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US Food and Drug Administration: out50 en

US Food and Drug Administration: out50 en

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Published by: FDA on Jan 19, 2008
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EUROPEAN COMMISSION
DIRECTORATE-GENERAL XXIVCONSUMER POLICY AND CONSUMER HEALTH PROTECTIONDirectorate B - Scientific Health Opinions
Unit B3 - Management of scientific committees II
OPINION OF THESCIENTIFIC STEERING COMMITTEEONANTIMICROBIAL RESISTANCE28 May 1999
(With minor editorial amendments agreed on 24-25 June 1999)(Bibliography updated on 20 September 1999)
 
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EXECUTIVE SUMMARY.................................................................................................71.INTRODUCTION.....................................................................................................131.1.Background......................................................................................................131.2.The Proposal....................................................................................................141.3.Mandate and Terms of Reference....................................................................141.4.Scope of Report...............................................................................................151.5.Procedures for Authorising Antimicrobials.....................................................161.6.Sale and Supply...............................................................................................162.THE BASIS OF RESISTANCE TO ANTIMICROBIALS.......................................182.1.Basis of Antibacterial Action..........................................................................182.2.Basis of Resistance and Selection of Resistant Populations............................182.2.1.Mechanisms.......................................................................................182.2.2.Selection of Resistant Populations....................................................192.3.Laboratory Determination of Resistance.........................................................192.4.Transfer of Resistance.....................................................................................202.5.Relationship Between Drug Administration and Prevalence oResistance........................................................................................................213.PREVALENCE OF ANTIMICROBIAL RESISTANCE IN PATHOGENSFROM HUMANS, ANIMALS AND PLANTS, AND ITS IMPACT ONHEALTH AND PRODUCTIVITY...........................................................................223.1.Resistance in Bacteria from Humans...............................................................223.1.1.Prevalence..........................................................................................223.1.2.Clinical Impact..................................................................................263.2.Resistance in Bacteria from Animals..............................................................283.2.1.Prevalence..........................................................................................28
 
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3.2.2.Impact on Veterinary Medicine and Effects on Human Health.........333.2.3.Impact on Animal Production............................................................353.3.Resistance Amongst Bacteria in Plant Protection...........................................363.3.1.Prevalence..........................................................................................363.3.2.Impact on health and productivity.....................................................363.4.Resistant bacteria in the environment..............................................................373.4.1.Prevalence..........................................................................................373.4.2.Impact on health................................................................................383.5.Antibiotic resistance marker genes in genetically modified plants.................383.5.1.The fate of plant DNA in the gastro-intestinal tract..........................393.5.2.The potential for integration of DNA from food into intestinalmicroorganisms.................................................................................393.5.3.The probability of expression of an integrated gene inintestinal microorganisms..................................................................393.5.4.The protein encoded by antibiotic resistance gene in plant as apotential safety issue..........................................................................403.5.5.Impact on human health, on animal health and animalproduction..........................................................................................404.AMOUNTS OF ANTIMICROBIALS USED...........................................................424.1.Human medicine..............................................................................................424.2.Veterinary medicine and animal husbandry....................................................434.3.Human vs. animal consumption......................................................................444.4.Plant Protection...............................................................................................444.5.Conclusions.....................................................................................................455.RELATIONSHIP OF THE USE OF ANTIMICROBIALS TORESISTANCE AND ITS TRANSFER BETWEEN ECOSYSTEMS......................465.1.Human Medicine.............................................................................................475.1.1.Use and availability of antibacterials.................................................475.1.2.Type of antibacterial..........................................................................48

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