Select Committee on European Communities Second Report - Written Evidence

Memorandum by Mr Mark Cantley

  Evidence from Mr Mark F Cantley, in a personal capacity, but drawing upon his professional experience,

    (a)  as a member of staff of the European Commission, Directorate-General XII (Science, Research and Development) from 1979 to 1992,

    —  as a member of the "FAST" programme team (Forecasting and Assessment in Science and Technology), sub-programme "Bio-society", 1979-1983;

    —  as Head of Unit XII-F-1 "CUBE" (Concertation Unit for Biotechnology in Europe), 1984-92, Secretariat of the inter-DG Biotechnology Steering Committee and Biotechnology Regulation Inter-service Committee ("BRIC"), during the preparation of the Directives EEC/90/219 and 220;

    (b)  as a member of staff of the OECD (Organisation for Economic Co-operation and Development), 1993-present, heading the Biotechnology Unit in the OECD Directorate for Science, Technology and Industry.


  1. As an active participant, on behalf of the European Commission (EC), in the OECD Group of National Experts on Safety in Biotechnology from its beginnings in the early 1980s, I accepted fully the OECD report, published in 1986, "Recombinant DNA Safety Considerations"; and its reasoning, reflected in the Recommendation of the Council of the OECD adopted on 16 July 1986 ("concerning safety considerations for applications of recombinant DNA organisms in industry, agriculture and the environment") which inter alia recognised,

    "that there is no scientific basis for specific legislation to regulate the use of recombinant DNA organisms".

  2. This reflected our experience in DG XII with the operation of the EEC Council Recommendation 82/472 (concerning the registration of recombinant DNA work), the advice of the scientific community (in particular, as articulated by the European Science Foundation, drawing on the recommendations of its Liaison Committee on Recombinant DNA Research), and international experience, particularly in the United States in the years following the Asolomar Conference of February 1975.

  3. Nothing that has occurred during the subsequent 12 years has invalidated those judgments, in spite of massive expansion of industrial and agricultural applications of modern biotechnology in many parts of the world and commercialisation of the resulting products. There has nonetheless occurred in Europe, a significant expansion of debate and legislative activity specific to the practice and products of genetic engineering. Similarly under Article 19.3 of the Convention on Biological Diversity (CBD), and a subsequent decision of the Third Conference of the Parties to the CBD, considerable effort is currently being devoted to the drafting of a proposed "Biosafety Protocol".

  4. The reasons for these developments have been political rather than scientific, and details have been recorded in an encyclopaedia article of near two hundred pages.[1] The final section, "Synthesis and Conclusions: Learning from History" is attached to this submission, by permission of the publishers (Appendix).


  5. Progress in human understanding, and particularly in science, is often achieved by recognising that a long familiar question is mis-formulated—that it incorporates implicit assumptions which are inaccurate, reflecting ignorance, prejudice or misconception. The OECD statement quoted above did not dismiss the many and various risks to human health or the environment which could arise in handling pathogens, importing exotic species, or running large-scale industrial fermentation plants. But it sought to emphasise that risks typically arise, not from the use of specific molecular techniques of great precision per se, but from the nature of the organism being handled, the gene(s) being introduced, and the context of the application. And many of these risks are long familiar, and have given rise to appropriate risk management procedures, implemented by various prudent practices, the training of professionals in the matters concerned, and corresponding regulatory and enforcement systems.

  6. This recognition led subsequent OECD work on safety in modern biotechnology to fragment into more specific consideration of the various different sectors of application—in live vaccines, as biofertilisers, in foods, in agricultural crop plants, etc. We would not wish to dismiss as valueless the intensive scrutiny which has been brought to bear upon biotechnology-derived innovations and applications, in agriculture, the food chain, vaccinology and other fields. Various agricultural practices have been highly destructive of the environment, and even inappropriately directed scrutiny can have accidental benefits in contributing to more prudent practices. But although burning down the house to produce roast pig sometimes works, it is not a rational or efficient method.


