strong> Continuum Paradigm• <strong>Food</strong> Security:<strong>Food</strong> System Protection• Supply sufficiency• <strong>Food</strong> Safety:• System reliability• <strong>Food</strong> <strong>Defense</strong>:• System resiliency• <strong>Food</strong> Quality:• Supply desirability• <strong>Food</strong> Protection:• Safety & <strong>Defense</strong> continuum©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.1


<strong>Food</strong> Security Reality©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.2010 U.S. <strong>Food</strong> Import Sources – USDA-ERS©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.2


Early Examples <strong>of</strong> <strong>Food</strong> Attacks• Athenian poisoning <strong>of</strong> Kirrha <strong>of</strong> the AmphictyonicLeague with the plant root <strong>of</strong> helleborous(Christmas rose) in 590 - 600 B.C• Contamination <strong>of</strong> wine left behind for Africanwarriors with m<strong>and</strong>agora by the CarthaginianGeneral Maharbal• Plague contamination <strong>of</strong> wells during the BlackDeath©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.<strong>Food</strong> as a Modern State Weapon• WW II Japanese use <strong>of</strong> food <strong>and</strong> water to attackthe population <strong>of</strong> at least 11 Chinese cities– Bacillus anthracis– Shigella spp– Vibrio cholerae– Salmonella paratyphi– Yersinia pestis©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.3


Disgruntled EmployeesGrocery store worker accused <strong>of</strong> poisoning beefThursday, February 13, 2003 Posted: 5:04 PM EST (2204 GMT)GRAND RAPIDS, Michigan -- A former supermarket employee was indicted on charges <strong>of</strong>poisoning about 200 pounds <strong>of</strong> ground beef with insecticide <strong>and</strong> sickening more than 40people.©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.Competitive Sabotage61 Students felled by rat poison in central ChinaMonday, September 29, 2003Dozens <strong>of</strong> elementary school students <strong>and</strong> teachers inHunan Province were hospitalized after ingesting ratpoison with their school breakfasts in an apparentdeliberate mass poisoning, state media said Sunday.©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.4


Misguided CompetitionChina dairy boss pleads guilty in melamine caseWed Dec 31, 2008 8:24am ESBEIJING (Reuters) - The chairwoman <strong>of</strong> aChinese dairy company went on trial onWednesday over a tainted milk sc<strong>and</strong>al. . . Atleast six children have died <strong>and</strong> more than290,000 made ill from the contaminated milk,battering already dented faith in China-madeproducts <strong>and</strong> prompting massive recalls aroundthe world.©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.Criminals <strong>and</strong> DeviantsMan jailed over store food safety plotItaly on alert for water poisonerItalian police have launched a searchto track down a mystery poisoner whohas been injecting a soapy liquid intoplastic bottles <strong>of</strong> mineral water.Salesman Shane Ward, 53, left a jiffy bag in the fresh vegetable department <strong>of</strong>Morrisons' King's Lynn branch marked for the attention <strong>of</strong> the store manager. Itcontained a jar <strong>of</strong> baby food - which he claimed he had contaminated - along with anote saying he had struck at nine other Morrisons stores,.©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.5


Domestic Extremists & Cults• Rajneeshee cult contamination <strong>of</strong> salad barswith S. typhimurium (1984, 751 ill).©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.Targeted Political Attacks350 Iraqi Policeman Suffer <strong>Food</strong> PoisoningOctober 11, 2006BAGHDAD, Iraq -- Authorities arrested the head <strong>of</strong>the mess hall where at least 350 Iraqi policemensuffered food poisoning, <strong>and</strong> a military spokesmansaid Monday that it was likely the poisoning wasintentional.©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.6


Terrorists“Terrorist groups have a lesser interest in biologicalmaterials <strong>and</strong> are most interested in chemicals such ascyanide salts to contaminate food <strong>and</strong> water supplies”CIA Testimony to Congress 2002Documents Seized inAfghanistan (Tarnak Farms)Indicate Interest©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.NCFPD VisionDefending the safety <strong>of</strong> the foodsystem through research <strong>and</strong>educationShaun KennedyKenne108@umn.edu612-624-2247http://www.ncfpd.umn.edu©2011 National Center for <strong>Food</strong> Protection <strong>and</strong> <strong>Defense</strong>. All rightsreserved. Do not copy or distribute without permission <strong>of</strong> NCFPD.7


