commiss direct ec amend council direct eec place plant protect product market text eea relev commiss european commun regard treati establish european commun regard council direct eec juli place plant protect product market amend commiss direct ec articl thereof annex iib iiib direct eec set requir dossier submit applic inclus activ substanc consist micro organ virus annex direct authoris plant protect product base prepar micro organ virus annex iib iiib applic precis detail requir inform circumst condit technic protocol data gener provis introduc order permit applic prepar dossier differenti data requir chemic substanc micro organ respect requir issu fate behaviour environ residu specif chemic infect specif micro organ introduc precis regard data requir experi gain evalu activ substanc consist micro organ area occup health consum exposur environment risk subject major scientif committe plant provid opinion dealt principl micro organ plant protect product committe provid comment earli draft data requir recommend made committe opinion includ propos amend text draft data requir account commiss measur provid direct accord opinion stand committe plant health adopt direct articl annex ii direct eec amend set annex direct articl annex iii direct eec amend set annex ii direct articl member state bring forc law regul administr provis compli direct latest forthwith inform commiss thereof member state adopt provis refer direct accompani refer occas offici public member state determin refer made articl direct enter forc dai public offici journal european commun articl direct address member state brussel commiss david byrn member commiss oj oj scientif committe plant scp micr final annex annex ii direct eec amend point ad introduct quot derog point activ substanc consist micro organ virus test analys obtain data properti safeti respect aspect human health conduct offici offici recognis test facil organis satisfi requir point introduct annex iii quot part replac quot part introduct activ substanc defin articl includ chemic substanc micro organ includ virus part data requir activ substanc consist micro organ includ virus purpos annex ii part term quot micro organ quot defin quot microbiolog entiti cellular cellular capabl replic transfer genet materi quot definit appli limit bacteria fungi protozoa virus viroid ii micro organ subject applic relev knowledg inform literatur provid import inform inform obtain characteris identif micro organ inform found section ident biolog properti inform form basi assess human health environment effect newli gener data convent toxicolog patholog experi laboratori anim requir applic justifi basi previou inform micro organ propos condit harm effect human anim health groundwat unaccept influenc environ iii pend accept specif guidelin intern level inform requir gener test guidelin accept compet author usepa guidelin test guidelin annex ii part adapt micro organ test includ viabl viabl micro organ blank control iv test detail descript specif materi impur provis section point provid materi specif manufactur prepar authoris studi conduct micro organ produc laboratori pilot plant product system studi repeat micro organ manufactur demonstr test materi essenti purpos test assess micro organ genet modifi defin council direct eec april deliber releas environ genet modifi organ copi evalu data assess risk environ state articl direct eec submit vi relev data analys statist method full detail statist analysi report point estim confid interv exact valu state signific signific vii case studi dose extend period dose prefer singl batch micro organ stabil permit studi perform singl batch micro organ similar batch state studi impli dose relationship dose advers effect report viii plant protect action due residu effect toxin metabolit signific residu toxin metabolit expect relat effect activ substanc dossier toxin metabolit submit accord requir annex ii part ident micro organ identif characteris micro organ import inform kei point decis make applic address applic perman commun address provid posit telephon fax number person contact addit applic offic agent repres member state applic inclus annex submit rapporteur member state appoint commiss address local offic agent repres provid posit telephon fax number person contact produc address produc produc micro organ provid address plant micro organ produc contact point prefer central contact point includ telephon fax number provid view provid updat inform respond queri aris product technolog process qualiti product includ relev individu batch inclus micro organ annex locat number produc inform requir notifi commiss member state speci descript strain characteris micro organ deposit internation recognis cultur collect access number detail submit ii micro organ subject applic identifi name speci level scientif taxonom group famili genu speci strain serotyp pathovar denomin relev micro organ state micro organ indigen indigen speci level intend area applic wild type spontan induc mutant modifi techniqu annex ia part annex ib direct eec case differ modifi micro organ parent wild strain provid iii technolog identifi characteris micro organ strain level test procedur criteria identif morpholog biochemistri serolog molecular identif provid iv common altern supersed name code name develop provid relationship pathogen specif materi manufactur formul product content micro organ minimum maximum content micro organ materi manufactur formul product report content express term number activ unit volum weight manner relev micro organ inform provid relat pilot plant product system inform requir provid commiss member state industri scale product method procedur stabilis product result chang specif puriti ident content impur addit contamin micro organ desir plant protect product contamin includ contamin micro organ level natur accept contamin judg risk assess point view compet author ident maximum content contamin micro organ express unit report inform ident provid outlin annex ii part section point relev metabolit expect concern human health environ form micro organ identifi characteris state growth stage micro organ annex iib introduct viii relev detail inform compon condens cultur medium provid case chemic impur relev human health environ ident maximum content express term provid case addit ident content kg provid inform ident chemic substanc addit provid outlin annex ii part section point analyt profil batch relev data outlin annex ii part section point report unit biolog properti micro organ histori micro organ natur occurr geograph distribut familiar interpret avail relev knowledg micro organ present histor background histor background micro organ test research project commerci provid origin natur occurr geograph region place ecosystem host plant host anim soil micro organ isol state method isol micro organ report natur occurr micro organ relev environ strain level case mutant genet modifi micro organ defin annex ia part