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EnsuringGlobalFoodSafety Thispageintentionallyleftblank
EnsuringGlobalFoodSafety ExploringGlobalHarmonization SECONDEDITION Editedby AleksandraMartinovic
UniversityofDonjaGorica,CentreofExcellence-FoodHub,Podgorica,Montenegro SangsukOh
DepartmentofFoodScienceandTechnology,EwhaWomansUniversity,Seoul,Korea HuubLelieveld
GlobalHarmonizationInitiative(GHI),Vienna,Austria
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TypesetbyTNQTechnologies
1.Introduction:Ensuringglobalfood safety:Apublichealthpriorityand aglobalresponsibility
JulieLarsonBricher
2.Safetyandsecurity:thecostsand benefitsoftraceabilityand transparencyinthefoodchain
KatyA.Jones
2.1Theburdenoffoodborneoutbreaks
2.1.1Eachyear48millionpeopleget sickfromfoodborneillnesses, 128,000arehospitalized,and 3000die
2.1.2About23%ofU.S.foodrecalls costthefoodindustryover$30 millionand14%cost organizationsover$50million
2.1.3Reducingfoodborneillnessesby just1%wouldpreventnearly 500,000Americansfromgetting sickeachyear
2.4Thecostsassociatedtoalackof
AhmadDin,NealD.Fortin,AlidaMahmudova, BernardMaister,HalideGokc¸eTu ¨ rkoglu, FehmiKeremBilgin,JoeLederman, MargheritaPaolaPoto,V.D.Sattigeri,MunGiSohn, JuanjuanSun,AltinayUrazbaeva, YuriyVasilievandRebecaLo´pez-Garcı´a
3.5TheroadtoharmonizationinLatin
3.5.1Introduction
3.5.2Stepstowardharmonization
3.5.3Thechallengesofregionalfood
3.5.4Regionalintentionsfor
3.5.5Generalregulatorystructure
3.5.6Tradeagreements
3.5.7Conclusions
3.6EuropeanUnion
3.6.2Institutional
3.6.4Principlesandconcepts
3.6.5Standards
3.6.6Authorizationrequirements
3.6.7Foodsafetylimits
3.6.8Processrequirements
3.6.9Labeling
3.6.10Humanrighttofood/food
3.7.1Introduction
3.7.2Fundamentalinstitutional
3.7.3Standards
3.8TheRussianFederation
3.8.1Russianfoodlaw
3.8.2Institutions
3.8.4Generalfoodsafety
3.8.5Authorization
3.9.3Developments
3.9.5Theaddresseesoffoodlaw
3.9.6CodexAlimentarius
3.9.7Institutional
3.9.8Principlesandconcepts 73
3.9.9Standards 74
3.9.10Authorizationrequirements 74
3.10.3Principlesandconcepts 79
3.10.4Standards 79
3.10.5Authorizationrequirements 80
3.10.6Foodsafetylimits 81
3.10.7Processrequirements 82
3.10.8Labeling 83
3.10.9Humanrighttofood/food
3.14.6Authorizationrequirements 106
3.14.7Foodsafetylimits 107
3.14.8Processrequirements 108
3.14.9Labeling 109
3.14.10AppsdevelopedbyFSSAI 111
3.14.11Humanrighttofoodand foodsecurity 111
3.14.12Specificissues 111 Furtherreading 111
3.15Pakistan 112
3.15.1Foodsafetystandardsand regulations 112
3.15.2Statusoffoodlawsand regulations 113
3.15.3Principlesandconcepts 113
3.15.4Labeling 114
3.15.5Conclusion 115
3.16EasternAfrica 115
3.16.1Introduction 115
3.16.2Institutional 118
3.16.3Principlesandconcepts 118
3.16.4Standards 119
3.16.5Authorizationrequirements 120
3.16.6Foodsafetylimits 120
3.16.7Processrequirements 121
3.16.8Labeling 121
3.16.9Humanrighttofood/food
3.16.10Specificissues 122
3.17RepublicofSouthAfrica 123
3.17.1Historyandbackground 123
3.17.2Foodregulatorysystem 124
3.17.3Majorlaws 126
3.17.4Additionalaspects
3.17.5Labeling
3.18Privatefoodlaw
3.18.1Introduction
3.18.2Triangularstructure
3.18.3Standards
3.18.4Standardsetting organizations
3.18.5Harmonization
3.18.6Enforcement
3.18.7Accreditation
4.Theglobalharmonizationinitiative HuubLelieveldandVeslemøyAndersen
4.7.1Workinggroupnomenclature offoodsafetyandquality 142
4.7.2Workinggroupchemicalfood safety 143
4.7.3Workinggroupeducationand trainingoffoodhandlers 143
4.7.4Workinggroupethicsinfood safetypractices 143
4.7.5Workinggroupfood microbiology 144
4.7.6Workinggroupfoodpackaging materials 144
4.7.7Workinggroupfood preservationtechnologies 144
4.7.8Workinggroupfoodsafetyin relationtoreligiousdietarylaws 145
4.7.9Workinggroupgenetic toxicologyandgenomics 145
4.7.10Workinggroupglobalincident alertnetwork 146
4.7.11Workinggroupmycotoxins 146
4.7.12Workinggroupnanotechnology andfood 146
4.7.13Workinggroupnutrition 147
4.7.14Workinggroupreducing postharvestlosses 147
4.7.15Workinggroupscience communication 147
4.7.16Workinggroupfoodlawand regulations 147 4.8GHIlibrary 148 4.9Conclusion 148 References 148
5.Foodsafetyregulationswithin countriesofincreasingglobal supplierimpact
OdelYunLIandXian-MingShi
5.1Introduction 151
5.1.1Internationalfoodsuppliers 151
5.1.2Globalfoodsupplychain 154
5.1.3TheimpactofE-commerce platformonglobalfoodsupply 154
5.2Regulationsofglobalfoodsuppliersby internationallawandstandards 154
5.2.1Therecommendationsofthe codexalimentariuscommission 154
5.2.2Sanitaryandphytosanitary standardsoftheWorldTrade Organization 155
5.3Regulationsofglobalfoodsuppliersby domesticlaws 155
5.3.1USA 155
5.3.2EU 155
5.4Conclusion:supplierchangeandglobal foodsafetyregulation 156 Furtherreading 157
6.Asimplifiedguidetounderstanding andusingfoodsafetyobjectivesand performanceobjectives
L.G.M.Gorris,M.B.ColeandTheInternational CommissiononMicrobiologicalSpecifications forFoods
6.1Introduction 159
6.2Goodpracticesandhazardanalysis criticalcontrolpoint 160
6.3Settingpublichealthgoals the conceptofappropriatelevelof protection 160
6.4Foodsafetyobjectives 161
6.5Performanceobjectives 162
6.6Thedifferencebetweenfoodsafety objectives,performanceobjectives, andmicrobiologicalcriteria 162
6.7Responsibilityforsettingafoodsafety objective 163
6.8Settingaperformanceobjective 163
6.9Responsibilityforcompliancewiththe foodsafetyobjective 163
6.10Meetingthefoodsafetyobjective 164
6.11Notallfoodsafetyobjectivesare feasible 164
6.12Concludingremarks 164
6.13AbouttheICMSF 165 Acknowledgments 165 References 165 Furtherreading 166
7.Regulatingemergingfoodtrends: acasestudyininsectsasfoodfor humans
