- Email: [email protected]
Controlling the risks to health and environment from biotechnology — what is the European Community doing?
TIBTECH - MAY 1987 [V01.5]
of its own research from overseas suppliers. European companies are on the move however. The Swiss online host Datastar, for instance, now has its own marketing team in the USA selling British and Dutch biomedical databases. Biotechnology produces large and complex data files and the stringent demands of handling material of this nature is exactly the sort of problem to stimulate developments in advanced hardware and software. To take two examples, transputer technology is being applied by Chemical Design Ltd, Oxford, UK to a high power graphics processor which would initially deal with protein structures and receptor-ligand docking problems. The University of London together with the Imperial Cancer Research Fund UK are developing a knowledge based system for mol[]
[]
[]
ecular biology with GEC Ltd as part of the UK's 5th generation Alvey Programme.
Conclusion Is then the application of information to biotechnology merely another technique, maybe on a par with chromatography or centrifugation, or is it a critical foundation element which should receive support even in the face of more immediate demands from experimental scientists? Certainly it is difficult at the moment to assess the impact of databases, databanks or graphical displays on any specific commercial product. On one hand, the influence of information is so pervasive as to be almost invisible, and on the other, the development of most specific applications is only at the beginning of a curve that will take 10 or 15 []
[]
[]
[]
[]
[]
[]
Controlling the risks to health and environment from biotechnology- what is the European Community doing? Cynthia Whitehead The EEC is an economic community w h i c h must endeavour to unify the regulation of trade and environment among its member states. The establishment of international regulatory standards in biotechnology will be relatively less hindered by entrenched national legislation and practices than in other industrial sectors. Rapid progress towards a c o m m o n biotechnology market will benefit both manufacturers and research in Europe, and provide c o m m o n standards of health and environmental protection. During the past three years, the European Community (EC) has b e e n quietly and steadily laying the foundation for a framework of poliCynthia Whitehead is Editor of the European Environment Review, 23, A v. Eisenhower, B-1030 Brussels, Belgium.
cies and laws that will identify and control the risks to h u m a n health and the environment that might arise from the commercial application of the many new techniques of genetic manipulation. In fact, the work actually started somewhat earlier. In 1982 later than
years to culminate. Growth in very few of these areas is unlikely to take place without the investment of public money on a large scale and it is to this difficult proposition that European funding agencies must now address themselves.
References 1 National Research Council (1986) Nomenclature and Information Organization. National Academy Press, Washington D.C. 2 Rogosa, M., Krichevsky, M.I. and Colwell, R.R. (1971) Int. J. Syst. Bacterio]. 20, 6A-175A 3 Coulson, A. F. W. and Collins, J.F. Biological Sequence Analysis. A d vanced Architecture Computing Requirements. Report prepared under contract with the European Economic Communities. Copies may be obtained from CUBE-DGXII, 200 rue de la Loi, B-1049 Brussels, Belgium []
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[]
in the USA, the Community looked at the risks that might come from r-DNA research, and adopted the Council (see Glossary) Recommendation 82/472/EEC on the registration of work involving r-DNA. This urged the member states to set up national notification schemes and containment guidelines. Most of the member states have done so; several of the schemes are mandatory, some involve containment guidelines, but one member state in which considerable research is going on - Italy - has nothing. At the same time, the Commission of The European Communities (see Glossary) decided that the field of biotechnology applications covered such a diverse number of industrial sectors and products, that a crosssectoral, community-wide approach was vital to ensure that European companies would be in a position to compete successfully on the world markets. Hence, in February 1982, the Biotechnology Steering Committee (BSC) was set up to coordinate EC policies affecting or affected by developments in biotechnology. The BSC is composed of the directorsgeneral of the Commission services concerned: internal market and industrial affairs; environment, con-
© 1997, Elsevier Publications, Cambridge 0166- 9430/87/$02.00
T I B T E C H - M A Y 1987 [Vol. 5]
sumer protection and nuclear safety; employment, social affairs and education; agriculture; under the chairmanship of Dr Paolo Fasella, Director General for Science, Research and Development. Regulation was marked as a special area of attention. Later, in July 1985, a further interservice committee was set up to work at a more technical level on regulation. This Biotechnology Interservice Regulation Committee (BRIC) has six tasks: • to review the regulations applied to commercial applications of biotechnology; • to identify existing laws and regulations that may govern commercial applications of biotechnology; • to review the guidelines for r-DNA research; • to clarify the regulatory path that products must follow; • to determine the adequacy of current regulations on risks, and to initiate specific actions where additional regulations are deemed to be necessary; • to ensure the coherence of the scientific data that will form the basis of risk assessment 1. BRIC's function is to coordinate the work of the separate services, not to direct them, so that they retain their frill authority