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FSVP Requirements Module: Ensuring the Safety of Foods Imported into the United States for Human and Animal Consumption

Asyoualreadyknow,the2011FoodSafetyModernizationAct(FSMA)setforthanewpreventionparadigmforensuringthesafetyoffoodconsumedintheU.S.thatgiveseveryoneinthesupplychainarole.Thosewhomanufacture/process,package,orholdfoodhaveprimaryresponsibility for food safety and must satisfy FDA food safetystandards, including complyingwith the Preventive Controls rules.This is true whether they are inside or outside the U.S. FDA isresponsibleforoverseeingcompliancewiththesestandards.

For domestic firms, FDA and the U.S. states and territories areestablishingan integrated foodsafetyregulatorysystemtooverseecompliancewiththePreventiveControlsrules(HumanFoodandFoodforAnimals). FDA also conducts foreign inspections, but inspectingforeign firms ismoredifficult. That iswhyCongressprovidedFDAwithanewtooltohelpensurethatforeignfacilitiesaremeetingtheirfoodsafetyobligations.TheForeignSupplierVerificationPrograms(FSVP)rulerequiresthatU.S.foodimportersverifythattheirforeignsuppliers are producing food using processes and procedures thatmeettheU.S.levelofpublichealthprotection.So,whetheryouarea

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FSVP Module for Preventive Controls


foreign supplier exporting to the U.S., or whether you are a U.S.processorwhoimportsingredients,youneedtounderstandthisruleandif/howitimpactsyou.ThismodulewillexplaintherequirementsoftheFSVPruleandhowitwillfunctioninpractice.

FSVP Module Description and Target Audience

This module will explain the requirements of the FSVP rule. Themodule is specifically designed for the foreign suppliers thatmanufacture, process, pack, or hold food intended for human oranimal consumption in the U.S. The FSVP rule itself imposesrequirements on importers, not foreign suppliers. Nevertheless,importersmaymakerequestsofforeignsupplierstoassistinmeetingtheimportersobligations.

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Ensuring the Safety of Foods Imported into the U.S. for Human and Animal Consumption


FSVP Module: Goal and Objectives

ThegoalofthismoduleisforparticipantstobeabletorecognizehowtosupportU.S.importersinmeetingtheirFSVPresponsibilities.Morespecifically,theywillbeableto:

1. ExplainthepurposeofFSVPrequirements.2. DefineanFSVPimporter.3. Defineaforeignsupplier.4. Describe the foods subject to and exempt from FSVP

requirements.5. DescribetheFSVPrequirements(standardandmodified)and

towhomtheyapply.6. Discuss the importance of early communication between

importers,foreignsuppliers,andothersinthesupplychaininmeetingFSVPrequirements.

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Purpose of the FSVP Rule

ThepurposeoftheFSVPruleistoprovideadequateassurancesthatforeignsuppliersproducefoodusingprocessesandproceduresthatprovidethesamelevelofpublichealthprotectionastheFSMARisk‐BasedPreventiveControlsorProduceSafetyrequirements—thatis,thesamelevelofprotectionrequiredofU.S.producersandthatthefood is not otherwise adulterated or misbranded with respect toallergens.

U.S.‐basedFSVPimportersmustkeepveryclearrecordsformeetingeveryrequirementoftheFSVPrule,andFDAwillbecheckingtheirrecords to make sure they are performing their responsibilitiesappropriately. Theymay be asking you, as the foreign supplier, toprovideadditionalinformationthathelpsdemonstratethattheyhavemettheirresponsibilitiesundertheFSVPruleandwewilltalkmoreabout that later. It is important tonote,however, thatFDAhasallowedimportersalargeamountofflexibilityinimplementingthe FSVP rule, in acknowledging the variability in importingarrangements.Thus,whileFDAissettingforthrequirementsforimporterstoassessandverifythattheirsuppliersaremeetingU.S. food safety requirements, FDA is, inmost cases, enablingimporterstofigureoutthebestwaytomeetthoserequirementsgiventheirspecificsituations.Pub

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FDA Definitions

The definition of food for the purposes of FSVP is the same as itsdefinition in theU.S.Food,DrugandCosmeticAct (FD&CAct).Theterm“food”means“(1)articlesusedforfoodordrinkformanorotheranimals,(2)chewinggum,and(3)articlesusedforcomponentsofanysucharticle(Section201(f),FD&CAct).

