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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(80)467 final
Brussels.28July1980
DRAFTCOUNCILRECOMMENDATION
concerningtheregistration of
recombinant DNA(desoxyribonucleic acid)work
(submittedtotheCouncilbytheCommission)
v-7
c-î-; '*'.\^ .:;7V-s"'--y
C0MC80)467final

DRAFTCOUNCILRECOMMENDATION
concerningtheiregistration ofrecombinant DNA(desoxyribonuc Leicacid)
work
REASONSFORPROPOSAL
I.INTRODUCTION .
Ananalysisofthecurrentsituationandofresultsofwork
accomplished inthecourseofthelasttwoyears,intheUnitedStates
aswellasinEurope,toevaluatetheimportanceofthedangers
. !
resultingfromgeneticengineering,hasshownthattheconjectural
risksassociatedwiththeworkinvolvingtheproductionorutilization
ofrecombinant DMAareprobalynon-existent orsmall.\;
Itisapparent,moreover,thatthevoluntarymeasuresofcontroland
safety,suchashavebeenrecommendedtoresearchworkersinthe
majorityofwesterncountries,functioninasatisfactory manner,
withoutexcessivebureaucracy andinawaywhichallowscontinual
adaptationinviewoftherapidprogressinknowledgeandtechniques
intheareaoffundamental andappliedbiology.Ithasbeen
ascertainedultimatelythatnationalrecommendations fortheclassi­
ficationofworkaccordingtorisk.categoriesandsafetymeasures
/
donotradicallydifferfromoneMemberStatetoanotherandindeedtend
toconvergetoacertainuniformity.
/ ■i
However,certainquestionscanberaisedconcerningeffectsinthe
longtermofpossiblecontamination,which,althoughunlikely,•
remainspossible.Itisthereforehighlydesirablethataprecise

inventoryisatalltimesandeverywhereavailabletoallowthe
possibleimpositionofpreventivemeasuresofprotection -aswellas
toallowtheoriginofanycontamination tobetraced.Itisnevertheless
advisableinordertodothisthateachMemberStatebefreetoadopt*
adequatelegislativeregulatoryoradministrative measuresandthat
nationalorregionalauthorities beentrustedwithitsexecution.
Lastly,!theadoptionofacommondefinitionofworkinvolving
recombinant DNAwillhelptofacilitate adialoguebetweenMember
!' • • ••Stateslinordertopursuegraduallyaharmonisation ofnationaldispositions .
NATUREANDOBJECTOFTHEDRAFTRECOMMENDATION
t■
Thedraftrecommendation proposedbytheCommissiontotheCouncilasks
MemberStatestoadoptacommondefinitionofworkinvolvingrecombinant DNA
andtoactinsuchawaythatnolaboratorycanundertakethisworkwithout
havingpreviouslynotifiedthecompetentregionalornationalauthorityand
depositedwiththeminformationdefiningthenatureoftheactivityenvi­
sagedandwhichallows.evaluationoftheplannedconditionsofsafety .
andprotectionintheexecutionofthisactivity.
TheCommission deems,intakingaccountofpresentknowledgeontheweak
gravityofriskandonitspurelyconjecturalnature,thatthis
recommendation toMemberStatesisbothnecessaryandsufficient.
Itisnecessarybecausenoexperimental analysishasbeenabletobemade
onLongtermeffectswhichworkongeneticengineering couldhaveonthe
adaptationandgradualevolutionofmicroorganisms ,carriersofforeignDNA.
Microorganisms mightbeabletosucceedin.crossinglaboratorybarriers
andtofindahabitatinwhichtosurvive.Theriskissmallandunlikely
sincealltheworkcarriedoutuptonowshowsthatcellsintowhich
recombinant DNAhasbeentransferred haveatowercapacityforsurvivalin
naturalconditionsandthattheirinfectivity,inthecaseoftransfer
undertakenwithpathogenicmicroorganisms ,isgenerallyreduced.*
Nevertheless,itisdesirableintheunlikelycaseofanunforeseen
contamination thattheMemberStatescanhaveavailableatalltimesa
/'preciseinventoryLcenabletheoriginofcontamination tobetraced.

ThedraftCommission recommendation isconsideredsufficientsince
alldatacollectedinthecourseofthelasttwoyearsshowsthatthe
safetyproblemposedbygeneticengineeringislowanddoesnotjustify
theadoptionofdetailedlegislation ofwhichtheprincipaleffectwouldbe
toslowdownthedevelopmentofresearchandpreventtheadaptation ^
andthecontinuousevolutionofprotectionmethodsandtheclassification
ofworkaccordingtorisk',categories.Inparticularthreetypes
ofinformation,gatheredinthecourseofthelasttwoyears,justifies
theCommissionintakingthisposition.
-thenegativeresultsofanalysesundertakenintheUSAandinEurope
toestablishtherealityofcertainriskswhichcouldresultfrom
geneticengineering;
-theabsence,eventhoughagreatamountofworkingeneticengineering
hasbeenconductedthroughouttheworld,ofasinglecaseofcontamination
oraccidentalinfection;
-thedisciplineofalleuropeanresearchwdrkerswhohaveimmediately
agreedtofollowthesafetyandprotectionmeasuresproposedbythe
-consultative committeeswhichhavebeencreatedineachMemberState
todefineandfocusanationalpolicyonth^matter. ,
It,isonthebasisoftheseobservations thattheCommissionhas
decided,afterconsultation ofnationalexpertsnominatedbythe
CommitteeforResearchinMedicineandPublicHealth(CRM)andof ■
representatives oftheEuropeanScienceFoundation (ESF)andofthe
EuropeanMolecularBiologyOrganization (EMBO),topresenttothe
Councilthepresentdraftrecommendation whichreplacesthedraft
directivesubmittedtotheCouncilon4thDecember1978,justified
atthattimebythepreoccupations anduncertainties onthegravity
ofriskslinkedwithcertainactivitiesingeneticengineering..

