council decis octob establish guidanc note supplement annex vii direct ec european parliament council deliber releas environ genet modifi organ repeal council direct eec ec council european union regard treati establish european commun regard direct ec european parliament council paragraph annex vii thereto regard propos commiss direct ec stipul genet modifi organ hereinaft refer gmo product market notif submit compet author member state gmo market time direct ec notifi ensur monitor report deliber releas gmo carri accord condit authoris place market gmo pursuant articl articl articl direct notif plan monitor includ propos time period monitor plan accord annex vii direct ec annex vii direct ec supplement note provid detail guidanc object gener principl design monitor plan refer annex committe set articl direct ec consult june deliv opinion commiss propos decis adopt decis articl guidanc note set annex decis supplement annex vii direct ec articl decis address member state luxembourg octob council presid hansen oj annex introduct direct ec introduc oblig notifi implement monitor plan order trace identifi direct indirect delai unforeseen effect human health environ gmo product market notifi requir articl direct submit part notif place market gmo plan monitor accord annex vii direct includ propos time period monitor plan propos period consent annex vii describ gener term object achiev gener principl design monitor plan refer articl articl articl guidanc note supplement inform provid annex vii context direct expand object monitor expand gener principl monitor outlin gener framework develop post market monitor plan place market gmo notifi articl direct legal oblig ensur monitor report carri condit consent articl detail written consent case explicitli monitor requir accord annex vii includ oblig report commiss compet author addit ensur transpar accord articl result monitor made publicli monitor plan gmo market develop case case basi take account environment risk assess modifi characterist specif gmo question intend receiv environ guidanc note make refer gener framework attempt provid explicit detail develop monitor plan cover gmo complement framework specif supplementari guidanc monitor plan checklist regard trait crop group gmo monitor defin gener systemat measur variabl process time assum specif reason collect data ensur standard condit met examin potenti respect baselin background essenti identifi type effect variabl monitor importantli tool system measur time period measur monitor result import develop research effect monitor gener surveil requir methodolog develop prior commenc monitor programm monitor regard research se mean evalu verifi result assumpt aris previou research evalu potenti risk research object gmo combin gmo product market notif submit compet author member state gmo market time notif accord articl technic dossier inform includ full environment risk assess environment risk assess aim case case basi identifi evalu potenti advers effect gmo direct indirect delai human health environ aris place market assess account potenti long term effect interact organ environ evalu potenti advers effect found common methodolog base independ verifi scientif evid individu gmo differ consider term inher characterist modifi speci specif modif result characterist characterist larg determin natur potenti effect aris place market gmo confirm pre market risk assess gmo accur place market possibl occurr potenti advers effect foreseen evalu post market monitor requir articl direct foreseen purpos background foreseen object post market monitor detail annex vii confirm assumpt occurr impact potenti advers effect gmo environment risk assess correct identifi occurr advers effect gmo human health environ anticip environment risk assess gener principl monitor detail articl direct ec context guidanc note refer post market monitor take place consent place gmo market grant articl direct requir notifi submit part notif plan monitor accord annex vii consent articl time period monitor plan oblig person sell product user inter alia case cultiv level inform deem locat basi report submit notifi accord consent framework monitor plan compet author receiv origin notif inform commiss compet author result detail articl consult member state adapt monitor plan monitor period plan essenti respect type monitor develop monitor plan case specif monitor gener surveil consid addit monitor potenti advers cumul long term effect consid compulsori part monitor plan case specif monitor includ monitor plan focu potenti effect aris place market gmo highlight result conclus assumpt environment risk assess whilst predict effect occur basi risk assess scientif inform consider difficult plan potenti effect variabl foreseen predict plan monitor surveil plan optimis chanc earli detect effect design monitor plan incorpor gener surveil unanticip unforeseen advers effect cost effect case specif monitor gener surveil account context monitor plan accord latest scientif insight practic member state assist monitor gener duti articl requir compet author organis inspect control measur ensur complianc direct member state entitl accord treati measur monitor inspect nation author gmo product market recognis action substitut monitor plan notifi respons consent relev parti form part interpret data collect monitor account exist environment condit activ order determin baselin gener surveil environment monitor programm gener similarli