The Food Safety Modernization Act (FSMA) finalized rules requiring importers to verify that imported foods are produced in a manner that meets U.S. safety standards through Foreign Supplier Verification Programs (FSVPs). Importers must identify hazards, evaluate risks posed by foods and suppliers, conduct supplier approval and verification activities, and implement corrective actions. Compliance dates are 18 months after rule publication or six months after suppliers must meet U.S. standards. The rules aim to shift the focus from responding to contamination to preventing it in order to ensure the safety of the U.S. food supply.

1. 1
FOOD SAFETY AND MODERNIZATION ACT
UPDATE
November 2015
The FDA FoodSafetyModernizationAct(FSMA) isthe mostsweepingreformof ourfoodsupplylawsin
more than 70 years. The lawaimsto ensure the U.S.foodsupplyissafe by shiftingthe focusfrom
respondingtocontaminationtopreventingit.
FSMA Final rule on foreignsupplierverificationprograms for importers offood for humans and
animals
The FDA FSMA RULE ON ForeignSupplierVerificationProgramsforimportersof foodforHumanand
Animalsisnowfinal,andcompliance dates forsome businessesbeginin18 months.
The final rule requiresthatimportersperformcertainrisk-basedactivitiestoverifythatfoodimported
intothe UnitedStateshas been producedinamannerthat meetsapplicable U.S.safetystandards. This
rule isthe resultof significantlevel of outreachbythe FDA to industry,consumergroupsandfederal,
State and local regulatorybodies.
Whois coveredby the rule?
 Anyimporterwhoisthe U.S. owneror consignee of afoodofferedforimport
intothe UnitedStates. If there is noU.S. ownershiporconsignee,the importer
isthe U.S. agencyor representative of the foreignownerof consignee atthe
time of entry.
What is an FSVP? (ForeignSupplierVerificationProgram)
 FSVP isa program that importerscoveredbythe rule musthave inplace a
program to verifythattheirforeignsuppliersare producingfoodinamanner
that providesthe same level of publichealthprotectionasthe preventive
controlsor produce safetyregulations,asappropriate,andtoensure thatthe
supplier’sfoodisnotadulteratedandisnotmisbrandedwithrespecttoallergen
control.
 Importersare responsibleforactionsthatinclude:
o Determiningknownorreasonablyforeseeable hazardswitheachfood
o Evaluatingthe riskposedbya food,basedonthe hazardanalysis,and
the foreignsupplier’sperformance
o Usingthat evaluationof the riskposedbyan importedfoodandthe
supplier’sperformancetoapprove suppliersanddetermine appropriate
supplieractivities

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o Conductingsupplierverificationactivities
o Conductingcorrective actions
Importersmustestablishandfollowwrittenprocedurestoensure thattheyimportfoodsonlyfrom
foreignsuppliersapprovedbasedonanevaluationof the riskposedbythe importedfoodandthe
supplier’sperformanceor,whennecessaryona temporary basis,fromunapprovedsupplierswhose
foodsare subjectedtoadequate verificationactivitiesbefore beingimported.
Importersare requiredtodevelop,maintainandfollow anFSVPforeachfoodbroughtintothe United
Statesand the foreignsupplierof thatfood.
Importersare not requiredtoevaluate the foodandsupplierorconductsupplierverificationactivitiesif
theyreceive adequateassurancesthatasubsequententityinthe distributionchain,suchasthe
importer’scustomer,isprocessingthe foodforfoodsafetyinaccordance withapplicable requirements.
Importersmustalsodisclose indocumentsaccompanyingthe foodthatthe foodisnot processedto
control the hazard.
Hazard Analysis:
An importerisrequiredtoidentifyandevaluate the knownorreasonablyforeseeablehazardsforeach
type of foodit importsto determineif there are anyhazardsrequiringacontrol. Thisis done basedon
experience, illnessdata,scientificreportsandotherinformation. The hazardsinclude:
 Biological Hazards,including parasites anddisease causingbacteria
 Chemical Hazards,includingradiological hazards,pesticide anddrugresidues,natural
toxins,fooddecomposition,unapprovedfoodorcoloradditives,andfoodallergens
 Physical hazards,suchas glassand metals
Foodcouldhave hazards reasonablylikelyto cause illnessorinjurythatoccurnaturally,andare
unintentionallyintroduced. They couldbe hazardsthat are intentionallyintroducedforpurposesof
economicgain,suchas substitutingalesscostlyingredient.
The analysismust assess the probability that these hazards will occur in the absence of controlsand
the severityofthe illnessorinjury that couldoccur.
The evaluationwouldhave toconsiderfactorsthatinclude the following:
 Formulationof the food
 Conditionanddesignof the facilityandequipmentthatproducesthe food
 Raw Materialsandotheringredients
 Transportationpractices
 Harvestingtoraisingto manufacturingtoprocessingtopackaging
 Storage and distribution
 Sanitation,includingemployeehygiene

