CELEX: 51979PC0158
Language: en
Date: 1979-03-30
Title: PROPOSAL FOR A COUNCIL DECISION adopting a five-year research and training programme (1980-1984) of the European Atomic Energy Community in the field of biology - Health Protection (Radiation Protection Programme) (submitted to the Council by the Commission)

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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                  COM ( 79 ) 158 final
                                                  Brussels , 30 March 1979
                     PROPOSAL FOR A COUNCIL DECISION
       adopting a five-year research and training programme
       ( 1980-1984 ) of the European Atomic Energy Community
            in the field of biology - Health Protection
                   ( Radiation Protection Programme )
            ( submitted to the Council by the Commission )
                            XV :-
  COM 79 ) 158 final .
 ---pagebreak---                                          CONTENTS
                                                                         Page
0 . Summary                                                                1
1.    Introduction                                                          3
    e
2 . Role of the Radiation Protection Programme of the Commission            3
      2.1 .   Objectives of research activities                             3
      2.2 .   Coordination in radiation protection                          4
              - a Community responsibility
3 . Present situation in radiation protection research and its              4
      consequences
      3.1 .   The Community 's present research programme                   4
      3.2 .    ICRP and UNSCEAR                                             5
      3.3 .    Consequences for the Community programme                     5
      3.3.1 . Scientific reorientation                                      5
      3.3.2 . Organisational improvement : a rolling programme              6
 4 . The Radiation Protection Programme Proposal 1980-1984                 8
       4.1 .    Proposed research activities                               8
       4.1.1 . Radiation dosimetry and its interpretation                  9
       4.1.2 . Behaviour and control of radionuclides in the environment  13
       4.1.3 . Short-term somatic effects of ionizing radiation           16
       4.1.4 . Late somatic effects of ionizing radiation                 18
       4.1.5 . Genetic effects of ionizing radiation .                    22
       4.1.6 . Evaluation of radiation risks                              27
       4.2 .    Implementation                                            29
       4.2.1 . Participating laboratories                                 29
       4.2.2 . Management                                                 29
       4.2.3 . Coordination                                               30
       4.2.4 . Evaluation                                                 30
       4.2.5 . Dissemination of results                                   32
       4.3 .    Funds                                                     32
       4.3.1 . Staffing                                                   32
       4.3.2 . Financial allocation                                       32
       4.3.3 . Financial breakdown                                        34
  APPENDIX I           Scientific achievements                            35
  APPENDIX II          Proposai for a Council decision + ANNEX             48
  APPENDIX III         Opinion of the ACPM " Radiation Protection"         51
   APPENDIX IV         Opinion of the Scientific and Technical Committee  52
 ---pagebreak---  Summary
The present proposat for an extension of the Commission 's Radiation Protection
Programme is submitted pursuant to article 7 of the EAEC Treaty . It is
proposed as a rolling programme and covers the period from 1.1.1980 to
31.12.1984 .  Scientific and administrative reasons have guided the Commission
to propose such a rolling programme to take rapid advantage of recent progress
in radiation protection research and of the changing requirements for radiation
protection in the Community , and furthermore to facilitate the management of
the programme . The year 1980 is the last of the present programme ( 1976-1980 )
and would thus become the first year of the new programme .
The Programme is designed to gain adequate understanding and control of
radiation risks with two main objectives :
    improvement of scientific and technical knowledge with a view to updating
    basic standards for the health protection of the general public and
    workers against the hazards arising from ionizing radiation ;
-   evaluation of the biological and ecological consequences of nuclear
    activities and of the use of nuclear energy and ionizing radiation , in
    order to ensure an adequate protection of man and of the environment
    whenever unacceptable harm could otherwise be caused to them .
The Programme will consist of six major closely integrated activities or
sectors which - arbitrarily but conveniently - serve to indicate its overall
structure :
-   radiation dosimetry and its interpretation ,
-   behaviour and control of radionuclides in the environment ,
-   short-term somatic effects of ionizing radiation ,
    late somatic effects of ionizing radiation ,
-   genetic effects of ionizing radiation ,
-   evaluation of radiation risks .
The implementation of past programmes has shown that its execution in research
contracts with National Institutions and Universities (" indirect action")
combined with an efficient management with the help of the ACPM and based on
objective procedures for evaluation are the appropriate means for the
 ---pagebreak---                                      - 2 -
execution of this Community research programme .   Improvements to the
mechanism   by which the programme is managed are constantly sought and
implemented as appropriate .   In general it keeps the administrative charge
for contractors and scientists as low as reasonably achievable , while
guaranteeing as far as possible that the objectives of the programme are
reached .
The Commission estimates the global needs for the whole duration of the
Programme ( 1980-1984 ) to be 68,2 million EUA and 64 staff .  10 million EUA
of the total 68,2 million EUA are already covered by the programme decision
1976-1980 .
A compilation of some important achievements is given in Appendix I.
 ---pagebreak---                                        - 3 -
1 . Introduction
    On 15 March 1976 the Council adopted a research and training programme
    for the European Atomic Energy Community in the field of Biology-Health
    Protection ( Radiation Protection Programme ) for the 5-year period from
    1.1.1976 to 31.12.1980 . The budget allocation was 39 million EUA .
    The present proposal for an extension of the Commission 's Radiation
    Protection Programme is submitted pursuant to article 6 of the EAEC
    Treaty, taking into account recent progress of knowledge and the changing
    requirements for radiation protection in the Community which are factors
    leading to an evolution of the scientific content of the programme .
2 . Role of the Radiation Protection Programme of the Commission
    2.1 . Objectives of research activities
           The use of energy of nuclear origin , including the probable use of
           thermonuclear fusion in a more distant future , the handling of waste ,
           effluent and fuels throughout their cycles and the various uses of
           ionizing radiation and radioisotopes , including medical diagnosis and
           therapy , are all factors calling for adequate prevention and control
           measures to ensure protection against ionizing radiations .
           The role of this scientific research programme is to supply suffi­
           cient information to contribute to a framework for making informed
           decisions on issues on which public opinion has become very sensiti­
           ve . Therefore , the Radiation Protection Programme of the Commission
           is designed to gain adequate understanding and control of radiation
           risks with two main objectives :
           - improvement of scientific and technical knowledge with a view
              to updating basic standards for the health protection of the
              general public and workers against the hazards arising from
              .  .  .            *
              ionizing radiation .
           - evaluation of the biological and ecological consequences of
             nuclear activities and of the use of nuclear energy and ionizing
              radiation , in order to ensure an adequate protection of man and
             of the environment whenever unacceptable harm could otherwise'
             be caused to them .
      * The preparation of basic safety standards for protection against
         ionizing radiation is one of the tasks incumbent on the Commission
        resulting from the Euratom Treaty .
 ---pagebreak---                                       _ A -
           It is evident that these objectives directly concern Community
          policies of undisputed importance : the social , the environment
          and the energy policies .
    2.2 . Coordination in radiation protection ~ a Community responsibility
          Radiation hazards do not stop at national boundaries and the
          problems to which they give rise are basically similar in every
          Member State . Limited scientific manpower and financial resources
          contrast severely with the complexity and the extent of the
          problems to be solved . From the start of its activities in this
          area, the Commission accordingly made efforts to establish co­
          operation between the appropriate national institutes on work
          concerning the focal points of the programme . The success of these
          efforts is evidenced today by the fact that the majority of the
          national institutions and many of the university institutes active
          in this field are to be found among the participants in the
          Community programme . Unnecessary redundancy of work has been
          avoided and the best use of the available limited capacities is
          being achieved through dovetailing of the projects and joint
          planning arrangements .
          This programme does not duplicate national efforts . It stimulates
          and complements them in topics of common interest . Joint planning
          and coordinated projects have appreciably improved the effective­
          ness of radiation protection research in the Member States .
3 . Present situation in radiation protection research and its consequences
    3.1 . The Community 's present research programme
          The programme has yielded various types of results corresponding
          to important scientific progress . Statistically, during 1977, more
          than 600 scientific publications have resulted from this programme ,
          and about 550 scientists belonging in almost all cases to national
          institutes , have joined in this work ( corresponding to 300 scien-
          tists-years ). From the published work a few examples of achievements
          are listed in Appendix I , although a complete evaluation of the
          present programme 1s premature since results are available only
          from the first two years of the 5-year period .
 ---pagebreak---                                    - 5 -
        Besides the contribution from the present and earlier research
        programme to the worldwide compilation and evaluation of UNSCEAR
        and ICRP , the Commission 's services have prepared monographs on
        special research subjects ( e.g. treatment of acute radiation in­
        jury, risk evaluation of Ra~22^, collection of neutron dosimetry
       data , intercomparisons ). Furthermore , the scientific data produced
        have been evaluated through the continuous activities of study
       groups in each of the programme sectors .
3.2 .   ICRP and UNSCEAR
       Two important events characterize the present situation in radia­
       tion protection . On the one hand a very complete and updated
       compendium of scientific information on radiation effects , sources
       and risks , has been recently published by UNSCEAR*. This report
       evaluates , in view of risk estimates , research results on long-term
       somatic and genetic effects available up to 1977 . Its influence
       on future radiation protection research will be considerable ,
       especially as it sheds new light on many problems .
       Moreover ICRP     has issued new recommendations . Following these ,
       a revision of the basic radiation protection standards of Euratom
       is under way . Detailed guidance for their application has yet to be
       produced , especially as regards the introduction of new concepts
       such as detriment , collective dose equivalent , optimization and
       justification of irradiation .
       Scientists who are actively involved in the Community 's    Radiation
       Protection Programme have participated in the preparation of both
       documents , and research results from this programme have contributed
       to the considerable increase of knowledge in radiation protection .
3.3 . Consequences for the Community programme
       3.3.1 . Scientific reorientation
               It is clear from the previous paragraphs that such changing
               concepts in radiation protection , should be reflected in
               any future programme . As a result changes in the scientific
               content proposed can be seen under point 4 , where new
               subjects and priorities have been introduced .
*     United Nations Scientific Committee on the Effects of Atomic Radiation .
**    International Commission on Radiological Protection .
 ---pagebreak---                                  - 6 -
3.3 = 2 . Orgamsational improvement : a rolling programme
          Among consequences for the management of the programme ,
          attention has to be drawn to the proposal of making a rolling
          programme , 1980 being an overlapping year . This is based on
          the following considerations :
          - Modification and in some cases reorientation of research
            projects is a necessary consequences of the present situation .
            However such major reorientation could not be done easily
            during the last year of a programme . Considering the long
             duration of work needed in radiation protection research ,
            it would seem better to allow a phased period to reorient
            for a new multiannual programme .
          - The compulsory detailed evaluation of research projects ,
            taking into account actual contracts and new proposals ,
            would greatly benefit from an overlapping year , assuring
            thus evolution as well as continuity of the programme .
            Present contracts could come to their normal end or to be
            extended at the end of the overlapping year whilst new
            contracts could be started during its course .