AdinaAlexandraBaicu
7.1Introduction 167
7.3Whyeatinginsects? 168
7.4Theconsumersarehavingasay 168
7.5Regulatoryaspectsregardinginsectsfor humanconsumption 169
7.5.1CodexAlimentarius 169
7.5.2Regulatingedibleinsectsinthe EuropeanUnion 169
7.5.3Regulatingedibleinsectsinthe USA 170
7.5.4Regulatingedibleinsectsin Canada 170
7.5.5Regulatingedibleinsectsin AustraliaandNewZealand 171
7.5.6Regulatingedibleinsectsin AfricaandAsia 171
7.6Conclusions 171 References 172
8.Somethoughtsonthepotentialof globalharmonizationof antimicrobialsregulationwithafocus onchemicalfoodsafety
JaapC.Hanekamp
8.1Introduction 175
8.2Globalestimatesofantimicrobialsin foodanimals thewrongandtheright trousers 175
8.3The“nature”ofantimicrobials 176
8.4Aprecautionarytaleand chloramphenicol 177
8.5Riskprofileoffoodscontaining CAP ofexposurelevelsand toxicologicalmodels 179
8.6Towardastraightforward resolution IntendedNormalUse 180 References 183
9.Substantiatingregular,qualified,and traditionalhealthclaims
BertSchwittersandJaapC.Hanekamp
9.1Introductionandbackground 187
9.2Whentruthandcertaintymust compete 188
9.3Qualifyingthecertaintyof information 188
9.4RCT’sandplausibility 188
9.5Traditionalmedicinalproductsinthe EU 189
9.6Healthclaimsbasedontraditionaluse 190 9.7Basicevidentialrequirements 190 9.8Qualifyingtheexpert 191
9.9Reliabilityoftheexpert’sopinion 191 9.10Principlesandmethodology 192 9.11Degreeofscrutiny 192
9.12Extrapolatingresultsobtainedin diseasedsubjects 192
9.13Plausibility 193
9.14Thewayforward 194 References 194
10.Benefitsandrisksoforganicfood
H.K.S.DeZoysaandVidurangaY.Waisundara
10.1Themodernfoodmarket 197
10.2Whyorganicfood? 197
10.2.1Consumerattitude, behavioralintentions,and preferencetowardorganic andnonorganicfood products 198
10.3Organicfoodproductionandmarket 200
10.3.1Farmingtypes 201
10.3.2Retailmarketingaspectsof organicfood 202
10.4Impactandbenefitsoforganicfood 203
10.4.1Nutritionalcomposition 203
10.4.2Healthbenefits 205
10.4.3Environmentalconcerns 206
10.4.4Safetyaspects 207
10.5Limitations,gaps,andfuture research 208
10.6Conclusions 210 References 210
11.Mycotoxinmanagement:an internationalchallenge
RebecaLo´pez-Garcı´a
11.1Introduction 213
11.2Mycotoxinregulations 214 11.3Harmonizedregulations 214
11.3.1Australia/NewZealand 215
11.3.2EuropeanUnion 215
11.3.3MERCOSUR 215
11.3.4ASEAN 215
11.3.5CodexAlimentarius 216
11.4Tradeimpactofregulations 217
11.5Technicalassistance 218
11.6Conclusion 218 References 219
12.Novelfoodprocessingtechnologies andregulatoryhurdles
GustavoV.Barbosa-Ca ´ novas, DanielaBermu ´ dez-Aguirre, BeatrizGonc¸alvesFranco,KezbanCandogan andGaYoungShin
12.1Introduction 221
12.2Noveltechnologies 222
12.3Nonthermaltechnologies 223
12.4Thermaltechnologies 224
12.5Legislativeissuesconcerningnovel technologies 225
12.6Globalharmonizationconcerning noveltechnologies 225
12.7Finalremarks 227 References 227
13.Processingissues:acrylamide,furan, and trans fattyacids
LaurenS.JacksonandFadwaAl-Taher
13.1Introduction 229
13.2Acrylamide 229
13.2.1Introduction 229
13.2.2Occurrenceandlevelsof acrylamideinfood 230
13.2.3Mechanismofformation 233
13.2.4Factorsaffectingformation 234
13.2.5Preventionandmitigation 236
13.2.6Healtheffectsofdietary acrylamide 239
13.2.7Regulatorystatus/risk management 240
13.3Furan 241
13.3.1Introduction 241
13.3.2Occurrenceandlevelsof furaninfood 241
13.3.3Mechanismsofformation 244
13.3.4Factorsaffectingfuran formationandmitigation infood 245
13.3.5Healtheffectsofdietary furan 246
13.3.6Regulatorystatus 246
13.4Transfattyacids 247
13.4.1Introduction 247
13.4.2Regulatorystatus/risk management 247
13.4.3Hydrogenation 248
13.4.4Decreasing trans fattyacids infatsandoils 248 13.5Conclusions 249 References 250
14.Foodsafetyandregulatorysurvey offoodadditivesandother substancesinhumanfood
LarryKeener
14.1Introduction 259
14.1.1Foodadditive 259
14.1.2Processingaids 262
14.1.3Cosmeticadditives comparisonofEUandUS coloradditiveregulations 264
14.1.4Prohibitedandbanned substances 268
14.1.5Conclusion 272 References 273
15.Foodcontactmaterialslegislation: sanitaryaspects
AlejandroAriosti
15.1Introduction 275
15.1.1Scope 275
15.1.2Food packaging environmentinteractions 275
15.1.3Importanceofassessingand controllingtheinteractions 279
15.1.4Hygienicrequirementsof FCMs 279
15.2FCMslegislationintheEuropean Union 285
15.2.1EUFrameworkRegulation onFCMs 285
15.2.2EUregulationonGMP 286
15.2.3EUlegislationonspecific FCMs 286
15.2.4EUlegislationonspecific substances 289
15.2.5Legislationonkitchenware madeofmelamineor polyamideoriginating orconsignedfromChina orHongKong 289
15.2.6ECrecommendationonthe coordinatedcontrolplanof migratingsubstancesfrom FCMs 289
15.3TheCouncilofEuropetechnical recommendationsonFCMs 289
15.4FCMslegislationinthe UnitedStates 290
15.5FCMslegislationintheMERCOSUR 294
15.6FCMslegislationinJapan 297
15.7FCMslegislationinChina 299
15.7.1GBstandardsofgeneral application(horizontal) 300
15.7.2CommodityGBstandards 303
15.7.3GB31603-2015“general healthcodeforproductionof FCMsandproducts” 304
15.7.4Compliancetestingmethods 304
15.8ComparisonofFCMslegislations 305
15.9Conclusions harmonization,mutual recognition,andnewlegislations 306 Listofacronyms
16.Nanotechnologyandfoodsafety
SyedS.H.Rizvi,CarmenI.Moraru, HansBouwmeester,FransW.H.Kampersand YifanCheng
16.1Introduction 325
16.2Nanotechnologyandfoodsystems 325
16.2.1Structureandfunction characterizationand modification 326
16.2.2Nutrientdeliverysystems 326
16.2.3Sensingandsafety 327
16.2.4Antimicrobials 327
16.2.5Foodpackagingandtracking 328 16.3Currentstatusofregulationof nanomaterialsinfood
16.3.1NorthAmerica
16.3.2Europe
16.4Hurdlesinevaluationandregulation oftheuseofnanotechnologyin foods 331
16.4.1Lackofagooddefinition 331
16.4.2Detectionofmanmade nanomaterialsincomplex matrices,includingfoods 332
16.4.3Assessmentofexposureto nanoparticles 332
16.4.4Toxicityofnanoparticles 333
16.4.5Characteristicsandbehavior ofnanoparticlesinfood
17.Monosodiumglutamateinfoods anditsbiologicalimportance
HelenNonyeHenry-Unaeze 17.1Introduction
18.Respondingtoincidentsoflowlevelchemicalcontaminationand deliberatecontaminationinfood
ElizabethA.Szabo,ElisabethJ.Arundell, HazelFarrell,AlisonImlay,TheaKing, CraigShadboltandMatthewD.Taylor
18.1Introduction 359
18.2Riskanalysis 360
18.3Generalcontrolmeasuresfor chemicals 362
18.3.1Maximumresiduelimitsfor agriculturalandveterinary residuesinfood 362
18.3.2Maximumlevelsfor contaminantsinfoods 363
18.4Casestudy1 364
18.4.1Naturallyoccurring contamination:ciguatoxins 364
18.5Casestudy2 368
18.5.1Deliberatetamperingof strawberrieswithneedles 368
18.6Casestudy3 370
18.6.1Environmental contamination per-and poly-fluoroalkylsubstances 370 18.7Conclusion
19.Nutraceuticals:possiblefuture ingredientsandfoodsafetyaspects
M.A.J.S.vanBoekel
19.1Introduction
19.5Regulationsandsafetyissues
20.Nutritionandbioavailability:sense andnonsenseofnutritionlabeling
AdeliaC.Bovell-Benjamin
20.5.3AustraliaandNewZealand 395 20.5.4Developingcountries CodexAlimentarius 402
20.6Nutritionlabelingindifferent countries 404
20.7Consumerunderstandinganduse ofnutritionlabels 405
20.7.1Front-of-packnutrition labelingsystem 407
20.7.2GlobalsituationofFoPL 407
20.7.3FuturedirectionsofFoLP 408 20.8Bioavailabilityandnutritionlabel 408 20.9Conclusion 411 20.10Futurescope
21.Thefirstlegislationforfoodswith healthclaimsinKorea
JiYeonKim,SewonJeong,OranKwonand SangsukOh
21.1Background 417 21.2Health/FunctionalFoodAct 417 21.3HealthclaimsallowedforHFFs 418 21.4Scientificsubstantiationofhealth claimsforHFFs 418
21.4.1Identificationandstabilityof functionalingredientsor components 418
21.4.2Safetyevaluationof functionalingredientsor components 418
21.4.3Reviewofscientific substantiationofhealth claims 419
21.4.4Re-evaluation 420 21.4.5Kindsoffunctional ingredients 420
21.4.6Connectionofscientific evaluationtoconsumer understanding 421 21.5Futuredirections 421 References 422
22.Bioactivity,benefits,andsafetyof traditionalandethnicfoods
AdeliaC.Bovell-Benjamin
22.4Methodology 424
22.5Structureofthereview 424
22.6Foodandchronicdiseases 424
22.7Biologicalmechanismofbioactive foodcompounds 425
22.8Bioactivefoodcompoundsin traditional/ethnicfoods 427
22.8.1LatinAmerica 427
22.8.2Africa 429
22.8.3Asia 431
22.9Conclusion 434
22.10Futurescope 434 Acknowledgments 435 References 435 Furtherreading 438
23.Waterdeterminationinfood
Heinz-DieterIsengard
23.1Introduction 439
23.2Watercontent 439
23.2.1Importanceofwatercontent 439
23.2.2Methodstodeterminewater content 440
23.2.3Dryingtechniques 440
23.2.4KarlFischertitration 440
23.3Waterdeterminationindairy powders 441
23.3.1Thelactoseproblem scientificbackground 441
23.3.2Thelactoseproblem economicaspects 441
23.3.3Referencemethodfor determiningmoisturein milkpowders 441
23.3.4Massloss,moisturecontent, andwatercontent comparisonofresults obtainedbydifferent methodsforvariousdairy powders 442
23.3.5Ovendrying 442
23.3.6Referencedrying 442
23.3.7KarlFischertitration 442
23.3.8Generalprocedure 442
23.3.9Resultsanddiscussion 443
23.3.10Concludingconsiderations 446
23.4Watercontentdeterminationby near-infraredspectroscopy 447
23.4.1Rapidwaterdetermination bynear-infrared spectroscopy 447
23.4.2Waterdeterminationin awheypowderbyNIR spectroscopy 447
23.4.3Resultsanddiscussionof NIRmeasurements 448
23.4.4Concludingconsiderations 448
23.5Summary 450 References 450
24.Globalharmonizationofanalytical methods
PamelaL.Coleman,AnthonyJ.Fontanaand JohnSzpylka
24.1Introduction 453
24.2Methodsforestablishingthebasic composition,quality,oreconomic valueoffoods 454
24.3Methodsforestablishingthenutrient contentoffoods 456
24.4Methodsfordetectingorconfirming theabsenceofcontaminantsin foods 458 24.5Conclusion 459 References 459
25.Globalharmonizationofthecontrol ofmicrobiologicalrisks
CynthiaM.Stewart,FrankF.Bustaand JohnY.H.Tang
25.1Introduction 461
25.2Microbiologicalfoodsafety management 461
25.3Emergingfoodbornepathogens 462
25.3.1 Salmonella spp. 463
25.3.2 Staphylococcusaureus 463
25.3.3 Campylobacter spp. 464
25.3.4 Escherichiacoli 464
25.4Microbiologicalcriteria 465
25.5Microbiologicaltesting 466
25.6Validationofmicrobiological methods 467
25.6.1Associationofanalytical communities 468
25.6.2Internationalorganization forstandardization 468
25.7Harmonizationofglobalregulations for Listeriamonocytogenes in ready-to-eatfoods 469
25.8Conclusion 472 References 472
26.Testingforfoodsafetyusinghuman competentlivercells(HepG2): areview
FirouzDarroudi
26.1Introduction 475
26.2Assessmentofhumanfoodsafety andthecurrentproblemsusing existing invitro and invivo assays 475
26.3HumanHepG2cellsystem 476
26.4SpecificfeaturesofhumanHepG2 cells 476
26.5Validationandapplicationofhuman HepG2cellsandtheirS9-fractionsin genetictoxicologystudiesfor assessingfoodsafety 477
26.5.1Assessmentofthegenotoxic potentialofknown carcinogenand noncarcinogens 477
26.5.2Assessmentofthegenotoxic potentialofmycotoxins 478
26.5.3Assessmentofthegenotoxic potentialofheterocyclic aromaticamines 479
26.5.4Antigenotoxicpotentialof glycinebetaineona heterocyclicaromatic amineTrp-p-2inHepG2 cells 479
26.5.5Toxicitystudiesof compoundsand mechanisticassayson NAD(P)H,ATP,DNA contents(cellproliferation), glutathionedepletion, calceinuptake,andradical oxygenassayusinghuman HepG2cells 480
