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<p align="justify">22 February 1993 <b><br><br>Doc. 6780</b></p>



<p align="justify">1403-17/2/93-3-E</p>

<p align="justify"><b>REPORT</b></p>

<p align="justify"><b>on developments in biotechnology</b></p>

<p align="justify"><b>and the consequences for agriculture</b></p>

<p align="justify"><b>(Rapporteur: Mr GONZALEZ LAXE, </b></p>

<p align="justify"><b>Spain, Socialist)</b></p>

<hr size="1">


<p align="justify"><i>Summary</i></p>

<p align="justify">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Biotechnology has the potential to fundamentally change present agricultural practices and structures by increasing yields, making plants and animals resistant to certain pests and diseases. It can produce new living organisms, plants and animals which could never have been produced by traditional  breeding methods. These can in turn be used in the production of new or modified food and non-food products as well as in new production processes. The use and release of biotechnological inventions could also cause nuisance and present hazards to existing ecosystems and humans. They could even lead to unnecessary suffering of animals. Biotechnology is a human intervention in the life processes and should therefore be subject to bioethical considerations. A European legal framework for the regulation of biotechnological interventions on animals and plants is at an early stage of development. </p>

<p align="justify">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;The Council of Europe should enlarge its work on bioethics to include biotechnological manipulations of animals and other living organisms in our ecosystems. Member governments and the European Community should continue to improve the regulatory framework for the encouragement of positive uses of biotechnology and for the elimination of abuses and any hazards resulting from biotechnology work. Research and training in the field as well as public information should be strengthened.</p>

<p align="justify"><b>I. Draft recommendation</b></p>

<p align="justify">1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Biotechnology which in a sense has a history as long as bread making and brewing can be defined as the use of biological organisms, systems and processes in industrial, manufacturing and service activities. The elucidation of the nature and functioning of the nucleic acids (DNA and RNA) in the 1950s has paved the way for the manipulation of the building blocks of living organisms so that cells or molecules can be altered. The gene pool available for &quot;crossing&quot; has been widened far beyond the limits of sexual compatibility. </p>

<p align="justify">2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Biotechnology's application in the agricultural sector (including forestry and fisheries) has resulted in the production of new animals which could not have been bred with traditional methods and the creation of new pest resistant and other genetically modified plants. The use of tissue culture has permitted the rapid regeneration of cells into identical full sized plants and animals (clones). Some of the new animals and plants have already been patented.</p>

<p align="justify">3.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Biotechnology can be used to promote contrasting aims: </p>

<p align="justify">i.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to raise agricultural outputs or reduce inputs; </p>

<p align="justify">ii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to make luxury products or basic necessities;</p>

<p align="justify">iii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to replace chemical herbicides and insecticides or target them more efficiently; </p>

<p align="justify">iv.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to upgrade pedigree flocks and herbs or expand indigenous stock in developed countries; </p>

<p align="justify">v.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to convert grain into biodegradable plastics or into methanol for fuel;</p>

<p align="justify">vi.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to hasten maturity in livestock or prevent sexual maturation in locusts or in farmed salmon;</p>

<p align="justify">vii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to produce more nutritious and better flavoured foods or diagnose tests for bacterial contamination;</p>

<p align="justify">viii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to engineer crops for fertile temperature zones or for semi-arid regions;</p>

<p align="justify">ix.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to fight viral epizootic or build up populations of endangered species;</p>

<p align="justify">x.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to reduce production of &quot;greenhouse gases&quot; or utilise them in food production;</p>

<p align="justify">xi.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to clone meat animals for particular markets or form embryo banks to maintain genetic diversity.</p>

<p align="justify">4.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Assembly is convinced that biotechnology offers the agricultural sector (including forestry and fisheries) important new development perspectives for plant and animal breeding, for the production of food as well as non-food products (energy, pharmaceuticals, medicine). </p>

<p align="justify">5.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Biotechnology can also be misused, for example for the production of new diseases or for the creation of animals or plants which could have unwanted negative effects on specific ecosystems. The altering of genes and cells and the manipulation of life processes of animals can also result in unnecessary suffering and thus violate animal welfare regulations.</p>

<p align="justify">6.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Assembly is of the opinion that the manipulation of genes and life processes must be subjected to a careful monitoring by the application of appropriate policies in order to detect inherent risks, avoid harmful aspects and promote promising developments.</p>

<p align="justify">7.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; It has taken note with satisfaction of Recommendation No. R (92) 9 of the Committee of Ministers to member states on the potential ecological impact of the contained use and deliberate release of genetically modified organisms. </p>