          - In the past the initial phase of contract negotiations was
            often very difficult for the contractors as well as for the
            Commission . For instance , due to the programme decision in
            March 1976 , a first review of proposals by the ACPM could be
            done only in May 1976, and this then had to be followed by
            negotiations with contractors . Thus signing of contracts ,
            which were to start on 1.1.1976, was delayed until the end
            of 1976 .
          - The number of excellent scientists working in radiation
            protection is very limited and it takes many years to
            build up good and serious research projects . Maintaining
            collaboration with excellent groups is a vital part of the
            programme . Thus it is regrettable that the Commission 's
            services have to ask and try to convince contractors at
            the end of a five-year period to keep their research groups
            at work for about another year at their own financial risk
            until the signing of contracts legalizes the situation .
 ---pagebreak---   - Moreover if decisions on a possible continuation are not
     taken well in advance of the end of a contract , there is
     often moral pressure brought to bear on the services of
     the Commission and the ACPM to continue the contract . In
     fact , a late Council decision tends to limit unduly the
     possibilities of the ACPM to advise rejection or reorient­
     ation of proposed projects and of the contractors to dis­
     mantle research groups or to use them for other projects .
     Social problems for the research personnel engaged in
     contracts should be minimized .
All these factors point towards a decision for a rolling
programme including 1980 as an overlapping year . The budget
of the year 1980 will be completely covered within the upper
limit of 39 million EUA of the period 1976-1980 . Existing
contracts will continue in 1980 until the date of termination
which was originally foreseen in the contract or which would
become necessary for other reasons . New contracts can be con­
cluded in 1980 with a duration of up to 5 years to the end of
1984 , following the lines of the new scientific programme .
 ---pagebreak---                                       - 8 -
4.   The Radiation Protection Programme Proposal 1980-1984
     4.1 .  Proposed research activities
            The proposed Radiation Protection Programme of the Community
            endeavours , through a co-operative European effort , to increase
            knowledge in radiation protection while taking into account
            particular problems and skills available in Europe .
            The programme will consist of' six major activities or sectors which
            - arbitrarily but conveniently - serve to indicate its overall
            structure*:
               radiation dosimetry and its interpretation ,
            -  behaviour and control of radionuclides in the environment ,
            -  short-term somatic effects of ionizing radiation ,
            -   late somatic effects of ionizing radiation ,
            -  genetic effects of ionizing radiation ,
            -  evaluation of radiation risks .
            The information obtained from previous Commission research
            programmes and from research conducted elsewhere in the world in
            comparable fields has been examined , the present state of knowledge
            reviewed , especially as presented in the UNSCEAR report , future
            needs for practical protection measures and guidelines have been
            designed and the necessary research subjects identified .
            The programme proposed by the Commission is based on foreseeable
            requirements of radiation protection in the Community and on the
            updating and adaptation of the activities already in progress ,
            in the light of the expected development of nuclear facilities and
            other sources of ionizing radiation and of their possible effects
            on man and the environment .  It is necessary to stimulate research
            on various subjects which are of crucial importance for the future
            and proposals to this effect are outlined in the following pages .
   No such subdivision can adequately define the complex scientific content
   of a balanced radiation protection programme . There is an apparent over­
   lapping between sectors and there are subjects related to all or several of
   the sectors . Dosimetry , for example , is a basic requirement for all
   sectors , synergistic effects are observed under many different conditions
   and the problems of low doses or low dose rates , as well as of the fundamental
   mechanisms of the observed effects or the need for epidemiological studies
   manifest themselves in several sectors .
 ---pagebreak---                                         9
4.1.1 . Radiation dosimetry and its interpretation
        Application of regulations for radiation protection and research on
        effects of ionizing radiation can only be carried out properly if it
        is possible to determine absorbed dose and / or other exposure
        parameters and interpret them in terms of biological effects and the
        risks to which they give rise .   Furthermore the directives of Euratom
        on Basic Standards require the measurement and recording of certain
        exposure data which should be carried out in a comparable manner
        within the Community .   Thus the following subjects require
        further investigation in support of the Radiation Protection
        Programme as a whole .
        -  Physical aspects of radiation effectiveness ( Microdosimetry )
           Biological effects of ionizing radiation are dependent on
           different irradiation parameters , especially on the radiation
           quality , interpreted as the spatial and temporal distributions
           of radiation energy absorption and transfer to biological tissues ,
           the distribution of energy deposition within sensitive sites , as
           well as the immediate biochemical effects .   Despite the
           considerable progress made in the acquisition    of the necessary
           physical data , more detailed investigations are required to
           establish convincing relationships between the form of
            radiation interaction and the dose-effect curves for external
            radiation and incorporated radio-nuclei .  Microdosimetric research
           on tumour induction and defects of organ function should be able to
            contribute to the solution of such urgent problems in radiation
           protection as     whether the relative risks from low doses and
           dose rates of both low and high -LET- radiations have been over
           or under-estimated , and any changes needed in Quality Factors ,
           with all the impact that such changes    might have on shielding
           design and personal dosimetry .
        -  Internal dosimetry
           Research is needed to develop further quantitative methods to
           assess the effective radiation dose in the case of incorporation
           of radioactive isotopes such as tritium and the transuranic
           elements and the inhalation of radioactive aerosols .   The
 ---pagebreak---                          - 10 -
improvement of dosimetric models used by ICRP for the lung , the
gut and the bone , estimation of lung and body content of alpha-
emitting radionuclides by whole body counter and excretion
measurements respectively , and     effects of labelled DNA precursors
in the cell nucleus    are   of     particular relevance for radio­
logical protection .
Dosimetry in case of external irradiation
External irradiation usually gives rise to quite inhomogeneous
dose distributions or to partial body irradiation making it
sometimes difficult to establish the dose in irradiated organs
or tissues under risk .    Therefore physical methods have to be
improved in order to relate field characteristics of external
radiation , such as exposure and quality and differences in
tissue densities , more accurately to the organ dose .
Personal dosimetry and area monitoring
Following the recommendations in recent ICRP publications the
revision of radiation protection standards needs to be backed up
by research into methods aimed at applying and evaluating these
recommendations .  The introduction of the effective dose
equivalent and the dose equivalent index means that existing
measuring methods have to be adapted and conversion factors and
functions have to be theoretically and experimentally established
for the different quantities , especially as regards instrument
calibration .
There are various ways of carrying out personal dosimetry in the
individual countries . An analysis will be made of parameters
such as internal and external irradiation , contamination ,
incorporation and excretion which must be determined , in order
to make decisions on risk estimates both for acute and chronic
exposures and therapeutic measures .     Measuring methods will be
developed and coordinated .     Research is required on protection
standards for beta-particles and on the information needed for
this purpose .  Information from intercomparison programmes and
field studies will complement the research results .
 ---pagebreak---                                - 11 -
-   Dosimetry of high - LET- radiation and neutrons
    Concerted support is presently necessary to achieve data on high-
    LET-radiations including neutrons of selected energies of practical
    importance . Although many physical data and measuring methods
    for neutrons have been published or elaborated in recent years ,
    completely satisfactory methods in personal neutron dosimetry
    as well as for neutron and high -LET-dosimetry for radiobiological
    experiments have yet to be devised . One problem will certainly
    be to collect and evaluate data that will enable a general
    consensus to be reached on neutron dosimetry itself .    In this
    area also intercompar i sons require a continuing effort , since
    those which have been carried out have revealed unexpected
    discrepancies in dosimetry procedures and accuracy .
A programme of continuing development and adaptation for all
dosimetric methods - as has taken place in the past - is required to
deal with changing needs of radiation protection .     For this , some
flexibility of approach is needed to tackle mission oriented problems
or to carry out exploratory studies of actual needs , or to develop
new instruments , thus guaranteeing flexibility and capability for
innovation in the future .
-   One such problem will be environmental dosimetry .    A more realistic
  . estimate should be made of the . dose to the public resulting from
    natural radioactivity and enhanced natural exposure .    This forms
    part of the proper assessment of the risk from man-made radiation
    sources .
-   Another problem of increasing concern is exposure in medical
    di agnosi s . This makes the greatest contribution of any man-made
    radiation source to the general population .    Dosimetric research
    will aim at reducing the non-essential dose from this exposure
    while maintaining the quality of the diagnostic information .
    It will also examine the usefulness of such data for epidemiolo­
    gical studies of radiation effects .
 ---pagebreak--- Still another problem is the possibility of using biologi cal
dosimetry for accidents to provide important additional
information on the effective dose received . Unfortunately
these methods have not proved entirely sufficient in certain
accidental situations . Research is needed on the improvement
of reliable biological dosimetric methods and on the influence
of a wide range of dose rates and non-uniform spatial dose
distributions on the biological indicators .
 ---pagebreak---                                      - 13 -
4.1.2 . Behaviour and control of radionuclides in the environment
        The programme of this sector is directed to the acquisition and impro­
        vement of data on the behaviour of particular radionuclides in various
        parts of the environment .   Such data are an essential input to assess­
        ments of the radiation detriment in terms of potential harm to health ,
        of routine activities and events ( such as accidents ) which result in
        the release of radioactive materials to the environment ( see section
        4.1 . 6 .). Important subjects , unconnected with nuclear power , which
        will be included in the programme are those human activities which
        cause man to be exposed to natural background radiation to an enhanced
        degree .
        The assessment of the detriment requires the estimation of individual
        and collective doses in the exposed population , usual ly by means of mo­
        dels which represent the way in which radionuclides are tranferred
        along various and often complex environmental pathways .
        In addition , the acquisition of these data will assist those who are
        responsible for authorizing the discharge of radioactive materials and
        setting suitable limits for such discharges to the environment and it
        will also improve the scientific basis of environmental monitoring
        programmes .
        Many data have already been accumulated on the behaviour of several
        radionuclides in particular sectors of the environment , for example ,
        from studies of fallout from the atmospheric testing of nuclear weapons
        and from laboratory experiments .    However , many gaps remain and many
        of the data which are available need to be improved in quality .
        In the conduct of this programme a reasonable balance between labora­
        tory and field experiments will be necessary ; although there is an
        increasing need for field work to confirm the validity of transfer
        coefficients derived from laboratory experiments .
        Useful information on the reliability of transfer coefficients and on
        any unexpected sources of contamination might also be derived from
        data recently collected in several monitoring programmes .
 ---pagebreak---                               - 14 -
Priority will be given to those . radionuclides and environmental path­
ways which are likely to be important in nuclear power programmes in
the coming decades or as a result of radioactive materials that may be
introduced into the environment from other sources . In compiling the
detailed programme , account will be taken of other Community program­
mes ( see footnote ) relevant to nuclear safety and environmental protec­
tion thus ensuring that appropriate liaison will be established .
Reviews of existing data and anticipated practices at various stages of
the nuclear fuel cycle indicate that the following are important acti­
vities in the context of the programme :
- Uranium mining and milling
- uranium enrichment plants
- reprocessing of irradiated fuels
- recycling of uranium and plutonium and the fabrication of mixed-
   oxide fuels
- the introduction of advanced reactor systems
- the possible introduction of alternative fuel cycles
- decommissioning of nuclear reactors
- the management , including disposal , of the liquid, gaseous and solid
   wastes that may be generated by all the above activities .