An FSVP is required to help ensure that imported food, like U.S.producedfood,isnotadulteratedunderSection402oftheFD&CActormisbranded as to allergen labeling under Section 403(w) of theFD&CAct(humanfoodonly).AdulterationisatermthathasbeenusedinU.S.foodlawsincetheearlypartofthelastcentury.Section402,describes what is meant by adulteration and is too lengthy andcomplex to cover here, but is generally considered in the hazardanalysis portion of this course. We are giving an abbreviateddefinitionfortheterminthisslide.Initsessence,asstatedpreviously,anadulteratedfoodisonethatispotentiallyinjurioustohealtheitherfromasingleexposureorchronicexposuretotheadulteratedfood.

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FDA Definitions (continued)

NotethattheFSVPimportermayormaynotbetheforeignsupplier’sdirect customer. A foreign suppliermay sell to an intermediary orsomeonewhopacksandlabelstheproduct.Nevertheless,undertheFSVPrule, the foreignsupplierwillbe theperson/businessoutsidetheU.S.thatusuallyhasthemosttodowiththesafetyoftheproductthatisproducedormanufactured.

TheFSVPruleanticipatesthattherewillbeaconnectionbetweentheimporter and the “foreign supplier,” whether direct or indirect,whereby the FSVP importer can evaluate the food and the foreignsupplierandverifythattheforeignsupplier’spracticesareproducingafoodassafeas foodproducedbyaU.S.supplier.TheFSVPrule iswrittentoincorporatesufficientflexibilitytoaccommodateavarietyof importing arrangements, but the basic concept is that the FSVPimportercaneffectivelyassessandverifythesafetyofeachimportedfood.

Definition: “The term ‘de minimis’ means insignificant. In this context, the term is referring to activities, such as labeling, that wouldn’t cause the food to become hazardous or unsafe.

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Thedefinitionofan“importer”isspecifictotheFSVPregulation(21CFR1.500)andmustbefullyunderstoodbeforegettingintotheFSVPrequirements.Theimporteristhe“U.S.ownerorconsignee”,alsoseparatelydefinedintheruleas“thepersonintheUnitedStateswho,atthetimeofU.S.entry,eitherownsthefood,haspurchasedthe food, or has agreed inwriting to purchase the food.” It isimportanttotheFSVPrulethattheFSVPimporterbelocatedintheU.S. because FDA will be inspecting these importers and/or theirrecordsforcompliancewiththerule.ItisthepersonintheU.S.whois taking responsibility formeeting theobligationsunder the FSVPrule.

If there is no owner or consignee in theU.S., the foreign owner orconsigneemaydesignateaU.S.agentorrepresentativetocarryouttheFSVPresponsibilitiesandthatpersonmustconsentinwritingtodo so. This requirement was put in so that U.S. agents orrepresentatives (such as U.S. agents for food facility registrationpurposes)wouldnotbeidentifiedastheFSVPimporterwithouttheirknowledge.

The FSVP regulation does not change the general procedures forimporting food; however, it does require the FSVP importer beidentifiedforeachlineentryoffoodofferedforimportintotheU.S.,oncethecompliancedatepertainingtothat foodarrives.Thus, it isimportant that whoever is filling out the U.S. Customs entry filingunderstandwho is the appropriate party to designate as the FSVP“importer” as that person will be seen by FDA as the personresponsibleforcomplyingwiththerequirementsoftheFSVPrule.

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TheFSVP “importer”definition isnot the sameas thedefinitionofimporterofrecordunderU.S.CustomsandBorderProtection(CBP)rules. However, it is possible that the importer of record mayappropriatelyserveastheFSVPimporter, if the importerofrecordalsomeetstheFSVPdefinitionofimporter.ItshouldalsobenotedthatmorethanonepersonmightfallundertheFSVP“importer”definitionforaparticularfoodandforeignsupplier.Itisalsopossiblethatunderaparticularimportingarrangement,theremaybenoonewhoclearlyfallsunderthedefinition.

Nevertheless,asyouwillsee,theFSVPrulerequiresthatsomeonebedesignatedastheFSVP“importer”atentryortheCustomsfilingwillberejected.WhoeverisidentifiedshouldhavealreadydonetheworknecessarytofulfilltherequirementsoftheFSVPrulefarinadvanceofshippingthefood.

We are spending time in describingwhowill be an FSVP importerbecausethisimporterisperhapsnottheperson/companywhoyoumightcurrentlyidentifyasyourcustomer,evenifyourcustomerisinthe U.S., if that customer does not meet the definition of FSVPimporter. Nevertheless, the FSVP importerwill be responsible forcomplyingwiththeobligationsset forth intheFSVPrule.Thus, theimportermaycontactyoudirectlyorthroughothermeansinordertofulfilltheimporter’sobligationsundertheFSVPrule;andFDA,inturn,willbechecking tomakesure that theFSVP importer iscomplyingappropriatelywiththeFSVPrule.Wewillcoverwhattheimporter’sobligationsareinupcomingslides.


