CELEX: 51980PC0467
Language: en
Date: 1980-07-28 00:00:00
Title: DRAFT COUNCIL RECOMMENDATION concerning the registration of recombinant DNA (desoxyribonucleic acid) work (submitted to the Concil by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (80) 467
Vol. 1980/0161
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                    COM(80)467 final
                                                     Brussels . 28 July 1980
                        DRAFT COUNCIL RECOMMENDATION
                       concerning the registration of
           recombinant DNA ( desoxyribonucleic acid ) work
           ( submitted to the Council by the Commission )
               v -7
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               V-          s"'  -
                                       . -y:;7
 C0MC80 ) 467 final
 ---pagebreak---                        DRAFT   COUNCIL RECOMMENDATION
concerning the iregistration of recombinant DNA ( desoxyribonuc Leic acid)
                           work
                       REASONS FOR PROPOSAL
I. INTRODUCTION .
   An analysis of the current situation and of results of work
   accomplished in the course of the last two years , in the United States
   as well as in Europe , to evaluate the importance of the dangers
                                                 .                   !
   resulting from genetic engineering , has shown that the conjectural
   risks associated with the work involving the production or utilization
   of recombinant DMA are probaly non-existent or small .       \;
   It is apparent , moreover , that the voluntary measures of control and
   safety , such as have been recommended to research workers in the
   majority of western countries , function in a satisfactory manner ,
   without excessive bureaucracy and in a way which allows continual
   adaptation in view of the rapid progress in knowledge and techniques
   in the area of fundamental and applied biology .    It has been
   ascertained ultimately that national recommendations for the classi­
   fication of work according to risk .categories and safety measures
                                                                           /
   do not radically differ from one Member State to another and indeed tend
   to converge to a certain uniformity .
                                     /                             ■ i
   However , certain questions can be raised concerning effects in the
   long term of possible contamination , which , although unlikely, •
   remains possible . It is therefore highly desirable that a precise
 ---pagebreak--- inventory is at all times and everywhere available to allow the
possible imposition of preventive measures of protection- as well as
to allow the origin of any contamination to be traced . It is nevertheless
advisable in order to do this that each Member State be free to adopt *
adequate legislative regulatory or administrative measures and that
national or regional authorities be entrusted with its execution .
Lastly ,! the adoption of a common definition of work involving
recombinant DNA will help to facilitate a dialogue between Member
         ! '                  •                                     •    •   •
States lin order to pursue gradually a harmonisation of national dispositions .
NATURE AND OBJECT OF THE DRAFT RECOMMENDATION
             t ■
The draft recommendation proposed by the Commission to the Council asks
Member States to adopt a common definition of work involving recombinant DNA
and to act in such a way that no laboratory can undertake this work without
having previously notified the competent regional or national authority and
deposited with them information defining the nature of the activity envi­
saged and which allows .evaluation of the planned conditions of safety     .
and protection in the execution of this activity .
The Commission deems , in taking account of present knowledge on the weak
gravity of risk and on its purely conjectural nature , that this
recommendation to Member States is both necessary and sufficient .
It is necessary because no experimental analysis has been able to be made
on Long term effects which work on genetic engineering could have on the
adaptation and gradual evolution of microorganisms , carriers of foreign DNA .
Microorganisms might be able to succeed in . crossing laboratory barriers
and to find a habitat in which to survive .   The risk is small and unlikely
since all the work carried out up to now shows that cells into which
recombinant DNA has been transferred have a tower capacity for survival in
natural conditions and that their infectivity , in the case of transfer
undertaken with pathogenic microorganisms , is generally reduced .      *
Nevertheless , it is desirable in the unlikely case of an unforeseen
contamination that the Member States can have available at all times a
                                                         /'
precise inventory Lc enable the origin of contamination to be traced .
 ---pagebreak--- The draft Commission recommendation is considered sufficient since
all data collected in the course of the last two years showsthat the
safety problem posed by genetic engineering is low and does not justify
the adoption of detailed legislation of which the principal effect would be
to slow down the development of research and prevent the adaptation ^
and the continuous evolution of protection methods and the classification
of work according to risk', categories . In particular three types
of information , gathered in the course of the last two years , justifies
the Commission in taking this position .
- the negative results of analyses undertaken in the USA and in Europe
    to establish the reality of certain risks which could result from
    genetic engineering ;
- the absence , even though a great amount of work in genetic engineering
    has been conducted throughout the world , of a single case of contamination
    or accidental infection;
- the discipline of all european research wdrkers who have immediately
    agreed to follow the safety and protection measures proposed by the
  - consultative committees which have been created in each Member State
    to define and focus a national policy on th ^ matter .                   ,
 It, is on the basis of these observations that the Commission has
 decided, after consultation of national experts nominated by the
 Committee for Research in Medicine and Public Health ( CRM ) and of   ■
 representatives of the European Science Foundation ( ESF) and of the
 European Molecular Biology Organization ( EMBO), to present to the
 Council the present draft recommendation which replaces the draft
 directive submitted to the Council on 4th December 1978 , justified
 at that time by the preoccupations and uncertainties on the gravity
 of risks linked with certain activities in genetic engineering .    .
