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1、SeeNovember28,2008UpdateInterimSafetyandRiskAssessmentofMelamineanditsAnaloguesinFoodforHumansaBACKGROUNDOnSeptember11,2008,FDAlearnedthatmelaminemaybecontainedinaninfantformulamanufacturedbyafirminChina.AsofSeptember21,2008,FDAlearnedthatatotalof52,857casesofnephrolithiasis(and,ins
2、omeinstances,renalfailure)hadbeenreportedinChinalinkedtoconsumptionofthiscontaminatedpowderedformula. Therehavebeenapproximately13,000hospitalizations,andatleast3deathshavebeenconfirmedtodate. Thevastmajorityofillnessesinvolvedchildrenundertheageof3years(82%<2years;17%2-3years;0.8%>
3、3years;andnocasesinvolvedadults). TheresultsofaninvestigationconductedinChinaindicatedthatChinese-producedpowderedinfantformulawaslinkedtotheseillnesses;nocaseswereassociatedwithliquidinfantformula.AninvestigationofpowderedformulaswasconductednationallybyChina'sGeneralAdministration
4、ofQualitySupervision,InspectionandQuarantine(AQSIQ)andrevealedcontaminationofpowderedformulasproducedby22companies. TestresultsconductedinChinaonsamplesofthepowderedinfantformulashowedthattheycontainedawiderangeofconcentrations(0.1ppmtogreaterthan2,500ppmmelamine). Inaddition,otherc
5、ountrieshavereporteddetectionofmelamineinotherproductcategories,suchasconfectionsandbeverages. Wenotethattherearegenerallyavailableanalyticalmethodsthatcanreliablydetectalevelof1ppmmelamineinsomefoodmatrices.IllnesseswerereportedindifferentregionsofChina,includingGanzu,Shaanxi,Ningx
6、ia,Jiangsu,Henan,Jiangxi,Hubei,Shandong,AnhuiandHunan. ApressreleasefromtheGanzuHealthBureauonSeptember11,2008statedthatduringthefirsthalfof2008,onehospitalinGanzutreated16infantswhohadkidneystones.The16infantsvariedinagefrom5monthsto11months;someofthecasesreportedlydevelopedrenalin
7、sufficiency. Inarecordreviewconductedfortheperiod2006tothepresent,hospitalsinGanzuidentifiedatotalof59casesofkidneystonesininfants,including1infantwhodied. Thecaseswerelocatedin24Ganzucountiesandmostofthecaseswerefromruralareas. Allofthecasesoccurredin2008;nonewereidentifiedin2006an
8、d2007. Medicalautho