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TheFSVPrulespecifiesthatallrequiredFSVPactivitiesbeperformedby a “qualified individual”, recognizing that different tasks requiredifferentqualifications.

Under theFSVPruleaqualified individual isapersonwhohas theeducation, training, or experience (or a combination thereof)necessarytoperformanactivityrequiredbytheFSVPrule.Aqualifiedindividualmustalsobeabletoreadandunderstandanyrecordsthatmustbereviewedinperformingtheactivity(21CFR1.503(a)).TheFSVP task to be accomplished determines what qualifications aqualified individual must have. Thus, the definition is simplystating thatwhoever is carryingoutaparticularFSVPactivityshouldbesomeonequalifiedtodoit.Thepersonsusedasqualifiedindividualscanbeanemployeeoftheimporter’scompany,butit isnotnecessarythattheybeemployees.

Remember,complyingwithFSVPrequirementsistheresponsibilityof theFSVP importer,notthe foreignsupplier.Asnotedbefore, theFSVP rule itself does not set forth any requirements for foreignsuppliers. The rule is only directed at importers, specifically thoseimporterswhowillimplementtheFSVPrequirementsforaspecificfoodandforeignsupplier.Nevertheless,theseFSVPimporterswillberesponsible forverifying that their foreign suppliersare complyingwithU.S.foodsafetyrules.And,insomecases,theimportermaybeable touseworkdoneby the supplier in supportofmeeting theserequirements.Wewilltalkmoreaboutthatlater.

What Foods Are Covered By FSVP?

FSVPappliestoallhumanfoodandfoodforanimalsofferedforimportandintendedforconsumptionintheU.S.,unlessexempted.

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Generally,theFSVPruleexemptsfoodsthatarenotsoldnorintendedforU.S. consumption, or foods forwhich the importers are alreadyregulatedunderotherU.S.regulations,e.g.,importersofseafoodandjuices are regulated under Hazard Analysis Critical Control Point(HACCP)regulations.Therefore,foodthatistransshippedthroughtheU.S.;foodimportedforprocessingandfutureexport;foodimportedinto the U.S. solely for research; food imported for personalconsumption, and in amounts considered consistentwith personalconsumption; or food produced in the U.S., then exported andreturned,areallexemptedfromtheFSVPrulerequirements.

TheFSVPrulealsoexemptsmeat,poultryandeggproductsthatareregulatedbytheU.S.DepartmentofAgriculture(USDA).Nevertheless,someimported(anddomestic)meat,poultryandeggproductsarenotcoveredbyUSDAlawsandregulationsand,thus,aresubjecttoFDAjurisdiction.Theseproductsmayinclude,forexample,venison,rabbit,gamemeats,duck,andshelleggs.

What About Low‐Acid Canned Foods?

Importersof lowacidcanned foodsarenotexempt fromFSVP,butimporters must verify and document that manufacturers arefollowingU.S.LACFrequirementsunder21CFRPart113,whichfocusonmicrobiologicalhazards.ForallmattersnotcontrolledbytheLACFrequirements, i.e., non‐microbiological hazards, the importer isrequiredtohaveanFSVP.

Animporterwhoimportsandusesrawmaterialsorotheringredientsinmanufacturing/processinganLACF in theU.S. isnot required tocomplywith FSVP requirements formicrobiological hazards, if theFSVP importer is in compliancewithpart113,but itmusthaveanFSVP for all other hazards (21 CFR 1.502(c)). In other words, an

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importer of raw materials who is in compliance with themicrobiologicalprovisionsoftheLACFrulemuststillhaveanFSVPforallotherhazards.

What About Foods Under FDA HACCP Rules?

Asmentionedearlier,importersoffoodscomplyingwithFDAHACCPrules for juiceandseafoodareexempt fromFSVPbecausetheyarealready subject to supply chain requirements under these existingregulations. This exemption is aligned with the exemption in thePreventiveControlsforhumanfoodruleforsuchfoods.

Similarly, importers who import and use raw materials andingredients for the manufacture/processing of juice and seafoodproductssubjecttoFDAHACCPrulesalsodonothavetocomplywithFSVP, as long as the importer is in compliance with FDA HACCPrequirements.

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Exemption for Alcoholic Beverages

FSMA also exempted alcoholic beverages that meet certainconditions, including that the foreign facility is the same type offacilityasthoseregulatedbytheDepartmentoftheTreasuryintheU.S.andthefacilityisrequiredtoregisterunderSection415.Again,this exemption is aligned with the exemption in the PreventiveControls for human food rule and also includes the exemption forpackagedfoodsshippedwithalcoholicbeveragesasdescribedinthePreventiveControlsforhumanfoodrule.