<p align="justify">8.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Assembly, recalling its<a href="/ASP/Doc/RefRedirectEN.asp?Doc= Recommendation 870"> Recommendation 870</a> (1986) on the biogenetic revolution in agriculture - a blessing or a curse, recommends that the Committee of Ministers:</p>

<p align="justify">i.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; extend its work on bioethics (that is the systematic study of human conduct towards life examined in the light of ethical values and principles) to include issues related to the production, release, use and trade of new or modified living organisms, animals and plants or food and non-food products, and work for a European harmonisation of legislation in this field;</p>

<p align="justify">ii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; invite the European Community and the European Patent Office to take part in this work;</p>

<p align="justify">iii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; initiate the work by convening a European conference with representatives of all relevant  professions and interest groups concerned to examine the scope and main content of European concerted action and use the experience already gained in the Council of Europe's work on bioethics;</p>

<p align="justify">iv.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; promote the setting up of national committees to analyse bioethical aspects regarding the use of biotechnology in the agricultural field, in particular with regard to field research. Such bodies could also give advice on the monitoring of new developments, on necessary policy reforms, on measures to be taken to preserve biodiversity and could be the national bodies of a European network co-operation;</p>

<p align="justify">v.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; draw up a European convention covering bioethical aspects of biotechnology applied to the agricultural and food sector. </p>

<p align="justify">9.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Furthermore, the Assembly asks the Committee of Ministers to call on governments of member states and the Commission of the European Communities:</p>

<p align="justify">i.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to increase and co-ordinate European research and development in the field of biotechnology but to give priority to research of existing natural biodiversity and the sustained development and exploitation of these resources; </p>

<p align="justify">ii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to encourage the creation of new enterprises to exploit inventions in biotechnology and adopt a regulatory framework for their operation;</p>

<p align="justify">iii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to pay special attention to the need for better and more information to the public through the organisation of information activities and exhibitions and through appropriate labelling;</p>

<p align="justify">iv.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to strengthen training programmes on biotechnologies and their applications in the field of agriculture, forestry, fisheries as well as food and non-food production and processing;</p>

<p align="justify">v.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to take action to protect biodiversity and ecosystems from all possible negative influences that biotechnological inventions might cause and to use biotechnology in preserving biodiversity;</p>

<p align="justify">vi.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to adopt a cautious policy with regard to the granting of patents for biotechnological applications so as to take due account of ethical considerations and environmental safety concerns;</p>

<p align="justify">vii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to implement technology assessments for biotechnology inventions as a precondition for further research and development and to work for the setting up of an international biotechnology assessment office;</p>

<p align="justify">viii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to encourage the inclusion of bioethics in the training of specialists in the field of biotechnology and favour the development of professional ethical norms for work regarding biotechnologies and their applications - including the setting up of professional bodies at institutional, national, European and international levels.</p>

<p align="justify"><b>II. Explanatory memorandum</b></p>

<p align="justify"><b>by Mr GONZALEZ LAXE</b></p>

<p align="justify"><b>Contents</b></p>

<p align="justify"><u>Page</u></p>

<p align="justify">Introduction &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 6</p>

<p align="justify">Biotechnology and its agricultural applications &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 7</p>

<p align="justify">Micro-biology applied to agriculture &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 8</p>

<p align="justify">The importance and limits of biotechnology as applied to</p>

<p align="justify">domestic animals including fish  &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 10</p>

<p align="justify">The economic and social aspects of advances in biotechnologies&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 11</p>

<p align="justify">The application of biotechnology in agriculture and </p>

<p align="justify">agro-food industry  &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;  13</p>

<p align="justify">Biotechnology - a challenge for science and technology </p>

<p align="justify">policies in Europe  &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;  14</p>

<p align="justify">Tentative conclusions  &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 15</p>

<p align="justify"><b>Introduction</b></p>

<p align="justify">1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The first patent for a biotechnological invention, a genetically modified bacterium, was granted in the United States in 1981. The new micro-organism was capable of producing enzymes that could degrade hydrocarbons. The first patented mammalian was a mouse (the &quot;onco mouse&quot; or &quot;Havard mouse&quot;. It was particularly susceptible to mammary tumours and therefore suited to cancer research. Genetically transformed crops with improved pest resistance, higher yields or other new qualities are currently being field-tested in Europe as well as in the United States of America and other industrialised countries. There has also been a number of examples of artificial interference with growth processes by the use of hormones and embryo transfers. Biotechnology has even allowed the production of entirely identical plants and animals (clones) from single cells which was impossible in traditional breeding. </p>