Particular attention will be paid to methods of estimating contamination
 levels , demarcating contaminated areas and reducing or eliminating radio­
nuclides transfers in accident situations .
Radionuclides which presently appear the most important are the trans­
uranic elements and also H-3 , C-14, S-35 , Kr-85 , Tc-99 , Ru-106, 1-129 ,
 1-131 as well as some activation products ( Mn-54 , C0-60) and natural
radioisotopes ( radium, thorium and daughter products ). The chemical
toxicity of some of these nuclides ( Tc-99, 1-129 ) must also be consi­
dered .
   - Programme  on management and storage of radioactive waste
   - Programme  on  plutonium utilization
   - Programme  on  uranium exploration and extraction
   - Programme  on  decommissioning of nuclear power plants
   - Programme  on  safety of light water reactors .
 ---pagebreak---                               - 15 -
The main environmental transfer processes requiring further investiga­
tion are summarised below :
- resuspension of radionuclides from the sea surface , silts and typi­
  cal European land surfaces ( particularly for Np , Pu , Am and Cm and
  long lived fission products ) ;
- the transfer of radionuclides deposited on the surface of agricultu­
  ral land to soil , water , plants and animals ( particularly for the
  transuranium nuclides , members of the thorium and radium decay chains
  and other radionuclides including S-35 , Tc-99 , Ru-106, 1-129 ).
  The way in which the systemic contamination of animals might be
  influenced by the incorporation of radionuclides in biological mate­
  rials and by chronic exposure conditions needs special attention ;
- the migration and retention of radionuclides in a range of rocks and
  soil types typical of Community countries ( particularly for the trans­
  uranium nuclides and long-lived fission products ) ;
- the transfer to sediments of radionuclides released to the aquatic
  environment , and their possible remobi li sat ion ( particularly the
  transuranium nuclides and long-lived fission products ) ;
- the regional distribution and behaviour of long lived radionuclides
  ( e.g. C-14, Tc-99 , 1-129 ) with particular reference to their exchan­
  ge between different sections of the environment ( e.g. exchange
  between the aquatic and terrestrial environments );
- the uptake by aquatic species of particular radionuclides ( e.g. Tc-99 )
  where more information is needed ;
- the investigation of possible synergistic effects of radionuclides
  and conventional pollutants released to the environment , with parti­
  cular reference to uptake of radionuclides into food chains ;
- the exchange of C-14 and HTO between the atmosphere and terrestrial
  environment ;
- the atmospheric dispersion and deposition processes in urban areas .
 ---pagebreak---                                        - 16 -
4.1.3 . Short~term somatic effects of ionizing radiation
        Radiation injury occurs at the time of exposure .    ALL subsequent
        bioLogicaL effects depend essentiaLLy on the rapid changes occurring
        during an extremeLy short period of time foLLowing the energy
        absorption .   A detaiLed knowLedge of these events wouLd aLLow
        to understand the mechanism of the radiation effects .
        For many years it has been known that free radicals and their reaction
        products play an essential role during the early phase of the radio­
        logical damage but only recent technological advances made it possible
        to measure and to identify them in biological material .     In relatively
        few years great progress was made and nowadays , the reaction of radio-
        induced free radicals with nucleic acids which are the main biological
        target of radiation are fairly well known .    Further studies in this
        field , if well coordinated , should give us a clear understanding of
        the primary mechanism of the radiation damage which would be invalu­
        able for the comprehension and possible control of the consequences of
        irradiation on living matter .
        The study of the early cellular and tissue effects of radiation injury
        from internal or external origin will be intensified in view of their
         increasing importance in industry , research and clinical medicine .
        Lesions which are amenable to treatment include mainly localized radio-
         lesions and damage to the lympho-hemOpoieti c system .   These pathogenic
         studies will be of basic importance for the development of therapeutic
         strategies .
         Because of the high incidence of acute , subacute or chronic local
         radiation injuries , the study of their mechanism , prognosis , compli­
         cations and treatment will be given special attention . Depending on
         the great variety in the modalities of irradiation , including external
         as well as internal irradiation ( absorption of radioactive material by
         ingestion , inhalation or wound ), they may involve not only the skin
         but also internal surfaces like those of gastro-intestinal tract , the
         respiratory tract and many other organs . The connective and vascular
         tissue which is present almost everywhere in the body deserves parti­
         cular studies with regard to possible late effects . The high inci­
         dence of cancerous transformation following the healing process is
 ---pagebreak---                               - 17 -
also typical for radiation burns .    Therefore , the pathogenesis of
these Lesions , of the complicating factors and of the mechanism and
the kinetics of cellular repopulation will be thoroughly investigated .
Also the study will consider the characteristics of antigenic changes
and possible neoplastic alterations of the damaged tissue , the role
of damage to the immune system and the specific problems encountered
when skin-graft therapy is applied .
Early effects of radiation injury to the hemopoietic system by total
or subtotal body irradiation and the therapy of those injuries have
been studied in previous programmes and considerable progress has
been made in understanding and treating the " bone marrow syndrome".
However , assessment of the impairment and regeneration potential of
the hemopoietic function by existing methods of diagnosis is not yet
optimal particularly with regard to the diagnosis of damage to stem
cells and to certain populations of lymphocytes .     Therefore , the use
of chromosomal preparations and other monitors of radiation damage
will be studied .   As far as therapy is concerned several problems
continue to require attention .    New radioprotectors have recently
been discovered which , if further investigated , could be valuable
for human application .   Problems of an immunological nature remain
a major difficulty , although advances in immunology have greatly
improved the feasibility of marrow transplantation in man .      These
advances include : the removal of immunologically reactive lympho­
cytes from the marrow suspension ( stem cell separation ); vastly
improved tissue typing and cryopreservation of stem cells ( marrow
banks ) and the feasibility of " manipulating " the immune reactivity
which plays a central role in the fate of patients who are treated
with a marrow graft ( immune-deficiency is the most serious late
 complication ). This part of the research programme will therefore
emphasize immunological problems such as :
a . further improvement of matching for newly discovered tissue
     antigens ;
b . separation and cryopreservation of stem cells, including a
     standardized method of assessing their viability ;
 c . monitoring and enhancing the immune reactivity of the marrow
     treated recipient to prevent late complications ( infections
     and possible radiation-induced neoplasia ).
 ---pagebreak---                                          - 18 -
4.1,4 , La te somatic effects of ionizing radiation
        Two types of harmful effects may be induced by radiation and some of
        these may only become manifest long after initial exposure .       In one
        type , involving the so-called " stochastic effects ", the frequency with
        which the effect occurs depends typically upon the size of radiation
        dose, but the severity of the effects does not in general depend upon
        the dose .   The induction of malignant disease constitutes the most
        important example of such effects .
        In the other type , involving " non-sotchasti c effects ", no significant
        harm is ordinarily detectable below a certain         dose      but the
        severity of the effect which is then produced may vary with the size
        of the dose .     The induction of cataract or of reduced fertility , and
        the impairment of organ function or blood supply represent changes of
        this type .
     - Induction of stochastic effects
        a . Human observations : Malignant changes induced by radiation are of
            particular importance in regard to radiation protection .      The Com­
            mission therefore emphasizes the continuing need for assessing the
            frequency with which different types of malignancy occur in excess
            of normal expectation in groups of people who have been irradiated
            ( for medical or other reasons ) at known dose levels , and have been
            or can be followed up comprehensively for long periods of time ,
            ideally for several decades , during which further radiation induced
            tumours may become detectable .
            Special attention should be given to dosimetry , length and effi­
            ciency of follow up , comparability of the control series , influ­
            ence of sex , of age at the time of exposure , mortality resulting
            from radiation-induced tumours , the way in which the latent inter­
            val between irradiation and detection of tumours varies with dose
            or with other factors , the influence of the quality of the radia­
            tion ( LET ), variation of this influence ( RBE ) with dose , and the
            form of dose-effect relationship .
            Groups of patients who have received repeated or extensive diagnos­
            tic radiological investigations will be studied whenever full
             records such as the frequency of death    from malignant disease are
             obtainable .
 ---pagebreak---                                   -  19 -
       Statistical studies of patients who had received internal or extern­
       al radiotherapy at moderate dosage , particularly in the treatment of
      non malignant disease should yield additional risk estimates for
       cancer induction in relevant organs .    These results will only be
      meaningful if control values can be established for the incidence
      of cancer in patients with the same diseases but who had not been
      treated by radiation . Such studies should also give some guidance
      on the safety requirements for these forms of therapy . Similar
      studies on the effects of radiotherapy for malignant disease ,
      whether given alone or in combination with chemotherapy , could also
      assist in defining the possible after-effects and the appropriate
      forms of treatments to minimize the frequency of such hazards .       In
      addition , these studies may throw light on possible synergism
      between radiation and chemical agents , or a greater sensitivity to
      radiation carcinogenesis of particular tissues in certain diseases .
' b . Animal studies :    in order to elucidate the mechanism of cancer
      induction , there is an evident need for fundamental experimental
      studies of the nature of this phenomenon , and of the frequency
      with which malignant changes are likely to be induced especially
      by low doses and low dose rates .    Such information can form a
      basis on which valid inferences can be made on the frequency of
      malignant change to be expected following the even lower doses
      involved in occupational or other exposure to radiation .
      Dose effect relationships at low doses , mi crodosimet ri c studies ,
      comparison of high and low LET radiation and of dose protraction
      will be carried out .
      Studies concerned with events after incorporation of radionuclides
      will take into account the following parameters : uptake ( by inges­
      tion , or inhalation ), radiation quality , biological half life ,
      organ distribution , affinity to particular tissues , inhomogeneity
      of deposition , metabolism and excretion and studies on
      the benefit or possible harm of chelating agents .
      Special emphasis will also be placed on the variation of factors
      which are likely to influence the carcinogenic process . These
       factors include age , sex , hormones , viruses ,, the immune system
       and local tissue reactions as endogenous , ? nd some aspects of
       cocar cinogenesi s and synergistic effects as exogenous factors .
 ---pagebreak---                                 - HU -
     The exact identification of the cells at risk and of the early
     and intermediate sequence of events during carcinogenesis will
     necessitate the development of new methods ( including biochemical
     and immunological markers ).   Furthermore , the link between muta­
     genic and carcinogenic effects should be elucidated .
     Standardization of animal experiments , of tumor nomenclature and
     quantification of morphological endpoints will be continued .
- Induction of non-stochastic effects
  In determining the procedures and the dose limits appropriate in
  radiation protection it is important to know the types of non-
  stochastic effects which may be induced by radiation in man , the
  severity of these various effects , and the dose level at which
  they are liable to be induced .   It is particularly important to have
  information on those effects which might be induced by doses amount­
  ing to a few tenths of a sievert each year continued over many years
  or decades .