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Evaluation Food Safetyand SupplierPerformance
 The Hazard Analysis
 Applicable FDA foodsafetyregulations,andinformationregardingthe foreign
supplier’scompliance
 The foreignsupplier’sfoodsafetyhistory
 Otherfactors includingstorage andtransportationpractices
The importercan relyon anotherentitytoperformthe riskfactorsso longas the importerreviews and
assessesthe relevantdocumentation.
SupplierVerification:
Basedon the evaluationof riskconducted,the importermustestablishandfollow writtenproceduresto
ensure thatit onlyimportsfromapprovedforeignsuppliersandmustconduct appropriate supplier
verificationactivities.
Several methodscouldaccomplishthisgoal theyinclude:
 Annual onsite auditsof the suppliers facility
 Samplingandtestingof product
 A reviewof the suppliersrelevantfoodsafetyrecords
An importercanrelyon anotherentitytodetermineandperformappropriate supplierverification
activities.
Corrective Actions:
If somethingisdiscoveredthatrequire corrective actionsthe importermusttake control andcorrectthe
foodsafetyissue. Thismustbe documented,testedforeffectivenessand evidence thatthe controlsput
inplace to preventa reoccurrence. If ithas beendeterminedthatthe supplierhasnotusedprocessand
proceduresthatprovide proof thatthe fooditemsare safe for consumption oradulteratedinanywayor
misbrandedwithrespecttoallergenlabelingthe product cannotbe made available fordistributionin
the UnitedStates.
Please note the FSVPdoesnotcoverthe fooditemslistedunderREGULATED HACCP and the following:
 Juice,fishandfisheryproductsincompliance withthe FDA’sHazardAnalysisandCritical
Control Point(HACCP)
 Certainmeat, poultryandeggproductsregulatedbythe U.S. Departmentof Agriculture
at the time of importation
 Foodthat is importedforprocessingandfuture export
Compliance Dates
The date bywhichimportersmustcomplywiththe FSVPregulationsisthe latestof the followingdates:

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 18 monthsafterpublicationof the final rule
 For the importationof foodfroma supplierthatissubjecttothe preventative controlsor
produce safetyrules,six monthsafterthe foreignsupplierisrequiredtomeetthe relevant
regulations
 For an importerthatis itself amanufacturerorprocessorsubjecttothe supply-chainprogram
provisionsinthe preventive controlsregulations,the date bywhichithasto complywiththose
provisions. A range of compliance dateswere establishedinthe preventivecontrolsrulesfor
the supply-chainprogramprovisions,whichvarybasedonthe size of the receivingfacilityand
whenthe receivingfacility’ssupplierisrequiredtocomplywiththe new FSMA regulations.
The recommendationisto start this verificationprocessnow, reviewall inbounditemsto determine
the originof that product and followthe guidelinessetforthlistedabove. In addition you needto
include all domestic suppliersinyour food safetyprograms. Requesta” LETTER OF COMPLIANCE”
from all your suppliers. This letterof compliance shouldinclude the following:
 Confirmationof writtenfood safetyprograms
 Sanitation controls
 Employee GMPtraining and personal hygiene practices
 Temperature control methods
 HACCP plans inplace
 History of regulatory inspectionsincludingFDAand USDA include any 439 forms and
corrective actions.
 Resultsof any “Third Party Audits” such as AIB
Update these letterson compliance annually and have them available for audits and inspections
The Food Safetyrulesand laws are here to stay. From farm to the dinner table all are now involved
and will be heldresponsible toprovide a safe wholesome foodproduct.
Please contactme if you have anyquestionsorconcerns
Regards
Howard Schwenzer
PresidentSchwenzerSafetyServices
Health& SafetyConsulting
AIBFood Defense Coordinator
OSHA OutreachTrainer