26.5.6Thegenotoxicpotentialof heavymetalsinHepG2 cells 481
26.5.7Toassessthegenotoxic potentialofhumandietary componentsinfermented foodandinalcoholic beveragesusingHepG2 cells 481
26.5.8ToassessDNAdamage induction,repairkinetics, andbiological consequencesofchemical mutagens/carcinogensin HepG2cells 482
26.5.9Applicationofhuman HepG2cellsystemto detectdietary antigenotoxicants 483
26.5.10Theuseofgenomicand proteomictechnologiesin HepG2cells 483
26.6Conclusion 485 Acknowledgments 485 References 485
27.Capacitybuilding LarryKeenerandTatianaKoutchma
27.1Introduction 489
27.2Capacitybuilding 490
27.3Theroleofmultilateralagreementsin achievingfoodsafety 492
27.3.1Historicaldevelopmentsin foodsafetymanagementand multilateralagreements 493
27.4Unilateralfoodsafetylegislationfor promotingcapacitybuilding 495
27.4.1U.S.FDAFoodSafety ModernizationAct 496
27.4.2EuropeanUnionGeneral FoodLaw 498
27.4.3SafeFoodforCanadiansAct 499 27.5Conclusion 500 References 502
28.Capacitybuilding:building analyticalcapacityformicrobial foodsafety
DebdeepDasgupta,MandyamC.Varadaraj andPaulaBourke
28.1Introduction 503
28.2Significanceofmicrobialfoodsafety 503
28.3 Staphylococcus anditsspecies 504
28.3.1Characteristics 504
28.3.2Methodsofdetection 505
28.4Listeriamonocytogenes 508
28.4.1Conventionalisolation methods 508
28.4.2Immunologicaldetection methods 510
28.4.3Nucleicacid basedmethods 510
28.4.4Othermethods 512
28.5Bacilluscereus 512
28.5.1Detectionmethods 513
28.6CapacitybuildinginIndia 515 References 517 Furtherreading 523
29.Roleofeducationandtrainingof foodhandlersinimprovingfood safetyandnutrition:theIndian experience
JamunaPrakash
29.1Foodenvironment:dietaryand nutritiontransitionasprime determinantsoffoodbehavior 525
29.1.1Foodandwaterborne infectionsareoneofthe
leadingcausesofillness amongyoungandoldalike, especiallyindeveloping
Listofcontributors FadwaAl-Taher,VDFFutureCeuticals,Inc.,Momence, IL,UnitedStates
VeslemøyAndersen,GlobalHarmonizationInitiative (GHI),Vienna,Austria
AlejandroAriosti,NationalInstituteofIndustrialTechnology(INTI) PlasticsCenter,BuenosAires, Argentina;DepartmentofFoodScience,Facultyof PharmacyandBiochemistry,UniversityofBuenos Aires(UBA),BuenosAires,Argentina
ElisabethJ.Arundell,TheNewSouthWalesDepartment ofPrimaryIndustries,Orange,NSW,Australia
AdinaAlexandraBaicu,UniversityofAgronomicSciencesandVeterinaryMedicineofBucharest,Romania
GustavoV.Barbosa-Cánovas,CenterforNonthermal ProcessingofFood,WashingtonStateUniversity, Pullman,WA,UnitedStates
DanielaBermúdez-Aguirre,CenterforNonthermalProcessingofFood,WashingtonStateUniversity,Pullman, WA,UnitedStates
FehmiKeremBilgin, IzmirBakirçayUniversity,Faculty ofLaw,Menemen, _ Izmir,Turkey
PaulaBourke,SchoolofBiosystemsandFoodEngineering,UniversityCollegeDublin,Dublin,Ireland
HansBouwmeester,DivisionofToxicology,Wageningen UniversityandResearch,Wageningen,theNetherlands
AdeliaC.Bovell-Benjamin,FoodandNutritionalSciences,TuskegeeUniversity,Tuskegee,AL,United States
JulieLarsonBricher,QuiddityCommunications,Inc., McMinnville,OR,UnitedStates
FrankF.Busta,UniversityofMinnesota,Minneapolis,St. Paul,MN,UnitedStates
KezbanCandogan,FacultyofEngineering,Department ofFoodEngineering,AnkaraUniversity,Ankara, Turkey
MelissaM.Card,InstituteforFoodLaws&Regulations, MSU,MichiganStateUniversity’sCollegeofLaw, UnitedStates
YifanCheng,DepartmentofFoodScience,CornellUniversity,Ithaca,NY,UnitedStates
M.B.Cole,Head,SchoolofAgricultureFoodandWine. UniversityofAdelaide,Urrbrae,SA,Australia
PamelaL.Coleman,MérieuxNutriSciences,Chicago,IL, UnitedStates
FirouzDarroudi,GlobalHarminizationInitiaitve(GHI), SectionofGeneticToxicologyandGenomics,Oegstgeest,TheNetherlands
DebdeepDasgupta,DepartmentofMicrobiology,SurendranathCollege-Kolkata,Kolkata,WestBengal,India
H.K.S.DeZoysa,DepartmentofBioprocessTechnology, FacultyofTechnology,RajarataUniversityofSri Lanka,Anuradhapura,NorthCentralProvince,Sri Lanka;DepartmentofBiology,UniversityofNaples FedericoII,Naples,Italy
AhmadDin,NationalInstituteofFoodScience&Technology,UniversityofAgriculture,Faisalabad,Pakistan
HazelFarrell,TheNewSouthWalesDepartmentofPrimaryIndustries,Taree,NSW,Australia
AnthonyJ.Fontana,MérieuxNutriSciences,Chicago,IL, UnitedStates
NealD.Fortin,InstituteforFoodLawsandRegulations, MichiganStateUniversity,EastLansing,MI,United States
BeatrizGonçalvesFranco,CenterforNonthermalProcessingofFood,WashingtonStateUniversity,Pullman, WA,UnitedStates
L.G.M.Gorris,FoodSafetyExpert,FoodSafetyFutures, Nijmegen,TheNetherlands
JaapC.Hanekamp,UniversityCollegeRoosevelt,Middelburg,theNetherlands;EnvironmentalHealthSciences,UniversityofMassachusettsAmherst,Amherst, MA,UnitedStates;HAN-Research,Zoetermeer,the Netherlands
HelenNonyeHenry-Unaeze,DepartmentofFood,Nutrition andHomeScience,FacultyofAgriculture,Universityof PortHarcourt,East-WestRoadChoba,Rivers,Nigeria
AlisonImlay,TheNewSouthWalesDepartmentofPrimaryIndustries,Silverwater,NSW,Australia
Heinz-DieterIsengard,UniversityofHohenheim,Institute ofFoodScienceandBiotechnology,Stuttgart,Germany
LaurenS.Jackson ,U.S.FoodandDrugAdministration, DivisionofFoodProcessingScience&Technology, BedfordPark,IL,UnitedStates
SewonJeong,BiofoodCRO,Seoul,Korea
KatyA.Jones,FoodLogiQ,Durham,NC,UnitedStates
FransW.H.Kampers,WageningenUR,Wageningen,the Netherlands
LarryKeener,InternationalProductSafetyConsultants, Seattle,WA,UnitedStates
JiYeonKim,DepartmentofFoodScienceandTechnology,SeoulNationalUniversityofScienceandTechnology,Seoul,Korea
TheaKing,TheNewSouthWalesDepartmentofPrimary Industries,Silverwater,NSW,Australia
