council direct april contain genet modifi micro organ eec council european commun regard treati establish european econom commun articl thereof regard propos commiss regard opinion european parliament regard opinion econom social committe treati action commun relat environ base principl prevent action object preserv protect improv environ protect human health council resolut octob fourth environment action programm european commun declar measur evalu biotechnolog regard environ prioriti area commun action concentr develop biotechnolog contribut econom expans member state impli genet modifi micro organ oper type scale oj oj contain genet modifi micro organ carri limit neg consequ human health environ due attent prevent accid control wast micro organ releas environ member state contain reproduc spread cross nation frontier affect member state order bring safe develop biotechnolog commun establish common measur evalu reduct potenti risk aris oper involv contain genet modifi micro organ set condit precis natur scale risk genet modifi micro organ fulli risk involv assess case case evalu risk human health environ lai requir risk assess genet modifi micro organ classifi relat risk present criteria provid purpos attent oper hazard genet modifi micro organ contain measur appli stage oper control emiss prevent accid person undertak time contain genet modifi micro organ instal forward compet author notif author satisfi propos instal carri activ manner present hazard human health environ establish procedur case case notif specif oper involv contain genet modifi micro organ take account degre risk involv case oper involv high risk consent compet author consid consult public contain genet modifi micro organ measur inform person liabl affect accid matter relat safeti emerg plan establish deal effect accid accid occur user immedi inform compet author commun inform assess impact accid take action commiss consult member state establish procedur exchang inform accid commiss set regist accid contain genet modifi micro organ commun monitor end member state suppli inform commiss committe set assist commiss matter relat implement direct adapt technic progress adopt direct articl direct lai common measur contain genet modifi micro organ view protect human health environ articl purpos direct micro organ microbiolog entiti cellular cellular capabl replic transfer genet materi genet modifi micro organ micro organ genet materi alter occur natur mate natur recombin term definit genet modif occur techniqu list annex part ii techniqu list annex part consid result genet modif contain oper micro organ genet modifi genet modifi micro organ cultur store transport destroi dispos physic barrier combin physic barrier chemic biolog barrier limit contact gener popul environ type oper oper teach research develop industri commerci purpos small scale litr cultur volum type oper oper type oper accid incid involv signific unintend releas genet modifi micro organ contain present delai hazard human health environ user natur legal person respons contain genet modifi micro organ notif present document requisit inform compet author member state articl direct appli genet modif obtain techniqu list annex articl purpos direct genet modifi micro organ classifi group ii satisfi criteria annex ii group ii group type oper criteria annex ii applic determin classif genet modifi micro organ case classif provision compet author ensur relev criteria aim obtain equival direct implement commiss draw guidelin classif procedur articl articl articl appli transport genet modifi micro organ road rail inland waterwai sea air direct appli storag transport destruct dispos genet modifi micro organ market commun legisl includ specif risk assess similar provid direct articl member state ensur measur avoid advers effect human health environ aris contain genet modifi micro organ end user carri prior assess contain risk human health environ incur make assess user due account paramet set annex iii relev genet modifi micro organ propos record assess user made summari form compet author part notif articl request articl genet modifi micro organ group principl good microbiolog practic principl good occup safeti hygien appli iii workplac environment exposur physic chemic biolog agent lowest practic level ii ii exercis engin control measur sourc supplement person protect cloth equip iii test adequ maintain control measur equip iv test presenc viabl process organ primari physic contain ii provid train personnel vi establish biolog safeti committe subcommitte requir vii formul implement local code practic safeti personnel addit principl contain measur set annex iv appli contain genet modifi micro organ group ii ensur high level safeti contain measur appli period review user account scientif technic knowledg rel risk manag treatment dispos wast articl instal time oper involv contain genet modifi micro organ user requir submit compet author commenc notif inform list annex separ notif made genet modifi micro organ group group ii articl user genet modifi micro organ classifi group type oper requir record work carri made compet author request user genet modifi micro organ classifi group type oper commenc contain requir submit compet author notif inform list annex articl user genet modifi micro organ classifi group ii type oper commenc contain requir submit compet author notif inform list annex user genet modifi micro organ classifi group ii type oper commenc contain requir submit compet author notif inform genet modifi micro organ inform personnel train inform instal inform wast manag inform accid prevent emerg respons plan assess risk human health environ refer articl detail list annex articl member state design author author compet implement measur adopt applic direct receiv acknowledg notif refer articl articl articl compet author examin conform notif requir direct accuraci complet inform correct classif adequaci wast manag safeti emerg respons measur compet author user provid inform modifi condit propos contain case propos contain proce compet author approv basi inform obtain modifi condit contain limit time contain permit subject specif condit case time