1Intentional <strong>Food</strong> Adulteration:Global Incidents / Private Sector ResponseMitchell Weinberg, Esq.Founder, President & CEOINSCATECHInternational Supply Chain Technologies CorporationIntentional <strong>Food</strong> AdulterationThe introduction <strong>of</strong> the FOOD SAFETY MODERNIZATION ACTrepresents an increased focus by both regulators <strong>and</strong> the foodindustry on FOOD DEFENSE (Intentional <strong>Food</strong> Adulteration):‣ Enhancing Global & National Security + Protecting OurBorders & Marketplace from adulterated products / ingredientsoriginating in high risk countries.SOURCES OF ADULTERATION:‣ Economically Motivated Actions‣ Disgruntled Employees‣ Politically Motivated GroupsINSCATECH Copyright 2012


2Economically MotivatedAdulterationDilutionWatered DownDairy ProductsMislabelingSunflower Oil Sold as Olive OilMethods <strong>of</strong> Intentional(Economically Motivated)<strong>Food</strong> AdulterationUnapprovedEnhancementsMelamine additionsto enhance proteinvalue / Use <strong>of</strong>Growth Hormones inMeatConcealmentSalmonella PeanutContamination / PoultryDiseases ConcealedSubstitutionHoney with Beet SugarCounterfeitingGrey Market Imitation CPG,example: repackagedyoghurtINSCATECH Copyright 2012Economically MotivatedAdulterationChinese Protein Export Adulteration – Unapproved Enhancement‣ The adulteration <strong>and</strong> contamination <strong>of</strong> several food <strong>and</strong> feed ingredientswith inexpensive melamine <strong>and</strong> other compounds - used to inflate theapparent protein content <strong>of</strong> products, so that inexpensive ingredients canpass for more expensive, concentrated proteins. The combination <strong>of</strong>melamine <strong>and</strong> cyanuric acid has been implicated in kidney failure.‣ 2007 - FDA disclosed 2.5 – 3 Million people in US consumed chickens thatwere fed contaminated vegetable protein from China‣ Melamine had been purposely added as a binder to fish & livestock feed inthe US & traced to suppliers in Ohio & ColoradoINSCATECH Copyright 2012


3Economically MotivatedAdulterationChinese Protein Export Adulteration –Unapproved Enhancement2008‣ China – baby formula recall – 294,000babies became ill, at least 6 died.‣ Europe – melamine found in chocolatespread imported across Europe2010‣ Chinese authorities still reporting seizures <strong>of</strong>melamine contaminated dairy productsINSCATECH Copyright 2012Economically MotivatedAdulterationUS – Substitution / Mislabeling‣ Sun Up substituted an inexpensive liquid beet sugar for some <strong>of</strong> the moreexpensive orange juice concentrate, then labeled the product unsweetenedorange juice concentrate <strong>and</strong> sold it to manufacturers <strong>and</strong> dairies for makingjuice sold through retailers.‣ Sun Up had used approximately 20 million pounds <strong>of</strong>sugar to "stretch" or adulterate its orange juice.‣ James V. Mays, former owner <strong>of</strong> Sun Up <strong>Food</strong>s Inc. <strong>of</strong>Benton, Ky., was sentenced to serve eight years inprison, & fined $100,000.‣ Cheated consumers out <strong>of</strong> at least $12 million.INSCATECH Copyright 2012