TatianaKoutchma,AgricultureandAgriFoods,Canada
OranKwon,DepartmentofNutritionalScienceandFood Management,GraduatePrograminSystemHealth ScienceandEngineering,EwhaWomansUniversity, Seoul,Korea
JoeLederman,FoodLegal,Australia
HuubLelieveld,GlobalHarmonizationInitiative(GHI), Vienna,Austria
RebecaLópez-García,LogreInternationalFoodScience Consulting,Mexico
AlidaMahmudova,BonaMenteConsultingLLCLaw Company,Azerbaijan
BernardMaister,IntellectualPropertyUnit,Universityof CapeTown,CapeTown,SouthAfrica
CarmenI.Moraru,DepartmentofFoodScience,Cornell University,Ithaca,NY,UnitedStates
SangsukOh,DepartmentofFoodScienceandTechnology,EwhaWomansUniversity,Seoul,Korea
MargheritaPaolaPoto,K.G.JebsenCentrefortheLaw oftheSea,UiT,Tromsø,Norway
JamunaPrakash,GlobalHarmonizationInitiative,Austria
SyedS.H.Rizvi,DepartmentofFoodScience,Cornell University,Ithaca,NY,UnitedStates
V.D.Sattigeri,FoodSafetyandAnalyticalQualityControl Laboratory,CentralFoodTechnologicalResearch Institute,Mysuru,Karnataka,India
BertSchwitters,IndependentResearcher
CraigShadbolt,TheNewSouthWalesDepartmentof PrimaryIndustries,Silverwater,NSW,Australia
Xian-MingShi,MOST-USDAJointResearchCenterfor FoodSafety,SchoolofAgricultureandBiology,State KeyLabofMicrobialMetabolism,ShanghaiJiaoTong University,Shanghai,China
GaYoungShin,CenterforNonthermalProcessingof Food,WashingtonStateUniversity,Pullman,WA, UnitedStates
MungiSohn,FoodScienceandBiotechnology,Collegeof LifeSciences,KyungHeeUniversity,Republicof Korea
CynthiaM.Stewart,SillikerFoodScienceCenter,South Holland,IL,UnitedStates
JuanjuanSun,FoodLaw,NantesUniversityofFrance, CenterforCoordinationandInnovationofFoodSafety Governance,RenminUniversity,Beijing,China
ElizabethA.Szabo,TheNewSouthWalesDepartmentof PrimaryIndustries,Silverwater,NSW,Australia
JohnSzpylka,MérieuxNutriSciences,Chicago,IL, UnitedStates
JohnY.H.Tang,UniversitiSultanZainalAbidin,Terengganu,Malaysia
MatthewD.Taylor,TheNewSouthWalesDepartmentof PrimaryIndustries,TaylorsBeach,NSW,Australia
TheInternationalCommissiononMicrobiological Speci ficationsforFoods,www.icmsf.org
HalideGökçeTürkoglu, _ IzmirBakirçayUniversity,FacultyofLaw,Menemen, Izmir,Turkey
AltinayUrazbaeva,StudyingAdvancedMasterProgramin European,InternationalBusinessLaw,LeidenUniversity
M.A.J.S.vanBoekel,FoodQuality&DesignGroup, WageningenUniversity&Research,Wageningen,the Netherlands
BerndvanderMeulen,GHI,Prof.ComparativeFood Law,RenminUniversityofChinaSchoolofLaw, UniversityofCopenhagen,EuropeanInstituteforFood Law,Amsterdam,TheNetherlands
MandyamC.Varadaraj,DepartmentofHumanResource Development,CentralFoodTechnologicalResearch Institute,Mysore,Karnataka,India
YuriyVasiliev,StavropolBranch,NorthCaucasusCivil ServiceAcademy,Russia
OdelYunLI,ShanghaiJiaoTongUniversity,Shanghai LegislativeResearchInstitute,Shanghai,China Listofcontributors
VidurangaY.Waisundara,AustralianCollegeofBusiness&Technology-KandyCampus,PeradeniyaRoad, Kandy,CentralProvince,SriLanka
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Chapter1 Introduction:Ensuringglobalfoodsafety: Apublichealthpriorityandaglobal responsibility JulieLarsonBricher QuiddityCommunications,Inc.,McMinnville,OR,UnitedStates
Onlyifweacttogethercanwerespondeffectivelytointernationalfoodsafetyproblemsandensuresaferfoodforeveryone.
Dr.MargaretChan,formerDirector-General,WorldHealthOrganization.
Dr.MargaretChan’swordsservedastheopeningquoteofthisbookduringits firstpublicationnearlyadecadeago.We haveseenimprovementsinglobalhealthoutcomesinthepast10years,inpartduetopoliticalandcommunitypressureto implementevidence-basedandscientificallyinformedhealthandfoodsafetypoliciesandlegislationonaglobalscale. Chan’swordsringespeciallytruetoday:Itwasonlythroughcommunityeffortthattheseimprovedoutcomeswere achieved anditisonlythroughcontinuedcommunityeffortthatwecanensurethatsafefoodinadequatesupplyisthe realityforalltheworld’speople.
Themarchtowardglobalizationappearsinexorable,evenasthetrendremainspoliticallycontroversialontheworld stage.TheInternationalMonetaryFunddefinesglobalizationas “theprocessthroughwhichanincreasinglyfree flowof ideas,people,goods,services,andcapitalleadstotheintegrationofeconomiesandsocieties” (IMF,2006).Atitscore, globalizationisaprocessdrivenbyfreetradeeconomicsandanidealdrivenbythepromiseofgreatersocietalbenefitsfor allpeoplesoftheworld.
Proponentsputforwardthataneconomywithoutbordersspursgreatermarketcompetitionandthereforeeconomic freedom,drivingdownpricesandincreasingavailabilityandvarietyofaffordablegoodsandservicesforagreaternumber ofpeople.Inturn,globalizationpromisesfurtherbenefits,suchasincreasesinproductivity,accesstonewtechnologiesand informationstreams,andhigherliving,environmental,andlaborstandardsforthoseinbothdevelopedanddeveloping countries.Criticschargethatinherenteconomicandinfrastructureinequalitiesthatexistbetweendevelopedanddevelopingnationsprecludelessdevelopedandpoorernationsfromfullyrealizingthesebenefits.
Whateverthemeasurablepositivebenefitsexperiencedbysomecountriesinrecentyears,thereremaintangible challengesnotonlybroughtonbytherapidaccelerationofglobalizationintheworldeconomybuttheimpactofglobal climatechangeontheplanet ’sfoodsupply.Perhapstherearenostatisticsmorecompellingthanthoseofthe2018World ResourcesInstitute’sreport, “CreatingaSustainableFoodFuture,” whichprojectsthatthehumanpopulationisexpectedto growfrom7billionin2010to9.8billionin2050.Thedemandforfoodisestimatedtoincreasebymorethan50%and demandforanimal-basedfoodsbynearly70%(WRI,2018).Accordingtothereport,majorchangestotheglobalfood system byfarmers,foodcompanies,consumers,andgovernments willbenecessarytomitigateloomingfoodshortages worldwide.
