BS EN 13441-2002 Biotechnology - Laboratories for research development and analysis - Guidance on containment of genetically modified plants《生物技术 研究、开发和分析实验室 抑制植物遗传变化指南》.pdf

1、BRITISH STANDARD BS EN 13441:2002 The European Standard EN 13441:2001 has the status of a British Standard ICS 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 13441:2002 This British Standard, having been prepared under the direction of the Sector Policy and Strate

2、gy Committee for Materials and Chemicals, was published under the authority of the Standards Policy and Strategy Committee on 25 January 2002 BSI 25 January 2002 ISBN 0 580 38922 7 National foreword This British Standard is the official English language version of EN 13441:2001. The UK participation

3、 in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publica

4、tions referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provis

5、ions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpr

6、etation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 10, an inside back cover and a bac

7、k cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN13441 November2001 ICS07.080 Englishversion BiotechnologyLaboratoriesforresearch,developm

8、entand analysisGuidanceoncontainmentofgeneticallymodified plants BiotechnologieLaboratoiresderecherche, dveloppementetanalyseGuidepourleconfinementdes plantesgntiquementmodifies BiotechnikLaboratorienfrForschung,Entwicklungund AnalyseLeitfadenfrdieEinschlieungvongentechnisch verndertenPflanzen ThisE

9、uropeanStandardwasapprovedbyCENon29September2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeo

10、btainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions

11、. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRN

12、ORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN13441:2001EEN13441:2001(E) 2 Contents page Foreword3 Introduction .4 1 Scope 5 2 Normativereferences 5 3 Termsanddefinitions. .5 4 Riskassessme

13、nt. .6 5 Containmentmeasures .6 Bibliography 10EN13441:2001(E) 3 Foreword ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC233“Biotechnology“,thesecretariat ofwhichisheldbyAFNOR. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendorse

14、ment,atthelatestbyMay2002,andconflictingnationalstandardsshallbewithdrawnatthelatestby May2002. ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropean FreeTradeAssociation. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing c

15、ountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden, SwitzerlandandtheUnitedKingdom.EN13441:2001(E) 4 Introduction ThemeasuresdescribedinthisEuropeanStandardared

16、esignedtocontaingeneticallymodifiedplants,wherethis isrequired.Geneticallymodifiedplantsincludethoseinwhichtheintroducedgeneticmaterialisderivedfrom anotherplantorfromanonplantsource,forexampleavirusorothermicroorganism.Containmentofgenetically modifiedmicroorganisms,thesubjectofDirective98/81/EC(in

17、cluding90/219/EEC)1and/orgeneticallymodified smallanimalsassociatedwithplantsisnotincludedinthisstandard;theircontainmentmayrequiredifferent measuresfromthosementionedhere. Thecontainmentprinciplesdescribedapplybothtogreenhouses,includinggrowthtunnels,andtothemore complexcontainmentfacilitiesrequire

18、dwhengreenhousesdonotprovidethedegreeofcontainmentrequired. Riskanalysisisrequiredtodetermineanyhazardanditsmagnitudeaswellasthecontainmentmeasuresneeded tominimizetherisk. Theselectionofcontainmentmeasuresforplantsclassifiedinagivengrouprequiresidentificationofthemeans includingworkpractices,bywhic

19、hparticularplantsmaybedispersedintherelevantsituation.Containment measuresusedforonespeciesmaybeirrelevanttoanother,whichisdispersedbydifferentmechanisms. Containmentmeasuresarethereforeselectedfortheparticularsituation. Inmanycases,containmentbybiologicalratherthanstructuralmeanswillbeappropriate.T

20、heuseofmalesterile plantsandmaternallyinheritedgeneticmodificationsareexamplesofpotentialbiologicalcontainmentmeasures. UsersofthisEuropeanStandardmaybeinvolvedwithhazardsassociatedwithmaterials,operationsand equipment.ThisEuropeanStandarddoesnotaddressalloffthesesafetyproblems.Itistheresponsibility

21、ofthe userofthisEuropeanStandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicability ofregulatorylimitationsfortheproposedwork.EN13441:2001(E) 5 1Scope ThisEuropeanStandardgivesbiological,physicalandproceduralcontainmentmeasuresforworkwithgenetically modifiedplantsincludingplan

