SPS三个案例.docx
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SPS三个案例.docx
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SPS三个案例
一
Accreditationofthird-partybodiestoconductfoodsafetyauditsandtoissuecertificationsInOctober2013,ChinaraisedconcernsregardingtheUSproposedFSMA-relatedruleallowingforaccreditationofthird-partyauditors/certificationbodiestoconductfoodsafetyauditsofforeignentitiesandtoissuefoodandfacilitycertifications(G/SPS/N/USA/2570).ChinanotedthatthestatisticsprovidedbytheUnitedStateshaddemonstratedagenerallysaferlevelofimportedfoodsthanfoodsdomesticallyproducedintheUnitedStates.ChinarequestedtheUnitedStatestoprovidescientificjustificationforproposingthisoverlyburdensomeandcostlyruleonimportedfoods.Chinaconsideredthattheproposedrulediscriminatedunjustifiablybetweenforeignanddomesticsourcesofsupplyandwentbeyondinternationalstandardswithoutscientificjustification.ChinaurgedtheUnitedStatestoaccepttheresultsofinternationallyaccreditedcertification/auditbodies,andqueriedhowtheUnitedStateswouldrecognizetheequivalenceofforeignfoodsafetyprogrammes,systemsandstandards.ReferencingArticle13oftheSPSAgreement,ChinaenquiredwhatmeasurestheUnitedStateswouldtaketoensurethatthird-partyauditors/certificationbodieswereWTO-compliant,andrecalledthatunderArticle10oftheSPSAgreement,MembersaretotakeintoaccountthespecialneedsofdevelopingcountryMembersinthepreparationofSPSmeasures.ChinaurgedtheUnitedStatestoseriouslyfulfilitsWTOobligations,takeconcretestepstobaseitsruleonthedisciplinesoftheSPSAgreementandtherelevantinternationalstandards,toensurethatthefinalrulewouldnotcreateunnecessaryobstaclestointernationaltrade.Belize,BrazilandKoreasharedChina'sconcerns.Brazilnotedinparticulartheroleofprivatethird-partyauditorsandcertificationbodies,and,withreferencetoArticle13oftheSPSAgreement,queriedhowtheUnitedStateswouldensurethatsuchbodiescompliedwiththerelevantprovisionsoftheSPSAgreement.BrazilalsorequestedmoreinformationonhowtheUnitedStateswouldrecognizetheequivalenceofforeignsystems.TheUnitedStatesrecalledthatithadprovidedinformationontheproposedruleintheCommitteeandelsewhere,includinginChina,andinvitedMemberstosubmittheircommentsthroughtheFederaleRulemakingPortal(http:
//www.regulations.gov)by26November2013.Thecommentperiodhadbeenextendedto120days,toensurethatMembershadenoughtimetoprovidetheircomments.
二
USproposedruleongoodmanufacturingpracticeforhumanfoodInJune2013,ChinaraisedconcernswiththeUSproposedruleon"CurrentGoodManufacturingPracticeandHazardAnalysisandRisk-basedPreventiveControlsforHumanFood",notifiedinG/SPS/N/USA/2502andG/SPS/N/USA/2503.Part117,SubpartC,regardingthepreventivecontrolmeasuresputinplaceandmonitoredbyoperatorsoffoodenterprises,exceededinternationalstandardswithoutscientificjustificationandwasthereforeincontraventionoftheSPSAgreement.Theoverbroadnatureofthisrequirementwouldresultinreducedeffectivenessandincreasedlabourcosts,thusresultinginabarriertotrade.ChinasuggestedthatinsteadtheUnitedStatesshouldrequiregoodmanufacturingpracticesandsanitationstandardoperatingprocedures,andfurthermoreemploytheequivalenceprinciple.Additionally,ChinatookissuewiththeinclusionofradioactivityhazardanalysisinthedraftPart117.130(b)(4),astheinternationallyrecognizedHACCPsystemonlyrequiredtheidentificationofbiological,chemical,andphysicalhazards.Theprobabilityofsuchahazardwasextremelylowanddidnotjustifythecostofrunningsuchmonitoringprogramswithinthefoodindustry.TheUnitedStatescouldraisetheissueofinclusionofradioactivityintotheHACCPsystematthemeetingoftheCodexAlimentariusCommissiontoallowforamorethoroughdiscussion.Lastly,therequirementinthedraftPart117.126thatallfoodenterprisesestablishawrittensafetyplan,exceededtherequirementsofHACCPandtheCodexstandards.Assuch,ChinarequestedthattheUnitedStatesprovideascientificbasisfortheserequirements.Chinasuggestedthatamoregradualapproachtotheestablishmentofhazardanalysiswithinfoodenterpriseswasappropriategiventhevaryingdegreesofriskassociatedwithdifferentproductsandthedisparityinresourcesamongcountries.TheUnitedStatesthankedChinaforitscommentsandrecalledthatthesemeasureshadbeennotifiedtotheSPSCommitteeon30April2013,andwouldbeavailableforcommentthrough16September2013.TheUnitedStatesurgedChinaandotherMembers,aswellasanyotherinterestedmembersoftheinternationalcommunity,toprovidecommentsontheproposedrule.CommentsshouldbesubmittedviatheFederaleRulemakingportal,availableat:
http:
//www.regulations.gov,inordertoensurethatthosecommentsbecamepartofthepublicrecord.ThedocketnumbersfortheproposedruleintheeRulemakingportalwere:
FDA-2011-N-0920forpreventivecontrolsforhumanfood,andFDA-2011-N-0921forproducesafety.CommentsmadeoutsideofthepublicrecordcouldnotbeconsideredbytheFDAintheprocessoffinalizingtheproposedrules.