assist context unexpect environ observ risk assess consid establish arisen consequ place market gmo result factor background measur protect human health environ consid design monitor plan design monitor plan found framework compris kei section monitor strategi monitor methodolog analysi report review monitor strategi monitor strategi importantli requir identif potenti effect aris place market gmo degre monitor approach time scale monitor instanc likelihood potenti direct indirect delai advers effect aris gmo consid line intend receiv environ direct effect refer primari effect human health environ result gmo occur causal chain event crop modifi resist specif insect direct effect includ death popul target target insect aris result toxin produc gmo indirect effect refer effect human health environ occur causal chain event case indirect effect aris reduct popul target insect impact popul organ feed insect indirect effect involv interact number organ environ make difficult predict potenti effect observ indirect effect delai factor consid part strategi effect refer effect human health environ observ period releas gmo effect direct indirect delai effect refer effect human health environ observ period releas gmo appar direct indirect effect stage termin releas build resist insect bt toxin continu exposur delai effect delai effect direct indirect impli time scale chang direct effect short term level detect indirect effect longer time period manifest account difficult imposs predict appear potenti unforeseen unanticip effect highlight risk assess gener surveil potenti unforeseen unanticip effect consid part monitor strategi risk assess monitor strategi identifi evalu obtain risk assess confirm line gmo receiv environ account conclus assumpt risk assess base scientif evalu recommend expert committe addit issu aris risk assess subject degre uncertainti effect releas larg scale requir part monitor strategi refer guidanc note supplement annex ii principl environment risk assess direct ec assist respect background inform background inform pertain gmo question includ data inform experiment releas scientif public relev compar evid releas plan design monitor plan data gain risk research studi monitor experiment releas importantli assist context approach approach monitor strategi case focu primari concern establish cyclic monitor process order continu improv qualiti programm approach provid mean detect potenti advers effect earli stage manifest earli detect advers effect attribut gmo rapid reassess implement measur reduc consequ environ design monitor plan gmo built step step approach take account exist data monitor methodolog step step approach case account scale releas step found evid experiment trial subsequ step base larg scale field trial ultim survei commerci plot experi inform gain monitor experiment releas gmo design post market monitor regim requir place market gmo exist observ programm adapt monitor gmo mean ensur compar limit expenditur resourc develop approach includ exist environ observ programm field agricultur food survei natur conserv ecolog long term monitor programm soil observ veterinari survei inclus programm part monitor plan firstli requir notifi gain agreement person organis includ nation author conduct work section focus case specif monitor gener surveil accord gener object annex vii consider type monitor system preclud case specif monitor case specif monitor serv confirm scientif sound assumpt environment risk assess potenti advers effect aris gmo correct approach focu potenti effect human health environ identifi risk assess take account locat soil type climat condit defin time period obtain result step develop monitor plan case specif monitor determin case specif object monitor strategi includ determin assumpt occurr impact potenti advers effect gmo made environment risk assess confirm case specif monitor conclus risk assess identifi absenc risk neglig risk case specif monitor requir potenti advers effect identifi environment risk assess includ monitor plan basi monitor contribut confirm reject assumpt effect intend gmo includ cultiv consider monitor potenti risk aris pollen transfer dissemin persist gmo degre phenomena occur depend scale receiv environ includ proxim scale product sexual compat convent crop speci wild rel convers potenti environment risk aris gmo approv import process assess extrem limit intention introduc environ dissemin potenti effect human health environ aris releas place market gmo firstli depend inher natur gmo specif genet modif potenti effect aris transfer pollen genet modifi crop gm crop relat wild type plant instanc larg depend genet modifi crop cross pollin presenc wild rel consid context subsequ effect potenti develop insect resist bt toxin link gmo modifi express specif toxin case gmo modifi herbicid toler gmo bt toxin gene similarli relev monitor potenti transfer antibiot resist gene consequ respect gmo includ antibiot marker gene part modif identif object basi potenti advers effect step identifi paramet measur order achiev object paramet method measur evalu valid fit purpos gener surveil gener surveil larg base routin observ quot quot approach identifi occurr unforeseen advers effect gmo human health environ predict risk assess involv observ phenotyp characterist detail analys preclud contrast case specif monitor gener surveil seek identifi record indirect delai cumul advers effect anticip risk assess carri longer time period possibl