annex ib direct eec detail inform provid product isol mean distinguish parent wild strain inform target organ descript target organ relev detail harm organ protect afford provid mode action princip mode action connect mode action state micro organ produc toxin residu effect target organ case mode action toxin relev inform site infect mode entri target organ suscept stage result experiment studi report state uptak micro organ metabolit toxin occur contact stomach inhal state micro organ metabolit transloc plant relev transloc take place case pathogen effect target organ infect dose dose need infect intend effect target speci transmiss possibl spread micro organ target popul target speci target speci applic propos condit host specif rang effect speci target harm organ inform effect target organ area micro organ spread occurr target organ close relat target speci expos experi toxic effect activ substanc metabol product human anim organ capabl colonis invad human anim includ immunosuppress individu pathogen state experi activ substanc product irrit skin ey respiratori organ human anim allergen contact skin inhal state develop stage life cycl micro organ inform life cycl micro organ symbiosi parasit competitor predat includ host organ vector virus present gener time type reproduct micro organ state inform occurr rest stage surviv time virul infect potenti provid potenti micro organ produc metabolit includ toxin concern human health environ develop stage releas infect dispers colonis abil persist micro organ inform life cycl typic environment condit addit sensit micro organ compart environ uv light soil water state environment requir temperatur ph humid nutrit requir surviv reproduct colonis damag includ human tissu effect micro organ state presenc specif virul factor temperatur rang micro organ grow determin includ minimum maximum optimum temperatur inform trigger studi effect human health section effect factor temperatur uv light ph presenc substanc stabil relev toxin state inform dispers rout micro organ air dust particl aerosol host organ vector typic environment condit relev provid relationship plant anim human pathogen exist speci genu activ relev contamin micro organ pathogen human anim crop target speci type diseas caus state mean distinguish activ micro organ pathogen speci genet stabil factor affect inform genet stabil mutat rate trait relat mode action uptak exogen genet materi environment condit propos provid inform provid micro organ capac transfer genet materi organ capac pathogen plant anim man micro organ carri relev addit genet element stabil encod trait inform product metabolit toxin strain belong microbi speci strain subject applic produc metabolit toxin unaccept effect human health environ applic natur structur substanc presenc insid cell stabil mode action includ extern intern factor micro organ action effect human anim target speci provid condit micro organ produc metabolit toxin inform mechan micro organ regul product se metabolit provid inform influenc produc metabolit micro organ mode action provid antibiot anti microbi agent micro organ produc antibiot substanc interfer antibiot human veterinari medicin avoid stage develop microbi plant protect product inform micro organ resist sensit antibiot anti microbi agent provid stabil gene code antibiot resist justifi micro organ harm effect human anim health transfer resist antibiot anti microbi agent inform micro organ introduct inform provid describ intend purpos prepar micro organ dose manner propos ii inform provid normal method precaut handl storag transport micro organ iii studi data inform submit demonstr suitabl measur propos emerg situat iv inform data refer requir micro organ function biolog function control bacteria control fungi control insect control mite control mollusc control nematod control weed field envisag field exist propos prepar micro organ field agricultur horticultur forestri viticultur protect crop greenhous amen weed control cultiv area home garden hous plant store product crop product protect treat detail exist intend term crop group crop plant plant product protect provid method product qualiti control full inform micro organ produc bulk provid product method process product subject continu qualiti control applic occurr spontan chang major characterist micro organ absenc presenc signific contamin monitor qualiti assur criteria product submit techniqu ensur uniform product assai method standardis mainten puriti micro organ haccp inform occurr occurr develop resist target organ inform occurr develop resist cross resist target organ provid manag strategi method prevent loss virul seed stock micro organ method prevent loss virul start cultur provid addit method prevent micro organ lose effect target speci recommend method precaut handl storag transport fire safeti data sheet similar requir chemic activ substanc articl direct eec provid micro organ procedur destruct decontamin case prefer sole mean safe dispos micro organ contamin materi contamin packag control inciner licens inciner method dispos safe micro organ kill prior dispos method dispos contamin packag contamin materi fulli data provid method establish effect safeti measur case accid inform procedur render micro organ harmless environ water soil case accid provid analyt method introduct provis section cover analyt method requir post registr control monitor purpos post approv monitor consid area risk assess case strain micro organ indigen intend area applic consid approv analyt method gener data requir direct purpos applic provid justif method separ guidanc develop method basi requir defin method post registr control monitor purpos descript method provid includ detail equip materi condit applic internation recognis method report practic method emploi simplest approach involv minimum cost requir commonli equip data specif linear accuraci repeat defin annex ii part point requir method analys micro organ residu section appli impur compon includ contamin micro organ chemic substanc micro organ origin manufactur process degrad storag relev impur impur defin concern human anim health environ metabolit metabolit includ product result degrad biosynthet reaction take place micro organ organ produc micro organ interest relev metabolit metabolit concern human anim health environ residu viabl micro organ substanc produc signific quantiti micro organ persist disappear micro organ concern human anim health environ request sampl provid sampl micro organ manufactur ii analyt standard relev metabolit toxin compon includ residu definit iii sampl refer substanc relev impur method analysi micro organ manufactur method identif micro organ method provid inform variabl seed stock activ micro organ method differenti mutant micro organ parent wild strain method establish puriti seed stock batch produc method control puriti method determin content micro organ manufactur materi product formul product method show contamin micro organ control accept level method determin relev impur manufactur materi method control absenc quantifi limit determin presenc human mammalian pathogen method determin storag stabil shelf life micro organ method determin quantifi residu viabl viabl activ micro organ relev metabolit toxin crop foodstuff feed stuff anim human bodi tissu fluid soil water includ drink water ground water surfac water air relev analyt method amount activ proteinac product includ test exponenti cultur cultur supernat anim cell bioassai effect human health introduct inform base properti micro organ organ section includ health medic report suffici decis micro organ health effect infecti pathogen toxic human ii inform provid provid prepar micro organ suffici permit evalu made risk man directli indirectli handl plant protect product micro organ risk man handl treat product risk man aris residu trace contamin remain food water addit inform provid suffici permit decis made micro organ includ annex condit restrict inclus annex risk safeti phrase introduc protect man anim environ includ packag contain identifi relev aid measur diagnost therapeut measur event infect advers effect man iii effect found investig report investig order evalu probabl mechan involv assess signific effect perform iv studi actual achiev dose coloni form unit kg bodi weight cfu kg unit report evalu micro organ carri tier wise manner tier tier includ basic inform basic studi perform micro organ expert judgment decid test programm case case basi newli gener data convent toxicolog patholog experi laboratori anim requir applic justifi basi previou inform micro organ propos condit harm effect human anim health pend accept specif guidelin intern level inform requir gener test guidelin usepa oppt guidelin tier ii studi conduct test tier shown advers health effect type studi perform depend effect observ tier studi perform studi applic seek agreement compet author type studi perform tier basic inform basic inform requir micro organ potenti advers effect abil colonis damag produc toxin relev metabolit medic data prejudic provis articl council direct eec novemb protect worker risk relat chemic physic biolog agent work articl council direct eec novemb protect worker risk relat biolog agent work practic data inform relev recognit symptom infect pathogen effect aid therapeut measur submit relev effect potenti antagonist investig report relev method kill render micro organ uninfect section point data inform relev effect human exposur qualiti confirm valid extrapol made conclus reach respect target organ virul revers advers effect data gener accident occup exposur medic surveil manufactur plant personnel report occup health surveil programm support detail inform design programm exposur micro organ submit report feasibl includ data relev mechan action micro organ report includ data person expos manufactur plant applic micro organ efficaci trial special attent devot suscept affect pre exist diseas medic compromis immun pregnanc breast feed sensitis allergen observ inform sensitis allergen respons worker includ worker manufactur plant agricultur research worker expos micro organ provid includ relev detail incid hypersensit chronic sensitis inform provid includ detail frequenc level durat exposur symptom observ relev clinic observ inform worker subject allergi test interview allergen symptom direct observ clinic case report open literatur micro organ close relat member taxonom group relat clinic case refer journal offici report submit report follow studi undertaken report complet descript natur level durat exposur clinic symptom observ aid therapeut measur appli measur observ made summari abstract inform limit anim studi perform report relat clinic case confirm valid interpret anim data man identifi unexpect advers effect specif human basic studi order make correctli interpret obtain result greatest import suggest test method relev speci sensit administr rout relev biolog toxicolog point view administr test micro organ depend main exposur rout human evalu medium long term effect acut acut semi chronic exposur micro organ option provid oecd guidelin extend studi concern recoveri period full macroscop microscop patholog perform includ explor micro organ tissu organ facilit interpret effect possibl recognis infect pathogen turn help take decis issu necess perform long term studi carcinogen point perform residu studi point sensitis aim test test provid suffici inform assess potenti micro organ provok sensitis reaction inhal dermal exposur maximis test perform circumst requir inform sensitis report acut toxic pathogen infect studi data inform provid evalu suffici permit identif effect singl exposur micro organ establish toxic pathogen infect micro organ time characterist effect full detail behaviour gross patholog find post mortem mode toxic action rel hazard rout exposur blood analys studi order evalu clearanc micro organ acut toxic pathogen effect accompani infect long term effect observ immedi view health evalu carri studi abil infect connect oral intak inhal intraperiton subcutan inject test mammal acut toxic pathogen infect studi estim micro organ activ toxin clearanc organ deem relev microbi examin liver kidnei spleen lung brain blood site administr perform observ made reflect expert scientif judgement includ micro organ numer tissu affect show lesion main organ kidnei brain liver lung spleen bladder blood lymphat ganglia gastrointestin tract thymu gland lesion inocul site dead moribund anim interim final sacrific inform gener acut toxic pathogen infect test assess hazard aris accid situat consum risk due exposur residu acut oral toxic pathogen infect circumst requir acut oral toxic pathogen infect micro organ report acut inhal toxic pathogen infect circumst requir inhal toxic pathogen infect micro organ report intraperiton subcutan singl dose intraperiton subcutan test consid highli sensit assai elicit infect circumst requir intraperiton inject requir micro organ expert judgement exercis evalu subcutan inject prefer intraperiton inject maximum temperatur growth multipl lower oc genotox test circumst requir micro organ produc exotoxin point toxin relev metabolit cultur medium test genotox test toxin metabolit perform purifi chemic basic studi toxic metabolit form studi micro organ consid depend expert judgement relev valid basic data case viru risk insert mutagenesi mammal cell risk carcinogen discuss aim test studi predict genotox potenti earli identif genotox carcinogen elucid mechan action carcinogen import flexibl approach adopt select test depend interpret result stage test condit genotox cellular micro organ studi break cell justif provid method sampl prepar genotox virus studi infecti isol vitro studi circumst requir result vitro mutagen test bacteri assai gene mutat test clastogen mammalian cell test gene mutat mammalian cell provid cell cultur studi inform report intracellular replic micro organ virus viroid specif bacteria