<p align="justify">2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; These and many other examples motivated Mr Soares Costa and others in October&nbsp;1990 to table a motion for a recommendation on the development in biotechnology and the consequences for agriculture (<a href="/ASP/Doc/RefRedirectEN.asp?Doc=Doc. 6321">Doc. 6321</a>). In 1986 the Assembly had already dealt with the subject in a report on the biogenetic revolution in agriculture (Rapporteur: Lord&nbsp;Kinnoull, <a href="/ASP/Doc/RefRedirectEN.asp?Doc=Doc. 5573">Doc. 5573</a>,<a href="/ASP/Doc/RefRedirectEN.asp?Doc= Resolution 870"> Resolution 870</a> (1986)). The complex nature of this science and its applications and the increasing interest for the subject among European politicians and the public at large inspired the Committee on Agriculture to hold a European Symposium on Developments in Biotechnology and the Consequences for Agriculture on 22&nbsp;November&nbsp;1991 in Paris. The French Parliamentary Office for the Assessment of Science and Technology Choices had agreed to be co-organiser of this event. It shared the committee's opinion that this new technological revolution, with its many potential consequences for humanity, the environment, the rural world, employment, and the agricultural sector would need to be carefully monitored by appropriate policies in order to detect inherent risks, avoid harmful aspects and promote promising developments. Your Rapporteur wishes to thank Mr Soares Costa for having initiated this study, Mr&nbsp;Jean-Yves Le Deaut, President of the French Parliamentary Office for the Assessment of Scientific and Technological Choices for having agreed to join the committee in organising the European Seminar, Mr&nbsp;Daniel&nbsp;Chevallier, MP, for his comprehensive report on the application of biotechnologies in agriculture and the agro-food industry which was presented at the seminar. Mr Philippe Bassinet, Chairman of the Committee on Science and Technology of the Parliamentary Assembly, for his assessment of the challenge for policy-makers in Europe, the distinguished scientists who had agreed to contribute to the symposium: </p>

  <blockquote><p align="justify">Professor John Beringer, Microbiology Department, School of Medical Sciences, University of Bristol (United Kingdom);</p>

  <p align="justify">Dr Volker Beusmann, Institute of Farm Economics, Federal Agricultural Research Centre (FAL), Braunschweig (Germany);</p>

  <p align="justify">Mr Pascal Bye, Director of Research, Laboratory of Agricultural Studies and Research, National Agricultural Research Institute (INRA) (France);</p>

  <p align="justify">Professor J. Schell, Max Planck Institute for Breeding Research, Cologne (Germany);</p>

</blockquote><p align="justify">Henri Heslot, Honorary Professor in molecular and cellular genetics, National Agronomic Institute (INRA), Paris-Grignon, member of the French Agricultural Academy (France);</p>

  <blockquote><p align="justify">Mr Louis-Marie Houdebine, Director of Research, Centre for Cellular Differentiation, National Agricultural Research Institute (INRA) (France).</p>

</blockquote><p align="justify">3.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Furthermore I would like to thank OECD for having supplied participants with its latest report on biotechnology, agriculture and food (Overview and Policy Conclusions, Paris, July 1991). The work of OECD has in particular formed the basis for the section on economic and social aspects of advances in biotechnology. Last but not least I wish to thank Mr Alain Deshayes, Director of Research at the French National Institute for Agronomic Research (INRA), for his valuable assistance in preparing the seminar and for the competent way in which he acted as its General Rapporteur. </p>

<p align="justify">4.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The European Community has an important programme of activities in respect of biotechnologies. This includes a regulatory framework with legal protection of biotechnological inventions and plant variety rights, and work on standardisation. The Community also has an important research and development programme in support of biotechnology and sponsors a vast training programme in this field. It does not fall within the scope of this report to review in detail these important activities which have been presented by the Commission in a communication to the Council entitled &quot;Promoting the competitive environment for the industrial activities based on biotechnology within the Community&quot; (document SEC (91) 629 final). Your Rapporteur, however, has taken advantage of this important text. </p>

<p align="justify">5.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The objective of the present report is to identify the main trends in recent development and to assess  some of the major economic and social aspects linked to the use of biotechnology for plant and animal breeding, food and non-food production. The main emphasis of the report is on agricultural issues, and industrial aspects are only briefly referred to. The report is to a large extent based on the findings of the above-mentioned symposium. </p>

<p align="justify"><b>Biotechnology and its agricultural applications</b></p>

<p align="justify">6.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The term &quot;biotechnology&quot; was unknown until only twenty years ago. The syllables &quot;bio&quot; and &quot;technology&quot; refer to respectively life processes and the means and technique to be used in reaching a specific objective. A logical definition of biotechnology would therefore be: the use of biological organisms, systems and processes in industrial, manufacturing and service activities.</p>