  This practical requirement applies especially for those tissues or
  organs in which the rate of fatal cancer induction per unit absorbed
  dose is likely to be low since for tissues like bone , skin and thyroid
  the annual dose limit is less likely to be determined by the possible
  induction of malignancies than by that of harmful non-stochastic
  changes .
  Information will be sought in man and in animals on the total accumu­
  lated dose delivered over a substantial proportion of a human or an
  animal 's lifetime which'would cause the same effects as are produced
  by a single dose .
  Guidance on these questions needs therefore to be obtained from a
  review both of effects caused in man and those induced in animals
  experimentally .   In man it is important to survey the dose above
  which various non-stochastic effects are observed , particularly in
  the course of radiotherapy at which the appropriate dose levels are
  reached , but including where possible , the effects of radiation at
  high LET and those of treatment with radionuclides where relevant .
  Study of the pathogenesis of these effects is likely to throw light
 ---pagebreak---                               w •
on the importance of mechanisms of repair .
                    In this connection it is also necessary to assess
the nature of any differences between the reactions of normal and
diseased tissues to radiation .    In many cases it is to be expected
that the accumulated doses which give rise to malignant changes in
a tissue will also have caused or initiated non-malignant changes .
Any interactions between the development of these two types of
effects or the influence of non-malignant changes on the frequency
of cancers are important . The examination of the early phase in
development of late non-stochastic effects could also prove important
for assessing the probability of such late effects .
In relation to the hazard involved in any radiation exposure during
pregnancy , teratogenic effects will be studied , particularly with
regard to the following : possible existence of a threshold , influ­
ence of LET , possible inacti vation , recovery or repair of embryonic
cells , relationship between damage to single cells of the embryo,
major failures in development of the foetus , dose / effects relation­
ship at various stages of embryologi cal development .
The frequencies with which different types of developmental defect
( most commonly of the nervous system ) are induced by radiation in man
and in any experimental model should be as close as possible .
A non-specific shortening of the life span by ionizing radiation still
remains uncertain , but its mechanism would call for study if its
existence were experimentally proven .
 ---pagebreak---                                      - 22 -
4.1.5 * Genetic effects of ionizing radiation
        The study of radiation effects on genetic material is important
        because radiations may increase the incics..ce of chromosomal syndromes
        and of hereditary diseases and because detailed analyses are required
        of the complex pathways through which the irradiated cell deals with
        pre-mutagenic and pre-carcinogenic lesions®     ThuB , the general objec­
        tives in this sector are to provide the information needed for :
        - assessing , through the use of the methods currently available
           ( direct estimation method and doubling dose method.), the genetic
          damage induced by radiation in man .    The knowledge required for
          this purpose includes estimates on the birth frequencies of genetic
          diseases , determination of the values of doubling doses and. an
           evaluation of yields of genetic defects per rad .
        - understanding the factors which govern , modify or prevent the
           establishment of damage .   The research carried out in the past now
          renders possible the genetical and biochemical characterization of
          some of the processes of DNA repair in human cells .     A stimulation
          of the research on the elucidation of mechanisms may not only allow
          a continuation of this work but , ultimately , it could provide new
          means for predicting interactions and effects , for establishing
          relationships between mutagenesis and carcinogenesis and for pre­
          venting or protecting against radiation damages .     It should also
          accelerate the development of methods for the detection of sensitive
          individuals and , among these , of individuals who are heterozygous
          for genetic diseases involving a repair deficiency and have an
          increased sensitivity to mutagens and carcinogens .
        For reaching these objectives , in the programme proposed below ,
        emphasis is placed , whenever possible , on the direct analysis of
        human systems .   However , the use of experimental species is maintained
        in all instances where there is no reliable alternative .
 ---pagebreak---                                   - 23 -
- Assessment and analysis of genetic damages in eukaryotes
   The gene mutations and chromosome aberrations which occur spontaneous­
   ly in man are a source of considerable hardship , being responsible for
  a substantial fraction of all spontaneous miscarriages and , in full-
   term survivors , congenital malformations , mental and physical disorders .
  The incidence of naturally occurring hereditary defec' - and diseases
   in human populations has been calculated by UNSCEAR so be approximately
   1.0 per cent for dominant and X-linked diseases , j„l per cent for
  recessive diseases , 0.4 per cent for chromoscaal diseases and 9.0 per
  cent for congenital malformations , multifactorial and irregularly
  inherited conditions . It is thus particularly important , in view of
  "the fact that irradiation is known to induoe mutations and chromosomal
  anomalies , to improve as much as possible the present methods of
  detection of genetic radiation effects and to establish , through an
  analysis of the mechanisms of induction , the list of various factors
  and circumstances which may contribute to an enhancement of incidence
  rates .
  Since human systems are usually not amenable to detailed genetic
 analyses , a substantial portion of the research effort will be carried
  out through the use of other eukaryotic material where the similarity
  of chromosomal organisation ( HJA , his tones .«.) and of cellular orga­
 nelles implies that many of the induction mechanisms for damage in
 the nucleus and in the cytoplasm are identical to those of man .        The
 programme involves s
 a) the improvement and development of assay system end experimental
      methods with increased resolving power for the detection of indu­
      ced alterations in both pomatic and gerra cells of man ,
 b ) elucidation of the mechanism lea-ing to chromosomal non–dis junction
      and other aberrations including str -Vies of the relationship between
      chromosome structure and behavi our 'aeterochrouatin , synaptlnemal
      complex and satellite association ;
 e ; study of poseible associat :- onn v> .  • radiosa ,-  -:±\y 9 rfip&ir
      and segregai; ional moiùali   ,
 ---pagebreak---                                _ 24 _
d ) specifio studies on the interactions and relationships between the
    "biological effects of radiation and other environmental agents p
e ) eluoidation through a few selected studies , of the effeots of
    irradiation on the mitochondrial genome and its implication for
    oellular survival *
Dos e-effeet relationship
It is particularly difficult to establish the relationship between
dose and effect in man beoause insufficient human data are available
and because the quantitative extrapolation cf experimental results to
man poses serious problems .    In view of the importance of dose-effect
relationships for the assessment of radiation risk , the programme
includes t
a) epidemiological surveys which focus attention on the relationship
    between the dose reoeived , the frequencies of aberrations in
    lymphocytes and the long term biological consequences of the expo­
    sure ( aplasia In germinal cells and induced effeots in live–bom
    and still-born children ),
b ) determination of the in vivo kinetics of lymphocytes with the view
    of facilitating the interpretation of doses from non uniform expo­
    sures ,
o) investigations with mammalian experimental species ( inoluding prima­
    tes when possible ) designed to collect more data ( genetic as well
    as cytogenetic ) which will be useful for quantitative extrapolation
    of radiation genet io hazards to man ,
d) studies aimed at the appraisal of the methods and assumptions invol­
    ved in risk assessment in extrapolating from somatic to germ oells
    and from experimental species to man ,
e ) studies on the induction of mutations in gorra oells and somatic
     oells at very low doses and dose-ralee end the development of
    techniques to facilitate such studies *
 ---pagebreak---                                           - 25    -
~ Biochemistry ar^d ;;.:;net;.cs of             ios y - i t ivity rr d repair
  As a oonsecrn-noe to thy slucid ^ Hon , no*? wall in progress , of UfA re­
  pair pathw; /» -In mioroorgani irns , research involving -the j&e of iraaan
  oella having mutations leading to repair deficiencies has ehr -n that
  th.® neahanxsraa lor rep&.. ving 1KA d&sne.g'e a.rs of grwt rel.''" .,109 to human
  healtJu Several speoix'io factors affooi, .. ^ir oapao-1 '1 „<b and a number
  of hereditary diseases that are aocotripaKi sc. c:f an i;-                                      sensitivi­
  ty to r&dintion and inoidsnt?© cf eanoer sre aaao&.at©:? with defects
  in UFA repair ,
  A largs part of the envisaged r3e«*«\rch                         t*? b© executed or. ffi&raaaXian,
  and pariicral&rly hvrasr., syst^a )vy.t th « u?s of &<m*4Mwa*lign material
  will "be necessary ftr the sr.iJ^e;.a « r. " c^pih ar.d tk * stwulliiig «f
  ooapl«x biochenloal --viid genetici surohre lar * .•
 £n© programme will include ?
  a ) surveying th© rad \i>t sne it iviiy of o                           of b^-ar                    ( fibro­
      blasts^ lyraphocyiee » «to c®® ) taken fr-n r- ora&l "                                       £jaup rb
       veil ss fro® rej..r©& srat&t it of tht -.- 1- .' . jr/x-i disea-.                    ?htiyfcjg enhan­
       ced saneiiivity t ? anTi'ron.meital                              Whsnev            r.Dasi'ble , a- detailed
       ar-'i ^ fsis of variation* in ra&ioaaif :;. ti                   b*tw •»"! ^&lvi3stfcl*i v,ill
      b« T£nd«r»ak«aa f
 Is ) idsr;'"j fi cation - and g-arveiica! . wi bir, cv                    ch^.i " .: .      .>   Ti<©n of
      variant isamnalian coll B'fcri*ir$ c\f ^ ir'rrr:.g H;:n9i '■ :, , -. ~s b.>& dafiiisro+-
       in rspiir of MA datiag® .
 o) inres £cat ion of the det-;. lied ensGyrRolog/ of IJfA repair ®athw»js
       ( this is beat e '. 'tiiffd at present in *-> f«                                 vk*s:." 3 fortsal
      hi o< heads try and gc»et$.x» a. re well e*-:T,> *> isfc «:?} &r i .. Vor-iss# c»£ tho
      Moch^tifa?. specificity -^u                                          ' -sw»c.«. of *•*& lesions
      in                 eywtwe *   1"'       vi-l'I 5r.-ui • ' •.- - a©         of ^ .- tsina i'r^th
      re-30^JI8® Sp3SÍ.fX.J Ãe^i^iS *;?■!                ■' . ■:■■" - Z"":bs8 7":.
                     r«»~<eir and th« rs,.^'£icr:Rhip f f                        t"
      r«^;.oa'bk*fc'ii,an and ch^oa:?;;-- "T'e a »> err-»i^
 ---pagebreak---                              - 26 -
d) studiea of mutagenesis and the role of constitutive and inducible
    repair pathways in mammalian oells 0 Use will also be made , in this
    part of the programme , of the several UNA repair deficient mutants
    recently isolated in Drosophila which provide an opportunity for
    studying the role of ENA repair pathways in the realization of ra­
    diation induced genetio damage in an eukaryotic model Bystem ,
e ) analysis of the relationships of UNA repair and related mechanisms
    to carcinogenesis e
 ---pagebreak---                                        - 27 -
4.1.6 . Evaluation of radiation risks
         Concepts used in radiation protection are Liable to be applied in
        different ways in the Member States . For this reason , it is necessary
        to attempt to establish common methods for assessing as accurately
        and objectively as possible the consequences of irradiation for man
        and his environment . The results of such exercise are also needed
        for decision making on siting and on choices for energy supply .