Importers of rawmaterials or other ingredients are also exempt iftheymanufacture,process,pack,orholdthealcoholicbeverage,theyare the typeof facility that is required to register as a food facilityundersection415oftheact,andtheyareexemptfromthepreventivecontrolsforhumanfoodregulation.

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What if the U.S. Importer is a Processor Who Imports Ingredients?

Asyouknow,thePCrulesrequiremanufacturers/processorstohavesupply‐chain preventive controls. So, if the FSVP importer is amanufacturer/processor, and the importer does not control all thehazards in the foodsreceived froma foreignsupplier, the importermustimplementappropriatesupply‐chainpreventivecontrols,whichprovideverificationsthataresimilartoFSVPverifications.Hence,ifthe FSVP importer is a U.S. manufacturer/processor who importsingredients, and is in compliance with the relevant supply‐chainprovisionsinthePreventiveControlsrule,theimporterisdeemedbyFDAtobeincompliancewithmostoftheFSVPrequirementsforthefood imported. Conversely, if the importer is amanufacturer/processorwhoimportsingredients,theimportermaychoosetocomplywiththeFSVPrequirementsratherthanthesupply‐chainrequirementsinthePreventiveControlsrule.FDAallowedthisflexibility to avoid imposing impose redundant requirements onmanufacturerstocomplywithbothPCandFSVPrules.

However, regardless of which rule is followed for supplierverification,theFSVPimportermuststillbeidentifieduponentryonthe U.S. Customs entry filing as the FSVP importer for the foodingredients/rawmaterialsimported. Pub

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Standard FSVP Requirements

What are the basic or standard FSVP requirements? The standardrequirements apply to themajority of foods imported into theU.S.(Note:Wewillcoversomeofthe“modified”FSVPrequirementsatalaterpoint inthismodule,suchasthosethatpertainto“verysmallimporters” or importers importing from “certain small foreignsuppliers.”)

FSVPimportersaregenerallytaskedwith1)carefullyconsideringthehazards of the foods they import and the risks suchhazards couldposetoU.S.consumersand2)workingwiththeirforeignsupplierstohelp ensure that such hazards are significantly minimized orprevented.Importersarealsoexpectedtoevaluatetheperformanceoftheir foreignsuppliers–theirprocessesandpractices,aswellastheirfoodsafetycompliancehistory.

Baseduponthisevaluation,theimporterwillchooseanappropriateverificationactivityoractivitiesthatwillhelpensurethattheforeignsupplier is producing food using processes and procedures thatprovide the same the level of public health protection as used bydomesticmanufacturers/processors.Theimportercanthenapprovethe supplier and determine and conduct verification activities thatwillhelpensurethatlevelofprotectionismaintained.

Additionally, theFSVPimportermustbeidentifiedatentryandtheimportermust document and retain records of all the steps of theFSVPprocess.Theimportermaybeaskingtheirforeignsuppliersforadditional information and records to help them meet theirresponsibilities.Theserecordsmakeuptheimporter’sFSVPthatFDAwill review forcompliancewith theregulation.An importer’sFSVPmust be reevaluated every three years or when the importer has

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reason to believe that the supplier may not be producing productconsistentwithU.S.foodsafetyrequirements.

Note:AnFSVPisnotonespecificthing.Itisessentiallyeverythingthat the FSVP importer has done to comply with the FSVPrequirementstohelpensurethattheimportedfoodwillmeettheU.S. level of public health protection, as well as the recordsdocumentingthattheseactivitieswere,andarecontinuingtobe,carriedout.

Hazard Analysis

Thehazardanalysisisprimarilydirectedatthefood.Theimporterisrequired to perform a hazard analysis for biological, chemical, andphysical hazards—whether the hazards are naturally occurring,unintentionallyorintentionallyintroduced.Oncehazardshavebeenidentified, theymustbeevaluated for theprobabilityofoccurrenceandtheseverityoftheillnessifconsumersareexposed.

This is essentially the same as hazard analysis as themanufacturer/processor is required to do under the PreventiveControls rule, except that the importer is not inside themanufacturing/processing facility where all the factors can beassessed. Importers can rely on the hazard analysis done by theirforeignsuppliersaslongastheyreviewandassessit.So,importersmayasktheirforeignsuppliersfortheirhazardanalyses,sotheywillnot have to repeat what their supplier has already accomplished.Nevertheless,itisleftuptotheimportertodeterminethebestwaytoperformthehazardanalysis.