<p align="justify">7.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Biotechnology applied to micro organisms, plants and animals for food and non-food products is more than just a new productivity increasing or problem solving technology. Biotechnology is dramatically changing the ways in which scientists can grasp the structure and function of biological systems. The knowledge revolution which this brings about will have far-reaching scientific, ethical and social consequences as well as economic effects especially in the agriculture and food sectors. Biotechnology might give mankind unprecedented possibilities to understand the critical biological factors which articulate the global ecosystem and perhaps a better capacity to anticipate and reduce threats to the ecosystem. This alone would be a sufficient reason to continue devoting resources and if necessary, increase, the funding of fundamental research in agro-food biotechnologies. </p>

<p align="justify">8.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The future impact of biotechnology on agriculture and the agro-industrial complex will depend on many factors. The most important ones can be enumerated as: further technological development; successful transfer of innovations from research laboratories to the production development stage; capital availability to implement planned industrial strategies; consumer acceptance of &quot;biotech products&quot; and the regulatory environment created by governments and the competent international organisations. The last two factors are closely linked. A constant awareness of the importance of public and regulatory acceptability of present developments must become an integral part of any long-term planning in this field. It is therefore of fundamental importance to gather and disseminate information regarding the environmental, health, safety and social desirability aspects of agricultural biotechnology.</p>

<p align="justify">9.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; In the case of plants every stage of life can be affected by biotechnology. The two main areas where biotechnologies are being applied concern selective plant breeding and the creation of new resistant strains. </p>

<p align="justify">10.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Animal biotechnologies can increase productivity in many ways. They are primarily utilised to protect animals against disease, for selective breeding, to control reproduction and to modify genetic characteristics. </p>

<p align="justify">11.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Food biotechnology offers a wide variety of options for improved quality, nutrition, safety and preservation of foods. Among the new or improved applications and technologies, are rapid food safety contamination tests, food enzymes (enzyme bio-reactors, enzyme encapsulation, protein engineering), food preservation by biological systems or modified food micro-organisms, new types of food (for example meat-like proteins) and plant cell as well as micro algal cultures to grow a wide range of useful compounds. </p>

<p align="justify">12.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Non-food uses of agricultural crops, according to some estimates, already reaching 20% or more of agricultural production in OECD countries, have great economic potential which biotechnology is enhancing. There are numerous examples in different fields, such as the applications of biotechnology to wood and biomass for energy and various other products, to the manufacture of starches or other polysacharides, and to that of hydro-carbons, oils and fats. Other important sectors of application are ornamental plants, tobacco, cotton and special plant fibres. Also, the development of new industrial products from transgenetic plants and animals, and the treatment of wastes from agro-food production, have become very attractive areas of research. </p>

<p align="justify"><b>Microbiology applied to agriculture and food</b></p>

<p align="justify">13.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The European Symposium on Development in Biotechnology and the Consequences for Agriculture devoted a separate session to this issue. Mr John Beringer stressed  the need to deal with the beneficial aspects of biotechnology before considering any risks it might entail. Microbes play a role in yoghurt production and for the making of important proteins and vitamins. </p>

<p align="justify">14.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Micro-organisms - although they may cause disease in both plants and animals - are nonetheless extremely useful and even indispensable allies which play an essential role in the production of food and drink through fermentation processes (bread, beer, dairy products etc.). They also serve to break down a great number of waste products generated by human activities and to manufacture important chemical compounds, foremost among which are antibiotics.</p>

<p align="justify">15.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Studies on the interaction between micro-organisms and plants or animals have helped in the understanding of how micro-organisms prompted or hindered the development of disease or stimulated the development or growth of organisms with which they are associated. The deeper understanding of these interactions acquired by scientists has made it possible to take action which reduces the adverse effects of certain micro-organisms (creation of resistant organisms by genetic engineering) or optimises their useful properties (pest control, symbiotic fixing of atmospheric nitrogen by rhizobia or improved assimilation of phosphorous thanks to mycchorhizae). </p>

<p align="justify">16.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mr Jeff Schell showed the relevance of plant biotechnologies for plant improvement. Biotechnology can help to resolve the paradox between the need for increased productivity in agriculture and the need to limit the adverse effects of intensive farming on the environment. </p>

<p align="justify">17.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Scientists already apply perfected techniques to render plants resistant to certain viruses and insects and hence to reduce the amounts of pesticides applied to crops.</p>

<p align="justify">18.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Biotechnology also makes it possible to increase the economic value of certain plant species by extending the range of uses for agricultural produce towards non-food uses. Colza provides an excellent example of this since, biotechnology has made it possible to control the composition of colza oil and adapt it to various uses (food, organic fuel, basic products for the chemical industry, etc.).</p>

