1.1 The Institute of Science in Society is an independent, non-profit research and educational organisation dedicated to developing and promoting socially responsible science, sustainable science, science for the public good and the integration of science in society. The Board of Directors and Founding Members include: Prof. Nick Furbank, Prof. Brian Goodwin, Dr. Mae- Wan Ho, Ms Angela Ryan and Prof. Peter Saunders.
1.2 Summary: We consider the scientific advice at present to be inadequate in terms of scope and balance, and insufficiently up-to-date. The precautionary principle does not appear to be part of the framework of advisory committees. The current system lacks the ability to respond to rapid scientific developments. We strongly support an overarching food committee which considers food safety, health, environmental, social and ethical impacts together; and which is also able to make proactive recommendations on research and development. It is necessary for the Government to be an "intelligent customer" for the advice it receives. Two specific issues we consider to be very important are discussed at greater length: the membership of the advisory committee and the nature of the evidence that is to be placed before it. The committee should include scientists who are not associated either directly or indirectly with the gene biotechnology industry, and the scientific evidence placed before the committee should, as far as possible, be publicly available. Under no circumstances should a new process or product be authorised if the committee has been denied access to evidence that it considered important.
2.1 We consider the scientific advice at present to be inadequate. The scientists on the committees are chosen largely from the ranks of those who are in one way or another predisposed in favour of gene biotechnology. The advice given often does not take the most recent scientific findings sufficiently into account. Furthermore, there has been no attempt, on the part of the Government, to obtain advice directly from the wider scientific community.
2.2 It is the Government that must decide on the framework within which the advisory committees should operate, and ministers must both accept this responsibility and be conscious of what it implies. The UK can choose to operate under the precautionary principle, as we strongly believe it should, so that before a new process or product is authorised it must be shown to be safe, or at least to have a level of risk acceptable given the need or likely benefits. Alternatively, it could follow the World Trade Organisation and other 'free trade' agreements and adopt what we might call the inverse precautionary principle, according to which any proposed new process or product must be authorised unless proven unsafe. The WTO decision preventing the EU from banning the import of products from cattle treated with rBST is an example. A NAFTA ruling last year requiring Canada to accept a new additive in petrol is another. As it is for the government, not the advisory committees, to decide which principle is to apply, ministers and civil servants must understand the issues well enough to make rational, responsible decisions.
2.3 The current system does not appear to have the ability to respond to rapid scientific developments. This reflects the lack of any independent advisory body whose remit it is to monitor and keep up with new developments, and the failure of decision-makers to obtain advice directly from the wider scientific community.
2.4 We strongly support the proposal for an overarching food committee which considers food safety, health, environmental, social and ethical impacts together. The issues are complex, many of them highly technical, and the field is developing rapidly and will have major impacts on all aspects of civil society. Such a body would also be expected to keep abreast of scientific developments and to make proactive recommendations on which lines of research and development should be encouraged or avoided.
2.5 While we do not expect ministers and civil servants to be experts in molecular biology, it would be useful if at least a few people in the relevant ministries were. Nevertheless, because it is the Government, not the advisory committee, that is ultimately responsible, ministers must be able to understand what the committee has concluded, and on what grounds. They should make it their business to know, at least in general terms, how genetic engineering is carried out, and how it differs from traditional breeding, and about phenomena such as horizontal gene transfer, on which genetic engineering is based. If they are going to approve products in which an expression such as 'substantial equivalence' appears, they should ask what precisely the term means, and be able to understand the answer they are given. While the advisory committee will make recommendations in individual cases, it is the government that must inform itself and the committee by commissioning research, and it should draw on a wide range of expertise. In Norway, for example, the relevant Government agency, the Directorate for Nature Management, has commissioned an independent scientist directly to produce a report on the ecological risks from horizontal gene transfer associated with the use of naked DNA in research, production and gene therapy (See Appendix. A copy of the summary of this report has been supplied to the Clerk of the Committee).