to examine, initiate and manage regulations within their respective areas of competence. The two services which might have the greatest interest in regulation Internal Market (DG III) and Environment (DG XI) - share the chairmanship, rotating every six months. BRIC's first step was to review the scope and applicability of existing EC legislation to biotechnology processes and products. At the same time, it tried to identify areas of higher risk which should be of special regulatory concern. The review covered a wide range of legislation, from directives on products (pharmaceuticals cosmetics, foodstuffs, food additives, agricultural and industrial chemicals) and industrial activities (major accident hazards, waste management, environmental impact assessment and worker protection). Gaps were found in all areas. In some cases, the scope of the existing directives was limited to chemical substances and could only be
amended to cover living organisms with great difficulty. In other cases, particularly in the product regulation area, directives had been adopted with the main purpose of harmonizing national standards and procedures; they often stopped far short of creating a unified EC regulatory system. At this stage, therefore, although the need for European legislation had been recognized, little had been done beyond urging member states to establish guidelines for laboratory recombinant DNA containment. A regulatory framework The second stage began in spring 1986, with the convening of a 2-day meeting of senior officials from the member states to discuss the biotechnology regulatory situation in Europe. Several things became clear at that meeting. A number of member states were about to adopt guidelines, procedures or new legislation governing the release of genetically modified organisms to the environment. There was general agreement that it would be far better if the European Community could quickly develop a framework of law governing biotechnology - both to protect the environment and to protect the common market. At about the same time and completely independently, five federations of industrial sectors using biotechnology which had formed a European Committee on Regulatory Aspects of Biotechnology (ECRAB) produced a well thought out proposal for a case-by-case notification and risk assessment scheme for the release of genetically modified organisms to the environment 2. In addition, Denmark formally notified the Commission of its intention to adopt new legislation on the production, import, sale or use of genetically engineered organisms or cells and, in response to the Commission's request, agreed to support efforts to develop Community legislation. Thus the emphasis of concern in Europe, voiced .independently in several countries and by representatives of both industry and government, was on the release to the environment of genetically modified
organisms, not on their contained, industrial use. European industries were feeling under considerable competitive pressure from US and Japanese producers; governments and industries were willing and even eager for the European Community to develop an overarching regulatory framework that would forestall potentially divergent national systems. On November 4th 1986, the Commission sent to Council a brief Communication, 'A Community Framework for the Regulation of Biotechnology '3. It said that it believed 'the rapid elaboration of a Community framework of biotechnology regulation to be of crucial importance to the industrialization of this new technology'. The Commission announced that it would bring forward legislative proposals before summer 1987 in two broad areas: (1) levels of physical and biological containment, accident control and waste management in industrial applications; (2) authorization of planned
TIBTECH - MAY 1987 [Vol. 5]
release of genetically engineered organisms into the environment. These proposals reflect the conclusions expressed in the 1986 OECD report 'Recombinant DNA Safety Considerations' which the Commission had been deeply involved in writing 4. Although the scope of the OECD report is quite limited because it concentrates on rDNA organisms and their contained, industrial use, it is the current point of departure for the discussion of control of risks from genetically modified organisms in general. The Commission clearly agrees with the OECD, those member states which are developing legislation, the USA, and ECRAB that the area of greatest concern - and the area of greatest ignorance and uncertainty is the release of genetically modified organisms to the environment. It does not believe that it is possible to propose 'general guidelines or testing requirements' for the time being. Instead, the Commission will propose a 'case-by-case evaluation and authorization procedure based on mandatory phased notification by industry'. Because it is acting so quickly, the Commission has the opportunity to create a unified European notification procedure, as it did for the marketing of new chemicals, free from the vested interests in longstanding national authorization laws that hamper such developments in other areas of product regulation. The Commission appears to be relying heavily on the OECD's work on industrial use. Its proposals will be aimed at ensuring common levels of containment, accident prevention and emergency response measures and waste management. The Directorate General for Social Affairs has been at work for some years on measures to protect workers against pathogenic biological agents and this work is directly relevant to the issue of the safety of genetically modified microorganisms. Models for legislation on waste management and accident prevention already exist among the Community's body of environmental legislation; the 1978 directive on toxic and dangerous waste (78/319/EEC) and the 'Seveso Directive' on the major accident hazards of industrial activities (82/501/EEC).
