TIBTECH - MAY 1987 [V01.5]

of its own research from overseas suppliers. European companies are on the move however. The Swiss on- line host Datastar, for instance, now has its own marketing team in the USA selling British and Dutch bio- medical 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 stim- ulate 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 prob- lems. The University of London to- gether with the Imperial Cancer Re- search 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 informa-

tion 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 scien- tists? 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

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 Organ- ization. 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. Ad - 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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Controlling the risks to health and environment

from biotechnology- what is the European Community

doing? Cynthia Whitehead

The EEC is an economic community which must endeavour to unify the regulation of trade and environment among its member states. The establishment of international regulatory standards in bio- technology wil l be relatively less hindered by entrenched national legislation and practices than in other industrial sectors. Rapid progress towards a common biotechnology market wil l benefit both manufacturers and research in Europe, and provide common stan-

dards of health and environmental protection.

During the past three years, the Euro- pean Community (EC) has been quietly and steadily laying the foundation for a framework of poli-

Cynthia Whitehead is Editor of the Euro- pean Environment Review, 23, A v. Eisenhower, B-1030 Brussels, Belgium.

cies and laws that will identify and control the risks to human 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

in the USA, the Community looked at the risks that might come from r-DNA research, and adopted the Council (see Glossary) Recommen- dation 82/472/EEC on the registra- tion 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 consider- able 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 cross- sectoral, 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 Commit- tee (BSC) was set up to coordinate EC policies affecting or affected by developments in biotechnology. The BSC is composed of the directors- general of the Commission services concerned: internal market and industrial affairs; environment, con-

© 1997, Elsevier Publications, Cambridge 0166- 9430/87/$02.00

TIBTECH - M A Y 1987 [Vol. 5]

sumer protection and nuclear safety; employment, social affairs and edu- cation; agriculture; under the chair- manship of Dr Paolo Fasella, Direc- tor General for Science, Research and Development. Regulation was marked as a special area of attention.

Later, in July 1985, a further inter- service committee was set up to work at a more technical level on regula- tion. This Biotechnology Interservice Regulation Committee (BRIC) has six tasks: • to review the regulations applied to commercial applications of bio- technology; • to identify existing laws and reg- ulations that may govern commer- cial 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 cur- rent regulations on risks, and to initi- ate specific actions where additional regulations are deemed to be neces- sary; • 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, initi- ate 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 Environ- ment (DG XI) - share the chairman- ship, rotating every six months.

BRIC's first step was to review the scope and applicability of existing EC legislation to biotechnology pro- cesses and products. At the same time, it tried to identify areas of higher risk which should be of spec- ial regulatory concern. The review covered a wide range of legislation, from directives on products (pharma- ceuticals cosmetics, foodstuffs, food additives, agricultural and industrial chemicals) and industrial activities (major accident hazards, waste man- agement, 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 regula- tion area, directives had been adopted with the main purpose of harmoniz- ing national standards and proce- dures; they often stopped far short of creating a unified EC regulatory system. At this stage, therefore, al- though the need for European legisla- tion had been recognized, little had been done beyond urging member states to establish guidelines for laboratory recombinant DNA con- tainment.

A regulatory f ramework 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 bio- technology regulatory situation in Europe. Several things became clear at that meeting. A number of mem- ber states were about to adopt guide- lines, procedures or new legislation governing the release of genetically modified organisms to the environ- ment. There was general agreement that it would be far better if the Euro- pean Community could quickly develop a framework of law gov- erning biotechnology - both to pro- tect the environment and to protect the common market.

At about the same time and com- pletely independently, five federa- tions of industrial sectors using bio- technology which had formed a European Committee on Regulatory Aspects of Biotechnology (ECRAB) produced a well thought out pro- posal 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 pro- duction, import, sale or use of gene- tically engineered organisms or cells and, in response to the Commis- sion's request, agreed to support efforts to develop Community legis- lation.

Thus the emphasis of concern in Europe, voiced .independently in several countries and by representa- tives of both industry and govern- ment, 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 Com- munity to develop an overarching regulatory framework that would forestall potentially divergent national systems.

On November 4th 1986, the Com- mission sent to Council a brief Com- munication, 'A Community Frame- work for the Regulation of Biotech- nology '3. It said that it believed 'the rapid elaboration of a Community framework of biotechnology regula- tion to be of crucial importance to the industrialization of this new tech- nology'.

The Commission announced that it would bring forward legislative proposals before summer 1987 in two broad areas:

(1) levels of physical and bio- logical containment, accident con- trol 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 con- clusions 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 r- DNA 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 test- ing requirements' for the time being. Instead, the Commission will pro- pose 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 Euro- pean notification procedure, as it did for the marketing of new chemicals, free from the vested interests in long- standing 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 Direc- torate General for Social Affairs has been at work for some years on mea- sures 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 legisla- tion on waste management and acci- dent prevention already exist among the Community's body of environ- mental legislation; the 1978 direc- tive on toxic and dangerous waste (78/319/EEC) and the 'Seveso Direc- tive' on the major accident hazards of industrial activities (82/501/EEC).

Harmonization The European Community has a

longstanding commitment to wider international harmonization than just among the twelve member sta- tes. It believes that the global market is needed for European bio- technology products and has re- peatedly 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 interna- tional pooling of resources - scien- tific, technical, financial, and politi- cal. Only in this way can the truly international dimensions of the con- trol of risks from commercial appli- cations of biotechnology be success- fully controlled.

References 1 Commission of the European Com-

munities (1985) The Commission's Approach to the Regulation of Biotech- nology. Copies can be obtained on application to CUBE (Concertation Unit for Biotechnology in Europe), Commission of the European Com- munities, DG XII, 200, rue de la Loi, B-1049 Brussels, Belgium

2 ECRAB (1986) SwissBiotech. 4, 15-20 3 Commission of the European Com-

munities, Communication from the Commission to the Council, A Com- munity Framework for the Regulation of Biotechnology, COM(86) 573 final, Brussels, 4 November 1986

40ECD (1986) Recombinant DNA Safety Considerations, Organisation for Eco- nomic 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 which 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 mechanism by which computing achievements can be pooled and

shared among biotechnologists.

With the advent of relatively cheap computers about 15 years ago, scien- tists 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. Applica- tions ranged from the control of complex biotechnological processes with recording of various parameters

Centre for Biotechnology, Delft Univer- sity of Technology, Julianalaan 67, 2628BC Delft, The Netherlands.

and processing of data (e.g. van Breugel, 1986") to dedicated applica- tions 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 use- ful study-aid and, as the available graphics steadily improved, the acro- nym CAL (Computer Assisted Learn- ing) was added to the language. Spec- ialized 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