FDA 對(duì)三聚氰胺安全風(fēng)險(xiǎn)評(píng)估

《FDA 對(duì)三聚氰胺安全風(fēng)險(xiǎn)評(píng)估》由會(huì)員上傳分享，免費(fèi)在線閱讀，更多相關(guān)內(nèi)容在行業(yè)資料-天天文庫(kù)。

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