1. Introduction

2. The adequacy and quality of scientific advice at present

3. The role and framework of Advisory Committees

  3.1  The speed of change and the time involved in safety scrutiny

  3.2  EU: UK relationship

  3.3  The major role for Codex Alimentarius in the WTO mechanism for safety evaluation

4. The ability of the current system to respond to rapid scientific developments

5. The value of an overarching body for GMOs

6. The Government as an "intelligent customer" for advice received

7. Conclusions relating to the Committee's specific questions

8. A more detailed scientific analysis of GM issues

  8.1  Quality and rigor of existing criteria

  8.2  Substantial equivalence

  8.3  Immune and hormonal status

  8.4  Industrial crops: managing the risk of chemical entry to the food chain

  8.5  Conclusions on some new proposals for better safety scrutiny

9. Events relating to Dr Pusztai

  9.1  The World in Action programme

  9.2  August 10th

  9.3  August 11th

  9.4  August 12th

  9.5  Dr Pusztai's contract

  9.6  Dr Pusztai's Alternative Report

  9.7  Recent events

  9.8  Conclusions relating to Dr Pusztai

10. Annex

1. INTRODUCTION

  The Rowett Research Institute undertakes research in the field of nutritional science with emphasis on the role of diet in health. This has led us to assess how to improve the safety evaluation of novel foods and feeds including those that involve genetic modification. We also have or have had extensive involvement in both the UK and EU systems of scientific advice (see 10. Annex). Dr Chesson is a member of the EU's GMO and Animal Nutrition Committees and Professor James is currently developing for the EU a new approach to meet the broader concerns of the public and European Parliament about GMOs. In this submission we do not deal with environmental issues relating to GMOs but concentrate only on food safety. We consider that more stringent testing systems are needed than those which appear to be acceptable in the US. We are currently proposing new measures for Europe to improve further the assessment of GMOs by using recently developed screening techniques. We consider first the questions listed by the Clerk of the Committee, then provide more details of the safety issues and finally deal with recent events relating to Dr Pusztai.

2. THE ADEQUACY AND QUALITY OF SCIENTIFIC ADVICE AT PRESENT

  Our personal experience of the merit based selection process for membership of the new EU expert committee structure established in late 1997 revealed that the UK has the most numerous and impressive high quality range of scientific expertise of any country in Europe. In order to maintain a reasonable geographical balance of experts, the Commission properly had to limit the UK input to EU committees. Our current analyses also show that the UK Scientific Committee system tends to be better supported in terms of scientifically trained administrators and secretarial assistance than many EU countries and the current, albeit expanding, DGXXIV system in Brussels. Nevertheless the decision about five years ago to reduce the numbers of senior Whitehall civil servants seemed to have a selective effect in removing outstanding scientific expertise from UK committees dealing with food safety. The effectiveness of the UK committee system depends on maintaining very high quality scientists in the Civil Service.

3. THE ROLE AND FRAMEWORK OF ADVISORY COMMITTEES

  The UK and EU committees tend traditionally to be in responsive mode, ie they answer the specific questions put to them by Ministries. Effective and pro-active committee Chairmen have, however, always had the ability to initiate changes in committee processes and to push for new areas to be considered. The system could, however, benefit from the clear acceptance that Committees should be able to propose areas for further analyses. This could be particularly useful and relevant to GMOs (see below). In the EU's Scientific Steering Committee, there is an explicit requirement by the Commission that we should evaluate issues broadly and initiate new approaches to problem solving. This is a valuable innovation.

3.1 The Speed of Change and the Time Involved in Safety Scrutiny

  The time demands on UK scientists who serve on GMO scrutiny groups is likely to escalate markedly. At present the university or institute funding and assessment mechanisms make no allowance for this contribution so UK scientists are, in effect, doing the work in their spare time. Our current experience of serving on EU committees also shows that to play an effective and very active part requires allocating up to two days per week with additional help from scientific assistants. Yet no formal support is currently available from either the EU or UK for this work.