Inaddition,nearly2decadesintothe21stcentury,thechallengesofensuringfoodsecurity,foodsafety,andnutrition onaglobalscalecontinuetogrowincomplexity.Recentstatisticsshowthatthelevelsofworldhunger,malnutrition,and food-andwaterbornediseasesareamongthemostcriticalglobalpublichealthissuesfacingtheinternationalcommunity. Forexample:
l AccordingtotheFoodandAgricultureOrganization(FAO)oftheUnitedNations,10.9%oftheworld’spopulationare undernourished,downfrom14.5%in2005.Thispercentagestillrepresentsroughly770millionpeople(FAO,2018).
l Globally,22.7%ofchildrenunder fi vewhoexperienceundernourishmentsufferfromstuntedgrowth(FAO,2018).
l TheWorldHealthOrganization(WHO)reportsthatmorethan1000childrenunder fivediedailyfromdiarrhealdisease causedbyinadequateaccesstowatersanitation(WHO,2014).
l In2015,foodbornediarrhealdiseaseagentsalonewerethecauseofdeathformorethan230,000people(WHO,2018; WHO2015).
l Worldwide,nearly1in10peoplefallillfromallfoodbornediseases,whichequatesto33millionhealthylifeyearslost andresultsinthedeathsofapproximately420,000people(WHO,2015).Childrenaccountforone-thirdofdeathsfrom foodbornediseases.
l Indevelopedcountries,oneinthreeconsumersgetafoodbornediseaseassociatedwithmicrobesortheirtoxinsevery year.Thisdoesnotincludeotherfoodbornediseasesassociatedwithnaturallyoccurringorman-madechemicalcontaminants,suchasaflatoxin,acrylamide,furan,ordioxin(Schlundt,2008).
TheWHOInitiativetoEstimatetheGlobalBurdenofFoodborneDiseasesidenti fiestherapidglobalizationoffood tradeasaworldwidetrendthathasintroducedanincreasedpotentialforcontaminatedfoodtoadverselyaffectgreater numbersofpeople(WHO,2015).Asthefoodsupplychainbecomesmoreintegrated,thepotentialformassivefoodborne illnessoutbreakscausedbypathogens,chemicals,viruses,andparasitesincreases asdothedifficultiesincontrolling foodborneinfections,morbidity,disability,andmortality.
Rapidglobalizationalsohasexposedcriticalgapsinnationalandinternationalcapabilitiestoassureadequatelevelsof foodsafetyandquality.Disparitiesrelatedtonationalinfrastructuralandtechnologicalcapacitiesandinternationalfood production,distributionandhandlingstandards,andlawhavebecomemorevisibleasglobalcommercebecomesmore interconnected.Asaresult,WHOandotherfood-relatedinternationalpublichealth,development,andstandard-setting bodieshavetargetedthesegapsaspriorityitemsandareworkingtogethertoreinforcetheneedtouseanintegratedinternationalfoodsafetyregulatorysystemintheeraof “oneglobalmarket.”
Tobeeffective,suchasystemmustincludeadvancingtheuseofriskanalysisandmanagementtobetterdirectresourcestowardareasofhighrisk,providingascienti ficbasisforinternationalfoodsafetyaction,movingfromconventional “vertical ” legislationwithinnationstomore “horizontal” rulingsamongnationstoattainharmonizationofstandards andreducebarrierstotrade,andbuildingcapacitytopromotetheavailabilityanduseofnewfoodsafetytechnologies, testingandpreventingstrategiesthatwillreducethepublichealthrisksoffoodbornediseasearoundtheglobe.
Inthesecondeditionofthisvolume, EnsuringGlobalFoodSafety APublicHealthPriorityandaGlobalResponsibility,membersoftheGlobalHarmonizationInitiative(GHI)onceagaincontributetotheworlddialogue,discussing toolsforpromotingharmonizationofscientificmethods,standards,andregulations.Establishedin2004,GHIisanetwork ofinternationalscienti ficorganizationsandindividualscientiststhataimstoachieveobjectiveconsensusonthescienceof foodregulationsandlegislationtoensuretheglobalavailabilityofsafeandwholesomefoodproductsforallconsumers.
Withsupportandparticipationofitsindividualmembersandmemberorganizations,theGHI’sWorkingGroupshave conductedaseriesofmeetingsatwhichmembershaveformulatedapproachestocritically(re-)evaluatethescientifi c evidenceusedtounderpinexistingglobalregulationsintheareasofproductcomposition,processingoperations,and technologiesormeasuresdesignedtopreventfoodborneillness.Eachchapterisreflectiveofoutcomesofthesediscussions andprogressindevelopingstrategiesto findtheshortestroutetoachievingglobalharmonizationinconcertwithinternationalpublichealthandfoodsafetyauthorities,includingtheWHO,FAO,theCodexAlimentariusCommission(CAC), andtheInternationalOrganizationforStandardization(ISO).
GHI’soverarchingobjectiveistoprovideregulators,policymakers,andpublichealthauthoritieswithafoundationfor sound,sensible,science-basedinternationalregulationsinordertoeliminatehurdlestoscientifi cadvancementinfood safetytechnology.Forexample,thereisnoquestionthatthemorethattheavenuesofglobaltradenarrow,thehigherthe probabilityoftraffi cjamsinworldwidecommerce.Barrierstotradeintheformofdiffering andsometimes conflicting country-by-countryimport/exportrulesandrequirementscananddomakeitdifficultforfoodbusinessesto gettractioninoverseasmarkets.
Foodsafetyconcernsarefrequentlycitedbyindividualnationsasunderpinningthejusti ficationfortheirlegislativeacts andrulemaking andforerectingtradebarriersandothermeasuresthathavetheimpactofcurtailingfreetrade.Unfortunately,insomecases,thescienceusedtoinformandbolsterfoodsafetypolicymakingisinsufficient,inconsistent,or contradictory,creatingaroadblocktothepromulgationoflawsthathaveaclearandevidentbenefittoprotectingpublic health.
Nationaldifferencesinfoodsafetyregulationsandlawsalsotriggeraredlighttotheadvancesofferedbyscienceand technology.Thoughmanyfoodcompaniesthroughouttheworldhaveinvestedsignificantmoniestofoodsafetyand nutritiontechnologyresearchanddevelopmentefforts,industryisunderstandablyhesitanttoapplynewlydeveloped capabilitiesonaninternationalscaleinanuncertain,maze-likeregulatoryenvironment.
GHIanticipatesthateliminationofregulatorydifferenceswillmakeitmoreattractivefortheprivatesectortoinvestin foodsafetyandnutritionresearchanddevelopment,consequentlystrengtheningthecompetitivenessofeachnation’sfood industryandoftheindustriessupplyingthefoodsector.Harmonizingglobalregulationswillaidintheuptakeand applicationofnewtechnologiesandencouragethefoodindustrytoinvestintechnologiestoensurethesafety,quality,and securityoftheglobalfoodsupply.
Ultimately, “globalizing” foodsafetyregulationsandlawsbasedonsoundsciencecanonlyservetohelpbridgepublic healthgapsandcreateopportunitiesforallstakeholderstorealizethebigpicturebenefitspromisedbyeconomicglobalization,includingmeasurableglobalreductionsinmorbidityandmortalityassociatedwithfoodbornedisease;increases infoodavailabilitytocombatmalnutritionandenhancefoodsecurityforconsumersworldwide;anddecreasesinpoverty ratesamongless-developedorimpoverishednationsthroughcapacitybuildingthatenablesfullparticipationinthe globaleconomy.
Forpublichealthagenciesresponsibleforoverseeingthe safetyoftheinternationalfoodsupply,harmonizationof foodsafetyandqualitystandardsandregulationswillbringahigherlevelofcon fi dencethatriskreductionstrategiesand foodsafetymeasuresareeffectiveandt hatdecisionstakenarebasedonscience andnotonunderlyi ngpoliticalagendas thatmaybeincon fl ictwithpublichealthgoals.Harmonizationwilla lsoensurethatavailabler esourcesareallocated wheretheyhavethehighestimpactonthemostpressingfooddisease relatedproblems.