  7. The above reasoning was generally accepted in the European Commission and at Council in April 1990, when the Directives 90/219 and 220 were adopted. The Commission had felt itself obliged to legislate on the technology, in spite of OECD advice and US example, because it was faced with a proliferation of divergent national legislation, starting with the Danish Gene Technology Law of June 1986. The Catenhusen Commission (on Opportunities and Risks of Gene Technology) reported in January 1987, advocating legislation in Germany, which followed in 1990. (In both cases, the adverse consequences and absence of benefit from this restrictive legislation forced subsequent major amendment).

  8. It was also clear that the advent of gene technology presented a major opportunity to expand the authority of Environment Ministries, who encouraged and welcomed the initiative which was prepared within the Commission by the corresponding Directorate-General, DG XI (Environment).

  9. However, in deference to scientific opinion and the demands of existing regulatory authorities, the Commission's proposal acknowledged the logic of returning regulatory competence to the sectoral authorities concerned, even for the products of novel technology. It was clearly understood (and recorded by a Commission declaration in the Council minutes of 23 April 1990[2]) that, as modern biotechnology moved into application in various sectors, the sectoral legislation would add as necessary environmental safety requirements; and oversight of the placing on the market of genetically modified products would revert from Part C of 90/220 to the sectoral legislation concerned (cf Paragraph 2(b) of Article 10). An obvious example is in the Novel Foods Regulation.

  10. In practice, there has accumulated a substantial institutional investment, and stigmatisation of GMO products, which in the "post-BSE" climate of generalised distrust of innovation in the food supply makes it politically difficult to relax the current irrational and excessive regulation of such products. This apparently prudent behaviour in fact endangers human health and the environment, in diverting always limited administrative and scientific resources from real problems (e.g., the rise of food poisoning, AIDS, BSE[3]) to pseudo-problems. It is the more unfortunate, in discouraging investment in the use of these inherently safer and more precise tools, e.g., for less dangerous and more efficacious vaccines, for better control of microbial pathogens in food production, and for more environmentally friendly means of plant protection in agriculture.

  11. It may be appropriate to recall the plea of that great scientist and writer, Rachel Carson, in Silent Spring (1963), for more rational approaches to the control of pests:

    "We stand now where two roads diverge. But unlike the roads in Robert Frost's familiar poem, they are not equally fair. The road we have long been travelling is deceptively easy, a smooth superhighway on which we progress with great speed, but at its end lies disaster. The other fork of the road—the one "less travelled by"—offers our last, our only chance to reach a destination that assures the preservation of our earth.

    A truly extraordinary variety of alternatives to the chemical control of insects is available. Some are already in use and have achieved brilliant success. Others are still in the stage of laboratory testing. Still others are little more than ideas in the minds of imaginative scientists, waiting for the opportunity to put them to the test. All have this in common: they are biological solutions, based on understanding of the living organisms they seek to control, and of the whole fabric of life to which these organisms belong. Specialists representing various areas of the vast field of biology are contributing—entomologists, pathologists, geneticists, physiologists, biochemists, ecologists—all pouring their knowledge and their creative inspirations into the formation of a new science of biotic controls."

  That seems a far-sighted and prescient description of what modern biotechnology, through its inter-disciplinary efforts, is currently delivering through the seed industry.


  12. From what is said above, it should be clear that I view current regulatory structures for biotechnology in the EC as inappropriate, ill-conceived, and dangerous to the purposes they were thought to serve. In support of this, I would quote (as one authoritative example among many) the Director-General of the International Food Policy Research Institute, Dr. Per Pinstrup-Andersen, speaking at an OECD "Forum for the Future" conference held at OECD in June 1997, on "Agriculture on the Threshold of the 21st Century":

    "There are indications, however, that public pressure in Western Europe is likely to move governments to introduce legislation that will constrain or prohibit full utilisation of the opportunities offered by genetic engineering and other tools of modern science to be applied to food production and processing. Should such legislation spread within Western Europe and to the rest of the world, including the developing countries, the consequences for food security and nutrition could be severe . . ..