3.1 We recognise that there is bound to be a problem in choosing the members of an advisory committee. Inevitably, most of those with the necessary expertise will be involved in the activity that is to be regulated. In the case of genetically modified foods, many of the best qualified scientists are directly associated with companies in the food or chemical industry. Others are working in research institutes or universities that rely wholly or partly on funding from those industries. Members of the committee are required to declare their interest or leave the room when an application from a company with which they are associated is being discussed. This may well prevent any one company from going outside what is considered acceptable by the majority of those working in the industry. It does not, however, guarantee adequate regulation of the industry as a whole.
3.2 To achieve that, the committees must include qualified scientists who are not connected, directly or indirectly, with the industry. Genetic engineering is a rapidly evolving subject, and it is not easy for an outsider to be aware of the latest developments. Only someone with up-to-date knowledge can properly judge the evidence that is put before the committee. Only such a person will have the background to know which statements are plausible and which are not, and be able to ask appropriate questions in case of doubt. A year or two ago, faced with the statement that DNA is completely broken down in the gut, how many lay people would have thought to doubt that and ask for the evidence?
3.3 There is a place for lay people on regulatory bodies, but they are not a substitute for scientists completely independent of the industry. Lay people cannot make a proper contribution if they are obliged to accept as given that which they are told by scientists linked with the industry. Without the full, if frequently uncertain, scientific picture, they can do little more than put an ethical gloss on what industry has to say.
3.4 We cannot give examples of what has happened within the present committees as we do not have access to records of the discussions. Nevertheless, it is instructive to look at the booklet Ethics, Morality and Crop Biotechnology, published in 1996 by the BBSRC. It is difficult to see this as anything other than an apologia for gene biotechnology. In particular, it ends with a number of loaded questions, such as "Should the prime responsibility of scientists be to reduce risks to the absolute minimum, regardless of [our italics] the anticipated benefits?" The authors also state, "The history of science has proved to be highly unpredictable, and there can be no guarantee that "playing safe" by abandoning research and development in crop biotechnology will not deny us a technique which may prevent [italics in the original] an environmental disaster in fifty years time." This is an example of the 'inverse precautionary principle' mentioned above.
3.5 At present, both government and industrial funding in molecular genetics is heavily biased towards research connected in some way with the development of commercial products or techniques. As a result, most scientists who are sufficiently active and up-to-date are, directly or indirectly, involved in those developments. Far fewer are carrying out research that might throw light on the hazards. The Research Councils should give such research a much higher priority than at present.
3.6 Not only would the results of such research be of interest to regulatory bodies, by supporting it, the Research Councils would be helping to maintain a pool of scientists who could make valuable contributions to advisory committees. It is not just that they would be independent of industry, though that is indeed important. They would also approach issues from different points of view and with different, relevant experiences, complementing those of scientists involved in exploiting the technology.
4.1 The view has been expressed - in connection with evidence suggesting that the genetic engineering process itself is hazardous - that only results which have been peer-reviewed and published in learned journals should be taken into account. Yet the results of much of the work carried out by industry, including experiments designed to test the safety of new products, have been neither peer-reviewed nor published, but have nevertheless been accepted by the advisory committees in approvals of field trials and commercial releases. It is very important for the Government to ensure that scientific advisory committees base their recommendations on careful scrutiny of all relevant evidence on both sides of the debate, whether published or not.
4.2 Confidentiality can be invoked as a means of avoiding proper scrutiny. Companies often do, however, have legitimate concerns about commercially sensitive information. In such cases, evidence should be provided to the members of the advisory committee under conditions of strict confidentiality. Under no circumstances should a new process or product be authorised if the committee has been denied access to material it considered important. Except where the committee agrees that confidentiality is appropriate, all evidence should be made publicly available so that as many people as possible are able to comment on it. In this way, expertise beyond that possessed by the members of the committee can be brought into service.
28 March, 1999 This document was prepared by Dr. Mae-Wan Ho and Ms Angela Ryan, Biology Department, The Open University, Milton Keynes. Professor Peter Saunders, Department of Mathematics, Kings College, London
Article first published 1999
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