wider area type gener surveil includ locat area paramet measur larg depend type unanticip advers effect survei unanticip advers effect cultiv ecosystem bio divers cumul environment impact multipl releas interact requir approach gener surveil effect aris gene transfer gener surveil compat make establish routin surveil practis monitor agricultur crop plant protect veterinari medic product ecolog monitor environment observ natur conserv programm monitor plan provid detail relev inform collect establish routin surveil practic conduct parti retriev made consent holder establish routin surveil practis gener surveil practis practis need fulfil relev gener surveil baselin determin baselin statu receiv environ pre requisit identif evalu observ monitor short baselin serv point refer effect aris place market gmo compar baselin determin prior attempt detect monitor effect parallel monitor quot gmo area quot compar quot gmo refer area quot provid altern import environ highli dynam reliabl inform statu receiv environ basi adequ environment observ system requir prior implement monitor programm environment polici action environ observ programm design proven suspect plausibl ecosystem relationship account assist determin statu environ expect develop environ exampl indic statu receiv environ includ anim plant micro organ organ group ecosystem relev indic consid basi characterist gmo question paramet monitor sexual compat organ gmo relev context indic speci number measur paramet fit variabl exist includ like number growth rate bio mass reproduct effort popul rate increas decreas genet divers baselin relat manag practic result gmo includ pesticid usag respect cultiv crop speci modifi toler herbicid resist insect monitor plan herbicid toler genet modifi crop herbicid convent crop part baselin time period monitor carri time period suffici length detect potenti effect delai effect identifi environment risk assess consider interplai estim level risk durat releas prolong period releas increas risk cumul effect appear effect prolong period hand monitor focu delai indirect effect consid extend monitor plan period consent case persist gmo environ potenti signific propos time period monitor plan includ outlin frequenc visit inspect interv review monitor plan account appear potenti effect highlight risk assess consider advers effect result dissemin reproduct persist surviv gmo environ place market matter dai month genet modifi microb releas bio remedi programm extend number year crop speci concern likelihood dissemin persist modifi sequenc consid term cross sexual compat speci plan inspect larg depend type effect monitor effect aris pollen transfer visibl flower pertin visit site prior flower establish extent sexual compat speci present vicin similarli monitor appear volunt subsequ grow season link time seed shed persist germin subsequ seed bank prior visit prior onset monitor order establish relev baselin monitor plan time period fix indefinit review amend light result obtain monitor programm assign respons ultim notifi consent holder respons direct ensur monitor plan includ notif put place appropri implement instanc respons notifi submit part notif articl direct plan monitor accord annex vii suitabl propos monitor plan criteria applic place market gmo judg plan judg sole basi adequ requir fulfil requir laid direct oppos strict align guidanc note articl subsequ requir place market gmo product notifi ensur monitor report carri condit consent achiev implement monitor plan respons step monitor plan assign notif appli case specif monitor gener surveil part monitor plan whilst notifi retain respons ensur monitor carri preclud parti consult user involv monitor carri task monitor plan requir case gener surveil includ commiss member state ca parti emploi contract conduct monitor studi structur involv detail notifi consent holder respons compil monitor data result ensur transmiss inform commiss compet author monitor plan respect identif advers effect similarli note preclud member state carri addit monitor form case specif monitor gener surveil aim surveil enabl risk manag measur delai undesir unidentifi effect aris framework prior risk assess consid substitut monitor plan remain respons notifi implement consent relev parti form part exist system extend exist monitor gener surveil system address potenti advers effect aris place market gmo system includ observ programm field agricultur food survei natur conserv long term ecolog monitor system environ observ programm veterinari survei seed product system follow oecd certif rule includ routin inspect field surround area adapt field monitor paramet monitor surveil convent commerci crop carri matter member state regard calcul fertilis applic pest diseas weed control type monitor surveil conduct regular basi grow season consult sell relev agronom product grower attach similar servic sale genet modifi seed repres compani contract consult provid form gener surveil instruct surveil monitor report distribut grower purchas genet modifi seed stock contractu agreement formul condit sale feasibl grower agronom consult conduct survei major unforeseen effect dissemin establish volunt plant adjac area clear instruct provid circumst foreseen monitor surveil advers effect incorpor routin practic determin agronom input pest weed control monitor methodolog section guidanc type paramet element identifi monitor part monitor programm mean conduct monitor includ area monitor frequenc