protozoa inform section demonstr micro organ replic warm blood organ cell cultur studi perform human cell tissu cultur organ select base expect target organ infect human cell tissu cultur specif organ mammal cell tissu cultur virus abil interact human genom kei consider inform short term toxic pathogen aim test short term toxic studi design provid inform amount micro organ toler toxic effect condit studi studi provid data risk handl prepar micro organ short term studi provid essenti insight cumul action micro organ risk worker intens expos addit short term studi provid inform design chronic toxic studi studi data inform provid evalu suffici permit identif effect repeat exposur micro organ establish relationship dose advers effect toxic micro organ includ noael toxin target organ relev time characterist effect full detail behaviour gross patholog find post mortem specif toxic effect patholog produc relev persist revers toxic effect observ discontinu dose mode toxic action rel hazard rout exposur short term toxic studi estim micro organ clearanc main organ perform investig includ pathogen infect end point circumst requir short term toxic minimum dai micro organ report choic test speci justifi choic studi length depend acut toxic clearanc data expert judgement requir decid rout administr prefer health effect repeat inhalatori exposur inform health effect repeat inhalatori exposur consid risk assess occup set repeat exposur influenc clearanc capac resist host human proper risk assess toxic repeat exposur contamin growth medium formul micro organ address mind formul plant protect product influenc toxic infect micro organ circumst requir inform short term infect pathogen toxic respiratori rout micro organ requir inform provid suffici assess human health effect case demonstr test materi inhal fraction repeat exposur expect propos treatment aid measur medic treatment aid measur event infect event contamin ey provid therapeut regim event ingest contamin ey skin full inform base practic experi exist case theoret ground effect altern treatment regim relev provid inform resist antibiot provid end tier tier ii specif toxic pathogen infect studi case carri supplementari studi clarifi advers human effect result earlier studi micro organ long term health effect studi chronic toxic pathogen infect carcinogen reproduct toxic carri toxin produc kinet studi perform studi requir design individu basi light paramet investig object achiev perform studi applic seek agreement compet author type studi perform vivo studi somat cell circumst requir result vitro studi neg test consider relev inform test vivo studi vitro studi metabolis system previous vitro cytogenet test posit vivo test somat cell metaphas analysi rodent bone marrow micronucleu test rodent conduct vitro gene mutat test posit vivo test investig unschedul dna synthesi mous spot test conduct genotox vivo studi germ cell aim test test condit point circumst requir result vivo studi somat cell posit vitro test germ cell effect justifi necess conduct test consid case case basi take account relev inform includ expect exposur suitabl test examin interact dna domin lethal assai potenti inherit effect possibl make quantit assess herit effect recognis view complex quantit studi requir strong justif end tier ii summari mammalian toxic pathogen infect evalu summari data inform provid point submit includ detail critic assess data context relev evalu decis make criteria guidelin refer risk man anim aris extent qualiti reliabl data base explain exposur anim human implic vaccin serolog monitor residu treat product food feed introduct inform provid prepar micro organ suffici permit evalu made risk man anim aris exposur micro organ residu trace metabolit toxin remain plant plant product ii addit inform provid suffici permit decis made micro organ includ annex direct eec condit restrict inclus annex direct eec relev set maximum residu level preharvest interv protect consum wait period protect worker handl treat crop product iii evalu risk aris residu experiment data level exposur residu requir justifi micro organ metabolit hazard human concentr occur result authoris justif base open literatur practic experi inform submit section section persist likelihood multipl crop feedingstuff foodstuff substanti estim persist competit micro organ relev secondari metabolit toxin crop environment condit prevail intend take account inform provid section deliv applic state extent basi consid micro organ multipli plant plant product process raw product inform requir consum expos micro organ consider time result consumpt treat food commod potenti effect consum deriv chronic semi chronic studi toxicolog end point adi establish risk manag viabl residu viabl micro organ micro organ capabl replic transfer genet materi relev quantiti micro organ produc metabolit toxin found persist section point full experiment residu data provid annex ii part section requir concentr micro organ toxin treat foodstuff feedingstuff expect occur concentr higher natur condit phenotyp state agreement direct eec conclus differ natur concentr elev concentr due treatment micro organ base experiment obtain data extrapol calcul model perform studi applic seek agreement compet author type studi perform viabl residu inform submit point suggest persist relev amount micro organ treat product food feed effect human anim investig justifi section micro organ metabolit degrad product hazard human concentr natur occur result authoris agreement direct eec conclus differ natur concentr elev concentr due treatment micro organ base experiment obtain data extrapol calcul model persist viabl residu special attent infect pathogen mammal found section inform suggest hazard consum worker case compet author requir studi similar provid part perform studi applic seek agreement compet author type studi perform summari evalu residu behaviour result data submit point fate behaviour environ introduct inform origin properti surviv micro organ residu metabolit intend form basi assess environment fate behaviour experiment data requir justifi assess fate behaviour environ perform inform justif base open literatur practic experi inform submit section function micro organ environment process defin section point interest ii inform provid relev inform prepar micro organ suffici permit assess fate behaviour residu trace toxin signific human health environ iii inform provid suffici decid micro organ includ annex condit restrict inclus annex hazard symbol introduc indic danger relev risk safeti phrase protect environ includ packag contain predict distribut fate behaviour environ micro organ metabolit time cours involv identifi measur minimis contamin environ impact target speci iv relev metabolit concern human health environ form test organ relev environment condit characteris relev metabolit present produc micro organ data outlin annex ii part point requir condit met relev metabolit stabl micro organ point toxic