4Economically MotivatedAdulterationEUROPE: The Tapiro CaseConcealment / Unapproved Enhancements‣ North & Central Italy: Discovery <strong>of</strong> crime ringconsisting <strong>of</strong> stockbreeders, sales agents, managers<strong>of</strong> zootechnical food factories <strong>and</strong> pharmaceuticalindustries, farmers <strong>and</strong> veterinarians.‣ Antibiotics, hormones & steroids sourced from Chinawere illegally dealt by criminal organizations tomanagers <strong>of</strong> zootechnical food factories &pharmaceutical industries across Europe.‣ Stockbreeders used these substances as growth promoters & to hide animaldisease. 44 persons arrested, 98 persons charged.INSCATECH Copyright 2012The Tapiro Case‣ ACIDO ACETILSALICILICO (ATS)‣ AMPICILLINA – AMPLISOL‣ AMOSSICILLINA - AMOXICILLINA‣ ERITROMICINA - ERITROMICINA TIOCIANATO (ERI)‣ BAYTRIL – ENROFLOXACINA – OFLOXACINA‣ CLORAMFENICOLO (CAF)‣ DIMETRIDAZOLO (DMZ)‣ AVIOCHINA‣ TETRACICLINA (TET)‣ FURALTADONE (FUR)‣ FURAZOLIDONE‣ GENTAMICINA (GEN)‣ MEBENDAZOLO (MBZ)‣ N-BUTANOLO‣ NEOMICINA (NEO)‣ OLAQUINDOX (OQ)‣ TRICHLORFON (TFC)‣ STREPTOMICINA (STP)‣ SULFADIMETOSSINA –SULFAMETAZINA (SFM)‣ OSSITETRACICLINA – OXYTETRACYCLINE‣ FLUMEQUINA – FLUMECHINA (FMQ)‣ TRIMETHOPRIM – TRIMETOPRIM (TRP)‣ TRIMETROSULFA‣ 17BETA–ESTRADIOLO‣ 17BETA-BOLDENONE O DEIDROTESTOSTERONE‣ CLORTETRACICLINA - CHLORTETRACYCLINE‣ COLISTINA SOLFATO – COLISTIN SULPHATE‣ DESAMETAZONE - DEXAMATHASONE‣ DIAVERIDINA – DENAVERINE‣ DOXYCYCLINA‣ POTASSIO‣ IVERMECTINA‣ IODIO‣ PIPERAZINA‣ SPIRAMICINA – SPIRAMYCIN‣ TIAMULINA‣ TILOSINA – TYLOSINA TARTRATA‣ ZINCO BACITRACIN‣ ECXNEL‣ GANADOL‣ LASOTA‣ NISTATINAINSCATECH Copyright 2012


5Economically MotivatedAdulterationIndia / Bangladesh – Unapproved Enhancements:‣ Formalin added to fish, fruit, meat, & milk forpreservation (linked to throat & blood cancer, asthma,skin diseases).‣ Toxic additives including auramine, rhodamine,malachite green, allura red, <strong>and</strong> Sudan red applied onfood items for colouring, brightness, <strong>and</strong> freshness(linked to liver <strong>and</strong> kidney damage, stomach cancer,asthma, <strong>and</strong> bladder cancer).‣ Urea added to rice to enhance whiteness (linked nervous system / kidneydamage <strong>and</strong> respiratory problems).INSCATECH Copyright 2012Economically MotivatedAdulteration‣ EXTORTION2010 – France - The owner La Romanée-Conti, (the legendaryvineyard <strong>of</strong> Burgundy, bottles sell for $10k+) received a threat thevineyard would be poisoned unless the owner paid one million euro.When the owner didn’t pay a map was delivered that identifiedseveral vines that had already been poisoned by drill <strong>and</strong> syringe.‣ COMPETITION2002 – China - 40 people died <strong>and</strong> 200 individuals were hospitalizedin Nanjing after the owner <strong>of</strong> a fast-food outlet poisoned acompetitor’s breakfast foods with rat poison.INSCATECH Copyright 2012


6Economically MotivatedIntentional <strong>Food</strong> AdulterationCOSTHEALTH IMPACTSource: A.T. Kearney, 2009, Drivers for EconomicAdulteration & <strong>Food</strong> <strong>Defense</strong>, Craig Henry, Ph.DDisgruntled Employees‣ 1997 – Texas – Lab Worker - Intentional contamination <strong>of</strong> muffins <strong>and</strong>donuts with laboratory cultures <strong>of</strong> Shigella dysenteriae. The eventcaused gastroenteritis in 45 laboratory workers <strong>and</strong> 4 were hospitalized.‣ 2003 – Michigan - a supermarket employee intentionally contaminated200 pounds <strong>of</strong> ground beef with an insecticide containing nicotine.Although the tainted meat was sold in only one store, 111 people,including approximately 40 children, were sickened.‣ 2009 – North Carolina – Domino’s Pizza contamination by employees –video distributed via YouTube.INSCATECH Copyright 2012