ToparaphraseWHODirectorGeneralChan,itisonlythroughcollectiveactionthatwecanfullyembraceourglobal responsibilitytorespondeffectivelytothechallengesofensuringfoodsecurity,foodsafety,andnutritionforeveryone.As theauthorsinthisvolumeattest,meetingthatglobalresponsibilityrequirescooperation,collaboration,andconsensus buildingifwearetoachieveharmonizationoffoodregulationsandstandards,andtherebyaccomplishevengreatergains inglobalpublichealth.
References
FoodandAgricultureOrganization,2018.WorldFoodandAgriculture-StatisticalPocketbook2018. http://www.fao.org/publications/card/en/c/ CA1796EN
InternationalMonetaryFund,2006.GlossaryofSelectedFinancialTerms. http://www.imf.org/external/np/exr/glossary/showTerm.asp#91 Schlundt,J.,2008.Foodsafety:ajointresponsibility.In:14thWorldCongressofFoodScienceandTechnology.Shanghai,China.October20,2008. WorldHealthOrganization,2014.PreventingDiarrhoeathroughBetterWater,SanitationandHygiene. https://www.who.int/water_sanitation_health/ publications/gbd_poor_water/en
WorldHealthOrganization,2015.WHOEstimatesoftheGlobalBurdenofFoodborneDiseases:FoodborneDiseaseBurdenEpidemiologyReference Group,2007 2015. http://www.who.int/iris/handle/10665/199350
WorldResourcesInstitute,2018.SynthesisReport:CreatingaSustainableFuture:AMenuofSolutionstoFeedNearly10BillionPeopleby2050.Full reporttobepublishedin2019. www.wri.org/publication/creating-sustainable-food-future
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Safetyandsecurity:thecostsand benefitsoftraceabilityandtransparency inthefoodchain KatyA.Jones FoodLogiQ,Durham,NC,UnitedStates
Thefoodsupplychainisoneofthemostimportantbusinessaspectsoffoodcompaniesandrestaurants.Itiscriticalto everyoperationandprovidesorganizationswiththeopportunitytobuildanddelivertheirbrandpromise.Aneffi cient, well-managedfoodsupplychaincanhelptoimproveoperationalefficiency,mitigaterisk,improvebrandreputation,and increase(ormaintain)consumerconfidenceintheproductsbeingservedtocustomers.
Butthesebenefitsareonlyachievableifsupplychainsarekeptsafeandsecure.Thisrequiressupplychainsthatare monitoredandtrackedusingstrongprocessessupportedwithadvancedtechnologies.Asafoodcompanyorrestaurant,itis criticaltotrackandmonitorthesupplychaintoreducetheoverallrisktothebrand andtothecustomers.Inthischapter, wewilllookintothecostsoffoodborneoutbreaksnotonlytosocietybuttotheimpactofthebusinessaswell.
2.1Theburdenoffoodborneoutbreaks 2.1.1Eachyear48millionpeoplegetsickfromfoodborneillnesses,128,000arehospitalized,and 3000die(CentersforDiseaseControlandPrevention,2015)
Manypeopleareundertheassumptionthatfoodborneillnessismoreofaproblemindevelopingcountrieswhereregulationsarenotasstrict,butithitsclosertohomemoreoftenthanwethink.TheCentersforDiseaseControlandPrevention(CDC)intheUnitedStatesofAmericacloselymonitorallcasesoffoodborneillnessthatcomethroughtheUnited States,andthestatisticsarenotpretty.
It’snearlyimpossibletoeradicatefoodborneillnesses.Therearetoomanyfactorsthatgointoit,someoutofour control,butmorecanbedoneforprevention.Whenorganizationsemployenhancedtraceabilityprograms,combinedwith effectivesafetyplans,auditingandcorrectiveactions,therisksofcontaminationcanbemuchlower.Dependingonwhere youare,companiesshouldbeabletomonitorexactlywheretheirfoodwas,is,andwillbe,maintainingtotalvisibility acrossthesupplychain andreactquicklywhenafoodsafetyissuehits.
Additionally,whenfoodborneillnessesoccur,traceabilitycanreduceexposure.Assoonastheadulteratedfoodis identi fiedandtherootcauseisidentifi ed,itcanberecalledtopreventfurtherillnessandusedtoanalyzethemedicalaction neededtorectifythesituation.
2.1.2About23%ofU.S.foodrecallscostthefoodindustryover$30millionand14%cost organizationsover$50million(GroceryManufacturersAssociation,2011)
Thesestatisticsarestaggering.Executingarecallonfoodproductscanbeamanufacturer’sworstnightmaresimply becauseofthetimeandmoneylost.Recallingproductsisanessentialpartofmaintainingpublichealth,butitcanbe stressful.
Considerone E.coli outbreakinGermany(CentersforDiseaseControlandPrevention,2014).It’sdif ficulttocontain, andinthisinstance,therewasnotstrongtraceabilitythroughoutthesupplychain.3800peoplewereaffectedworldwide, 47died,andEuropeanUnionfarmerslost V417million($611million)(Grieshaber,2011).Theholisticcostofthis incidentshowsthattraceabilityisessentialtohealthyfoodindustries.
AndaccordingtoastudyfromresearchersatJohnHopkinsBloombergSchoolofPublicHealth,asinglefoodborne diseaseoutbreakatafast-casualestablishmentcouldcostbetween$6330and$2.1millioninlostrevenue, fines,and lawsuits.Andthisisonlyonthe fi nancialside.
2.1.3Reducingfoodborneillnessesbyjust1%wouldpreventnearly500,000Americansfrom gettingsickeachyear
Ifwewereabletoreducefoodborneillnessby1%,nearly500,000Americanscouldavoidsickness.Thiswillrequirea morestrategicapproachfromindividualsandfoodorganizationsalike.
Reducingfoodborneillnessessodrasticallywillrequireanewperspectiveonhowweviewfoodborneillnessesand mitigaterisks.In2013,theUnitedStatesspentabout$40millionontreatingtheproblembutnotpreventingit.Throughthe adoptionoftraceabilitysupportedbytechnology,organizationscanshiftthefocustowardprevention,savingmoney,and lives.
Reducingfoodborneillnesseswillnotbeaneasytask,anditreliesonindividualorganizationsmakingdecisionsthat impactsocietyasawhole.Astheyemploytraceability,theywillstarttomakeanimpactandtakeusclosertoreducing theseissues.
2.2Thefoodsupplychain:increasingrisk Foodsupplychainsaregrowingincreasinglycomplex,global,andfresh.Consumersaredrivingformorefreshformat conceptsandwanthealthieroptionsoverall.Yetthatprofi leofsupplychainintheoryhasincreasedrisk.
Freshproduceitemslikecilantro,cucumbers,cantaloupes,andpeppersthatareofteneatenrawcausemorefoodborne illnessthananyothersinglecategoryoffood,accordingtoastudybytheCenterforScienceinthePublicInterest(CSPI) (FoodSafetyNews,2015).Thenonpro fitfoodsafetygroupreviewed10yearsofoutbreakdatatodeterminewhichfoods aremostoftenlinkedtooutbreaksoffoodbornediseaseandidentifytrendsinillnesses.Overtheperiodstudied,fresh producecaused629outbreaksandalmost20,000illnesses.