 ---pagebreak--- III . ANALYSIS , REVISION AND ADAPTATION OF NATIONAL AND COMMUNITY GUIDELINES
      The state of knowledge , research techniques and methods of risk
      evaluation have evolved considerably during the last few years and
      will continue to progress in the future .
                          *
      The Commission will follow closely problems related to work in genetic
      engineering and will take , if circumstances require it , all necessary
      and useful measures to maintain or reinforce arrangements for
      safety and risk evaluation in the Community of Member States .    To this
      end , experts , mandated by Member States , will meet at regular intervals
      and at least once a year , under the aegis of the Commission to :
      - undertake a general analysis of the situation in the Member States
        with regard to the production and utilization of recombinant DNA ,
      - examine all measures as elaborate as required , leading to harmonization ,
      - establish , should the case arise , according to progress in knowledge ,
        the list of work which , in all Member States , should be forbidden
        or subject to compulsory safety measures ,
      - in the case where unforeseen developments require it , modify the
        terms of the present recommendation or prepare the text for a draft
        Council directive .
 ---pagebreak---                         DRAFT COUNCIL RECOMMENDATION
         concerning the registration of work involving recombinant
             . desoxyribonucleic acid ( DNA)
 THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
 Having regard to the Treaty establishing the European Economic Community,
 Having regard to the draft Recommendation submitted by the Commission ,
 Having regard to the opinion of the Economic and Social Committee ,        ■
 Having regard to the opinion of the European Parliament ,
 Whereas the development of fundamental and applied biological research .
 is such as , to contribute to the economic expansion of the
 Member States , and whereas this implies , in several sectors , that recombinant
 DNA work will be performed on certain organisms ;
 Whereas the risks associated with work involving recombinant DNA are of a
 conjectural nature; whereas a permanent inventory within each Member State is
 necessary to allow the possible imposition of protection measures and , in the
'very unlikely event of conjectural hazards proving real , to trade the origin
 of any deleterious effects that may arise;
 Whereas a continual analysis of the situation in each Member State must be
 undertaken in order to promote progressively the harmonization of national
 provisions and, in the case where unforeseen developments require it,'
 to establish lists of work which ought to be banned or subjected to
 compulsory safety measures in all Community countries ; .
 ---pagebreak--- Considering the complexity of the problem posed by the conjectural risks
of certain type of work involving recombinant DNA , the rapid developments
in the understanding of this problem , the extension of the research sector
concerned and the importance that must be attached to the consideration
of local circumstances when assessing the hazards involved in performing
scientific work ;
Whereas it is , necessary , in order to safeguard scientific and industrial
secrecy and to protect intellectual property , to minimize the dissemination
of the terms of experimental protocols prepared for the execution of the
work as well as the dissemination of the substance of research projects based
on the production and utilization of recombinant DNA ;
HEREBY RECOMMENDS TO THE MEMBER STATES      :
that they adopt the laws , regulations and administrative provisions
in order that :
                    1 . Any laboratory wishing to undertake, in the
Notification
                        territory of a Member State , work involving recombinant
by
                        DNA   notifies the competent national or regional
laboratories
                        authority ;
Supplementary       2 . Such notification is accompanied , for each of the
informat ion            research projects envisaged , by the following documents :
 ---pagebreak---                                          - 3 -
                                  the portion of the experimental protocol which is
                                  required for the evaluation of safety at the site
                                 where the proposed activities are to be carried out /
                                  a   list of the protective and supervisory measures
             v'#   I ht ;
                                  to be applied throughout the duration of the
                    • i           experimental work /
                        I­
                 • <*". i
                                  a   description of the general education in recombinant
                                  DNA research and of the training received by the
                                 members of the staff who wilt participate in the ,
                                  proposed activities or will be responsible for
                                  supervision / monitoring or safety ;         -
                             Each notification and the accompanying documents are     ■
Classification               classified and stored by the national authorities or regional
of fi les                    authorities for safety and health protection to which they have
                             been submitted ;
           /
Consultation                 Each notification and its accompanying documents may be
of files                I    consulted by authorized national experts ;   -
Definition of           '5 , Work involving recombinant DNA is defined as the formation of
work involving 1             new combinations of heritable material by the insertion of
recombinant DNA ;            nucleic acid molecules produced    by whatever means outside ■
                             the cell , into any virus/ bacterial plasmid or other vector
                             system so as to allow their incorporation into a host
                             organism in which they do not naturally occur but in which
                             they are capable of continued propagation .