    Unfortunately, there is also a trend in several European societies to begin to consider that the application of science to agriculture may be part of the problem rather than part of the solution. Failure to understand that productivity increases in food production are an essential component of a future with food security for all has moved powerful societal groups to push for severely constraining legislation on agriculture research."[4]


  13. Based on the above general background, history, and the supporting materials cited, I would offer the following summary responses to the issues particularly mentioned in the request for evidence:

1. The appropriateness and efficacy of current regulation of

    (a)  research,

    (b)  release into the environment and

    (c)  novel foods and their labelling

at European Union level

  Response: largely inappropriate, inefficient and counter-productive, endangering health and the environment, and delaying beneficial innovations. The accompanying propaganda efforts by certain non-governmental organisations in Europe, with a talent for media publicity, have contributed to substantial misinformation at all levels, from the general public/consumers, to political leaders.

2. The appropriateness of current regulation at the level of the United Kingdom and other Member States

  Response: As Part B of Directive 90/220, relating to the control of research, is subject to national regulation, the UK has the opportunity (which it uses) to apply a balanced and pragmatic approach via bodies such as HSE and ACRE; but for commercial releases, the UK like other EU Member countries is constrained by the EU-level requirements and procedures of 90/220.

3. The most appropriate jurisdictions, (including international regulation and harmonisation) for decisions on genetically modified organisms

  Response: as was remarked by Montesquieu (De L'Esprit des Lois), "if it is not necessary to make a law, it is necessary not to make a law". There is no need for any "GMO-specific" jurisdiction, national or other. For those sectors some of whose products may require international regulation, and in which current or future products may comprise or contain GMOs, the most efficient and competent jurisdictions or bodies are likely to be those currently in place—e.g., the International Office for Epizootics, the OECD Seeds Schemes, the World Health Organisation, etc., for the various product groups falling within their areas of expertise and formal competence.

4. The effect of regulation on different sectors of the industry and on competition

  Response: the effects have been, and increasingly continue to be, massively detrimental to Europe as a location for research, development and commercialisation of products of modern biotechnology. The impact on the location of research and production facilities (i.e., to drive them outside Europe or dissuade inward investment from elsewhere) is already clear in the context of the pharmaceutical industry, the seed industry, and modern animal biotechnology.

4 June 1998

1   "The Regulation of Modern Biotechnology: A Historical and European Perspective. A Case Study in How Societies Cope with New Knowledge in the Last Quarter of the 20th Century", Mark F Cantley. Chapter 18 (pp. 503-681) of Volume 12: Legal, Economic and Ethical Dimensions (edited by D Brauer), of the Multi-Volume Comprehensive Treatise Biotechnology (Second, completely revised edition), edited by H-J Rehm and G Reed in co-operation with A Puhler and P Stadler. Pub: VCH, Weinheim, 1995. Back

2   Commission Declaration, in the minutes of the Council Meeting, 23 April 1990: Re Art. 10(2) of 90/220/EEC: "The Commission undertakes, when preparing legislation on marketing authorisation for products consisting of, containing or which could contain GMOs, to include in its proposals provisions for a specific environmental risk assessment of the product similar to that provided in this Directive. The Commission also undertakes, where appropriate, to propose modifications to existing product legislation in order to provide for such environmental risk assessment." Back

3   At a time (around 1990-91) when the Commission was liberally encouraged and enabled to finance research projects on "safety of GMOs", concerned staff had grant difficulty in mobilising resources for a Europe-wide research effort on spongiform encephalopathies-the risks of which were highlighted in the OECD's report (then in preparation), "Biotechnology, Agriculture and Food" (1992)-see p. 66. Back

4   "Major Uncertainties and Risks affecting long-term Food Supply and Demand", by Per Pinstrup-Andersen and Rajul Pandya-Lorch, IFPRI, paper presented at the OECD Forum for the Future, "The Agro-Food Sector on the Threshold of the 21st Century", Paris, 24-25 June 1997. Back

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