        The new principles of optimization and limitation in radiation protec­
        tion , which have been recommended in 1977 by ICRP , are based on a
        risk and detriment concept and require the assessment of realistic
        relationships between dosimetric quantities and genetic and carcino­
        genic risks . New dosimetric quantities and concepts have been
        developed ; among them are the effective dose equivalent and the dose
        equivalent index for the description of individual exposure , and
        the collective dose and the collective dose commitment for the assess­
        ment of the collective health detriment . The practical application
        of these new terms has to be tested and their relationship to measur­
        able quantities has to be determined .
        Three groups of problems must be considered .
        The first is the assessment of the individual and collective doses
        resulting from normal discharge and accidental releases of radio­
        active substances . This assessment of doses must rely on data obtain­
        ed by studying the movements of radionuclides in the environment
        as described under 4.1 . 2 ., and should lead to a better determination
        of the dose distribution among the population and the magnitude of
        the collective dose taking account with the natural background .
        Models are required also for any likely pathways of access to man
        and his environment , and involving the entire nuclear fuel cycle .
        As regards optimization in radiation protection which is currently
        advocated , account must be taken also of all the risks arising from
        human activities which make use of ionizing radiations or influence
        irradiation , such as those involving medical applications and
        technologically enhanced radioactivity . The programme will comprise
        successive phases of identifying the points to be studied , of assess­
        ing the doses received by workers and by the public , and of research
 ---pagebreak---                                - 28 -
into possible protection measures and their cost .
The second problem is methodological research on the assessment      of
the detriment . It must make use of data obtained through experiment­
al and epidemiological research described in the relevant sectors of
the programme . Two groups of problems should be considered . Firstly ,
those of the assessment of the detriment in the case of medium and
high level irradiation , applicable in the event of an accident .
Secondly , those related to low . doses , which are particularly relevant
for all occupationa ly exposed persons .
The third problem is the assessment of the economic and social
consequences of irradiation . This is a new subject which should be
developed in order to establish guidelines for " optimization" of
radiation protection activities based on the attainment of " as low
as reasonably achievable ( ALARA)" levels under conditions which apply
in Europe .
 ---pagebreak---                                    29 -
4.2 . Implementat ion
      The implementation of past programmes has shown that an " indirect
      action " combined with an efficient management with the help of the
      ACPM and based on careful evaluation are the appropriate means
      for carrying out this Community research programme . Some aspects
      of this system can be improved , but in any case it always has to
      keep the administrative charge for contractors and scientists as
      low as reasonably achievable . •
      4.2.1 .  Participating laboratories
               Continuing the policy which has operated from the very
               beginning of the programme , the Commission will endeavour
               to organize co-operation through cost-shared contracts
               with the appropriate national and university institutes
               working on the various focal points of the programme .
               Co-operative action and an organized distribution of tasks
               are necessary in view of the limited resources , the great
               number of different scientific aspects of radiation
               protection research , and the geographical scattering of
               those research groups which have the necessary specific
               competences .   In addition , the work of the Commission 's
               Biology Group at Ispra will continue to be an integral ,
               but small part of the programme , supplementing and
               supporting certain research carried out in the contract
               programmes .
      4.2.2 .  Management
               The Commission with the advice of the ACPM will be
               responsible for the management of the programme and its
               contracts and will ensure a close liaison with the
               corresponding research and development carried out in the
               Member States .   Obviously the ACPM has a direct influence
               on the management of the Community 's Radiation Protection
               Programme and , owing to the national status of its
               members , indirectly on that of the Member States .
 ---pagebreak---                            - 30 -
A. 2.3 . Coordination
         The best possible implementation and coordination is a
         main concern of the ACPM when it evaluates research
         proposals and contracts and advises on their relevance
         and integration into the programme and the selection of
         laboratories to which the work is to be entrusted .
         Particular attention will be given to    coordination
         throughout the programme .   Study group meetings / symposia
         and conferences have proved to be a most effective means
         of coordination because they are naturally adapted to
         scientific work and easily accepted by the scientist .
         These meetings / focussing on the evaluation of particular
         subject areas of the programme / will be attended by
         research workers involved in the contract programme / as
         well as scientists from non-participating laboratories or
         organizations and scientific staff members of the
         Commi ssion .
         Existing facilities for exchange of information and
         experience between the contractual partners should be
         supplemented by arrangements for working visits of limited
         duration by research workers engaged on the contract
         programme .   Past experience has shown the benefit to the
         Commission 's partners of improving the mobility of research
         workers by enabling them to work for periods ranging from
         a few months to two years in laboratories taking part in
         the programme .
         Working relatiore with the main international organizations
         active in the field of radiation protection will be
         maintained .
4.2.4 .  Evaluation
         Since the creation of the ACPM in 1968 / mechanisms for
         evaluating programmes have been developed but a higher degree
 ---pagebreak---                       - 31 -
of flexibility was necessary to apply them to radiation
protection research .   Universities and national institutions
are collaborating in the programme , in disciplines as different
as immunology and statistics .   Evaluation will be undertaken
by the ACPM and the Commission 's services on three levels :
The evaluation of research proposals before the beginning
of a proj ect :  Accepting or rejecting them , changing and
adapting the proposed projects in accordance with the agreed
programme guidelines .
Annual evaluation in the course of a project , for approval ,
modification , reorientation or possible new suggestions for
contractors :
    Results achieved are examined and evaluated annually when  1
    the Commission presents the Progress Report on " Radiation
    Protection" detailing the results of the previous year
    of all projects .  In this respect the scientific publica­
    tions , drawing attention to the results in the Community
    programme , of which reference is made in the Progress
    Reports , constitute a major element for evaluation .
-   Likewise annually the planned activities for the coming
    year are evaluated when discussing the " Work Programme of
    the Next Year".
    Finally , special subject areas are evaluated in study
    group meetings'and direct individual contacts .
The evaluation of results at the end of projects :    Final
reports and synthesis reports such as monographs are used to
this end .
 ---pagebreak--- A. 2 . 5 .  Dissemination of results
           The scientific research results of the programme are presented
           in articles published in scientific journals , in Euratom reports ,
           in monographs issued by the Commission , and in the proceedings
           of symposia and seminars .
Funds
The Commission will aim for maximum efficiency in the use of the funds
entrusted for the execution of this programme .       As it is essentially an
indirect action programme , the contracts must be allocated the major share
of the funds .
4.3.1 .    Staffing
           The Commission proposes a staffing of 64 officials for the period
           1980-1984 .    In this respect it has to be recalled that in 1973
           97 staff were authorized and in 1976 68 staff in addition to
           which 10 local agents for the Biology Group at Ispra were foreseen
           in the budget .
4.3.2 .    Financial allocation
           The Commission has evaluated the global needs for the programme at
           58,2 million EUA for the period 1981-1984 to which will be added
           about 10 million EUA for the year 1980 , which are already covered
           by the budget allocation of 39 million EUA for the period 1976-1980 .
           This is certainly a substantial increase in absolute figures as
           compared with the actual programme .    However , in view of the generally
           accepted great social relevance of radiation protection , its
           importance for energy production , and the resulting high requirements
           in radiobiological research , this amount is estimated necessary to
           establish a well balanced programme covering all priority aspects .
           Its content is based on a reorientation and evolution of the present
           programme , an evolution which accentuates new aspects as the
           evaluation of radiation risks and the treatment of acute irradiation ,
           particularly when local .
            Expansion will be limited and will affect only the contractual
            activities , which will be allocated more than 81 % of the total
            funds ( less than 7 % for management and administration of the
            programme ) .
            The following particular elements have been used as a base for
            the budget estimate of 58,2 million EUA :
 ---pagebreak---                                - 33 -
    - the expenditure of the year 1980, originally planned as
        t'-.' last year of the current programme ( 1976-1980 )
       ( 10 mi l l ion EUA ) ;
   - the need to take account , in some measure , of the increase
      of costs (+ 6% per year );
  - the restoration of the Commission 's participation in
      contract expenditure from an actual mean of 33% to its
      previous              level of 40% . This guarantees a signifi­
     cant Commission presence in the combined effort being
     made in Europe in radiation protection research and in
     particular allows the mobility of research workers in
     European laboratories ;
 - a limited expansion (+ 15% of the cor' > actual activities ).
 The amount of 10 million EUA for the year 1980 is complete­
 ly covered by the budget allocation of 39 million EUA for
 the period 1976-1980 . It corresponds to
 - staff expenditure , recurring administrative expenditure
    and expenditure relating to the use by the Biology Group
    of the scientific and technical services of the Ispra
    Joint Research Establishment , as requested for the 1980
    budget ,
- the Community 's financial contribution to contracts
    relating to the year 1980 or as appropriations outstanding
    from earlier years authorized within the ceiling of
   39 million EUA of the 1976-1980 programme ;
The amount of 10 million EUA for the year 1980 is the result ,
not of any real expansion , but of the following factors :
- inflation rated during the period 1976-1980
- the influence of " gross salaries " as opposed to
   "net salaries " which were previously taken into account .
 ---pagebreak---                             - 34 -
The summarized calculation is as follows :
Budget 1980                                           10,0 mi l lion      EUA
Budget 1981-84 based on budget 1980
+ 6 % increase per year                               46.4 mi l lion EUA
Restoration of 40 X mean participation
in contracts                                      +    6,9 mi l lion      EUA
Expansion of certain activities based on
an increase of 15 % of the contracts              +    4,9   mi l lion EUA
TOTAL 1981-1984                                       58,2 mi l lion      EUA
TOTAL 1980-1984                                       68,2 mi l lion      EUA
Financial breakdown
As a guideline , expenditure by categories is broken down in the
following manner :
                                                 million EUA
                                        1980      1981-84         Total        V.
Contractual activities :               7,770        47,800        55,570      81
  expenditure for contracts ,
  cash                               ( 5,8S0 )      ( 38,9 )
  expenditure for Commission
  personnel working under
  the contracts                      ( 1,920 )      ( 8,9 )
                                                              I
Biology Group at Ispra :               1,410          6,500         7 / 910   12
   expenditure for research          ( 0,110 )      ( 0,5 )
   infrastructure and
   technical support                 ( 0,330 )      < 1,5 )
  personne l                         ( 0,970 )      < 4,5 )
Management and administration :        0,830          3,900        4,730       7
   expenditure for experts'
   fees , meetings , etc .         i ( 0,140 )      ( 0,7 )
   headquarters personnel            ( 0,690 ) I    < 3,2 )
TOTAL                              M 0,010          58,200        68,210
 ---pagebreak---                                                                      APPENDIX I
                                       - 35 -
                             RESEARCH WORK 1976-1978
                  – A survey of some scientific achievements -
 The research results obtained from the European Communities' Radiation
 Protection Programme help to extend the scientific basis on which a reliable
 evaluation of the biological and ecological consequences of using ionizing
 radiation and of activities in the field of nuclear technology can be made
 and the best possible protection can be provided for man and his environment .
 These research projects contribute to obtaining a more accurate assessment
of the radiation risk and to reduction of uncertainties artd contradictions .
The programme currently comprises 130 contracts with about 240 research
projects ; more than 500 research workers are participating on either a
full-time or a part-time basis .