effect relev metabolit independ presenc micro organ relev metabolit expect occur environ concentr consider higher natur condit inform relationship natur occur wild type rel account vi perform studi refer applic seek agreement compet author studi perform type studi conduct inform section account persist multipl relev inform persist multipl micro organ environment compart justifi exposur environment compart micro organ occur special attent competit environment condit prevail intend popul dynam season region extrem climat hot summer cold winter rainfal agricultur practic appli intend estim level micro organ time product propos condit soil inform viabil popul dynam report cultiv uncultiv soil repres soil typic commun region exist anticip provis choic soil collect handl refer part point introduct test organ associ media rockwool includ test rang water inform report viabil popul dynam natur sediment water system dark illumin condit air case concern oper worker bystand exposur inform concentr air mobil spread micro organ degrad product relev environment compart evalu justifi exposur environment compart micro organ occur context intend field greenhous applic soil crop life cycl stage includ occurr vector persist abil organ colonis adjac habitat interest spread persist probabl transport rang special attent toxic infect pathogen report inform suggest hazard human anim environ case compet author requir studi similar provid part perform studi applic seek agreement compet author type studi perform effect target organ introduct inform ident biolog properti inform section central assess impact target speci addit inform found fate behaviour environ section residu level plant section inform natur prepar manner defin natur extent potenti exposur inform submit accord section provid essenti inform effect mammal mechan involv experiment data requir justifi assess effect target organ perform inform ii choic target organ test environment effect base ident micro organ includ host specif mode action ecolog organ knowledg choos test organ organ close relat target organ iii inform provid prepar micro organ suffici permit assess impact target speci flora fauna risk exposur micro organ environment signific impact result singl prolong repeat exposur revers irrevers iv inform provid micro organ relev inform provid prepar suffici decid micro organ includ annex condit restrict inclus annex permit evalu short long term risk target speci popul commun process classifi micro organ biolog hazard precaut protect target speci hazard symbol introduc indic danger relev risk safeti phrase protect environ mention packag contain report potenti advers effect found routin investig environment effect undertak report requir compet author addit studi investig probabl mechan involv assess signific effect biolog data inform relev assess ecolog profil micro organ report vi studi averag achiev dose cfu kg bodi weight unit report vii conduct separ studi relev metabolit toxin product constitut relev risk target organ effect evalu result relat micro organ studi perform applic seek agreement compet author studi perform type studi conduct inform section account viii order facilit assess signific test result obtain strain record origin relev speci test ix test perform justifi target organ expos micro organ justifi micro organ toxic effect pathogen infect vertebr plant reaction target organ investig effect bird aim test inform toxic infect pathogen bird report effect aquat organ aim test inform toxic infect pathogen aquat organ report effect fish aim test inform toxic infect pathogen fish report effect freshwat invertebr aim test inform toxic infect pathogen freshwat invertebr report effect alga growth aim test inform effect algal growth growth rate capac recov report effect plant alga aim test inform effect plant alga report effect bee aim test inform toxic infect pathogen bee report effect arthropod bee aim test inform toxic infect pathogen arthropod bee report select test speci relat potenti plant protect product foliar soil applic special attent organ biolog control organ plai import role integr pest manag effect earthworm aim test inform toxic infect pathogen earthworm report effect target soil micro organ impact relev target micro organ predat protozoa bacteri inocul report expert judgement requir decid addit studi decis consider inform section data specif micro organ expect exposur inform observ carri efficaci test special attent organ integr crop manag icm addit studi addit studi includ acut studi addit speci process sewag system higher tier studi chronic lethal reproduct studi select target organ perform studi applic seek agreement compet author type studi perform summari evalu environment impact summari evalu data relev environment impact carri guidanc compet author member state format summari evalu includ detail critic assess data context relev evalu decis make criteria guidelin refer risk environ target speci aris extent qualiti reliabl data base issu address distribut fate environ time cours involv identif target speci popul risk extent potenti exposur identif precaut avoid minimis contamin environ protect target speci quot usepa microbi pesticid test guidelin oppt seri februari http www epa gov oppbppd biopesticid guidelin seri htm oj doc vi concis outlin report peer review meet micro organ oj oj method test dermal sensitis suitabl test micro organ sensitis inhal greater problem compar dermal exposur micro organ valid test method develop kind method great import micro organ regard potenti sensitis approach take consider immuno compromis sensit individu popul pregnant women born children elderli consequ absenc proper test method micro organ label potenti sensitis applic demonstr sensitis potenti submit data data requir regard obligatori option provision base inhal studi replac intratrach studi present test method design perform solubl chemic method develop relev micro organ annex ii annex iii direct eec amend point ad introduct quot derog point activ substanc consist micro organ virus test analys obtain data properti safeti respect aspect human health conduct offici offici recognis test facil organis satisfi requir point introduct annex iii quot part replac quot part introduct part data requir authoris plant protect product base prepar micro organ includ virus term quot micro organ quot defin introduct annex ii part appli annex iii part ii relev data analys statist method full detail statist analysi report point estim confid interv exact valu state signific signific iii pend accept specif guidelin intern level inform requir gener test guidelin accept compet author usepa guidelin test guidelin annex ii part adapt micro organ test includ viabl viabl micro organ blank control iv studi impli dose relationship dose advers effect report test detail descript specif materi impur provis section point provid vi case prepar dealt extrapol annex ii part accept provid effect formul compon pathogen infect evalu