22、tswherethetransferredgeneticmaterialisderivedfromanonplantsource.Itdefines measurestominimizehazardsidentifiedbyriskanalysis. Containmentmaybeprovidedinagreenhouseorinagrowthroom,laboratoryorothercontainmentfacility. Containmentofgeneticallymodifiedmicroorganismsand/orsmallanimalsassociatedwithplant

23、sisnotincludedin thisstandard.ContainmentofmicroorganismsinlaboratoriesiscoveredinEN12128. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromotherpublications.These normativereferencesarecitedattheappropriateplacesinthetext,andthepublicationsarelistedherea

24、fter.For datedreferences,subsequentamendmentstoorrevisionsofanyofthesepublicationsapplytothisEuropean Standardonlywhenincorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicationreferredtoapplies(includingamendments). EN12128,BiotechnologyLaboratoriesforresearch,develo

25、pmentandanalysisContainmentlevelsof microbiologylaboratories,areasofrisk,localitiesandphysicalsafetyrequirements. EN12741, BiotechnologyLaboratoriesforresearch,developmentandanalysisGuidanceforbiotechnology laboratoryoperations. 3 Termsanddefinitions ForthepurposesofthisEuropeanStandard,thefollowing

26、termsanddefinitionsapply. 3.1 biologicalcontainment useofplantswhichareunabletoremainviableinnaturalenvironmentalconditionsintheareaofthecontainment facility,orwhichlackreproductivemechanismsrequiredfordispersal 3.2 geneticallymodifiedplant plantinwhichthegeneticmaterialhasbeenalteredinawaythatdoesn

27、otoccurnaturallybymatingand/ornatural recombination NOTE Withinthetermsofthisdefinition,geneticmodificationoccursatleastby theuseofthetechniqueslistedinDirective 98/81/EC,Annex1PartA(1). 3.3 greenhouse structurewithawall,aroofandafloordesignedandusedprincipallyforgrowingplantsinacontrolledand protec

28、tedenvironmentDirective98/81/EC NOTE AnalternativedefinitioninprEN130311dealingwithstructuralaspectsofgreenhousesis:astructureusedforthe cultivationand/orprotectionofplantsandcropswhichpromotessolarradiationtransmissionundercontrolledconditionsto improvethegrowingenvironment,andwhichisofasizethatena

29、blespeopletoworkwithinitprEN130311. 3.4 hazard intrinsicpotentialpropertyorabilityofsomething(e.g.anyagent,equipment,materialorprocess)tocauseharm EN1620 NOTE Harmisaninjuryordamagetohealthofpeopleand/ortheenvironment. 3.5 physicalcontainment systemforconfiningamicroorganismand/ororganismorotherenti

30、tywithinadefinedspaceEN1620EN13441:2001(E) 6 3.6 risk probabilityofoccurrenceofahazardcausingharmandthedegreeofseverityoftheharm 4Risk assessment Theanalysisofriskshouldtakeaccountoftheinfluenceofregional,climaticandotherenvironmentalconditions whichcanalsodeterminewhethercontainmentisrequired.Theha

31、zardspresent,andthustheneedforandthe natureofcontainmentmeasures,shouldbeassessedonacasebycasebasis,foreachenvironmentalsituation. Forgeneticallymodified plants,thepotentialhazardsareasfollows: a) thattheymaybeabletocauseharmtopeoplebyvirtueoftoxigenicorallergenicproperties;and/or b) maybecomeestabl

32、ishedintheenvironmentandcausechangesinecosystems; c) mayexpressotherunwantedtraits. Controlofhazardrequiresthatthemeansbywhichthegeneticallymodifiedplantsaredispersedisidentifiedand appropriatestepstakentopreventdispersion. Thecontainmentmeasuresappropriateforworkwithgeneticallymodifiedplantsaredete

33、rminedbytherisk assessmentoftheproposedwork,carriedoutinaccordancewithEuropeanandnationalregulations. 5Containment measures 5.1General Containment,whenrequired,willbeachievedbytakingappropriatestepstopreventdispersalbytheprocess relevanttoaparticularplantand/orbyparticularworkpractices. 5.2Useofconv