In the first three years of the current programme , about 1.800 individual
articles have been published ; numerous monographs , proceedings and technical
reports on radiation protection subjects provide evidence of intense scientific
act ivity .
Every year , about 40 symposia , seminars and meetings of study groups , experts
and committees with about 1000 participants ensure coordination and stimulation
and have a catalytic effect on national , bilateral       and multilateral programmes .
In executing the programme , the Commission bore in mind the facts that :
        -   sociopolitical objectives are increasingly becoming criteria
            for radiation protection    research policy ;
        -   the individual research activities should be more closely
            harmonized in a broader context .
With the means at its disposal , therefore , the Commission has :
        -   developed long-term research programmes ;
            intensified research in areas of great significance to
            the public ( e.g. evaluation of the radiation risk );
        -   promoted the practical application of scientific results
            ( e.g. development of personal dosimeters , diagnosis and
            treatment of acute radiation injury , execution of inter-
            comparison programmes );
 ---pagebreak---                                      - 36 -
        -  prepared longer-term forecasts ( e.g. tritium study );
        -  given its backing to the rapid translation of scientific
            knowledge into decision-making processes ( e.g. establishment
           of basic safety standards - formulation of criteria for
            siting-deci sions ) .
In approach to its work , the Commission employed the following criteria which
have had a beneficial influence on research in the Community :
            intensification of interdisciplinary fields of research
            and co-operation in the projects being promoted ( e.g. group
            contracts , EULEP, CENDOS , Primary effects group );
            improvement of information exchange and co-operation between
            scientists engaged in similar fields of work ( e.g. study
            groups , conferences , exchanges of scientists );
         -   adaptation of research projects to scientific progress
             (a permanent task in co-operation with the ACPM ).
Only a few individual projects of the wide range of scientific results
obtained over the last years can be briefly described for the sake of
example . For this reason , a number of details from the areas of dosimetry ,
environmental contamination , somatic and genetic radiation effects and
 risk analysis have been selected and presented .
 ---pagebreak---                                      - 37 -
Radiation dosimetry and its interpretation
The main objective of dosimetry is to obtain reliable measurements and
calculations of absorbed dose and dose distributions .     They are necessary
to improve understanding of the biological effects in order to make a
proper assessment of the radiation hazard and they are essential to assure
protection of exposed workers .
-  Co-operative research in radiation protection depends largely on the
   degree of standardization of experimental methods and materials .
   A number of dosimetric intercompari sons have therefore been carried out ,
   for instance on personal dosimeters , on X-ray dosimeters and with
   neutrons .   All these intercompari sons revealed quite a number of
   imperfections in experimental arrangements , differences in the basic
   values used to determine the absorbed dose , and discrepancies in
   dosimetry procedures .   The intercompari sons induced a considerable
   improvement in research procedures , and increased the accuracy and
   reproducibility of the measurements .    For example , in the last X-ray
   intercompari son series it was found that previously-observed large
   standard deviations of results from several     laboratories could be
   eliminated , especially after visits had been made to the laboratories .
   The measurement and calculation of underlying parameters in dosimetry
   have made important progress .    A low-energy electron transport simulation
   ( 10 eV - 30 KeV ) in water was satisfactorily terminated ;   cross-sections ,
   stopping powers and W-values for different materials and different
   particles were measured and the cross-section library in transport codes
   improved .   Some problems of measurement of the components of a mixed
   neutron and gamma radiation field were solved ;     the track structure of
   electrons and charged particles and the production of secondaries and
   their radial distribution were investigated .     Microdosimetric quantities
   were established and extended to tissue regions of 10 to 100 nm diameter ;
   they have been used in defining a measure of radiation quality and in
   microdosimetric models developed for the interpretation of mutation and
   survival data from mammalian cells .
   The investigation of fundamental mechanisms in radiation physics has
   indicated interesting possibilities in the use of lyoluminescence in
   radiation accident dosimetry , since some human tissues have lyoluminescent
   properties .
 ---pagebreak---                                     - 38 -
  Fundamental aspects of the mathematical analysis of tumour induction by
  ionizing radiations have been investigated .     Statistical methods for the
 assessment of tumour rates and of tumour prevalences as a function of
 time after irradiation were tested .      It was possible to prove a
 statistically significant increase in the development of mammary tumours
 in Sprague-Dawley rats at fast neutron doses as low as 0,1 rad .       The
 relative biological effectiveness ( RBE ) of these neutrons seems to reach
values of 100 or more at low doses .       At higher doses the RBE decreases
to values already known from other experiments .
 Radionuclides with low energy beta-particle or Auger electron emission
 incorporated in various organs , cells or subcellular structure were
  shown to cause biological effects which largely depend on the spatial
 overlapping of the site of decay and of the radiosensitive structure .
 The critical microvolume for late effects appeared to be the nucleus of
  stem cells .   Based on measurements of the rate of stem     cell turnover ,
 the update of the radionuclide into the stem cell nucleus , and dose
  calculations for particular microdistributions , different modifying
  factors were defined and calculated in order to estimate the biological
  effect per unit intake .    It was thus possible to compare the radiation
  effects of certain tritiated or 1-125 labelled organic compounds with
  those from inorganic tritium or 1-125 with a view to defining limits
  of intake .
  Although completely satisfying personal dosimeters for neutrons do not
»
  yet exist , progress has been made in developing the albedo dosimeter
  and nuclear track detectors .    With new etching techniques it is now
  possible to make visible tracks of low energy recoil nuclei and
  alpha-particles .
  A small beta-dosimeter for measurement of dose at the surface of
  beta-sources has been developed , allowing precise dose evaluation for-
   fingers , hands and forearms .
 ---pagebreak---                                       - 39 -
 Behaviour and control of radionuclides in the environment
The main objective of the present programme is to acquire the necessary data
to be introduced into the various models describing the transfer of radio­
nuclides in the environment , used to estimate radiation detriment .     Another
aim is to find methods of estimating the possible damage caused to the envi­
ronment and its components , together with methods of controlling it .
- Numerous results have been collected on the radiochemical , chemical , biolo­
  gical and oceanographical aspects of various radionuclides and on the trans­
  fer of associated pollutants in different marine ecosystems .      Special atten­
  tion has been given to the long-term behaviour of the transuranic elements ,
  the possible synergistic effects of radionuclides and conventional pollu­
  tants ( heat , chlorine compounds , etc .) and the behaviour of stable and radio­
  active isotopes .   Mathematical models evaluating the cycling of chemicals
  in the marine environment have been considerably amended .     These studies
  have improved the predictive capability needed for control of the areas sur­
  rounding reprocessing plants and in case of accidental releases .
- Research on radiocontamination of terrestrial and freshwater ecosystems was
  centred mainly on actinides but also on some important radioi sotopes with .
  long half-lives such as H-3 , Tc-99 , 1-129, Pu-239 and Pu-240 .    A sensitive
  method for Pu determination in large soil samples is now available .      Never­
  theless many of the data at present available need to be improved in quality ;
  for instance , the observed modification of Pu transfer factors as a result
  of ageing must be quantified and explained .     Initial observations on the
  properties of technetium have stressed both its mobility and its toxicity
  for living organisms .
~ Research conducted on tritium has revealed that there might be an       enhanced
  risk where the tritium is incorporated into living organisms before it be­
  comes diluted into the environment .
- Work on 1-129 is in progress and the extraction method developed is now
  applied to thyroid samples collected in selected areas of the Community .
- Studies on possibilities of decontaminating agricultural areas after an
  accident have been performed and several methods of decontamination were
  investigated . Application of chelating polyamine to soils already offers
  prospects of greatly reducing the soil plant transfer of some activation
  products .
 ---pagebreak---                                       - 40-
Short-term somatic effects of ionizing radiation
The main objectives of the 1976-1980 programme in this sector are diagnosis
and treatment of acute radiation injury .
- After total-body irradiation at relatively high dose , the stem cells of
  the hemopoietic system are the first to show severe damage .        In man ,
  these cells are present in the bone marrow .       In principle , the trans­
  plantation of a certain amount of marrow from a healthy donor should cure
  the heavily irradiated individual .      In practice however , experiments have
  shown that this procedure presents many difficulties which are progres­
  sively being overcome by a continuous research effort .        For example , the
  donor and the acceptor need to be genetically as close as possible ,
  otherwise the transplanted marrow reacts against the recipient and might
   even cause death .   This is the so-called graft - versus- host reaction .
   The minimum number of bone marrow cells which is required for a complete
   recovery of the patient has now been established .      Through extensive
   experimentation with human and monkey bone marrow cells , preservation
   of the regenerative capacity of these cells after storage can now be
   guaranteed .   The minimum whole-body dose of radiation which will permit
   a " take " in given conditions has also been established .     Several methods
   have been developed to prevent or treat the graft - versus- host reaction .
   Recently, progress has been made in the collection and use of hemopoietic
   stem jcells from th6 peripheral blood .
   Considerable progress has also been achieved regarding the elucidation of
   damage induced in     deoxyribonucleic acid CDNA )    by ionizing radiation .
   Physical , chemical and biological techniques have been successfully applied
   to probe the major radiation-induced lesions in nucleic acids and their
   constituents .   A broad knowledge has been gained about the sites and
   structural properties of free radicals as reactive species mediating the
   pathway to stable chemical alterations .     The latter have been analysed in
   detail , thus providing a clue to alterations which are of importance in
   biological malfunctions .   Biologically viable damage , such as base alte­
   rations and strand-breaks , has been well characterized in suitable model-
    systems .
 ---pagebreak---                                      - 41-
Late somatic effects of ionizing radiation
In the current programme    special attention is given to late somatic
effects after acute or chronic irradiation or incorporation of radio-
isotopeS ;  Studies are concentrated on irradiation levels in medical
diagnostics and on those radioisotopes which are potentially among the most
harmful , such as plutonium and the other actinides .      Epidemiological studies
of irradiated human groups with a view to formulating risk estimates in
radiobiological protection are of great practical importance .
- EULEP has continued its effort on a successful coordination of research
  in the area of late somatic effects , with Emphasis on standardization of
  experimental conditions in the laboratories involved in late effects
  research , on coordination of the planning of the corresponding coope­
  rative research projects , on the execution of specific projects in the
  area of carcinogenic and non-carcinogenic late effects and on the radio-
  toxicity of incorporated radionuclides .     Intercomparisons were performed
  in dosimetry , and first steps were taken towards standardization of labo­
  ratory animals .  Semi-annual workshops on the pathology of radiation-
  induced lesions succeeded in standardizing terminology , especially on
  tumour classification .   Results are published in the EULEP pathology
  atlas , an important source of reference .
- Also in the context of EULEP , a multidi sciplinary research group has con­
  tinued its coordinated investigation into the importance of vascular eff­
  ects in the development of late radiation damage .       Quantitative biological
  measurements in the cerebral Cortex indicated that the gross vascular
  abnormalities are preceded by a significant increase in vascularity .