III.ANALYSIS,REVISION ANDADAPTATION OFNATIONAL ANDCOMMUNITY GUIDELINES
Thestateofknowledge,researchtechniques andmethodsofrisk
evaluationhaveevolvedconsiderably duringthelastfewyearsand
willcontinuetoprogressinthefuture.
*
TheCommissionwillfollowcloselyproblemsrelatedtoworkingenetic
engineering andwilltake,ifcircumstances requireit,allnecessary
andusefulmeasurestomaintainorreinforcearrangements for
safetyandriskevaluationintheCommunityofMemberStates.Tothis
end,experts,mandatedbyMemberStates,willmeetatregularintervals
andatleastonceayear,undertheaegisoftheCommissionto:
-undertakeageneralanalysisofthesituationintheMemberStates
withregardtotheproductionandutilization ofrecombinant DNA,
-examineallmeasuresaselaborateasrequired,leadingtoharmonization ,
-establish,shouldthecasearise,accordingtoprogressinknowledge,
thelistofworkwhich,inallMemberStates,shouldbeforbidden
orsubjecttocompulsorysafetymeasures,
-inthecasewhereunforeseendevelopments requireit,modifythe
termsofthepresentrecommendation orpreparethetextforadraft
Councildirective.

DRAFTCOUNCILRECOMMENDATION
concerningtheregistration ofworkinvolvingrecombinant
.desoxyribonucleic acid(DNA)
THECOUNCILOFTHEEUROPEANCOMMUNITIES,
HavingregardtotheTreatyestablishing theEuropeanEconomicCommunity,
HavingregardtothedraftRecommendation submittedbytheCommission,
HavingregardtotheopinionoftheEconomicandSocialCommittee, ■
HavingregardtotheopinionoftheEuropeanParliament,
Whereasthedevelopmentoffundamental andappliedbiologicalresearch .
issuchas,tocontributetotheeconomicexpansionofthe
MemberStates,andwhereasthisimplies,inseveralsectors,thatrecombinant
DNAworkwillbeperformedoncertainorganisms;
Whereastherisksassociatedwithworkinvolvingrecombinant DNAareofa
conjecturalnature;whereasapermanentinventorywithineachMemberStateis
necessarytoallowthepossibleimpositionofprotectionmeasuresand,inthe
'veryunlikelyeventofconjectural hazardsprovingreal,totradetheorigin
ofanydeleteriouseffectsthatmayarise;
WhereasacontinualanalysisofthesituationineachMemberStatemustbe
undertakeninordertopromoteprogressively theharmonization ofnational
provisionsand,inthecasewhereunforeseendevelopments requireit,'
toestablishlistsofworkwhichoughttobebannedorsubjectedto
compulsorysafetymeasuresinallCommunitycountries;.

Consideringthecomplexityoftheproblemposedbytheconjecturalrisks
ofcertaintypeofworkinvolvingrecombinant DNA,therapiddevelopments
intheunderstanding ofthisproblem,theextensionoftheresearchsector
concernedandtheimportancethatmustbeattachedtotheconsideration
oflocalcircumstances whenassessingthehazardsinvolvedinperforming
scientific work;
Whereasitis,necessary,inordertosafeguardscientific andindustrial
secrecyandtoprotectintellectual property,tominimizethedissemination
ofthetermsofexperimental protocolspreparedfortheexecutionofthe
workaswellasthedissemination ofthesubstanceofresearchprojectsbased
ontheproductionandutilization ofrecombinant DNA;
HEREBYRECOMMENDS TOTHEMEMBERSTATES:
thattheyadoptthelaws,regulations andadministrative provisions
inorderthat:
Notification
by
laboratories1.Anylaboratorywishingtoundertake,inthe
territoryofaMemberState,workinvolvingrecombinant
DNAnotifiesthecompetentnationalorregional
authority;
Supplementary
information2.Suchnotification isaccompanied,foreachofthe
researchprojectsenvisaged,bythefollowingdocuments :

-3-
v'#Iht;
•i
I­
•<*".itheportionoftheexperimental protocolwhichis
requiredfortheevaluationofsafetyatthesite
wheretheproposedactivities aretobecarriedout/
alistoftheprotective andsupervisory measures
tobeappliedthroughout thedurationofthe
experimental work/
adescription ofthegeneraleducationinrecombinant
DNAresearchandofthetrainingreceivedbythe
membersofthestaffwhowiltparticipate inthe,
proposedactivities orwillberesponsible for
supervision/monitoring orsafety; -
Classification
offiles
/
Consultation
offilesIEachnotification andtheaccompanying documentsare ■
classified andstoredbythenationalauthorities orregional
authorities forsafetyandhealthprotection towhichtheyhave
beensubmitted;
Eachnotification anditsaccompanying documents maybe
consultedbyauthorizednationalexperts;-
Definitionof'5,
workinvolving1
recombinant DNA;Workinvolvingrecombinant DNAisdefinedastheformationof
newcombinations ofheritablematerialbytheinsertionof
nucleicacidmoleculesproducedbywhatevermeansoutside ■
thecell,intoanyvirus/bacterialplasmidorothervector
systemsoastoallowtheirincorporation intoahost
organisminwhichtheydonotnaturallyoccurbutinwhich
theyarecapableofcontinuedpropagation.