FOODSAFETYMODERNIZATIONACT(FSMA)-TheBureau…食品安全现代化法案（FSMA）-局…

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1、FOODSAFETYMODERNIZATIONACT(FSMA)ANOVERVIEWBeverleyMillerDate:25October2011TheFoodSafetyModernizationAct,anamendmentoftheFederalFood,DrugandCosmetic(FD&C)Act,wassignedintolawonJanuary4,2011byPresidentObama.TheActprovidesalegislativemandatetorequirescience-basedpreventivecontro

2、lsacrossthefoodsupplychainratherthanareactiveapproachtofoodsafetyproblems.THEFOODSAFETYMODERNIZATIONACTFoodborneillnessabigproblemintheU.S.A.RecentdatafromtheCentersforDiseaseControl&Prevention:About48million(1in6)Americansgetsick;128,000arehospitalizedand3,000dieeachyearFood

3、bornediseasesalargelypreventablepublichealthburdenWHYtheFSMA?1.Improvingcapacitytopreventfoodsafetyproblems;2.Improvingcapacitytodetectandrespondtofoodsafetyproblems;3.Improvingthesafetyofimportedfood.FEATURESOFFSMATitles1-3RegistrationBiennialregistrationrenewalasofOctober1

4、,2012;SuspensionofregistrationHazardanalysisandrisk-basedpreventivecontrolAuthoritytocollectfeesforre-inspection;mandatoryrecalls;voluntaryqualifiedimporterprogramme(VQIP);UniqueIdentificationNumberforeachregisteredfacility(studyunderway).1.Improvingcapacitytopreventfoodsafet

5、yproblemsIdentificationandinspectionoffacilities;increasedfrequencyofinspection.(Inyear1-atleast600foreignfacilitiestobeinspected)Identificationandinspectionatportsofentry;2.ImprovingcapacitytodetectandrespondtofoodsafetyproblemsLaboratoryAccreditationforAnalysisofFoods;(Fore

6、ignlabswhichsatisfyaccreditationstandardsshallbeaccredited);Enhancedtracking/tracingoffoods(startingwithpilotprojects)&recordkeeping;Foodborneillnesssurveillancesystem;Mandatoryrecallauthority.2.Improvingcapacitytodetectandrespondtofoodsafetyproblems(cont’d)Section202oftheAct

7、,directstheFDAto:-EstablishaprogrammeforthetestingoffoodsbyaccreditedlaboratoriesbyJanuary2013;EstablishapubliclyavailableregistryofaccreditationbodiesrecognizedbytheSecretaryandoflaboratoriesaccreditedbyarecognizedaccreditationbodybyJanuary2013;Requirethatanychangesthatwould

8、affecttherecognition/accreditationbereportedtotheSecretary.FSMA&Lab.