<p align="justify">19.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; It would be wrong to set &quot;traditional&quot; techniques against those derived from molecular biology. A great effort must be made to ensure that both &quot;old&quot; and &quot;modern&quot; technologies are integrated into the same process aimed at plant improvement.</p>

<p align="justify">20.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Europe should realise that the United States of America is at present leading the field in the development of plant-based biotechnology. Therefore, it is imperative for Europe to strengthen its research and development capacity in order to play a proper role in the development of these technologies over the next decade. </p>

<p align="justify">21.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mr Henri Heslot spoke of the scientific and industrial issues at stake in protein engineering. One important challenge is to reach a better understanding of how modifications of proteins' structures lead to functional modifications. It is still very difficult to predict the three-dimensional structure of proteins and a major research effort should be made at European level. </p>

<p align="justify">22.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; A few examples could illustrate what could be obtained by selective modification of certain proteins: thermo-resistant alpha-amylase had permitted a more effective transformation of starch into glucose, and a glucose isomerase had been made more efficient for the conversation of glucose into isoglycose of which six million tonnes were produced annually. </p>

<p align="justify">23.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; He also said that it was possible to direct proteins towards certain areas of the cell or to secrete them outside the cell: in this way transgenetic animals could be obtained which secrete proteins of pharmaceutical interest. Protein engineering also offers considerable possibilities for the production of new vaccines. </p>

<p align="justify">24.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Europe should better realise the importance of protein engineering. In this connection he spoke of the stimulation provided by the European BAP (Biotechnology Action Programme) and BRIDGE (Biotechnology Research for Industrial Development and Growth in Europe) programmes and of the establishment of European &quot;laboratories without walls&quot;, a wager that was coming off because of the synergies it had encouraged. </p>

<p align="justify"><b>The importance and limits of biotechnology as applied to domestic animals including fish</b></p>

<p align="justify">25.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Valuable traits in farm animals have been improved by selective breeding extending over hundreds of years. In the modern era the rate of livestock improvement has greatly benefited from advances in quantitative genetics and reproductive biology such as artificial insemination and embryo transfer. However, the annual genetic gain for desirable traits such as growth rate, health, leanness or milk yield in ruminants is generally under 2%, and since the generation interval in animals such as cattle is very long the result of technological improvements are only visible after a long period. Biotechnology has the potential to offer greater improvements, partly because modern techniques can help to shorten these intervals and partly because of the gain which can be achieved using the products of biotechnology. With a world population of over five thousand million people and an estimated doubling during the next forty years, new ways of enhanced food production need to be explored. The impact of new discoveries will be felt not only in developed economies because half the world's 1,2 thousand million cattle equivalents reside in Asia, Africa and the Indian sub-continent. </p>

<p align="justify">26.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mr Houdebine explained during the symposium that advanced biological systems are being studied mainly to improve:</p>

<p align="justify">i.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; animal quality in terms of production performance or the controlled expression of introduced foreign genes;</p>

<p align="justify">ii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; animal health with respect to disease resistance; and </p>

<p align="justify">iii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; animal welfare by diagnosis of management stress effects.</p>

<p align="justify">27.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The first application presented by Mr Houdebine concerned the use of molecular probes for the sexing of embryos and animal breeding. Although still very expensive (FF&nbsp;1&nbsp;500 per test), the sexing technique can determine the sex of the embryo in four hours. It will increase the efficiency of animal breeding, for example, to produce milk of a given quality through the use of genes involved in the synthesis of milk proteins as a probe.</p>

<p align="justify">28.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; He then showed the importance for stock breeding of certain recombinant proteins such as the growth hormone, bovinesomatotropin (BST). He said that BST, in contrast to what had been reported, has no drawbacks either for the animals treated or for consumers of milk. BST helps to increase productivity and thus reduces production costs but it also helps to reduce pollution since fewer cows are needed for the same volume of milk produced. Therefore it did not seem logical from a scientific point of view to outlaw the use of BST. Mr Houdebine also drew attention to the advantages of recombinant vaccines, which are pure and without danger, though less immunogenic, and to the progress achieved in the practice of artificial insemination and of transferring embryos fertilised in vitro. Besides other advantages, the latter technique is ten times cheaper than traditional breeding. As for cloning, by transfer of embryo cell nuclei from an &quot;élite&quot; animal to enucleated ova, it is not yet widely practised owing to its high cost. </p>