Harmonization
References
The European Community has a longstanding commitment to wider international harmonization than just among the twelve member states. It believes that the global market is needed for European biotechnology products and has repeatedly stated its preference for the OECD as a forum for international harmonization. It would like to see its efforts to develop Community legislation paralleled by an international pooling of resources - scientific, technical, financial, and political. Only in this way can the truly international dimensions of the control of risks from commercial applications of biotechnology be successfully controlled.
1 Commission of the European Communities (1985) The Commission's Approach to the Regulation of Biotechnology. Copies can be obtained on application to CUBE (Concertation Unit for Biotechnology in Europe), Commission of the European Communities, DG XII, 200, rue de la Loi, B-1049 Brussels, Belgium 2 ECRAB (1986) SwissBiotech. 4, 15-20 3 Commission of the European Communities, Communication from the Commission to the Council, A Community Framework for the Regulation of Biotechnology, COM(86) 573 final, Brussels, 4 November 1986 40ECD (1986) Recombinant DNA Safety Considerations, Organisation for Economic Co-operation and Development, Paris
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The European Bank of Computer Programs in Biotechnology (EBCB) L. A. Robertson and K. Ch. A. M. Luyben Commercial software is usually only available for non-specialist applications in w h i c h large numbers of people may be interested. For biotechnologists who see the computer as a means to an end in teaching or research and development, programming can be time consuming and frustrating. There is, therefore, a need for a m e c h a n i s m by which computing achievements can be pooled and shared among biotechnologists. With the advent of relatively cheap computers about 15 years ago, scientists were not slow to realize their potential for controlling equipment and rapidly processing large amounts of data. Few commercially produced programs were available and therefore many researchers started to write their own. Applications ranged from the control of complex biotechnological processes with recording of various parameters
Centre for Biotechnology, Delft University of Technology, Julianalaan 67, 2628BC Delft, The Netherlands.
and processing of data (e.g. van Breugel, 1986") to dedicated applications where micro-computers have been used to cut both the costs and the 'donkey work' in something as simple as electrode monitoring (e.g. Ref. 1). People also realized that these micro-computers could become a useful study-aid and, as the available graphics steadily improved, the acron y m CAL (Computer Assisted Learning) was added to the language. Specialized CAL programs are appearing on the market (e.g. the range pub*Van Breugel, J. (1986)Ph.D. Thesis. Delft University Press.
(~ 1987, Elsevier Publications,Cambridge 0166- 9430187/$02.00
of its own research from overseas suppliers. European companies are on the move however. The Swiss online host Datastar, for instance, now has its own marketing team in the USA selling British and Dutch biomedical databases. Biotechnology produces large and complex data files and the stringent demands of handling material of this nature is exactly the sort of problem to stimulate developments in advanced hardware and software. To take two examples, transputer technology is being applied by Chemical Design Ltd, Oxford, UK to a high power graphics processor which would initially deal with protein structures and receptor-ligand docking problems. The University of London together with the Imperial Cancer Research Fund UK are developing a knowledge based system for mol[]
[]
[]
ecular biology with GEC Ltd as part of the UK's 5th generation Alvey Programme.
Conclusion Is then the application of information to biotechnology merely another technique, maybe on a par with chromatography or centrifugation, or is it a critical foundation element which should receive support even in the face of more immediate demands from experimental scientists? Certainly it is difficult at the moment to assess the impact of databases, databanks or graphical displays on any specific commercial product. On one hand, the influence of information is so pervasive as to be almost invisible, and on the other, the development of most specific applications is only at the beginning of a curve that will take 10 or 15 []
[]
[]
[]
[]
[]
[]
Controlling the risks to health and environment from biotechnology- what is the European Community doing? Cynthia Whitehead The EEC is an economic community w h i c h must endeavour to unify the regulation of trade and environment among its member states. The establishment of international regulatory standards in biotechnology will be relatively less hindered by entrenched national legislation and practices than in other industrial sectors. Rapid progress towards a c o m m o n biotechnology market will benefit both manufacturers and research in Europe, and provide c o m m o n standards of health and environmental protection. During the past three years, the European Community (EC) has b e e n quietly and steadily laying the foundation for a framework of poliCynthia Whitehead is Editor of the European Environment Review, 23, A v. Eisenhower, B-1030 Brussels, Belgium.
cies and laws that will identify and control the risks to h u m a n health and the environment that might arise from the commercial application of the many new techniques of genetic manipulation. In fact, the work actually started somewhat earlier. In 1982 later than
years to culminate. Growth in very few of these areas is unlikely to take place without the investment of public money on a large scale and it is to this difficult proposition that European funding agencies must now address themselves.