ButthatdoesnotmeanAmericansshouldavoidfruitsandvegetables,CSPIsays.Whilethenumberofoutbreaksand illnessesislarge,onapound-for-poundbasisfreshproduceissaferthanmanyotherfoods.
Overtheperiodstudied,therewasatotalof193,754illnessesreportedfrom9626outbreaks.Ofthetotalnumberof reportedoutbreaks,theCDCwasabletoidentifyboththefoodsourceandthecontaminantinfewerthan40%.CSPIonly reviewedthe3485solvedoutbreaks.
Thereportalsofoundthatseafoodcausedmoreillnessesperpoundconsumedthananyotherfoodcategory,while fruits,vegetables,anddairycausedthefewestillnessesperpoundconsumed.
2.3Workingtowardtraceabilityandtransparency Nowthatwehaveestablishedtheburdenoftheissueandtheassociatedriskinthefoodsupplychain,weaskourselves whataretherealcostsassociatedwithafailureintransparencyandtraceability?
Foodregulatoryrequirementshaveshiftedinnature;now,ratherthanprimarilyfocusingonrespondingtofoodsafety incidents,thereisanincreasedemphasisonfoodsafetyprevention.Fortunately,thereareavarietyoftoolstohelpfood andbeveragemanufacturersensurethattheyarecompliantwithfoodsafetyregulations;thekeyispreparingforfood safetyauditsinadvance.Auditscanoccurin-housebyadedicatedteamorbyanexternalauditor,withthepurposebeingto identifyareasforimprovementtoprocessesandsystems.
UnderU.S.FoodandDrugAdministration(FDA)guidelinesandregulationsundertheFoodSafetyModernizationAct, foodandbeveragemanufacturersmusthaveafoodsafetyplaninplacethatincludesoversightandmanagementof preventivecontrolsestablishedineachmanufacturingfacility.Regulatoryauditsandauditreportsmustbesubmittedtothe FDA.In2019,theFDAannouncedtheNewEraofSmarterFoodSafetyinitiativethatencompassesfourpillarsthat includetech-enabledtraceability,smartertoolsforprevention,adaptingtonewbusinessmodelsinretail,andfoodsafety culture.TheblueprintreleasedalsoincludesproposedSectionFSMA204rulemakingtoharmonizethekeydataelements andcriticaltrackingeventsneededforenhancedtraceability(FDANewEraofSmarterFoodSafety).
InEurope,theEuropeanFoodSafetyAuthority(EFSA),establishedin2002,overseestheregulationofthefoodsupply chain.Theorganization’smissionis “todeliverindependent,high-qualityandtimelyscienti ficadviceonrisksinthefood chainfromfarmtoforkinanintegratedmannerandtocommunicateonthoserisksinanopenmannertoallinterested partiesandthepublicatlarge.”
TheexactsamelawthatestablishedEFSA,RegulationEC/178/2002,alsoestablishedthebasisforfoodtraceabilityin Europe.Underthelaw,anyfoodproducedinEuropeorimportedintoEuropeissubjecttoanincrediblyhighstandardfor traceability.Theregulationrequiresthatbothfoodmanufacturersanddistributorsdemonstrate “theabilitytotraceandfollow food,feed,andingredientsthroughallstagesofproduction,processing,anddistribution“ (EuropeanCommission,2019).
Althoughgoingthroughanauditcanbeastressfulevent,apassingresultwillassureyouandyourteamthatyour companyhasachievedasatisfactoryleveloffoodsafety.Asuccessfulauditalsoletsconsumersknowthatyourcompany prioritizestheirwellbeing.
2.4Thecostsassociatedtoalackoftraceability Withamanaged,improved,andefficientfoodsupplychaininplace,businessescanbegintoreapotherbenefits.Thiscan include financialgains,suchasanincreaseincreditrequestapprovalsandareductionininsurancepremiumcosts.
2.4.1Issueswithlabelingandbrandclaims Providingproofofyourproductclaimsisbyitselfenoughtoboostyourbusiness’ reputationintheindustryand worldwide.Withaccesstorobustsupplychaindata,companiescanproactivelyremoveanyissuesthatmaynegatively impactyourbrandinthefuture.Byidentifyingqualityissuesinadvance,youcanprotectyourbrandcommitmentandyour business’ reputation.
Forexample,youcancommunicateacrossyoursupplychaintopreventpoorortaintedproductsfrombeingdelivered toyourconsumer.Toexaminetherealpotentialreturnoninvestmentthatsupplychaintransparencycanachieve,letus lookatanexample:
Aconsumerpackagedgoodscompanythatproducesnut-freegranolabarshasbeennotifiedthatalotfromitsoat supplieractuallycontainedtracesofwalnut,whentheallergenclaimonthepackagingdoesnotlisttreenuts.Theissues haveonlybeenidentifiedafterthebatchhasbeensentouttoretailersandputonshelves.Thebatchof1500caseshadan averagesalepriceof$40,totaling$60,000worthofsales.$20,000ofthatsales figurewassunkmanufacturingcosts(the costoftherawingredients,manufacturing,andlabor).
WithoutSupplyChainTraceability:Themanufacturerisslowtorespondtothecrisis. Ittakestimeforstafftoidentifyifthecontaminatedbatchhasbeensentto figureoutexactlywhichstoresweresentthe taintedproduct.Thisequatestoalaborcostof$1,000.Oncetheshipmentlocationshavebeenidentified,themanufacturerhastheopportunitytogetthesalesbackquicklyiftheycanreplacetheproduct.Thereisa6%logistics costof$3,000torecalltheproductsanda$9,000costtoexpeditedeliveryofthenewproduct.Allofthisisontop ofthe$20,000costofmanufacturingthenewproduct.Thisisatotalcostof$33,000.However,becausetheproduct defectwasnotcaughtbeforeitwentonsale,themanufacturer’sreputationisseverelydamaged.Consumersnolonger trusttheirproduct,andtheyseea20%dropinsales.Thecompany’ssharepricealsofallsasaresult.
WithSupplyChainTraceability:Withenhancedtraceabilityinplace,thesituationisadifferentstory.Corporatefood safetycanusedatatoinstantlyseethatthecontaminatedbatchhasonlybeensenttothreestorelocations.The$1,000 laborcostissigni ficantlyreduced. Companiesthatutilizetraceabilitycanalsobenefitfromanaverage30%reductioninthedirectcostsassociatedwitha recall.Soinsteadofthelogisticalcoststotaling$12,000,thecostsonlytotal$8000.Thatisasavingof$4000. Becausethecompanyisabletoquicklyrespondtotheissueandpullthetaintedproductfromtheexactstorelocations, thedamagetotheirbrandisgreatlyreduced.Theymayseeasmallreductioninsalesbutnotnearthedamagecaused fromalong,drawn-outrecallplayedoutinthenewsmediaandsocialmedia.
2.4.2Restrictionstomarketaccess Withglobalizationcomestheopportunityforbusinessestoenternewmarketsacrosstheworldwithrelativeease.A traceablesupplychaincanhelptoeasecomplianceregulationonaglobalscale.Withatraceablesupplychain,youcan ensurethatalltradingpartnersmeetorexceedtheminimumacceptablestandardsformarketsacrosstheglobe.
