FDA有关117法规的一些问题解答Key Facts about Preventive Controls for Human Food.docx

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1、KeyFaCtSaboutPreventiveCOntrO1SforHUmanFOodPreventivecontro1sarestepsthatyouzadomesticorforeignfoodfaci1ity,musttaketoreduceore1iminatefdsafetyhazards.Theru1eonPreventiveContro1sforHumanFoodismandatedbythe2011FDAFoodSafetyModernizationAct.Theru1ea1soincorporatestheCurrentGoodManufacturingPractice(CG

2、MP)requirements,whichhavebeenupdated. DOTHEREQUIREMENTSFORPREVENTIVECONTRO1SFORHUAANFOODAPP1YTOME? DOTHEREQUIREMENTSFORCURRENTGoODMANUFACTURINGPRACTICES(CGMPS)APP1YTOME? WHENDOIHAVETOBEINCOMP1IANCEWITHTHERU1E? WHATCURRENTGOODAANUFACTURINGPRACTICESWEREUPDATEDUNDERTHISRU1E? WHATARETHEREQUIREMENTSREGAR

3、DINGFDSAFETYP1ANS? WHATDOIDOIFAHAZARDCOU1DFITNDERDIFFERENTPREVENTIVECONTRO1S? WHATISTHEFOODSAFETYP1ANBUI1DER?HOWDOIUSEIT? ARETHEREANYOTHERRESOURCESTOHE1PMEFO11OWTHISRU1E? Dotherequirementsforpreventivecontro1sforhumanfoodAPP1YTOME?Ingenera1,therequirementsapp1ytoyouifyoumanufacture,process,pack,orho

4、1dhumanfoodforconsumptionintheUnitedStates,whetheryourfaci1ityisdomesticorforeign.Therequirementsapp1ytoyouifyouarerequiredtoregisterwithFDAundersection415oftheFedera1Food,Drug,andCosmetic(FD&C)Act.Entitiesdefinedasfarmszretai1foodestab1ishments,andrestaurantsaresomeoftheentitiesthatarenotsubjecttot

5、hepreventivecontro1requirementsbecausetheyarenotrequiredtoregister.Inaddition,therearesevera1exemptionsormodifiedrequirementsthatmayapp1y. DOTHEREQUIREMENTSFORCURRENTGOODAAANUFACTUR1NGPRACTICES(CGMPS)APP1YTOME?Ingenera1,therequirementsapp1ytoyouifyoumanufacture,process,packorho1dhumanfood.Aswiththep

6、reventivecontro1srequirements,thereareexemptionsandmodifiedrequirements,buttheyarenotidentica1. WHENDOIHAVETOBEINCOMP1IANCEWITHTHERU1E?September18,2017:Sma11businesses(businesseswithfewerthan500fu11-timeequiva1entemp1oyees)OfficeofFoodsandVeterinaryMedicine2/6September17,2018:Verysma11businesses(ave

7、raging1essthan$1mi11ionperyear(adjustedforinf1ation)inannua1sa1esofhumanfoodp1usthemarketva1ueofhumanfoodmanufactured,processed,packed,orhe1dwithoutsa1e)September17,2018:Faci1itiessubjecttothePasteurizedMiIkOrdinance(PMO)(fortheirGradeA,zmi1kandmi1kproducts);comp1iancedatewasextendedtoa11owtimeforch

8、angestothePMOtoincorporatetherequirementsofthispreventiveContro1sru1e)*AUotherbusinesses(a1soknownas“1arge“businesses)wererequiredtobeinComp1ianceonSeptember19,2016.Notethatcomp1iancedatesforsomefaci1itiesandactivitieshavebeenextended.SEEA11FSMACOMP1IANCEDATEShttps:/www.fda.gov/food/guidanceregu1ati

9、on/fsma/ucm540944.htm WHATCURRENTGOODMANUFACTURINGPRACTICES(CGMPS)WEREUPDATEDUNDERTHISRU1E?Nowyouarerequiredtobeincomp1iancewithsomeprovisionsthatwereoptiona1before.Training:Managementisrequiredtoensurethata11emp1oyeeswhomanufacture,process,packorho1dfoodarequa1ifiedtoperformtheirassignedduties.Thee

10、mp1oyeesmustbetrainedintheprincip1esoffoodhygieneandfoodsafety,inc1udingtheimportanceofemp1oyeehea1thandhygieneasappropriatetothefood,thefaci1ity,andtheindividuasassignedduties.Recordsoftrainingmustbemaintained.A11ergencross-contact:FDA1ongstandingpositionthatCGMPsaddressa11ergencross-contactisnowex

11、p1icitintheregu1atorytext.Youarerequiredtoemp1oypracticesandprocedurestocontro1a11ergencross-contact.Humanfoodby-productsusedforanima1foods:TheupdatedCGMPscontainprovisionsforho1dinganddistributinghumanfoodby-productsthatareusedforanima1food.HumanFoodBy-ProductsforUseasAnima1Food(GuidanceforIndustry

12、-Draft)hnps;/ZWvVW,fda,govdown1oad5Anima1VeteHnaryGujdanceCEp1ianceEnfoeneniGUidanCefOr1ndUStrVUCM499201.DdfhttDs:/WWW.fda.qovdown1oadsAnimaIVeterinaryGUidanCeCOmO1ianCeEnfOrCement/Guidancefor1ndustrv/UCM499201.udf WHATARETHEREQUIREMENTSREGARDINGFOODSAFETYP1ANS?You,adomesticorforeignfoodfaci1ity,mus

13、t(1)haveandimp1ementawrittenfoodsafetyp1anthatidentifiesfoodsafetyhazardsthatrequireapreventivecontro1and(2)imp1ementpreventivecontro1stosignificant1yminimizeorpreventthehazard.Thep1anisrequiredtoinc1udethefo11owing:OAZARDANA1YSIS:Youarerequiredtoidentifyanyknownorreasonab1yforeseeab1e(i.e.zpotentia

14、1)bio1ogica1,chemica1,andphysica1hazards,anddetermineifanyofthosehazardsrequireapreventivecontro1.CurrentGoodManufacturingPractice,HazardAna1ysis,andRisk-BasedPreventiveContro1sforHumanFoodhttps:/WWW.federa1reqister.qovdocuments2015/09/17/201521920/CUnentqoodmanufacturinqPraetiCehazardana1vsisandris

15、kbasedprevenivecontro1sforhumanHazardAna1ysisandRisk-BasedPreventiveContro1sforHumanFoodhttps:/WWW.federa1register,gov/d。CUmentS/2017Q8312017T8464hazardana1ysisandriskbasedpreventivecontrosforhumanfoodguidanceforindustryavaiIabi1i1yHazardana1ysisandrisk-basedpreventivecontro1sforhumanfoodDraftGuidan

16、cefor1ndustryh1tDS:www.fda.qov/down1oads/Ft)Od/GuidanceRequ1atiotVFSMA/UCM517394.Ddfhttps:/WWW.fda.govdownbadsFxdGuidanceRegu1ationFSMAUCM517394.pdfPREVENTIVECONTRO1S:Ifthehazardana1ysisidentifiesahazardthatrequiresapreventivecontro1,youarerequiredtodeve1opandimp1ementacontro1tosignificant1yminimizeorp