  These changes were not associated with any marked ultrast ructural changes
  and therefore are considered as a primary effect of radiation .       The slight
   increase in the total   deoxyr ibonuclei c acid ( DNA }   content of the brain
  over the same time period might indicate the increase in vascularity to be
  an active process .
 ---pagebreak---                                      - 42-
A chelating agent was shown to be effective in removing plutonium from the
Lung .    Toxicity studies have shown that it is more toxic than other known
agents like DTPA but a single injection may be sufficient treatment .           The
importance of this research is that it could lead to removal of intracel­
lular plutonium .    The clearance of plutonium nitrate from intramuscular
retention sites has been measured .
Am-241 is present in irradiated nuclear fuel .          Realistic levels of permis­
sible exposure to airborne Am-241 can only be set if adequate data on its
retention and distribution within the body are available .           The behaviour
of Am-241 in nine men with long-standing burdens after accidental inhala­
tion was investigated .    This work was later extended to include studies
                                    241 .  _      . 238
of the comparative retention of          AmO ^ and      PuO ^ in the lungs of a
subject more recently exposed .     This study is of particular importance ,
not only because of interest in the lung clearance of PuC^, but also
because the detection of the 60-keV gamma rays from associated Am-241 is
frequently used for determining pulmonary deposits of plutonium .
 Data on the various steps involved in the production of radiographs are
 important for the optimization of image quality ( i.e. diagnostic value ).
 Such data were obtained by spect romet ri c and dosimetric investigations
 of X-ray spectra and by determination of the spectral sensitivity of
 the various image-recording systems .       The influence of different posi­
 tioning , geometrical and exposure factors on the organ doses was esti­
 mated . in order to reduce the risk to the patient .
t
  A significant protection against late effect has been demonstrated in mice
  treated with a mixture of chemical protectors and then exposed to X-rays .
  The protection was effective mainly against thymic lymphoma , myeloid
  leukemia , sarcoma , glomerulosclerosis and non-cancerous lung lesions .
  Studies with a short-lived alpha-emitting osteotropic Ra-224 have shown
  that dose protraction by fractionated application results in a higher
  incidence of osteosarcoma ( increasing with protraction time and total
  dose ).
 ---pagebreak---                                    - 43-
 The highest osteosarcoma incidence of more than 90 percent was observed
 after a mean skeletal dose totalling 1080 rad over a period of 36 weeks .
 Other recent results have indicated that the bone tumour incidence after
 incorporation of a short-lived beta emitter ( Lu-177 ) can also be enhanced
 if the dose is given in fractions over an extended period rather than in
 a single amount .
 The process of cancer induction by ionizing radiation is likely to be
 influenced by viruses . Comparative studies of various populations of
 viruses in radiation-induced leukemia were performed and two lines of
 splenotropic viruses have been isolated and characterized on a physico­
 chemical basis and identified as endogenous murine viruses .    After in­
 corporation of Ra-224 in mice , a transient expression of C-type RNA
viruses immediately after the start of irradiation and a second type
of virus expression during the time of tumour development ( 11 to 12
 months after irradiation ) have been observed in the skeleton .
 Synergistic effects between radiation and other environmental factors
 will have to be taken into account in risk evaluation because they may
 influence the biological radiation effects .  Research was therefore
 recently begun on synergistic effects .
One effect can be reported as example : the development of radiation-
 induced osteosarcoma seems to be accelerated by application during the la­
 tency period of cyclophosphamide , a widely used antimitotic agent .
"Epidemiological studies on patients treated with Thorotrast or Ra-224
 are in progress .  Preliminary results were achieved regarding risk
 coefficients for Ra-224 .  Further statistical analysis will still be
 necessary when all relevant data have been collected .
 ---pagebreak---                               - t>L -
Genetic effects of lonizlr ? radiation
The objectives , in this sector , aim    essentially at the analysis in
depth of the mechanisms governing the evolution of induced genetic
lesions in irradiated cells and at establishing methods for
assessing the nature and frequencies of cytogenetic damage in exposed
individuals .
– Research on sensitivity and repair in experimental species , and
   particularly bacteria , yeast , and Tetrahymena greatly contributed
   to our understanding of the very complex ways through which the
   irradiated cell copes with its lesions .   Many of the enzymatic and
   regulatory processes involved in repair , and among others " S.O.S. "
   induction ( an emergency syndrome which activates a complex metabolic
   pathway as a response to unrepaired DNA lesions and is probably
   involved both in mutagenesis and in malignant transformation of
   mammalian cells ), have been identified and the major pathways for
   mutagenesis reconstituted .
- On the basis of results and clues obtained from research on micro­
 • organisms , various biochemical techniques , gene localization methods ,
   screening tests and procedures for prenatal diagnosis have been
    successfully developed for the purpose of detecting and specifying
   WA repair defects in humans and thereby establishing a modern
   molecular approach to the protection of man against radiation .
   Among many significant achievements , the work carried out
    allowed the isolation and characterization of the first human
   mutant cells affected in post-replication repair and contributed
    to the revelation of the existence of the first human cell line abnormally
    sensitive to ionizing radiation .  Various relationships of radiation
    sensitivity to sister chromatid exchange , mutagenesis and predispo­
    sition to cancer were established for oertain repair deficient lines ;
    for the disease Xeroderma pigmentosum seven genetically different
    forms were detected by means of complementation analyses .  Prom
    research carried out on monkeys , the conclusion was reached that
    a dose of 85O rad severely affects the primate ovary and evidence
    was obtained which suggests the existence of inducible repair
    systems similar to the S.O.S. repair mechanism found in baoteria*
 ---pagebreak---                              - 45 -
- In the area of radio cytogenetics , advances have been made with re­
  gard to our understanding of the mechanisms by which ionizing radia­
  tion produces chromosome aberrations and of the dependence of dose-
  effect relations on radiation quality ana different sets of experimen­
  tal conditions 9 Evidence has been obtained , through an analysis
  of mutation inoidence at 13 X-chrornosome loci in Drosophila , which
  suggests proportionality between spontaneous and induced mutation
  rates ,, The dose-response relationship after X-irradiation has been
  established for anomalies in the distribution of sex-chromosome in
  mammalian germ-cells «  Successful approaches towards the analysis
  of radiation effects on human meiosis were carried out in two diffe­
  rent directions , through the development of culture techniques and
  by three-dimensional reconstructions of human nuclei from electron
  micrographs •
 ---pagebreak---                                       - 46 -
Evaluation of radiation risks
The perception and evaluation of the " radiation risk " have evolved to such
an extent that it has become necessary to analyse thoroughly all its aspects .
Work has been initiated in this direction during the present programme , with
the intention of determining the optimal conditions for the implementation
of nuclear energy . Therefore , research was started on the economic and social
consequences of irradiation , on the assessment of the radiological detriment ,
i.e. the global deleterious effects for a population which could arise from
radiological exposure , and on the assessment of the individual and collective
doses in respect of normal discharges of nuclear power installations and in
the event of an accident .
- Values are now available concerning certain parameters to be used for
    the assessment of the collective dose . In particular , a long-distance
    atmos-pheric dispersion model ( MESOS model ) has been developed which enables
    the atmospheric contamination to be evaluated on the basis of gaseous ef­
    fluents at intermediate distances . In addition , mapping of the geographical
    distribution of the populations in the nine Community countries has been
    completed and is based on a programme which provides data relating to the
  ■ population distribution for a unit grid mesh of 10 km x 10 km . It should
    6e noted that this work , which was carried out with the aim of obtaining
    an accurate idea of the collective dose received by the European popula­
    tion , can also be used for many other purposes . Moreover , a model of the
    dispersal of contaminated products associated with the distribution and
    marketing networks has been compiled for marine products in France . It
    can be applied to the other Community countries .
 - As regards the attempts to assess the radiological detriment , a great
    many studies , both bibliographical and experimental are at very advanced
     stage ; however a new line of thought emerges from the epidemiological
     studies concerning individuals that have been irradiated either as part
     of medical treatment or as a consequence of their occupational activity .
     In the latter case , a feasibility study has been initiated on the pre­
     paration of a European irradiation register for workers directly assigned
     to tasks in which they are exposed to irradiation .
 - As regards the application of methods for evaluating the economic and
     social consequences of irradiation , research has been directed towards the
 ---pagebreak---                                        - 47 -
   determination of Levels that are 'as low as reasonably achievable "
   ( ALARA ). Various methods , by which radiation protection can be optimized ,
   have been indexed in such a way as to highlight their respective advantages
   and disadvantages . First of all , the multicriteria method was applied for
   a selected objective ( fuel cycle for a programme of 100 1-GWe PWR reactors );
   this method , which requires a certain amount of weighting in relation to
   the various criteria on the basis of which it is intended to assess the
   options , brings out the variability of the choice of options ( in other
  words the " ALARA " levels ) in the light of the priorities put forward by
  the decision-makers .
                                           *
                                              *
This selection of results from current projects in the Radiation Protection
Programme clearly shows that definite results have been achieved in several
are'as , which to a large extent are already of significance as regards
practical application .    Simultaneously , it can be seen that there are many
interim results which require further intensive work ;      it is precisely these
which will be of considerable value in the coming months and years .      Part of
the research programme is on a long-term basis , and results can only be
expected in a more distant future .      It is anticipated that this work will ,
in particular , provide basic data on the radiation effects of low and very
low doses , which is an extremely important radiation protection problem .
Finally , it should be mentioned , that the results of research in the field
of radiation protection often have effects extending into other , related
fields .    The example of bone-marrow transplantation is typical of the close
relations between radiation protection and medical therapy .      This complex
method , being deve loped for treatment of severe radiation accidents is
presently attempted for clinical treatment of leukemia .
 ---pagebreak---                                     - 48 -                  APPENDIX II
PROPOSAL FOR A COUNCIL DECISION ADOPTING A FIVE-YEAR RESEARCH AND TRAINING
PROGRAMME ( 1980-1984 ) OF THE EUROPEAN ATOMIC ENERGY COMMUNITY IN THE FIELD
      OF BIOLOGY - HEALTH PROTECTION ( RADIATION PROTECTION PROGRAMME )
The Council of the European Communities ,
Having regard to the Treaty establishing the European Atomic Energy
Community, and in particular Article 7 thereof ,
Having regard to the proposal from the Commission , submitted after consulting
the Scientific and Technical Committee
Having regard to the opinion of the European Parliament ,
Having - regard to the opinion of the Economic and Social Committee ,
Whereas it is in the interest of the Community to supplement , broaden and
deepen the information necessary for an objective evaluation of the effects
of and the hazards arising from ionizing radiation     in order to guarantee an
adequate protection of man and the environment ,
Whereas a scientific collaboration , exchange of information and mobility or
 interchange of scientists at Community level is a necessity in radiation
protection .