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Evaluation and Approval of the Foreign Supplier

TheFSVPimportermustalsoevaluatetheforeignsupplier—suchasthe supplier’s general food safety procedures and practices, andhistoryof compliancewithU.S. foodsafety requirements, includingcompliancewiththePreventiveControlsrules.Theimportershouldalso consider whether the supplier has been subject to any FDAenforcementactivities,andmaywishtolookatseveralyearsofdatainFDAdatabasestoseeiftheforeignsupplierhasreceivedwarningletters,hadshipmentsrefusedentryforfoodsafetyviolations,or isunderanimportalert.Theimportermayasktheforeignsupplierforadditional information regarding the supplier's compliancehistory.Theimportershouldconsiderwhetherthesupplierhasresolvedanypreviousproblem.

Once the importer’s qualified individual is satisfied with theevaluationsofthefoodhazardsandforeignsupplier’sperformance,theimportercanapprovetheforeignsupplier.Theimportercanonlyimport from “approved foreign suppliers.” However, the rule doesallowforuseofatemporarysupplierundercertaincircumstances—for instance,when the previously approved supplier is not able toexporttheproduct.FDAwilllikelyprovidemoreguidanceonwhenthisisacceptableandtheconditionssurroundinguseofatemporarysupplier, but FDA states in the rule that food imported from atemporarysuppliermustbeverifiedassafe.

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Verification Activities

Oncetheimporter’scompliancedatearrives,allthesestepsmustbecarriedoutbefore theFSVPimporter importsthefirstshipmentofproductintotheU.S.,soitisimperativethatFSVPimporters,foreignsuppliersandothersengagedintheimportationoffoodunderstandtheFSVPrequirementsinadvanceofthefirstshipment.Verificationactivities are required to be established and conducted prior toimportingthefoodandperiodicallythereafter.

It is important tonote that it is the importer,not the foreignsupplier,whodecideswhatverificationactivitiesareadequate,thefrequencyofthoseactivitiesbasedonfoodriskandsupplierevaluations,andwhowill carry themout.There shouldbenoconcernsregardingaconflictofinterest.

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Appropriate Verification Activities

FDAhasstatedthatappropriateverificationactivitiesincludeaudits,samplingandtesting,andsupplierrecordsreviews,aswellasothermethodsthatwillhelpensurethatthehazardsrequiringcontrolarebeingsignificantlyminimizedorprevented.

For hazards that may result in serious illnesses or death (aSAHCODHA hazard), the default verification activity is an annualonsite audit, although the importer may determine that anotheractivity or activities would provide the appropriate verification. Ifthereisapotentialfororapasthistoryofaseriousbiologicalhazardassociatedwiththefood,theimportermaywishtoverifyforaperiodof timethat thepracticesorcorrectiveactionstakenbythe foreignsupplierhavetakencareoftheproblem.Therefore,anannualorevenmore frequent audit may be appropriate, perhaps coupled withperiodictestingoftheproductorreviewingrecordsofothertesting.Thepoint is thattheverificationmethod(s)mustbeappropriatetothehazardbeingcontrolled.

Bylisting“otherappropriatesupplierverificationactivities,”FDAisexpressingawillingnesstoacceptotherverificationactivities,aswellasacknowledgingthatappropriateverificationactivitiesneedtobedecidedbasedontheevaluationofriskofthesupplierandfood,asdescribedabove.Severalverificationactivitiesmaybeappropriatetoensurethehazardisbeingproperlycontrolled.Whateververificationactivitiesarechosen,theyshouldbesuitableforthecircumstances.

Theimportermayrelyonaforeignsupplier'sfoodsafetyrecordsortesting as long as the importer reviews and assesses theappropriatenessoftherecordsortestingresults.Whileanimportermaynot relyon a foreign supplier's self‐audit, the foreign suppliermaysupplytheresultsofathird‐partyauditthatisdonebyaqualified

Definition: Audit: “the systematic, independent, and documented examination (through observation, investigation, discussions with employees of the audited entity, records review, and, as appropriate, sampling and laboratory analysis) to assess an audited entity’s food safety processes and procedures.” (21 CFR 1.500)

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auditorwhoisfreefromanyconflictofinterest.Suchanauditmaybesupplied to several different customers for use as a verificationactivity.

Verification Findings and Corrective Actions

When a verification activity is carried out, it must be properlyconducted and the importermust review the results to determinewhether any corrective actions are necessary, on the part of theforeignsupplier, the importeroranotherparty inthesupplychain.The corrective actions may necessitate a change in the foreignsupplier’s procedures, but it also may indicate that a differentverification activity is needed. The importer may also decide toreplacethatforeignsupplierwithanothersupplier.Anyfindingsandcorrectiveactionsmustbedocumented.