instal refer articl involv genet modifi micro organ group contain absenc indic contrari compet author proce dai submiss notif earlier agreement compet author involv genet modifi micro organ group ii contain proce consent compet author compet author commun decis write latest dai submiss notif oper notifi articl articl absenc indic contrari compet author proce dai submiss notif earlier agreement compet author oper notifi articl proce consent compet author compet author commun decis write latest dai submiss notif purpos calcul period refer paragraph period time compet author await inform request notifi accord paragraph carri public inquiri consult accord articl account articl user awar relev inform modifi contain signific consequ risk pose contain categori genet modifi micro organ chang compet author inform notif articl modifi inform subsequ compet author signific consequ risk pose contain compet author requir user modifi condit suspend termin contain articl member state consid provid group public consult aspect propos contain articl compet author ensur oper commenc emerg plan drawn protect human health environ instal event accid emerg servic awar hazard inform thereof write inform safeti measur correct behaviour adopt case accid suppli manner request person liabl affect accid inform repeat updat interv made publicli member state concern time make member state concern basi consult framework bilater relat inform dissemin nation articl member state measur ensur event accid user requir immedi inform compet author articl provid inform circumst accid ident quantiti genet modifi micro organ releas inform assess effect accid health gener popul environ emerg measur inform paragraph member state requir ensur emerg medium long term measur immedi alert member state affect accid collect inform full analysi accid make recommend avoid similar accid futur limit effect thereof articl member state requir consult member state liabl affect event accid draw implement emerg plan inform commiss accid scope direct give detail circumst accid ident quantiti genet modifi micro organ releas emerg respons measur emploi effect analysi accid includ recommend limit effect avoid similar accid futur commiss consult member state establish procedur exchang inform paragraph set dispos member state regist accid scope direct occur includ analysi accid experi gain measur avoid similar accid futur articl member state ensur compet author organ inspect control measur ensur user complianc direct articl member state send commiss end year summari report contain notifi articl includ descript propos risk genet modifi micro organ year member state send commiss summari report experi direct time septemb year commiss publish summari base report refer paragraph time commiss publish gener statist inform implement direct relat matter long inform harm competit posit user articl commiss compet author divulg parti confidenti inform notifi provid direct protect intellectu properti right relat data receiv notifi inform notif submit direct disclosur harm competit posit treat confidenti verifi justif case compet author decid consult notifi inform confidenti inform notifi decis case inform submit articl confidenti descript genet modifi micro organ address notifi purpos contain locat method plan monitor genet modifi micro organ emerg respons evalu forese effect pathogen ecolog disrupt effect reason notifi withdraw notif compet author respect confidenti inform suppli articl amend adapt annex ii technic progress decid accord procedur defin articl articl commiss assist committe compos repres member state chair repres commiss repres commiss submit committe draft measur committe deliv opinion draft time limit chairman lai urgenc matter opinion deliv major laid articl treati case decis council requir adopt propos commiss vote repres member state committe weight manner set articl chairman vote commiss adopt measur envisag accord opinion committe measur envisag accord opinion committe opinion deliv commiss delai submit council propos relat measur council act qualifi major expiri period month date referr council council act propos measur adopt commiss save council decid measur simpl major articl member state bring forc law regul administr provis compli direct octob forthwith inform commiss thereof articl direct address member state luxembourg april council presid reynold oj oj oj oj annex part techniqu genet modif refer articl inter alia ii recombin dna techniqu vector system previous cover recommend eec ii techniqu involv direct introduct micro organ herit materi prepar micro organ includ micro inject macro inject micro encapsul iii cell fusion hybrid techniqu live cell combin herit genet materi form fusion cell mean method occur natur part techniqu refer articl ii consid result genet modif condit involv recombin dna molecul genet modifi organ vitro fertil conjug transduct transform natur process polyploidi induct annex techniqu genet modif exclud direct condit involv genet modifi micro organ recipi parent organ mutagenesi construct somat anim hybridoma cell product monoclon antibodi cell fusion includ protoplast fusion cell plant produc tradit breed method clone pathogen natur occur micro organ fulfil criteria group recipi micro organ oj annex ii criteria classifi genet modifi micro organ group recipi parent organ pathogen adventiti agent proven extend histori safe built biolog barrier interf optim growth reactor fermentor confer limit surviv replic advers consequ environ vector insert character free harm sequenc limit size genet sequenc requir perform intend function increas stabil construct environ requir intend function poorli mobiliz transfer resist marker micro organ acquir natur acquisit compromis drug control diseas agent genet modifi micro organ pathogen safe reactor fermentor recipi parent organ limit surviv replic advers consequ environ genet modifi micro organ includ group meet condit construct singl prokaryot recipi includ indigen plasmid virus singl eukaryot recipi includ chloroplast mitochondria plasmid exclud virus consist genet sequenc speci exchang sequenc physiolog process annex iii safeti assess paramet account relev accord