<p align="justify">29.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mr Houdebine also said that animal transgenesis, will have no impact on agriculture so long as advantageous genes, such as those conferring resistance to diseases or improved growth, are not been isolated. The introduction of the growth hormone gene had been a failure: the level of gene expression, a thousand times above normal, did not equate with animal physiology and animals obtained had proved to be too fragile for mass breeding purposes. </p>

<p align="justify"><b>The economic and social aspects of advances in biotechnologies</b></p>

<p align="justify">30.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Biotechnologies at the beginning of the 1980s had been presented as &quot;the business of the century&quot; with a potential market estimated at 60 thousand million U.S. dollars before the year 2000. However, Mr Beusmann explained that nowadays an attitude of prudence with regard to the applications of modern biology prevailed. The economic assessment of not yet applied biotechnologies in agriculture faced the following problems:</p>

<p align="justify">-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; there exists no single biotechnology, but a wide range of technologies, varying in technical feasibility, profitability, etc., and thus with greatly varying economic impact potentials;</p>

<p align="justify">-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; government policies and general economic trends for biotechnologies are subject to major uncertainties;</p>

<p align="justify">-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; biotechnology induced quality improvements, consumer acceptance, environmental safety concerns and intellectual property protection are difficult to assess in economic terms. </p>

<p align="justify">31.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Another limitation to economic assessments is that they do not sufficiently integrate the impacts on farming with those on the up-stream and down-stream sectors of agriculture. Finally, the links between biotechnology and the long-term global food supply have not yet been clearly assessed. </p>

<p align="justify">32.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mr Beusmann also said that economic analyses were mainly concerned with the consequences of biotechnologies for production and agricultural markets. Aggregate estimates of impacts on agricultural production and market balances published for the United States and Europe had revealed that biotechnology had a big potential to increase productivity, by decreasing costs per unit of output (for example less chemicals) or by increasing yields per unit of input. However, in highly developed countries, these biotechnology effects are likely to be partly offset by an expected decline of productivity increases due, amongst others, to a slackening of more traditional technological factors. In some sectors this decline can already be observed. </p>

<p align="justify">33.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Specific impact assessments for recombinant bovine somato tropin (BST) have shown that even for a product with a technically, large productivity enhancing capacity that is relevant to a large sector of agriculture, the main direct result (in a quota system) will be cost reduction rather than production increases. If there were production increases, they would take time, and on an aggregate level, would be smaller than first expected. Current forecasts mention possible production increases of 10% to 16% which will not arrive suddenly, but within a time frame of five to ten years. Thus, earlier forecasts of milk increases of 25% to 40%, which had led to concern about further milk surpluses, might have been true for individual cows during trials, but as general economic assessments, have been widely exaggerated. Over a longer period, however, BST could have a significant influence on milk production and farm structure, if the new product were profitable which is not yet the case in all circumstances.</p>

<p align="justify">34.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Analysis in the United States and the European Community indicate that there would be a reduction in yield increases of traditionally bred species if biotechnology were not applied. The use of biotechnology however could lead to important surplus production problems in the absence of political reforms.</p>

<p align="justify">35.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mr Beusmann expressed the opinion that biotechnology, like other technical changes, would lead to downward pressure on food prices and thus to structural changes at the farm and employment levels. New markets either for quality food products or for non-food products from agriculture, could alleviate this downward pressure. </p>

<p align="justify">36.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; While biotechnology could play a leading role in the development of non-food products from agriculture, conversion towards such products would be hampered by policies supporting farm gate prices for food and by the fact that the price of non-renewable resources did not sufficiently internalise long-term scarcities. A division has been made between product innovations, new markets for existing products or substitutes for agricultural products, and process innovation. </p>

<p align="justify">37.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; He believed that biotechnology will accelerate ongoing structural changes of the agro-food sector towards increased vertical integration of agriculture with up and down-stream sectors. Biotechnology adoption rates can be expected to increase with management quality which means that they are likely to increase with farm size (measured by income potential, not acreage). In general, biotechnology tends to facilitate concentration in the up- and down-stream sectors of agriculture and in agriculture itself. </p>

<p align="justify">38.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; International trade and competitive advantages may shift in the long term towards countries which have both good capabilities in biotechnology and viable farms, if trade policies would allow  for such shifts. Economic impacts could be substantial. Experience with high fructose corn syrup (HFCS) in the United States has demonstrated that the speed of adjustment to new biotechnology could be very high if incentives were adequate, although the substitution of sugar by HFCS has been strongly accelerated by sugar price protection in industrialised countries. </p>

<p align="justify">39.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Shifts in trade and competitiveness have to be monitored as they can have both positive and negative consequences for developing countries. The danger of negative impacts on the Third World in general, expressed over the past few years, has probably been over-estimated. </p>