References 1 National Research Council (1986) Nomenclature and Information Organization. National Academy Press, Washington D.C. 2 Rogosa, M., Krichevsky, M.I. and Colwell, R.R. (1971) Int. J. Syst. Bacterio]. 20, 6A-175A 3 Coulson, A. F. W. and Collins, J.F. Biological Sequence Analysis. A d vanced Architecture Computing Requirements. Report prepared under contract with the European Economic Communities. Copies may be obtained from CUBE-DGXII, 200 rue de la Loi, B-1049 Brussels, Belgium []
[]
[]
in the USA, the Community looked at the risks that might come from r-DNA research, and adopted the Council (see Glossary) Recommendation 82/472/EEC on the registration of work involving r-DNA. This urged the member states to set up national notification schemes and containment guidelines. Most of the member states have done so; several of the schemes are mandatory, some involve containment guidelines, but one member state in which considerable research is going on - Italy - has nothing. At the same time, the Commission of The European Communities (see Glossary) decided that the field of biotechnology applications covered such a diverse number of industrial sectors and products, that a crosssectoral, community-wide approach was vital to ensure that European companies would be in a position to compete successfully on the world markets. Hence, in February 1982, the Biotechnology Steering Committee (BSC) was set up to coordinate EC policies affecting or affected by developments in biotechnology. The BSC is composed of the directorsgeneral of the Commission services concerned: internal market and industrial affairs; environment, con-
© 1997, Elsevier Publications, Cambridge 0166- 9430/87/$02.00
T I B T E C H - M A Y 1987 [Vol. 5]
sumer protection and nuclear safety; employment, social affairs and education; agriculture; under the chairmanship of Dr Paolo Fasella, Director General for Science, Research and Development. Regulation was marked as a special area of attention. Later, in July 1985, a further interservice committee was set up to work at a more technical level on regulation. This Biotechnology Interservice Regulation Committee (BRIC) has six tasks: • to review the regulations applied to commercial applications of biotechnology; • to identify existing laws and regulations that may govern commercial applications of biotechnology; • to review the guidelines for r-DNA research; • to clarify the regulatory path that products must follow; • to determine the adequacy of current regulations on risks, and to initiate specific actions where additional regulations are deemed to be necessary; • to ensure the coherence of the scientific data that will form the basis of risk assessment 1. BRIC's function is to coordinate the work of the separate services, not to direct them, so that they retain their frill authority to examine, initiate and manage regulations within their respective areas of competence. The two services which might have the greatest interest in regulation Internal Market (DG III) and Environment (DG XI) - share the chairmanship, rotating every six months. BRIC's first step was to review the scope and applicability of existing EC legislation to biotechnology processes and products. At the same time, it tried to identify areas of higher risk which should be of special regulatory concern. The review covered a wide range of legislation, from directives on products (pharmaceuticals cosmetics, foodstuffs, food additives, agricultural and industrial chemicals) and industrial activities (major accident hazards, waste management, environmental impact assessment and worker protection). Gaps were found in all areas. In some cases, the scope of the existing directives was limited to chemical substances and could only be
amended to cover living organisms with great difficulty. In other cases, particularly in the product regulation area, directives had been adopted with the main purpose of harmonizing national standards and procedures; they often stopped far short of creating a unified EC regulatory system. At this stage, therefore, although the need for European legislation had been recognized, little had been done beyond urging member states to establish guidelines for laboratory recombinant DNA containment. A regulatory framework The second stage began in spring 1986, with the convening of a 2-day meeting of senior officials from the member states to discuss the biotechnology regulatory situation in Europe. Several things became clear at that meeting. A number of member states were about to adopt guidelines, procedures or new legislation governing the release of genetically modified organisms to the environment. There was general agreement that it would be far better if the European Community could quickly develop a framework of law governing biotechnology - both to protect the environment and to protect the common market. At about the same time and completely independently, five federations of industrial sectors using biotechnology which had formed a European Committee on Regulatory Aspects of Biotechnology (ECRAB) produced a well thought out proposal for a case-by-case notification and risk assessment scheme for the release of genetically modified organisms to the environment 2. In addition, Denmark formally notified the Commission of its intention to adopt new legislation on the production, import, sale or use of genetically engineered organisms or cells and, in response to the Commission's request, agreed to support efforts to develop Community legislation. Thus the emphasis of concern in Europe, voiced .independently in several countries and by representatives of both industry and government, was on the release to the environment of genetically modified