articl characterist donor recipi parent organ characterist modifi micro organ health consider environment consider characterist donor recipi parent organ name design degre related sourc organ inform reproduct cycl sexual asexu parent organ applic recipi micro organ histori prior genet manipul stabil parent recipi organ term relev genet trait natur pathogen virul infect toxic vector diseas transmiss natur indigen vector sequenc frequenc mobil specif presenc gene confer resist host rang potenti signific physiolog trait stabil trait natur habitat geograph distribut climat characterist origin habitat signific involv environment process nitrogen fixat ph regul interact effect organ environ includ competit symbiot properti abil form surviv structur spore sclerotia characterist modifi micro organ descript modif includ method introduc vector insert recipi organ method achiev genet modif involv function genet manipul nucleic acid natur sourc vector structur amount vector donor nucleic acid remain final construct modifi micro organ stabil micro organ term genet trait frequenc mobil insert vector genet transfer capabl rate level express genet materi method sensit measur activ express protein health consider toxic allergen effect viabl organ metabol product product hazard comparison modifi micro organ donor recipi parent organ pathogen capac colon micro organ pathogen human immunocompet diseas caus mechan pathogen includ invas virul communic infect dose host rang possibl alter possibl surviv human host presenc vector mean dissemin biolog stabil antibiot resist pattern allergen avail therapi environment consider factor affect surviv multipl dissemin modifi micro organ environ techniqu detect identif monitor modifi micro organ techniqu detect transfer genet materi organ predict habitat modifi micro organ descript ecosystem micro organ accident dissemin anticip mechan result interact modifi micro organ organ micro organ expos case releas environ predict effect plant anim pathogen infect toxic virul vector pathogen allergen colon predict involv biogeochem process avail method decontamin area case releas environ annex iv contain measur micro organ group ii contain measur micro organ group ii chosen user categori micro organ oper question order ensur protect public health gener popul environ type oper consid term unit oper characterist oper dictat physic contain stage select design process plant oper procedur fit assur adequ safe contain import factor consid select equip need implement contain risk effect consequ equip failur engin practic requir increasingli stringent standard reduc risk failur consequ failur toler specif contain measur type oper establish take account contain categori bear mind specif circumst oper specif contain categori viabl micro organ contain system physic separ process environ close system exhaust gase close system treat minim releas prevent releas prevent releas sampl collect addit materi close system transfer viabl micro organ close system perform minim releas prevent releas prevent releas bulk cultur fluid remov close system viabl micro organ inactiv valid mean inactiv valid chemic physic mean inactiv valid chemic physic mean seal design minim releas prevent releas prevent releas close system locat control area option option purpos built biohazard sign post option access restrict nomin personnel option airlock personnel wear protect cloth work cloth complet chang decontamin wash facil provid personnel personnel shower leav control area option effluent sink shower collect inactiv releas option specif contain categori control area adequ ventil minim air contamin option option control area maintain air pressur neg atmospher option input air extract air control area hepa filter option control area design spillag entir content close system option control area sealabl permit fumig option effluent treatment final discharg inactiv valid mean inactiv valid chemic physic mean inactiv valid chemic mean annex part inform requir notif refer articl person respons carri contain includ respons supervis monitor safeti inform train qualif address instal grid refer descript section instal descript natur work undertaken classif micro organ group group ii scale oper summari risk assess refer articl part inform requir notif refer articl date submiss notif refer articl parent micro organ applic host vector system sourc intend function genet materi involv manipul ident characterist genet modifi micro organ purpos contain includ expect result cultur volum summari risk assess refer articl part inform requir notif refer articl inform requir part descript section instal method handl micro organ descript predomin meteorolog condit potenti sourc danger aris locat instal descript protect supervisori measur appli durat contain contain categori alloc wast treatment provis safeti precaut adopt part inform requir notif refer articl technic give inform reason state level detail requir respons subset consider vari natur scale propos contain case inform submit compet author requir direct refer made inform user date submiss notif refer articl respons person inform genet modifi micro organ ident characterist genet modifi micro organ purpos contain natur product host vector system applic cultur volum behaviour characterist micro organ case condit contain releas environ overview potenti hazard releas micro organ environ substanc produc micro organ intend product inform personnel maximum number person work instal number person work directli micro organ inform instal activ micro organ technolog process descript section instal predomin meteorolog condit specif hazard aris locat instal inform wast manag type quantiti potenti hazard wast aris micro organ wast manag techniqu includ recoveri liquid solid wast inactiv method ultim form destin inactiv wast inform accid prevent emerg respons plan sourc hazard condit accid occur prevent measur appli safeti equip alarm system contain method procedur resourc descript inform provid worker inform compet author enabl draw establish emerg respons plan instal accord articl comprehens assess refer articl risk human health environ aris propos contain inform requir part