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Regular and “For Cause” Reevaluation of FSVPs

TheFSVPrulerequires thatanFSVP importermust reevaluate theFSVP at least every three years. In addition, an importer mustpromptlyreevaluateitsFSVPwhenitbecomesawareofafoodsafetyproblem associated with the food it imports. In other words, animportermustreevaluateitsFSVPwhenevertheimporterhascausetodoso,suchasadeficiencyfoundduringaverificationactivityorachangeinaforeignsupplier’spracticesthatmightgiverisetoafoodsafetyconcern.

Nevertheless, even if an FSVP importer has no known cause toreevaluatetheFSVP,theimporterstillmustregularlyreevaluatethehazardanalysis(foodrisk)andforeignsupplierperformanceatleastevery three years to see if the FSVP is still valid. Of course, theimportermustdocumenttheperformanceofthereevaluation.

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Creating and Maintaining Records

FSVP importers must keep very clear records for meeting everyrequirementoftheFSVPrule,andFDAwillbecheckingtheirrecordstomakesuretheyareperformingtheirresponsibilitiesappropriately.It is important to note, that FDA has allowed a large amount offlexibility in implementing the FSVP rule, acknowledging thevariability in importing arrangements. Thus, while FDA set forthrequirementsforimporterstoverifythattheirsuppliersaremeetingU.S.foodsafetyrequirements,FDAislettingimportersdeterminethebest way to meet and document FSVP requirements given theirspecific situations.Records generallymust bekept for at least twoyears.

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FSVP Importer Is Accountable—Reliance on Others

The FSVP importer is responsible for assuring that all FSVPrequirementsaremet.FDArecognized,however,thatthereisgreatvariability in food importation arrangements and, for that reason,builtflexibilityintotheFSVPrule(seeKeyPoint).VirtuallyallstepsoftheFSVPrequirementscanbecarriedoutbyentitiesotherthantheU.S.‐basedFSVPimporter.

Still,theFSVPimportermustmakesurethattheFSVPrequirementshave been carried out by qualified individuals AND the FSVPimporter’s qualified individualmust reviewwhatwas done, as theFSVPimporterwillbeheldaccountable fortheFSVPprogram.FDAwill review the FSVP importer’s records to determine compliancewith the FSVP rule and take appropriate regulatory action if theimporterhasnotfollowedtherule’srequirements.

Key Point: In the preamble to the FSVP final rule, FDA stated “[w]hen foods are obtained from entities such as brokers, distributors, warehouses and consolidators, rather than the entity that manufactured/processed, raised or harvested the food, it could be difficult for the importer to know the identity of the producer (e.g., because the consolidator might refuse to reveal this information due to concern that the importer might decide to buy directly from the producer in the future). It would be impractical and burdensome to have to conduct supplier verification of each original producer of the food and could result in multiple audits. For these reasons, for hazard analysis, evaluation for foreign supplier approval and verifications, the rule allows an importer to obtain information needed to meet certain FSVP requirements from other entities, such as a distributor or consolidator of the food. This will reduce the need for importers to directly verify the compliance of producers from which the importers did not directly purchase the imported food.”

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Modified Requirements

UptothispointwehavefocusedonthestandardrequirementsoftheFSVPrule.Thereareinstances,however,whereanFSVPimporterisable to followmodified requirements.ModifiedFSVP requirementsapplyifyouarea“verysmallimporter”andifyouareimportingfoodsfrom“certainsmallforeignsuppliers”(21CFR1.512(a)).

ModifiedrequirementsalsoapplyiftheFSVPimporterisimportingfood fromforeignsupplier(s) incountrieswith foodsafetysystemsrecognized by FDA as “comparable” or “equivalent.” And finally,modified requirements apply if the FSVP importer is importingdietarysupplementsordietarysupplementcomponents.

Asmentionedearlierandhereonthisslide,dietarysupplementsforhumans or animals are NOT EXEMPT from FSVP requirements.Importers must assure that manufacturers of these substances—finished products, ingredients, and components—are followingCGMPs. FSVP requirements for dietary supplements and dietarysupplement components need more time to explain than can becovered in thismodule.Moredetail isprovided in theFSPCAFSVPcourse.

Importersorforeignsuppliersmustfirstmeetthecriteriatoqualifyformodifiedrequirementsandmust continue todemonstrate theireligibility for these programs. Also, importers that do qualify candecidewhethertheywishtofollowthestandardrequirementsorthemodifiedrequirements.

Wewillcoverthefirstthreesituationsinmoredetailinthenextfewslides.

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“Certain Small Foreign Suppliers”

Let’sbeginwithdefining“certainsmallforeignsuppliers.”Asyoucanseefromtheslide,therearethreecategories.BecausethiscoursefocusesonthePCrule,wewillelaborateonthemodifiedFSVPrequirementsthatapplytoverysmallsupplierssubjecttothePCrules.