7Politically Motivated Groups‣ 1978 - In an effort to damage Israel’s economy, citrus fruit exportedto several European countries was contaminated with mercury,which led to significant trade disruption.‣ 1984 - the Rajneeshee religious group contaminated salad bars inthe U.S. state <strong>of</strong> Oregon in hopes <strong>of</strong> affecting the outcome <strong>of</strong> a localelection. This incident caused 751 cases <strong>of</strong> salmonellosis <strong>and</strong>resulted in the hospitalization <strong>of</strong> 45 victims.INSCATECH Copyright 2012Politically Motivated GroupsINSCATECH Copyright 2012


8Insurance Industry Response‣ Historically - Most liability insurance policies did not coverthe expenses <strong>and</strong> lost income associated with intentional foodadulteration.‣ As a result Contaminated Products & Product Recall Insurancehave been created.INSCATECH Copyright 2012Insurance Industry Response‣ Specialty recall coverage is available to cover certain recallrelatedlosses that <strong>of</strong>ten are excluded from general liability <strong>and</strong>property policies. In general, specialty policies can be triggeredby some or all <strong>of</strong> the following insured events:‣ Malicious product tampering‣ Product extortion‣ Adverse publicity concerning contamination or tampering‣ Government recallINSCATECH Copyright 2012


9Insurance Industry ResponseMalicious Product TamperingTriggered by the actual or threatened intentional, malicious orillegal alteration or contamination <strong>of</strong> an insured product so as torender it unfit for the use for what it was intended or create suchan impression with the public.‣ SO, there is a deliberate desire to cause economic harmor inflict bodily injury. The harm is directed againstinsured <strong>and</strong> it is known to the public.‣ Examples: pins found in lettuce at a major mid Atlanticretailer; cyanide in Chilean grapes; glass in baby food jars,etc.17INSCATECH Copyright 2012Insurance Industry ResponseProduct Extortion - any threat or connected series <strong>of</strong> threats tocommit a malicious product tampering <strong>of</strong> the insured product, forthe purpose <strong>of</strong> dem<strong>and</strong>ing extortion monies communicated to theinsured.‣ Basically I threaten to contaminate your product if you don’tpay me!Example: Australia Mars c<strong>and</strong>y received threat that c<strong>and</strong>y barswould tampered post production unless $$ received. All c<strong>and</strong>ypulled from shelves; significant br<strong>and</strong> rehab expense. Cost <strong>of</strong>$8 MM US - sadly $$ was used to pay gambling debts.INSCATECH Copyright 2012


10Insurance Industry ResponseAdverse Publicity‣ Coverage for adverse publicity is sometimes provided inconnection with a contamination or tampering incident.‣ Such coverage typically requires that either the insuredproduct or the br<strong>and</strong> name has been specifically identified.‣ For example, an FDA enforcement report that identifies theproduct would trigger coverage, but an FDA advisory warningconsumers not to consume a specific food, regardless <strong>of</strong>br<strong>and</strong> or producer, might not.19INSCATECH Copyright 2012Insurance Industry ResponseGovernment Recall‣ In the past, coverage for government recalls had limitedapplication in the United States as FDA did not havem<strong>and</strong>atory recall authority over food items other than infantformula.‣ However, since the FSMA granted the FDA m<strong>and</strong>atory recallauthority on Jan. 4, 2011, future FDA recalls might triggersuch coverage.20INSCATECH Copyright 2012


11Insurance Industry ResponseCovered LossesPolicies may cover some or all <strong>of</strong> the following recall-relatedexpenses:‣ Transporting, storing <strong>and</strong> disposing <strong>of</strong> the recalled product‣ Hiring <strong>and</strong> paying temporary staff to manage the recall‣ Paying overtime‣ Pre-recall testing‣ Third-party recall expenses‣ Product rehabilitation costs‣ Loss <strong>of</strong> gross pr<strong>of</strong>its‣ Crisis management expenses21INSCATECH Copyright 2012Some Key ExclusionsMost carriers have “no coverage” for any loss arising out <strong>of</strong>, basedupon, attributable to or involving, directly or indirectly:‣ A carcinogenic contamination‣ Any accidental contamination that occurs after the insuredhas knowledge <strong>of</strong> a defect or deviation in the production,preparation or manufacture <strong>of</strong> an insured product(s), or anycircumstance(s) which have resulted in or are likely to resultin such deviation or defect, for which the insured fails to takecorrective action.22INSCATECH Copyright 2012