ident plant protect product inform provid provid micro organ suffici precis identifi defin prepar inform data refer requir plant protect product view identifi factor alter properti micro organ plant protect product comparison micro organ treat annex ii part direct eec applic address applic perman commun address provid posit telephon fax number person contact addit applic offic agent repres member state authoris sought address local offic agent repres provid posit telephon fax number person contact manufactur prepar micro organ address manufactur prepar micro organ prepar provid address manufactur plant prepar micro organ manufactur contact point prefer central contact point includ telephon fax number provid manufactur micro organ origin produc data annex ii part submit previous detail inform speci descript requir annex ii part section impur requir annex ii part section provid trade propos trade manufactur develop code number prepar current trade name propos trade name develop code number prepar refer dossier current name number provid full detail differ provid propos trade give rise confus trade authoris plant protect product detail quantit qualit inform composit prepar micro organ subject applic identifi name speci level micro organ deposit recognis cultur collect access number scientif state group assign bacteria viru denomin relev micro organ strain serotyp addit develop phase micro organ spore mycelium market product state ii prepar inform report content micro organ plant protect product content micro organ materi manufactur plant protect product includ maximum minimum nomin content viabl viabl materi content formul content compon product condens cultur medium contamin micro organ deriv product process content express term provid articl direct eec chemic term micro organ number activ unit volum weight manner relev micro organ iii formul identifi chemic annex direct eec includ direct accord iupac ca nomenclatur structur structur formula provid compon formul relev ec einec elinc number ca number exist provid inform provid fulli identifi formul specif provid trade formul exist provid iv formul function adhes sticker antifoam agent antifreez binder buffer carrier deodor dispers agent dye emet emulsifi fertilis odor parfum preserv propel repel safen solvent stabilis synergist thicken wet agent miscellan identif contamin micro organ compon deriv product process contamin micro organ identifi outlin annex ii part section point chemic inert compon product identifi outlin annex ii part section point inform provid fulli identifi compon condens cultur medium detail inform composit provid compon physic state natur prepar type code prepar design quot catalogu pesticid formul type intern code system gifap technic monograph quot prepar defin precis public full descript physic natur state prepar provid propos suitabl descript type prepar propos definit function biolog function control bacteria control fungi control insect control mite control mollusc control nematod control weed physic chemic technic properti plant protect product extent plant protect product authoris sought compli relev fao specif agre group expert pesticid specif fao panel expert pesticid specif registr requir applic standard state diverg fao specif detail justifi appear colour odour descript colour odour physic state prepar provid storag stabil shelf life effect light temperatur humid technic characterist plant protect product physic biolog stabil prepar recommend storag temperatur includ inform growth contamin micro organ determin report condit test perform justifi ii addition case liquid prepar effect low temperatur physic stabil determin report cipac method mt mt mt mt iii shelf life prepar recommend storag temperatur report shelf life year shelf life month temperatur specif report inform gifap monograph factor affect stabil effect exposur air packag product stabil explor explos oxidis properti explos oxidis properti determin defin annex iii part section point justifi technic scientif perform studi flash point indic flammabl spontan ignit flash point flammabl determin defin annex iii part section point justifi technic scientif perform studi acid alkalin ph acid alkalin ph determin defin annex iii part section point justifi technic scientif perform studi viscos surfac tension viscos surfac tension determin defin annex iii part section point justifi technic scientif perform studi technic characterist plant protect product technic characterist prepar determin permit decis made accept test perform temperatur compat surviv micro organ wettabl wettabl solid prepar dilut wettabl powder water dispers granul determin report cipac method mt persist foam persist foam prepar dilut water determin report cipac method mt suspens suspens stabil suspens water dispers product wettabl powder water dispers granul suspens concentr determin report cipac method mt mt mt spontan dispers water dispers product suspens concentr water dispers granul determin report cipac method mt mt dry siev test wet siev test order ensur dustabl powder suitabl particl size distribut eas applic dry siev test conduct report cipac method mt case water dispers product wet siev test conduct report cipac method mt mt particl size distribut dustabl wettabl powder granul content dust fine granul attrit friabil granul size distribut particl case powder determin report oecd method nomin size rang granul direct applic determin report accord cipac mt water dispers granul accord cipac mt ii dust content granular prepar determin report cipac method mt relev oper exposur particl size dust determin report oecd method iii friabil attrit characterist granul determin report internation agre method data report method emulsifi emulsifi emuls stabil emulsifi emuls stabil emulsifi prepar form emuls determin report cipac method mt mt ii stabil dilut emuls prepar emuls determin report cipac method mt mt flowabl pourabl rinsabl dustabl flowabl granular prepar determin report cipac method mt ii pourabl includ rins residu suspens suspens concentr suspo emuls determin report cipac method mt iii dustabl dustabl powder determin report cipac method mt suitabl method physic chemic biolog compat product includ plant protect product authoris physic compat physic compat recommend tank mix determin report chemic compat chemic compat recommend tank mix determin report examin individu properti prepar establish reason doubt possibl reaction take place case suffici provid inform justif practic determin chemic compat biolog compat biolog compat tank mix determin report effect antagon fungicid effect activ micro organ mix micro organ chemic interact plant protect product chemic product appli crop expect condit prepar investig base efficaci data interv applic biolog pesticid chemic pesticid order avoid loss efficaci adher distribut seed case prepar seed treatment distribut adhes investig report case distribut cipac method mt summari evalu data present point data applic field