monitor monitor paramet element firstli identifi relev paramet element monitor justif select larg depend conclus environment risk assess decis paramet element monitor case case basi line modifi characterist gmo question includ like monitor intend effect target organ aris modif monitor corn borer popul respect cultiv bt maiz varieti specif element consid part monitor plan exampl element present preclud effect target organ aris modif includ develop resist wild rel pest organ chang host rang dispers pest organ virus develop virus dispers establish persist target environ eco system cross breed occurr mean rate cross breed sexual compat wild rel natur popul unintend basic behaviour organ reproduct number progeni growth behaviour surviv abil seed bio divers number composit speci area sampl monitor plan includ detail monitor carri area level individu member state geograph region individu site plot area deem area sampl monitor respect effect aris place market gmo identifi includ purpos refer control refer control area sampl suffici repres term environ condit meaning conclus drawn sampl methodolog scientif statist sound basi data provid import inform variat indic increas power effect detect area monitor regard genet modifi crop speci characterist inher modifi reproduct dissemin type ecosystem affect consid determin habitat select monitor relev area monitor includ select agricultur field crop commerci grown surround habitat extend monitor surveil adjac neighbour cultiv cultiv area post harvest surveil area volunt plant protect area type habitat disturb area speci rich plant commun prone invas disturb area low veget high abund herb grass suitabl purpos monitor firstli wide distribut found close intens cultiv agricultur area area typic roadsid ditch edg field accident loss dispers seed occur instanc monitor possibl transfer genet materi sexual compat organ convent crop consid requir evalu extent crop grown adjac neighbour area inspect monitor plan frequenc inspect includ timet time number intend visit site respect detail section consider importantli time potenti advers effect area monitor sampl analysi methodolog subsequ monitor paramet element identifi outlin includ techniqu sampl analysi standard methodolog provid like european cen standard oecd method monitor organ environ refer sourc methodolog provid method monitor scientif sound valid experiment condit appli consider characterist method select specif reproduc limit detect limit avail control monitor plan methodolog expect updat select monitor approach strategi statist analysi emploi design sampl test methodolog order determin optim sampl size minimum monitor period requir statist level effect detect collect collat data monitor plan case specif monitor gener surveil identifi data collect collat import parti emploi contract collect data notifi provid standard mechan format protocol data collect record mean ensur consist standardis record sheet direct log registr data standardis quot spread sheet quot portabl comput provid notifi detail data collat importantli inform retriev parti consult user deadlin interv report detail result monitor analysi report review monitor plan data review discuss analysi evalu evalu data includ statist analysi standard error valu enabl subsequ decis sound basi includ decis evalu highlight risk assess correct respect correct baselin control relat statu receiv environ paramount accur evalu statist analysi provid inform type methodolog includ sampl test evalu result monitor survei reveal paramet monitor programm respons preliminari find examin potenti neg impact vulner habitat organ group suggest interpret data collect monitor consid light exist environment condit activ environ observ assess requir establish consequ gmo result environment factor place gmo market evalu baselin comparison respect monitor plan structur result case specif monitor gener surveil addit research decis make process renew approv product report place market gmo notifi articl direct legal oblig ensur monitor report carri condit consent report monitor submit commiss compet author member state time frame submiss laid inform made publicli line requir articl direct background notifi describ condit report monitor plan addit indic relev inform collect establish routin surveil practis made consent holder compet author provid monitor plan notifi consent holder ensur transpar result measur monitor programm monitor plan identifi gather inform report publish achiev inform sheet user stakehold workshop present exchang inform stakehold archiv compani document inclus compani web site public inform trade scientif public provis articl direct relat report accord articl inform risk user sourc notifi immedi requir measur protect human health environ inform compet author thereof addit notifi requir revis inform condit notif review adapt monitor plan view static fundament monitor plan methodolog review interv updat adapt articl direct compet author receiv origin notif basi report submit notifi accord consent framework monitor plan adapt monitor plan monitor period implement revis monitor plan remain respons notifi review examin effect effici data measur collect includ sampl analysi review evalu monitor measur effect address evalu question aris risk assess specif model predict purpos valid base data collect subsequ apprais conduct similarli develop progress sampl analyt techniqu account review adjust method monitor goal monitor programm adapt upgrad