<p align="justify">40.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Biotechnology is expected to contribute to the continuing, long-term trends reducing the share of total employment in agriculture. International leaders in biotechnology may increase their international market shares and, thus, save employment in agriculture, if trade policies allow for it. However, this would come at the expense of countries which lag behind with the loss of more jobs  and no guarantee of a globally positive net effect. Employment reductions may be partly offset by new employment in down-stream sectors, particularly the food related services.</p>

<p align="justify">41.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Biotechnologies are in some way related or relevant to nearly all major agricultural policy questions of our time. If they were situated at the very heart of a problem, as is often the case, they may provide new and better solutions (reduction of chemicals, of factor inputs, of food contamination, more food for the Third World) but they may also aggravate certain problems (marketing balances, loss of employment, more concentration), or they might do both at the same time. </p>

<p align="justify">42.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; As biotechnologies are likely to become more and more central to technical change in agriculture and food production, agricultural policies will have to cope with them, and to make use of them on a continued basis. The main message is that biotechnology in agriculture is not a global issue but one that has to be addressed in a differentiated way, on a case by case basis. </p>

<p align="justify">43.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mr Bye added to these observations: generally speaking the agro-food industry devotes only a small proportion of its turnover to research. A situation of unstable prices and segmented markets is not conducive to the development of biotechnologies. That is why marketing is given greater importance than technological innovation in this field. The success of high fructose corn syrup had been the result of four favourable circumstances:</p>

<p align="justify">i.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the mastering of the technology has been achieved;</p>

<p align="justify">ii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the industrial production had been encouraged by patent rights which protect the production;</p>

<p align="justify">iii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the market had been guaranteed by the Coca Cola and Pepsi Cola companies wanting to use the syrup; and</p>

<p align="justify">iv.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; sugar prices as well as trade rules had placed the syrup in a favourable position in relation to sugar.</p>

<p align="justify"><b>The application of biotechnology in agriculture and agro-food industry</b></p>

<p align="justify">44.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mr Daniel Chevallier, MP, in his comprehensive analysis of the problem, pointed to the importance of strengthening all aspects of research in this area and of improving education. Biotechnology should be taught as part of a multi-disciplinary training with reference to the operation of ecosystems. Patentability of inventions in biotechnology involves both ethical and economic issues. While it appears impossible to appropriate a living being, for example a micro-organism which exists in nature, by means of a patent, it seems permissible to recognise some ownership over a microbe or living being which has been isolated and transformed by the inventor in order to fill a role which it does not play under natural conditions. </p>

<p align="justify">45.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; In view of the fact that no technique is completely reliable, it is essential to assess the scale of possible risks to the environment from biotechnologies. Accordingly, the study of the environmental effects of genetic engineering techniques and the dissemination of genetically modified organisms should be greatly intensified. The first objective should be the construction of a model of the overall ecosystem which approximated as closely as possible to reality, which would make it possible to study the consequences of various accident scenarios and to provide a remedy. An ecological ethics committee comprising representatives of all those involved in environmental protection, which could be consulted both by the authorities and by private individuals on all aspects of the problem, should be set up in different countries.</p>

<p align="justify">46.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; A harmonisation of the regulation of biotechnological experiments in Europe should be continued and should seek inspiration from the situation in France where a Committee on Bio-Molecular Engineering has done remarkable work.</p>

<p align="justify">47.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The diversity of the living world, which contributes to the major balances that made the biosphere habitable, is threatened with curtailment and will increasingly be confronted with the consequences of the use of biological techniques. These may simultaneously be a powerful aid to the retention and enrichment of genetic diversity and a cause of the curtailment of this diversity, particularly through the risks involved in the increasing homogenisation of species and the abandonment of varieties that were considered uninteresting or not very interesting in relation to genetic recombination. A vigorous policy for the retention of genetic diversity should therefore be pursued. </p>

<p align="justify">48.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; At world level, an international fund for plant genetic resources should be set up with a view to exploiting rationally the world's genetic diversity while protecting developing countries which possess immense genetic wealth but were short of money and skills.</p>

<p align="justify">49.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Little is done to make the public more knowledgeable about biotechnologies, yet it is the public attitude that will determine whether biotechnology will be applied on a large scale or remain permanently confined to the laboratory. Like the BBC, the public television companies should make a series of high-quality programmes on these technologies for the public in order to demystify them. </p>

<p align="justify">50.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Finally, food products resulting from procedures that, at any stage, involved genetic engineering should be specially labelled in order to ensure that consumers were fully informed. </p>

<p align="justify"><b>Biotechnology - a challenge for science and technology policies in Europe</b></p>