envisag field exist propos prepar micro organ field agricultur horticultur forestri viticultur protect crop glasshous amen weed control cultiv area home garden hous plant store product mode action uptak product occur contact stomach inhal pest control action fungitox fungistat action nutrient competit state state product transloc plant relev transloc apoplast symplast detail intend detail intend type harm organ control plant plant product protect provid interv applic plant protect product micro organ chemic pesticid list activ substanc chemic plant protect product plant protect product micro organ crop provid applic rate method applic rate applic unit ha treat term kg prepar term unit micro organ provid applic rate express kg ha kg kg tonn protect crop home garden rate express kg kg content micro organ materi dilut sprai bait treat seed content micro organ report number activ unit ml relev unit method applic method applic propos fulli indic type equip type volum diluent unit area volum number time applic durat protect maximum number applic time report relev growth stage crop plant protect develop stage harm organ interv applic dai state durat protect afford applic maximum number applic wait period precaut avoid phytopathogen effect succeed crop relev minimum wait period applic sow plant succeed crop avoid phytopathogen effect succeed crop state follow data provid section point limit choic succeed crop state propos instruct propos instruct prepar print label leaflet provid inform plant protect product packag compat prepar propos packag materi packag fulli term materi manner construct extrud weld size capac size open type closur seal design accord criteria guidelin fao quot guidelin packag pesticid quot ii suitabl packag includ closur term strength leakproof resist normal transport handl determin report adr method adr method intermedi bulk contain prepar child resist closur requir iso standard iii resist packag materi content report gifap monograph procedur clean applic equip clean procedur applic equip protect cloth detail effect clean procedur determin biotest report entri period wait period precaut protect man livestock environ inform provid follow support data provid micro organ provid section relev pre harvest interv entri period withhold period minimis presenc residu crop plant plant product treat area space view protect man livestock pre harvest interv dai relev crop entri period dai livestock area graze entri period hour dai man crop build space treat withhold period dai anim feedingstuff wait period dai applic handl treat product ii light test result inform specif agricultur plant health environment condit prepar provid recommend method precaut handl storag transport fire recommend method precaut handl procedur detail storag warehous user level plant protect product transport event fire provid relev inform combust product provid risk aris method procedur minimis hazard aris procedur preclud minimis gener wast leftov provid relev assess iso tr natur characterist protect cloth equip propos provid data provid suffici evalu suitabl effect realist condit field glasshous circumst measur case accid aris transport storag detail procedur event accid provid includ contain spillag decontamin area vehicl build dispos damag packag adsorb materi protect emerg worker bystand aid measur procedur destruct decontamin plant protect product packag procedur destruct decontamin develop small quantiti user level larg quantiti warehous level procedur consist provis place relat dispos wast toxic wast mean dispos propos unaccept influenc environ cost effect practic mean dispos feasibl control inciner case prefer sole mean safe dispos plant protect product formul contain contamin materi contamin packag control inciner licens inciner applic provid detail instruct safe dispos method dispos plant protect product packag contamin materi propos fulli data provid method establish effect safeti analyt method introduct provis section cover analyt method requir post registr control monitor purpos desir plant protect product contamin level accept contamin judg risk assess point view compet author product product subject continu qualiti control applic qualiti criteria product submit analyt method gener data requir direct purpos applic provid justif method separ guidanc develop method basi requir defin method post registr control monitor purpos descript method provid includ detail equip materi condit applic exist cipac method report practic method emploi simplest approach involv minimum cost requir commonli equip section appli impur compon includ contamin micro organ chemic substanc micro organ origin manufactur process degrad storag relev impur impur defin concern human anim health environ metabolit metabolit includ product result degrad biosynthet reaction take place micro organ organ produc micro organ interest relev metabolit metabolit concern human anim health environ residu viabl micro organ substanc produc signific quantiti micro organ persist disappear micro organ concern human anim health environ request sampl provid sampl prepar ii sampl micro organ manufactur iii analyt standard pure micro organ iv analyt standard relev metabolit compon includ residu definit sampl refer substanc relev impur method analysi prepar method full provid identif determin content micro organ prepar case prepar micro organ method capabl identifi determin content provid method establish regular control final product prepar order show organ establish uniform method identifi contamin micro organ prepar method determin storag stabil shelf life prepar provid method determin quantifi residu analyt method determin residu defin annex ii part section point submit justifi inform submit requir annex ii part section point suffici efficaci data provis efficaci data adopt commiss direct eec effect human health proper evalu toxic includ potenti pathogen infect prepar suffici inform acut toxic irrit sensitis micro organ addit inform mode toxic action toxicolog profil toxicolog aspect micro organ submit special attent formul perform toxicolog studi sign infect pathogen note toxicolog studi includ clearanc studi context influenc impur compon toxicolog behaviour essenti studi submit detail descript specif materi provid test conduct plant protect product authoris clear micro organ prepar condit cultur inform data submit context annex ii part tier test system appli studi plant protect product basic acut toxic studi studi data inform provid evalu suffici permit identif effect singl exposur plant protect product establish toxic plant protect product toxic plant protect product rel micro organ time characterist effect full detail behaviour gross patholog find post mortem mode toxic action rel hazard rout exposur emphasi estim toxic rang involv inform gener permit plant protect product classifi accord direct eec inform gener acut toxic test assess hazard aris accid situat acut oral toxic circumst requir acut oral test