Modified Requirements When Importing from “Certain Small Foreign Suppliers”

If the FSVP importer is importing food from one of the threecategoriesof“certainsmallforeignsuppliers”andwantstobesubject

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tothemodifiedFSVPrequirements,theimportermustobtainwrittenassurancefromtheforeignsupplierthatitmeetsthespecifiedcriteriafor one of the categories before approving the supplier for eachapplicablecalendaryear.

Modified Requirements When Importing from “Certain Small Foreign Suppliers”: “Qualified Facilities”

Iftheforeignsupplierisa“qualifiedfacility,”theimporterdoesnothavetomeetmostoftheFSVPrulerequirements,buttheimportermust:

1. Obtainwritten assurancebefore importing the food and atleastevery2years thereafter that the foreign supplier isproducing the food in compliancewithapplicableFDA foodsafetyregulations,orlawsandregulationsofacomparableorequivalentcountry,and

2. That assurance must include a brief description of thesupplier’spreventivecontrols,orastatementofcompliancewith relevant State or other non‐Federal, including foreign,foodsafetylawsandregulations.

Inotherwords,aforeignsupplier“qualifiedfacility”would,inmostcases, need to supply its FSVP importerwith a statement that it iscomplying with U.S. food safety requirements and provideinformationonhowitisdoingthat.ForqualifiedfacilitieslocatedincountriesthatFDAhasfoundtobeequivalentorcomparabletotheU.S.foodsafetysystem,thefacilitywouldneedtoprovideassurancethatitismeetingthatcountry’sfoodsafetyrequirements.

Note that themodified requirements that the FSVP importermustfollowarethoseofa“verysmallimporter,”butiftheFSVPimporteris

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not “verysmall” thereareadditional requirements,we’ll cover inafewmoments.

“Very Small Importers”

IftheFSVPimporterisaverysmallimporter—thatis,lessthanU.S.$1millionaverageperyearinsalesoverthelastthreeyears(adjustedfor inflation)forhumanfoodorU.S$2.5millionaverageforanimalfood,includingthevalueoffoodimportedandheldwithoutsale—theimportercanalsobesubjecttomodifiedFSVPrequirements.

Theabovecalculationsareadjustedforinflationwith2011asthebaseyear.FDAhaspublishedchartstohelpwiththis:https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm554484.htmNotethatthesefiguresincludesalesofanysubsidiariesandaffiliates.

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Modified Requirements for “Very Small Importers”

IftheFSVPimporterisa“verysmallimporter,”andimportingfromanyforeignsupplier(regardlessofsize),theimportermustobtain1)written assurance that the supplier’s food is being produced incompliancewithprocessesandproceduresthatprovidetheU.S.levelofpublichealthprotection,AND2)writtenassurancethatfoodisincompliance with U.S. adulteration provisions and allergen labeling(forhumanfood)provisions.

Thismustbedoneforeveryimportedfood,anditneedstobedonebeforeimportingthefoodandeverytwoyearsthereafter.

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What If the FSVP Importer Is Not a “Very Small Importer,” but Imports from “Certain Small Foreign Suppliers”?

IftheFSVPimporterisNOTa“verysmallimporter,”butdoesimportfrom“certainsmallforeignsuppliers,”theimportermustevaluatetheforeignsupplier’s compliancehistory,approve the foreignsupplier,and use only approved foreign suppliers. And, as noted earlier,importersmustobtainwrittenassurance from the foreign supplierbeforeimportingthefoodandatleastevery2yearsthereafterthatthe foreign supplier is producing the food in compliance withapplicable FDA food safety regulations (or, when applicable, therelevantlawsandregulationsofacountrywhosefoodsafetysystemFDA has officially recognized as comparable or determined to beequivalenttothatoftheUnitedStates).Thewrittenassurancemustincludeeither(abriefdescriptionofthepreventivecontrolsthatthesupplierisimplementingtocontroltheapplicablehazardinthefoodorastatementthatsupplierisincompliancewithState,local,county,tribal,orotherapplicablenon‐Federalfoodsafetylaw,includingtherelevantlawsandregulationsofforeigncountries.)Theimporterdoesnothavetoconductfurtherverificationactivities.Pub

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What If Assurances Are Invalid?

If the importer (“very small” or one importing from “certain smallforeign suppliers”) determines that the foreign supplier is notproducing food consistentwith the assurances provided or finds asafetyproblemrelatedtothefood,theFSVPimportermustpromptlytakeappropriatecorrectiveactions.

What Are Appropriate Corrective Actions?