organisms, not on their contained, industrial use. European industries were feeling under considerable competitive pressure from US and Japanese producers; governments and industries were willing and even eager for the European Community to develop an overarching regulatory framework that would forestall potentially divergent national systems. On November 4th 1986, the Commission sent to Council a brief Communication, 'A Community Framework for the Regulation of Biotechnology '3. It said that it believed 'the rapid elaboration of a Community framework of biotechnology regulation to be of crucial importance to the industrialization of this new technology'. The Commission announced that it would bring forward legislative proposals before summer 1987 in two broad areas: (1) levels of physical and biological containment, accident control and waste management in industrial applications; (2) authorization of planned
TIBTECH - MAY 1987 [Vol. 5]
release of genetically engineered organisms into the environment. These proposals reflect the conclusions expressed in the 1986 OECD report 'Recombinant DNA Safety Considerations' which the Commission had been deeply involved in writing 4. Although the scope of the OECD report is quite limited because it concentrates on rDNA organisms and their contained, industrial use, it is the current point of departure for the discussion of control of risks from genetically modified organisms in general. The Commission clearly agrees with the OECD, those member states which are developing legislation, the USA, and ECRAB that the area of greatest concern - and the area of greatest ignorance and uncertainty is the release of genetically modified organisms to the environment. It does not believe that it is possible to propose 'general guidelines or testing requirements' for the time being. Instead, the Commission will propose a 'case-by-case evaluation and authorization procedure based on mandatory phased notification by industry'. Because it is acting so quickly, the Commission has the opportunity to create a unified European notification procedure, as it did for the marketing of new chemicals, free from the vested interests in longstanding national authorization laws that hamper such developments in other areas of product regulation. The Commission appears to be relying heavily on the OECD's work on industrial use. Its proposals will be aimed at ensuring common levels of containment, accident prevention and emergency response measures and waste management. The Directorate General for Social Affairs has been at work for some years on measures to protect workers against pathogenic biological agents and this work is directly relevant to the issue of the safety of genetically modified microorganisms. Models for legislation on waste management and accident prevention already exist among the Community's body of environmental legislation; the 1978 directive on toxic and dangerous waste (78/319/EEC) and the 'Seveso Directive' on the major accident hazards of industrial activities (82/501/EEC).
Harmonization
References
The European Community has a longstanding commitment to wider international harmonization than just among the twelve member states. It believes that the global market is needed for European biotechnology products and has repeatedly stated its preference for the OECD as a forum for international harmonization. It would like to see its efforts to develop Community legislation paralleled by an international pooling of resources - scientific, technical, financial, and political. Only in this way can the truly international dimensions of the control of risks from commercial applications of biotechnology be successfully controlled.
1 Commission of the European Communities (1985) The Commission's Approach to the Regulation of Biotechnology. Copies can be obtained on application to CUBE (Concertation Unit for Biotechnology in Europe), Commission of the European Communities, DG XII, 200, rue de la Loi, B-1049 Brussels, Belgium 2 ECRAB (1986) SwissBiotech. 4, 15-20 3 Commission of the European Communities, Communication from the Commission to the Council, A Community Framework for the Regulation of Biotechnology, COM(86) 573 final, Brussels, 4 November 1986 40ECD (1986) Recombinant DNA Safety Considerations, Organisation for Economic Co-operation and Development, Paris
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[]
[]
[]
[]
[]
[]
[]
[]
The European Bank of Computer Programs in Biotechnology (EBCB) L. A. Robertson and K. Ch. A. M. Luyben Commercial software is usually only available for non-specialist applications in w h i c h large numbers of people may be interested. For biotechnologists who see the computer as a means to an end in teaching or research and development, programming can be time consuming and frustrating. There is, therefore, a need for a m e c h a n i s m by which computing achievements can be pooled and shared among biotechnologists. With the advent of relatively cheap computers about 15 years ago, scientists were not slow to realize their potential for controlling equipment and rapidly processing large amounts of data. Few commercially produced programs were available and therefore many researchers started to write their own. Applications ranged from the control of complex biotechnological processes with recording of various parameters
Centre for Biotechnology, Delft University of Technology, Julianalaan 67, 2628BC Delft, The Netherlands.
and processing of data (e.g. van Breugel, 1986") to dedicated applications where micro-computers have been used to cut both the costs and the 'donkey work' in something as simple as electrode monitoring (e.g. Ref. 1). People also realized that these micro-computers could become a useful study-aid and, as the available graphics steadily improved, the acron y m CAL (Computer Assisted Learning) was added to the language. Specialized CAL programs are appearing on the market (e.g. the range pub*Van Breugel, J. (1986)Ph.D. Thesis. Delft University Press.
(~ 1987, Elsevier Publications,Cambridge 0166- 9430187/$02.00