三
US2009FoodSafetyEnhancementAct.IndiaarguedthatvariousprovisionsoftheFSMAdidnotreflectthecoreprinciplesofequivalence(Article4)andharmonization(Article3)oftheSPSAgreement,andurgedtheUnitedStatestoensuretheFSMAwasinlinewiththeSPSAgreementsoasnottoaffecttradebetweenMembers.India'skeyconcernsrelatedtotheregistrationofForeignFoodFacilities,theVoluntaryQualifiedImporterProgram,CertificationandAuditandtheForeignSupplierVerificationProgram.TheUnitedStatesnotedthatFDAwasastransparentaspossible,includingmakingpresentationstotheSPSCommittee,holdingnumerousoutreachsessionswithallstakeholders,keepingcurrentinformationontheWeb.TheUnitedStateswascommittedtoimplementFSMAinatransparentmannerconsistentwithitsWTOobligationsandwouldtakeintoaccountrelevantCodexstandardsandguidelines.TheFDAhadissuedinterimfinalrulesrequiringpersonssubmittingpriornoticeofimportedfoodtoreportanyothercountries'refusalofthefood(G/SPS/N/USA/690/Add.11)andhadalsoamendedcriteriausedtoorderadministrativedetentionoffoodforhumanoranimalconsumption(G/SPS/N/USA/704/Add.2).TheFDAhadnotyetissuedregulationsfortheFSMAprovisionsfortheforeignsupplierandvoluntaryimporterprogrammes.Memberscouldcommentwhentheproposedruleswerenotified.TheUnitedStateswelcomedMembers'perspectivesonimplementationoftheFSMA.InMarch2012,IndiarecalledthatinOctober2011ithadraisedconcernsthattheFSMAputextraburdenonexporters,andreiteratedtheprovisionsofgreatestconcern.IndiaurgedtheUnitedStatestocommunicatethetimeframefortheissuanceoftheseregulations,andaskedwhethertheregulationswouldprovideforbilateralmutualrecognitionagreementsthatcouldhelpIndianexportersaccesstheUSmarket.Indiaalsorequestedinformationonhowmuchtimewouldbeprovidedtoexporterstomeetnewrequirements,asthiswouldrequiretechnicalassistanceandbetterunderstandingtoensureallregulationswerefullyfollowed.Indiaalsorequestedclarificationabouttheadditionalcoststoexportersfortheregistrationofforeignsuppliers.ChinaechoedtheconcernsofIndia,andrecalledtheUSdocumentG/TBT/W/349concerningtheuseoftheInternationalLaboratoryAccreditationCooperation(ILAC)MutualRecognitionArrangement(MRA)andtheInternationalAccreditationForum(IAF)MultilateralRecognitionArrangement(MLA)bycentralgovernmentbodies.ChinarequestedconfirmationthattheUSFDAhadtakenconcretestepstoaccepttestresultsissuedbytestinglaboratoriesfromexportingMembersaccreditedundertheILACMRAframework.TheUnitedStatesrecalledthatitnotifiedFSMAandcertainuserfeeratesinFebruaryandOctober2011,respectively(G/SPS/N/USA/2156andaddenda).Aninterimfinalrulehadbeennotified(G/SPS/N/USA/703/Add.3)toamendFDA'sregulationontherecordavailabilityrequirements.TheamendmentexpandsFDA'saccessauthoritytorecordsrelatingtoanyotherarticleoffoodthattheSecretaryofHealthHumanServicesreasonablybelievesislikelytobeaffectedinasimilarmanner.Tradingpartnersshouldsubmitcommentsonthenotifiedmeasures.TheUnitedStateshopedtosoonpublishproposedrulesrelatingtopreventivecontrolsforhumanfoodsandanimalfeed,producesafety,foreignsupplierverification,andthird-partyaccreditation.TheFDAwouldbemindfuloftheCodexAlimentariusstandards,guidelinesandrelatedtexts,whileensuringFSMAprogrammesprovidedtheappropriatelevelofhealthprotectionforUSconsumers.
Ruleonmaterialsderivedfromcattleandrecord-keepingrequirementsArgentinanotedthatnotificationsG/SPS/N/USA/933and934werepublishedasregularnotificationsbutwereofimmediateandcompulsoryimplementationdespitegivingatimeframeforcomments.Furthermore,ArgentinawasrecognizedasfreeofBSEbuthadtocomplywiththesamerequirementsimposedoncountriesaffectedwithBSE.TheUnitedStateswasrequestedtorecognizethedifferentdiseasestatusofMembersasrequiredinArticle6oftheSPSAgreement.ChinawasconcernedthattheproductdescriptioninthenotificationwastoogeneralandtheHStariffcodesfortheproductscoveredbythetwomeasuresshouldbeincluded.ThenotificationsbroadlyincludedalltradingpartnersexportinghumanfoodorcosmeticstotheUnitedStateswithouttakingintoaccounttheBSEstatusofdifferentcountriesorregions.Itwasnotnecessarytorestrictprod
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