12Some Key ExclusionsMost carriers have “no coverage” for any loss arising out <strong>of</strong>,based upon, attributable to or involving, directly or indirectly:‣ Any accidental contamination or malicious product tampering <strong>of</strong> acompetitor’s product that is similar to an insured product‣ Changes in population, customer tastes, economic conditions,seasonal sales variations, or competitive environment‣ Any injury, damage, or claim made by a third party arising out <strong>of</strong> or inconnection with the use or consumption <strong>of</strong> the insured product,including any defense costs related to a third party lawsuit.‣ Any illegal act <strong>of</strong> the insured’s directors, <strong>of</strong>ficers, or trustees.23INSCATECH Copyright 2012Private Sector ReactionsEurope – Intentional Adulteration - Perceived RiskSOURCE: Secufood: Security <strong>of</strong> European <strong>Food</strong> Supply Chain Study, April 2010.24


13Private Sector Response2010 - Peter Hayes, Frito Lay, Senior Group Manager, Manufacturingoperations Support <strong>and</strong> <strong>Food</strong> Security:‣ “We recognize we can never make the system bulletpro<strong>of</strong>, but our jobis to mitigate 90 percent <strong>of</strong> the risks <strong>and</strong> a lot <strong>of</strong> that is aboutperception,”‣ The key to improving food defense is to remain vigilant, said Hayes.“We underst<strong>and</strong> a lot <strong>of</strong> this infrastructure was created in the shadow<strong>of</strong> 9/11 <strong>and</strong> there were a lot <strong>of</strong> knee-jerk reactions,” he said. “We haveto make sure [our systems] are relevant to the risks <strong>of</strong> today <strong>and</strong> thatwe use the information we have to identify new threats - that’s key forus.”25Source: Stelter Leischen,”<strong>Food</strong> <strong>Defense</strong>: How Frito LayProtects Its Supply Chain, Security Director News, May 2010INSCATECH Copyright 2012Private Sector Response2011 – Quotes Provided by Security Director <strong>of</strong> MajorGlobal CPG Company:‣ …as the substantial effects are connected more tothe spreading <strong>of</strong> the news rather than to thematerial damages that the event causes, thevictims usually tend to keep the tampering caseswrapped up in the greatest secrecy, whenever thisis possible. It is therefore generally acknowledgedby analysts that the news leaking out is just a sort<strong>of</strong> tip <strong>of</strong> the iceberg <strong>of</strong> a phenomenon which isquite more frequent than one might think.‣ …the main tool to fight against tampering forterrorist purposes is the intelligence <strong>and</strong>operational activity carried out by secret services.26INSCATECH Copyright 2012


14Private Sector ResponseUniversity <strong>of</strong> Minnesota Study – Retail <strong>Food</strong>, <strong>Food</strong> Service <strong>and</strong>Wholesale Suppliers‣ Firms are better prepared for food defense against terrorism withintheir own firms than they are in collaboration with their suppliers.‣ <strong>Food</strong>service retailers <strong>and</strong> their wholesale partners are placing agreater emphasis on defense efforts then grocery retailers <strong>and</strong> theirwholesale partners.‣ There is much room for improvement in coordination between firmsalong the food supply chain.27Source: Kinsey, Jean, Kateryna Kaynts, KoelGhosh:”Defending the <strong>Food</strong> Supply Chain: Retail <strong>Food</strong>,<strong>Food</strong>service <strong>and</strong> Their Wholesale Suppliers”, The <strong>Food</strong>Industry Center, University <strong>of</strong> Minnesota, November 2007INSCATECH Copyright 2012Private Sector Response‣ Retail <strong>Food</strong> Sector - No focus on supply chain; little to no focus onprevention outside <strong>of</strong> scope <strong>of</strong> control – “it’s not my problem” mentality‣ <strong>Food</strong> Services Retail Sector - Focus on perception as opposed toproblem; no steps to prevent problems outside <strong>of</strong> area <strong>of</strong> control.‣ <strong>Food</strong>service companies have invested more in food defense practicesprobably because they have a stronger br<strong>and</strong> to protect. Theircompany is their br<strong>and</strong> unlike retail food companies who sell a variety<strong>of</strong> br<strong>and</strong>s <strong>and</strong> manufacturers who <strong>of</strong>ten sell many types <strong>of</strong> products.Also, foodservice retailers are large <strong>and</strong> global <strong>and</strong> more vulnerable toattack as an American icon.28Source: Kinsey, Jean, Kateryna Kaynts, KoelGhosh:”Defending the <strong>Food</strong> Supply Chain: Retail <strong>Food</strong>,<strong>Food</strong>service <strong>and</strong> Their Wholesale Suppliers”, The <strong>Food</strong>Industry Center, University <strong>of</strong> Minnesota, November 2007INSCATECH Copyright 2012


