美国章121法规中英文全文.docx

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1、03法规中英文全文MitigationStrategiesToProtectFoodAgainstIntentiona1Adu1terationFoodandDrugAdministration,HHS.Action：Fina1ru1eSummaryTheFoodandDrugAdministration(FDAorwe)isissuingthisfina1ru1etorequiredomesticandforeignfoodfaci1itiesthatarerequiredtoregisterundertheFedera1Food,Drug,andCosmeticAct(theFD&CAct

2、)toaddresshazardsthatmaybeintroducedwiththeintentiontocausewidesca1epub1ichea1thharm.Thesefoodfaci1itiesarerequiredtoconductavu1nerabi1ityassessmenttoidentifysignificantvu1nerabi1itiesandactionab1eprocessstepsandimp1ementmitigationstrategiestosignificant1yminimizeorpreventsignificantvu1nerabi1itiesi

3、dentifiedatactionab1eprocessstepsinafoodoperation.FDAisissuingtheserequirementsaspartofourimp1ementationoftheFDAFoodSafetyModernizationAct(FSMA).DatesThisru1eiseffectiveJu1y26,2016.SeesectionV111forcomp1iancedates.Tab1eofContentsExecutiveSummaryPurposeandCoverageoftheRu1eSummaryoftheMajorProvisionso

4、ftheRu1eCostsandBenefitsI. BackgroundA. FDAFoodSafetyModernizationActB. ProposedRu1eonIntentiona1Adu1terationC. Appendix4toDraftRiskAssessmentD. Pub1icCommentsII. 1ega1AuthorityA. Section103ofFSMAB. Section106ofFSMAC. IntrastateActivitiesIII. Genera1CommentsontheProposedRu1eA. CommentsonOvera11Frame

5、workfortheRegu1atoryApproachB. OneSetofRequirementsUnderSections418and420oftheFD&CActC. RequireMeasuresOn1yintheEventofaCredib1eThreatD. Genera1CommentsonImp1ementationandComp1ianceE. CommentsonRequestsforAdditiona1ExemptionsF. OtherGenera1CommentsG. OtherIssuesDiscussedintheProposedRu1eIV. SubpartA

6、:CommentsonSpecificProvisionsA. RevisionstoDefinitionsA1soUsedinSection415RegistrationRegu1ations(21CFRPart1,SubpartH)andSection414RecordkeepingRegu1ations(21CFRPart11SubpartJ)B. OtherDefinitionsThatWeProposedToEstab1ishinPart121C. Additiona1DefinitionstoC1arifyTermsNotDefinedintheProposedRu1eD. Com

7、mentsAskingFDAtoEstab1ishAdditiona1DefinitionsorOtherwiseC1arifyTermsNotDefinedintheRu1eE. Proposed121.5ExemptionsV. SubpartC:CommentsonFoodDefenseMeasuresA. Proposed121.126RequirementforaFoodDefenseP1anB. Proposed121.130IdentificationofActionab1eProcessStepsC. Proposed121.135FocusedMitigationStrate

8、giesforActionab1eProcessStepsD. Fina1121.138MitigationStrategiesManagementComponentsE. Proposed121.140MonitoringF. Proposed121.145CorrectiveActionsG. Proposed121.150VerificationH. Proposed121.160Training(Fina1121.4)VI. SubpartD:CommentsonRequirementsApp1yingtoRecordsThatMustBeEstab1ishedandMaintaine

9、dA. Proposed121.301RecordsSubjecttotheRequirementsofThisSubpartDB. Proposed121.305Genera1RequirementsApp1yingtoRecordsC. Proposed121.310Additiona1RequirementsApp1yingtotheFoodDefenseP1anD. Proposed121.315RequirementsforRecordRetentionE. Proposed121.320RequirementsforOfficia1ReviewF. Proposed121.325P

10、ub1icDisc1osureG. Proposed121.330UseofExistingRecordsVII. SubpartE:CommentsonComp1ianceProposed121.401VIII. EffectiveandComp1ianceDatesIX. ExecutiveOrder13175X. Fina1Regu1atoryImpactAna1ysisXI. PaperworkReductionActof1995XII. Ana1ysisofEnvironmenta1ImpactXIII. Federa1ismXIV. ReferencesExecutiveSumma

11、ryPurposeandCoverageoftheRu1eThisregu1ationimp1ementsthreeprovisionsoftheFD&CAct,asamendedbyFSMA1thatre1atetotheintentiona1adu1terationoffood.Section418oftheFD&CAct(21U.S.C.350g)addressesintentiona1adu1terationinthecontextoffaci1itiesthatmanufacture,process,pack,orho1dfoodandarerequiredtoregisterund

12、ersection415oftheFD&CAct(21U.S.C.350d).Section419oftheFD&CAct(21U.S.C.350h)addressesintentiona1adu1terationinthecontextoffruitsandvegetab1esthatarerawagricu1tura1commodities.Section420oftheFD&CAct(21U.S.C.350i)addressesintentiona1adu1terationinthecontextofhigh-riskfoodsandexemptsfarmsexceptforfarmst

13、hatproducemi1k.FDAisimp1ementingtheintentiona1adu1terationprovisionsinsections418,419,and420oftheFD&CActinthisru1emaking.Thepurposeofthisru1eistoprotectfoodfromintentiona1actsofadu1terationwherethereisanintenttocausewidesca1epub1ichea1thharm.Thisru1eapp1iestobothdomesticandforeignfaci1itiesthatarere

14、quiredtoregisterundersection415oftheFD&CAct.Thisru1eestab1ishessevera1exemptionsasfo11ows:Theru1edoesnotapp1ytoaverysma11business(i.e.,abusiness,inc1udinganysubsidiariesoraffi1iates,averaging1essthan$10,000,000,adjustedforinf1ation,peryear,duringthe3-yearperiodprecedingtheapp1icab1eca1endaryearinbot

15、hsa1esofhumanfoodp1usthemarketva1ueofhumanfoodmanufactured,processed,packed,orhe1dwithoutsa1e,e.g.,he1dforafee),exceptthatthefaci1ityisrequiredtoprovideforofficia1review,uponrequest,documentationsufficienttoshowthatthefaci1ityqua1ifiesforthisexemption.Thisru1edoesnotapp1ytotheho1dingoffood,exceptthe

16、ho1dingoffoodin1iquidstoragetanks.Thisru1edoesnotapp1ytothepacking,re-packing,1abe1ing,orre-1abe1ingoffoodwherethecontainerthatdirect1ycontactsthefoodremainsintact.Thisru1edoesnotapp1ytoactivitiesofafarmthataresubjecttosection419oftheFedera1Food,Drug,andCosmeticAct(StandardsforProduceSafety).Thisru1edoesnotapp1ywithrespecttoa1c