carri applic justifi satisfact compet author articl direct eec invok test guidelin test carri accord method bi commiss direct eec acut inhal toxic aim test test provid inhal toxic rat plant protect product circumst requir test carri plant protect product fog equip aerosol powder signific proport particl diamet amp lt micrometr amp gt weight basi appli aircraft case inhal exposur relev appli manner gener signific proport particl droplet diamet amp lt micrometr amp gt weight basi volatil compon greater test guidelin test carri accord method direct eec acut percutan toxic circumst requir acut percutan test carri applic justifi satisfact compet author articl direct eec invok test guidelin test carri accord method direct eec addit acut toxic studi skin irrit aim test test provid potenti skin irrit plant protect product includ potenti revers effect observ circumst requir skin irrit plant protect product determin formul expect skin irrit micro organ shown skin irrit test guidelin sever skin effect exclud test guidelin test carri accord method direct eec ey irrit aim test test provid potenti ey irrit plant protect product includ potenti revers effect observ circumst requir ey irrit plant protect product determin formul suspect ey irrit micro organ ey irrit test guidelin sever effect ey produc test guidelin ey irrit determin accord method direct eec skin sensitis aim test test provid suffici inform assess potenti plant protect product provok skin sensitis reaction circumst requir test carri formul suspect skin sensitis properti micro organ formul skin sensitis properti test guidelin test carri accord method direct eec data exposur risk contact plant protect product oper bystand worker depend physic chemic toxicolog properti plant protect product type product undilut dilut formul type rout degre durat exposur suffici inform data gener report permit assess extent exposur plant protect product occur propos condit case concern possibl dermal absorpt base inform micro organ annex ii part section inform provid prepar present section annex iii part dermal absorpt data result exposur monitor product product submit abovement inform data provid basi select protect measur includ person protect equip oper worker label toxicolog data relat activ substanc copi notif safeti data sheet submit context european parliament council direct ec commiss direct eec march defin lai detail arrang system specif inform relat danger prepar implement articl direct eec submit formul inform submit supplementari studi combin plant protect product aim test case carri studi refer point combin plant protect product product label includ requir plant protect product plant protect product adjuv tank mix decis supplementari studi made case case basi take account result acut toxic studi individu plant protect product possibl exposur combin product concern inform practic experi product concern similar product summari evalu health effect summari data inform provid paragraph submit includ detail critic assess data context relev evalu decis make criteria guidelin refer risk man anim aris extent qualiti reliabl databas residu treat product food feed provis detail annex ii part section appli inform requir section provid extrapol residu behaviour plant protect product basi data micro organ special attent paid influenc formul substanc residu behaviour micro organ metabolit fate behaviour environ provis detail annex ii part section appli inform requir section provid extrapol fate behaviour plant protect product environ basi data annex ii part section effect target organ introduct inform provid micro organ suffici permit assess impact target speci flora fauna plant protect product propos impact result singl prolong repeat exposur revers irrevers ii choic target organ test environment effect base inform micro organ requir annex ii part inform formul compon requir section present annex knowledg choos test organ organ close relat target organ iii inform provid plant protect product relev inform provid micro organ suffici hazard symbol indic danger relev risk safeti phrase protect environ mention packag contain permit evalu short long term risk target speci popul commun process permit evalu special precaut protect target speci iv report potenti advers effect found routin investig environment effect undertak report addit studi investig mechan involv assess signific effect gener data relat impact target speci requir authoris plant protect product submit evalu inclus micro organ annex vi exposur data decid studi perform data obtain accord provis annex iii part section estim exposur organ relev inform plant protect product micro organ account relev paramet provid section appear data plant protect product stronger effect micro organ data effect target organ plant protect product calcul relev effect exposur ratio vii order facilit assess signific test result obtain strain relev speci test effect target organ effect bird inform provid annex ii part section point report predict effect plant protect product basi data micro organ justifi exposur bird occur effect aquat organ inform provid annex ii part section point report predict effect plant protect product basi data micro organ justifi exposur aquat organ occur effect bee inform provid annex ii part section point report predict effect plant protect product basi data micro organ justifi exposur bee occur effect arthropod bee inform provid annex ii part section point report predict effect plant protect product basi data micro organ justifi exposur arthropod bee occur effect earthworm inform provid annex ii part section point report predict effect plant protect product basi data micro organ justifi exposur earthworm occur effect soil micro organ inform provid annex ii part section point report predict effect plant protect product basi data micro organ justifi exposur target soil micro organ occur addit studi expert judgement requir decid addit studi decis consider inform section data specif micro organ expect exposur inform observ carri efficaci test special attent effect natur occur deliber releas organ import ipm compat product ipm consider addit studi includ studi addit speci higher tier studi studi select target organ perform studi applic seek agreement compet author type studi perform summari evalu environment impact summari evalu data relev environment impact carri guidanc compet author member state format summari evalu includ detail critic assess data context relev evalu decis make criteria guidelin refer risk environ target speci aris extent qualiti reliabl databas issu address predict distribut fate environ time cours involv identif target speci popul risk predict extent potenti exposur identif precaut avoid minimis contamin environ protect target speci quot usepa microbi pesticid test guidelin oppt seri februari http www epa gov oppbppd biopesticid guidelin seri htm collabor intern pesticid analyt council intern group nation pesticid manufactur associ oj oj oj oj