15Private Sector ResponseConclusions from the Operational <strong>Defense</strong> Competencies‣ Comparing the foodservice <strong>and</strong> retail food sectors based on thesecompetencies <strong>and</strong> their mean scores - found that the foodserviceindustry outperforms the retail food industry.‣ The foodservice retail sector ranks #1 followed by foodservicewholesalers, retail food wholesalers <strong>and</strong> retail food.‣ It was determined that the foodservice retail sector surpasses all theother three sectors in almost all the competencies except PhysicalSecurity where the retail food wholesalers rank higher, <strong>and</strong> SupplyChain Collaboration <strong>and</strong> Tracking/Monitoring where the foodservicewholesalers received higher mean scores.29Source: Kinsey, Jean, Kateryna Kaynts, KoelGhosh:”Defending the <strong>Food</strong> Supply Chain: Retail <strong>Food</strong>,<strong>Food</strong>service <strong>and</strong> Their Wholesale Suppliers”, The <strong>Food</strong>Industry Center, University <strong>of</strong> Minnesota, November 2007INSCATECH Copyright 2012Private Sector ResponseConclusions from the Operational <strong>Defense</strong> Competencies‣ By comparing the retail sectors, the firms <strong>and</strong> supply chain members<strong>of</strong> the foodservice retail sectors perceive much larger improvements intheir performance as a result <strong>of</strong> defense initiatives than do foodretailers.‣ This observation is consistent with the benchmark results presentedwhere the foodservice retail sector <strong>of</strong>ten had the highest competencyscores.‣ They had invested more in food defense <strong>and</strong> recovery <strong>and</strong> alsoperceived more benefits to that investment than did others.30Source: Kinsey, Jean, Kateryna Kaynts, KoelGhosh:”Defending the <strong>Food</strong> Supply Chain: Retail <strong>Food</strong>,<strong>Food</strong>service <strong>and</strong> Their Wholesale Suppliers”, The <strong>Food</strong>Industry Center, University <strong>of</strong> Minnesota, November 2007INSCATECH Copyright 2012


16Private Sector ResponseUniversity <strong>of</strong> Minnesota Study – Retail <strong>Food</strong>, <strong>Food</strong> Service <strong>and</strong>Wholesale Suppliers - Conclusion‣ In general, companies with larger revenue, cooperatives <strong>and</strong> thosewith a larger market scope are more engaged in food defensepractices.‣ Individual companies are doing better internally than they are doingwith their suppliers or than they perceive their suppliers to be doing.‣ Cross supply chain communication about practices & coordination willbe very important to continue to improve food defense practices <strong>and</strong>further strengthen the U.S. farm-to-fork supply chain continuum.31Source: Kinsey, Jean, Kateryna Kaynts, KoelGhosh:”Defending the <strong>Food</strong> Supply Chain: Retail <strong>Food</strong>,<strong>Food</strong>service <strong>and</strong> Their Wholesale Suppliers”, The <strong>Food</strong>Industry Center, University <strong>of</strong> Minnesota, November 2007INSCATECH Copyright 2012Supply Chain RisksA SUPPLY CHAIN ISAS STRONG AS ITSWEAKEST LINK…32INSCATECH Copyright 2012

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