<p align="justify">51.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mr Philippe Bassinet (Member of the French National Assembly and Chairman of the Committee on Science and Technology of the Parliamentary Assembly) explained that Europe counted about 800 biotechnology companies, the United States about 1 000 and Japan 300. It is clear that biotechnology creates new employment. More than 15 000 people are directly employed in biotechnology work in Europe. It is important to support this sector through research facilities and appropriate regulations so as to ensure that biotechnology enterprises stay in Europe. The sector is characterised by a number of small inventive companies which are often bought up by bigger ones as soon as they can register a product success. Large companies are continuously investing in the field and survey closely all new developments. In 1987 the total research and development budget for biotechnology amounted, for the United States, to 3 898 million ecus of which 2 538 million ecus was public investment. In the same year the total (public and private) investment in the United Kingdom, France, Germany and Italy combined was estimated at 1 661 million ecus of which the public share was 602 million ecus. The other EC countries accounted for some 130 million ecus in public finance, whereas the European Commission had a budget of 306 million ecus. In Europe a concerted effort in this sector has to be made in the coming years so as to maintain Europe's competitiveness. </p>

<p align="justify"><b>Tentative conclusions</b></p>

<p align="justify">52.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; On the basis of the findings of the symposium and the subsequent discussion in the Committee on Agriculture two main conclusions can be drawn: </p>

<p align="justify">53.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Firstly, ethical problems will need to be approached in a systematic way notably with regard to: </p>

<p align="justify">-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the property rights for living organisms or life processes;</p>

<p align="justify">-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the relations between the development, release and use of biotechnologically modified species or life systems and the environment;</p>

<p align="justify">-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; ethical and welfare aspects of biotechnological experiments with and inventions concerning animals;</p>

<p align="justify">54.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Standing Committee of the European Convention for the Protection of Animals kept for Farming Purposes has already discussed these matters and the Committee of Ministers has adopted a recommendation to member states on the potential ecological impact of the contained use and deliberate release of genetically modified organisms (Recommendation No. R (92) 9). Nevertheless these matters deserve the continued attention of parliaments and governments with a view to adapting legislation and policy measures to new situations and needs. It is above all necessary to harmonise European standards and practices. </p>

<p align="justify">55.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Secondly, biotechnology developments require:</p>

<p align="justify">-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the encouragement of research and development and the creation of new enterprises;</p>

<p align="justify">-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the adoption of safety regulations to avoid any nuisance, health hazard or harmful effects on human beings and the environment of such developments.</p>

<p align="justify">56.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; On both issues the public should be better informed and public and parliamentarian debates must put greater light on the use of biotechnology in agriculture and the potential for future developments.</p>

<p align="justify">57.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; While the problem of food supply in developing countries is most important, it does not fall within the scope of this report. It is certain that biotechnology offers new chances for these countries since it can increase yields despite harsh climatic conditions and poor soil. </p>

<p align="justify">Reporting committee: Committee on Agriculture.</p>

<p align="justify">Budgetary implications for the Assembly: none.</p>

<p align="justify">Reference to committee: <a href="/ASP/Doc/RefRedirectEN.asp?Doc=Doc. 6321">Doc. 6321</a> and Reference No. 1702 of 22 November 1990.</p>

<p align="justify">Draft recommendation: Unanimously adopted by the committee on 2 February 1993.</p>

<p align="justify">Members of the committee: <i>Mrs Gjørv (Chairperson)</i>, MM van der Linden, <i>Sipos (Vice-Chairmen)</i>, Anthopoulos, <i>Mrs Anttila</i>, <i>MM Bühler, de Carolis, Crowley</i>, Goerens, <i>Gonzalez&nbsp;Laxe</i>, Granstedt <i>(Alternate: Mrs Persson)</i>, Gunnarsson, <i>Hansen</i>, Howell <i>(Alternate: Alexander)</i>, Jeambrun <i>(Alternate: Grussenmeyer)</i>, <i>Kiratlioglu</i>, Lagorce, Lanner, <i>Lord Mackie of Benshie</i>, MM Mannino (<i>Alternate: Bosco</i>), Michels, <i>Ottenbourgh, Pirinski</i>, Pizzo (<i>Alternate: Rubner</i>), Rodrigues, Roger (<i>Alternate: Hunault</i>), <i>Scheer, Seiler</i>, Smolarek (<i>Alternate: Luczak</i>), <i>Jack Thompson, Vella</i>.</p>

<p align="justify">N.B.<i>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The names of those members who took part in the vote are printed in italics.</i></p>

<p align="justify">Secretary to the committee: Mr Lervik.</p>


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