As with standard FSVP requirements, corrective actions undermodifiedrequirementsdependonthecircumstances,buttheymustbeintendedtocorrecttheproblemforthelongterm.Forexample,theimporter can discontinue use of the foreign supplier or decide to

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impose a strict shipment‐by‐shipment verification requirement. Inany case, the corrective actions should be appropriate for thesituation at hand and the importermust document the correctiveactionstheytake.

If Food Is from a Recognized System

Theevaluationsofanothercountry’s systemarequitedetailedanddeliberative.Thus, theyare labor‐intensiveandtakeagreatdealoftime for the country seeking a comparability or equivalencedetermination,aswellastheU.S.FDA,tocarryouttheentireprocess.WecanexpectthatmorecountrieswithmaturefoodsafetysystemswillberequestingsuchdeterminationsfromFDA.

If an FSVP importer is importing food from a foreign supplier in acountry that has been found equivalent or comparable, the FSVPimporter is not required to perform a hazard analysis, conduct aforeign supplier evaluation for supplier approval, nor conduct thesupplierverificationsasdescribedearlier.

Key Point:

FDA has determined that New Zealand’s, Canada’s, and Australia’s food safety systems are comparable to that of the U.S. food safety system in providing a very similar level of public health protection.

More information is available on FDA’s website at: https://www.fda.gov/Food/InternationalInteragencyCoordination/InternationalCooperation/default.htm

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If Food Is from a Recognized System (continued)

However,beforeimportingafoodfromtheforeignsupplier,theFSVPimportermustdetermineanddocumentthattheforeignsupplierisundertheoversightoftheregulatoryauthoritywithwhomFDAhasthe systems recognition agreement, that the food in question fallsunderthescopeoftheofficialrecognitionofthecountry,ANDthattheforeignsupplierisingoodcompliancestandingwiththeforeignfoodauthority.TheFSVPimportermustdocumenteachoftheseandcheckperiodicallythattheyarestillvalid.

Aswithany imported food, ifany information indicates foodsafetyhazards associated with the food are not being significantlyminimized or prevented, the FSVP importer must take promptcorrectiveactionandidentifytheFSVPimporteratentry.

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The Importance of Communications Within Your Supplier/Importer Chain

It should have become clear in this module that communicationsamong the FSVP importer, the foreign supplier and others in theimportationchainarehighlyimportant.Whatisevenmoreimportantis that these discussionsmust take placeearly—longbefore foodshipments begin—onwho is theFSVP importer, howare theFSVPrequirementsgoing tobemet,what informationdoes the importerneedfromtheforeignsupplier,andsoforth.Anyoneinthesupplychaincaninitiatethediscussions,butitistheFSVPimporterwhoultimately will be responsible for complying with the FSVPrequirementsandwillbeheldaccountablebyFDA.Cooperationwillbe key. Foreign suppliers may be asked to provide additionaldocumentationtotheFSVPimporterinordertofacilitatecompliancewiththisrule.

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FSVP Module for Preventive Controls: Summary

So,toreviewourmainpoints—Foreignsupplierswillbeexpectedtowork with U.S.‐based FSVP importers and others in thesupply/importation chain to provide information that FSVPrequirementsarebeingmet—inparticular,thatforeignsuppliersaresupplyingfoodthatmeetstheU.S.levelofpublichealthprotection,isnotadulteratedunderSection402oftheFD&CActorinviolationoftheallergenlabelingprovisionsofSection403(w)(forhumanfoods)oftheFD&CAct.

FDAwillholdFSVPimportersaccountablefor:

Conductingahazardanalysistoidentifyknownorreasonablyforeseeablehazards,

Evaluatingandapprovingtheirforeignsuppliers,

Determiningwhatforeignsupplierverificationactivitiesarenecessaryandappropriateaswellastheirfrequency,

Takingcorrectiveactionsasnecessary,

ReevaluatingtheirFSVPforcauseandeverythreeyears,

Assuring that they are properly identified as the FSVPimporteronentryfiling,and

Documentingalloftheabove,keepingadequaterecords,andmakingthoserecordsavailabletoFDAuponrequest.

Also,FSVPimportersmayusemodifiedrequirementsiftheyqualifyas“verysmallimporters”orimportfoodfrom“certainsmallforeignsuppliers.”

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While the requirements of the FSVP rule are well delineated,implementationoftherequirementsisflexibleandtheFSVPimporteris enabled to use logic and judgment in complying with therequirements.These requirements are intended to ensure thatU.S.public health standards are satisfied and hazards prevented inimported foods ina similar fashionas theyare inU.S.domesticallyproducedfood.

FSVP Module for Preventive Controls: Questions

Notes:

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