34、entionalgreenhouses Wherethehazardisassessedasminimal,agreenhousedesignedtoprovideprotectionfortheplantsisacceptable forthecultivationofgeneticallymodifiedplants.Suchbasiclevelstructuresincludegrowthtunnels. NOTE RequirementsforcommercialgreenhousesaregiveninprEN1303113. 5.3Additionalcontainmentmeas

35、ures 5.3.1General Whencontainmentisrequired,conventionalgreenhousesorplanttunnelsareinherentlyunsuitablewithout applicationofadditionalfeaturestocontrolthedispersionofgeneticallymodifiedmaterialaspollen,seed,fruit and/orvegetativetissues.Wherecontainmentisneeded,itmaybeachievedbyphysicalcontainmentm

36、easures, biologicalcontainmentandappropriateworkpractices,eitheraloneorincombination. Anonexhaustivelistofcontainmentmeasureswhichwillreducedispersionisgivenin5.3.2to5.3.4.Appropriate measuresofcontainmentshouldbeselectedfromtheseandfromotherrelevantandvalidatedproceduresnot listed. 5.3.2 Dispersalb

37、ypollen Dispersalbypollenmaybecontrolledbyoneormoreofthefollowingmeans: a) coveringflowerswithfabricbagswhichwillretainpollen; b) fittingpollenretainingfiltersoverallopenings;dueattentionshouldbepaidtosealingplaceswherepipesand otherstructurespassthroughwalls;EN13441:2001(E) 7 c) usingmalesterilepla

38、ntsorplantssubjectedtoothersterilizationprocedures; d) ensuringthatexperimentalplantfloweronlywhensusceptibleplantsintheenvironmentarenotinflower; e) removingsusceptibleplantsfromtheimmediateenvironment; f) preventingingressandexitofbirdsandpollinatinganimalsbyfittingappropriatebarrierstoallopenable

39、 windowsandotheropenings; g) controllingaccesstothebuilding; NOTE Careshouldbetakenthatanyaccesscontrolmeasuresdonotconflictwithothersafetyregulations,suchasescape fromfire. h) usingreducedpressuretoensureinwardairflow; i) sterilizingor,whenappropriate,inactivatingplantdispersingmaterialinrunoffwate

40、r. 5.3.3 Dispersalasfruitandseeds Dispersalasfruitandseedsmaybecontrolledbyoneormoreofthefollowingmeans: a) preventingentryandexitofbirdsandotheranimalsbyfittingappropriatebarrierstoallopenablewi ndowsand otheropenings; b) filteringrunoffwater; c) sterilizingor,whenappropriate,inactivatingplantdispe

41、rsingmaterialin runoffwater; d) sealingplaceswherepipesandotherstructurespassthroughwalls; e) sterilizingor,asappropriate,steamingplantdispersing materialleavingthegreenhouse; NOTE Ifanautoclaveisused,itshouldbeofsuitableperformanceclassasdefinedinEN12347. f) usingsexuallysterileplants; g)controllin

42、g window opening; h) usingsolid,nonpenetrablefloor; i) controllingaccesstothegreenhouse. NOTE Careshouldbetakenthatanyaccesscontrolmeasuresdonotconflictwithothersafetyregulations,suchasescape fromfire. 5.3.4 Dispersalbyvegetativemeans Dispersalbyvegetativemeansmaybecontrolledbyoneormoreofthefollowin

43、gmeans: a) constructingawallaroundthefacilitybelowgroundtoadepthsufficienttopreventdispersion; b) transferringmaterialfromgeneticallymodifiedplantstootherfacilitiesonlywhenusingclosedrobust containers; c) sterilizingorasappropriate,inactivatingplantdispersingmaterialin materialleavingthegreenhouse;

44、NOTE Ifanautoclaveisused,itshouldbeofsuitableperformanceclassasdefinedinEN12347. d) fumigatingthebuildingafteruse; e) filteringrunoffwater; f) sterilizingorasappropriate,inactivatingplantdispersingmaterialin runoffwater;EN13441:2001(E) 8 g) sealingplaceswherepipesandotherstructurespassthroughwalls; h)controlling window opening; i) usingsolid,