Whereas the progress of knowledge , the new concepts in radiation protection
and the need for managerial improvement call for the replacement
of the present 1976-1980 programme by a new 1980-1984 programme , with 1980
as an overlapping year ; whereas Council Decision 76/309/Euratom^ should
therefore be repealed ;
 Whereas the research dealt with by this Decision is an appropriate way of
 pursuing such action , and it is therefore in the common interest to adopt
 a multiannual programme in the field of radiation protection ,
    OJ No L74 , 20 . 3.76 , p. 32
 ---pagebreak---                                     - 49 -
 HAS DECIDED AS FOLLOWS :
                                                                  •>
                                 Article 1
 A research and training programme in the field of radiation protection as
 defined in the Annex is hereby adopted for a five-year period beginning
 1 January 1980 .
                                   Article 2
The total amount required for the duration of the programme is estimated
at 68.2 million EUA , as defined in Article 10 of the Financial Regulation
of 21 December 1977, and the staff allocation at 64 persons .    These figure
are merely intended as a guide .
                                   Article 3
 Decision 76/309/Euratom is repealed with effect from 1 January 1980 .
    »
 Done at Brussels .                              For the Council
                                                 The President
 ---pagebreak---                                    - 50 -
                                                             ANNEX
                       RADIATION PROTECTION PROGRAMME
                             ( indirect action )                            ■
  The aim of the programme is , through a co-operative European effort , to
   increase knowledge in radiation protection while taking into account
  particular problems and skills available in Europe . It is designed to
  gain adequate understanding and control of the radiation risks encountered ,
  with two main objectives :
  - improvement of scientific and technical knowledge with a view of
     updating basic standards for the health protection of general public
     and workers against the hazards arising from ionizing radiation ;
  - evaluation of the biological and ecological consequences of nuclear
     activities and of the use of nuclear energy and ionizing radiation ,
     in order to ensure an adequate protection of man and of the environ­
     ment whenever unacceptable harm could otherwise be caused to them .
1 The programme will consist of six major areas . They are :
  #
  - radiation dosimetry and its interpretation ,
  - behaviour and control of radionuclides in the environment ,
  - short-term somatic effects of ionizing radiation ,
  - late somatic effects of ionizing radiation,
  - genetic effects of ionizing radiation ,
  - evaluation of radiation hazards .
  The activities shall be carried out mainly under research contracts
  and partly by the Commission 's Biology Group at the Ispra Establishment
  of the Joint Research Center .
 ---pagebreak---                                                          APPENDIX III
           Opinion of the Advisory Committee on Programme Management
          " Radiation Protection " on a proposal of the Commission for
              a Research and Training Programme ( 1980-1984 ) for the
           European Atomic Energy Community in the field of Biology-
                Health Protection ( Radiation Protection Programme )
During its meetings of 17 October 1978 and 13/ 14 November 1978, the
Advisory Committee on Programme Management " Radiation Protection" has
examined in detail the proposal of the Commission .for a Research and
Training Programme ( 1980-1984 ) for the European Atomic Energy Community
in the field of Biology-Health Protection ( Radiation Protection Programme )
and in particular the steps taken to assure coordination between national
and Community activities in this field .
The ACPM stated unanimously that it is in the interests of the Community
to supplement , broaden and deepen the information necessary for an object­
ive evaluation of the effects of and the hazards arising from ionizing
radiations in order to guarantee an adequate protection of man and the
environ ment .
   »
The ACPM agreed unanimously that the scientific content of the proposal
is based on a sound assessment of the current and foreseeable research
requirements of the Community in radiation protection .
The ACPM proposed unanimously to agree on a renewed multi annual programme
as an appropriate way of pursuing research in radiation protection .
                                                     J.W. HARMAN
                                               Président of the ACPM
 ---pagebreak---                                  52 -                     APPENDIX IV
                         Opinion of the
     Scientific and Technical Committee of 19 January 1979
                             on the
          Proposal for a " BIOLOGY-HEALTH PROTECTION .
         Radiation Protection " Programme for 1980-8 ^
The Scientific and Technical Committee , at the meeting of
 19 January 1979 ♦ examinated the draft proposal for a "Research
 and Training Programme ( 1980-198*0 for the European Atomic Energy
 Community in the field of Biology-Health Protection ( Radiation
 Protection Programme )", to be submitted to the Council by the
 Commission .
 The S.T.C. endorses the view already expressed by the A.C.P.M.
 namely that " it is in the interest of the Community to supplement ,
'broaden and deepen the information necessary for an objective
 evaluation of the effects of and the hazards arising from ionizing
 radiations in order to guarantee an adequate protection of man and
 the environment ".
 The S.T.C. also noted that the scientific and technical information
 arising from this programme will assist significantly in updating
 basic radiation protection standards .
 The S.T.C. very strongly supports the proposal of the Commission
 to implement an overlapping programme for both scientific and
 organizational reasons and expresses a favorable opinion on the
 proposed programme .
 ---pagebreak---                                  FINANCIAL RECORD
                           BIOLOGY AND HEALTH PROTECTION
                          RADIATION PROTECTION PROGRAMME
 1.     RELEVANT BUDGET HEADING
       – Item *   3352
       – Title :   Biology and health protection ( radiation proteotion )
 1 .1    TITLE OP THE PROJECT
                          Biology and health proteotion
                          Radiation protection
2.     LEGAL BASIS
       –   Application of Article 1 of the Treaty establishing the EAEC and
           Annex 1 thereof ;
       –   Council Decision of
3.     DESCRIPTION OP THE PROJECT
3.1      Description
Continuation of a coordinated research programme on radiation protection ,
implemented in particular through shared–cost contracts .
3»2      Objective
Study and assessment of the dangers arising from ionizing radiation , under
two main tasks :
–     improvement of scientific and technical knowledge , in order to update
      the Basic Safety Standards for the protection of the health of workers
      and the general public against the dangers arising from ionizing
      radiation ;
–     assessment of the biological and ecological consequences of nuclear
      activities and of the use of nuclear energy and ionising radiation ,
      in order to provide sufficient protection of man and the environment
      in the event of exposure to unacceptable hazards®
4.     JUSTIFICATION OF TKE PROJECT
This project comes under three policies whose importance is at present
undisput eds
–     social affairs
–     the environment
–     energy •
5.     FINANCIAL IMPLICATIONS OP THE PROJECT IN RESPECT OF EXPENDITURE
( including staff expenditure and administrative and technical operating
expenditure )
 ---pagebreak---               ; 5*1 Overall coat for -the vhoio oV its expacsted duration I                             143 210 000 EUA
                5*2 Chargeable to the Community Budget s                                                 68 210 000 EUA
                       Caargeable to national budgets i                                          V
                                                                                                 )       75 000 000 EUA
                       Cnargeable to other sectors at national levels                            )
                5.3    MJIil' I Aj îNUAL TIMS.TA.BLJ3
                              APPiyiPRIATIO::S FOR CQyXIT^W                              ( 0JA )
i                                                                                                                         I
                        1980                     1980
I
i                    Old proq .           ( New p rog •
                                                                  1981            1982              1983
                                                                                                                1984      j     1985
  Staïf                  3.583.000                             3.797.000      Α . 025 . 000      4.267.000    4.526.000
  Ad min * and
  tech » operati an 579.000                                      615.CÛ0          650.000           689.000      731.000
  Cont raote           ( 5.848.000 \         15.000.000       16.0Û0.0Û0      5.000.000          2.900.000
                                      1                  2
   Total                 4.162.000
                     (*5 . 84g . QOC'ï
                                          1.1 5 . 000 . 0C0   20.412.C00      9.675.000
                                                                                     V
                                                                                                 7.856.000  I 5. 257 .000J
                     VIO.OIO.OOCLΛ                                          * 58.200.000
                5.3.1.2 APPROPItT AT ION'S FOR PAYT-EOT                           ( EUA)
                         1980           I     1980
                                                                1981            1982 ..            1983        1984           1985
                     Old proq.             Ko» proç .
   Staff               3.583.000                              3.797.000      4.025.000         4.267.000     4.526.000
   Ariadii » and
   tech.                  579.000                               615.000         650.000            689.000     731.000
   operation
                                                              6.900.000
   Contracts           4.100.000                                             9.150.000         9.750.000    10.400.000      2.700.000
                                                            ( 1.756.000 )
                                                                          j
                                                                          T
  Tot * I              8.262.000
                                          V                 11.312.000 j 13.825.000          114.706.000    15.657.000      2.700.000
                                                                                  y
                                                                         = 58.200.000
                  The amount of 5 848 000 clfA is tne Cotouiunity's financial contribution to
                  the contracts in 19B0 , covered by previous oontmi ttsontB which are etill
                  outstanding and appropriations for commitment remaining from the old
                  programme .
                2
                  The appropriations for coraraitment amounting to 15 000 000 EUA will enable
                  contracts with an earliest starting date of 1 January 1981 to be prepared ,
                  committed and signed in 19&).
                3
                  This figure represunt6 appropriations for payment from the old programme .
 ---pagebreak---                                              - 3 -
     11 312 000 HJA in appropriations for payment f rom the new programme
   + 1 756 000 EGA in appropriations for payment from the old programme
     13 068 000 EUA
   *
     4 045 000 EUA of which to be covered by appropriations for the old
     programme which have not yet been included in the budget and 117 000 EUA
     of which to be covered by remaining appropriations for commitment#
   5»3»2     Mot hod of calculation
   In estimating expenditure for the years 198l-84 » a rate of increase of 6%
   has been assumed .
   (a)     Staff expenditure
          Staffing needs have been calculated on the baBis of a staff of 64
          for the programme : 41 Category A staff ;
                                   12 Category B staff ;
                                   10 Category C staff ;
                                    1 Category D staff .
          The total staff of 64 and the breakdown into grades corresponds to
          the staffing situation in the 1979 Budget .
   ( b ) Administrative and /or technical operating expenditure
          This heading covers expenditure connected with missions and the
          organization of meetings , the technical operating expenditure of the
          Ispra Biology Group and the use of the scientific and technical
          support of the JRC*s Ispra Establishment .
   ( e)   Contract expenditure
          Since the type of subject and the contractors * qualifications vary , it
          is not possible to establish a uniform method of calculation . However ,
          an average contribution of AOfo to the contractual partners * total
          costs has been taken as a basis for the estimate®        At all events the
          Advisory Committee on Programme fenagaraent will be consulted when the
          amount of Community participation is finally determinedo
   6.    FINANCIAL IMPLICATIONS ON THE STAFF AND FORMAL OPERATING APPROPRIATIONS
   ( See under paragraph 5 above )
   7.    FINANCING
  Appropriations to be entered under future budgets «
   8.    FINANCIAL IMPLICATIONS OF THE PROJECT IN RESPECT OF REVENUE
  –     Community tax on officials * salaries o
  Officials * contributions to the pension scheme .
   9.    TYPE OF COÎfPROL TO BE APPLIED
  – Scientific control by the Associations Management Committee , the
      Advisory Committee on Programme Manage merit ( ACPI'!) and the responsible
      officials in DG XII .
•*     Admini st rat i ve^cont rol by the Di rectorate~General for Financial Control
       with regard to the implementation of the Budget and to check that the
       expenditure is in order and conforms to the relevant provisions ; and
       by the Contracts Department of DG XII .