  New UK arrangements have recently been developed to help with the checking of other EU country analyses of GMOs. These clearances will be checked by some of a large group of experts who will now be expected to work individually by post and e-mail. Our experience suggests, however, that there is no substitute for conjoint deliberations in committee and that the somewhat mechanical scrutiny of increasing numbers of GMO dossiers will fail to deal with broader issues of concern. That is why we propose below a new initiative to upgrade the guidelines for screening new GMOs.

3.2 EU: UK Relationship

  The relationship between EU and UK committees is still too complex. As noted above, UK committees now have to respond extremely rapidly to the clearance of new foods by other member states. We know that some EU countries do not have the same range of expertise on their committees as the UK so it is theoretically possible for a company to seek clearance for a food in a less rigorous system than in the UK. When there is disagreement within the EU the Commission plans that its DGXXIV committee system provides the Commission with independent advice. It is therefore seen as potentially acting as an arbiter between two opposing national views.

  Sweden now presents an anomaly within the EU. It has the most long-standing Food Authority within the EU and a justified reputation for rigorous analysis of issues. This is expected of an exceptionally talented scientific nation. It has been claimed that Sweden has decided that the FDA system of clearance is, in principle, very effective and that therefore the US clearance of a product should be acceptable in Sweden. If this is ture, now that Sweden is an EU member this would, by implication sanction the new food within the EU unless the UK expert group responds promptly with an objection. We, however, set out below some scientific proposals which go beyond the FDA's current approach to GMOs. These proposals imply that the EU should take a distinctive position on GMOs which will enhance the safeguards and might go some way towards allaying the very different and greater concerns in Europe about the safety of GMOs.

  Given the very large surge in GMOs coming up for approval in the next ten years, we believe it is important that the UK's system of scrutiny is enhanced, preferably with an even greater involvement in the EU system of evaluation. We believe the Commission might welcome proposals from the UK for a greater interaction with our national bodies. Experience with handling BSE issues in Brussels suggests that a new interactive process could work well at a civil service level without the repeated need for Commissioner/Ministerial clearance of new analyses and information from the UK. The UK has certaintly benefited in BSE terms by providing the EU with extensive expertise and background information. Whilst doing this it is essential to recognise that the Commission, and especially DGXXIV, must be seen to be completely impartial.

3.3 The major role for Codex Alimentarius in the WTO mechanism for safety evaluation

  If the EU concludes that a biotechnological innovation is unacceptable on safety or other, eg environmental grounds, this may clash with current US, Japanese or Chinese assessments. The US government, for example, may then claim inappropriate trade discrimination and appeal to the WTO. The agreed mechanism then is for the Codex Alimentarius Commission (a joint WHO/FAO responsibility) to bedesignated the final arbitrator if the trade barriers depend on a health issue. Codex has already arbitrated against the EU ban on the use of hormones in beef production and the EU is currently required to provide positive evidence that hormone residues in meat are a risk to health. The same issue may arise if the EU follows the new decision by Canada to ban the use of bovine somatotrophin (BST) currently used throughout the US dairy industry. The decision may turn predominantly on animal rather than human health so how this is handled by the WTO remains unclear to us.

  Public Health has traditionally been of little import in WTO terms when there is a trade dispute. Thus when India tried to ban US cigarette imports, the WTO forced India to give access to US tobacco companies and use equivalent measures against cigarette use for both US and Indian products. Despite the huge financial muscle of US tobacco firms, the only measures available to India were to ban all cigarette advertising and discourage cigarette use through a variety of classic measures such as health education and smoking restriction in some public places.

  The reputation of Codex is disputed. It has evolved over decades as a useful system for specifying standards for pesticide residues and other safety measures as well as crude technical issues such as the methods needed to measure the nutrient content of foods for special dietary uses. It operates, however, through a series of committees with very heavy industrial involvement (particularly from the US) and very few representatives of the public interest. Only half of all member states ever become involved through their health ministries. When there is a health issue and Third World countries are very poorly represented. Modern and well accepted principles of public health, eg the concept that modest individual but universal risks cumulatively impose substantial health burdens on societies or that health education involving the labelling of foods to enable individual choice has limited application in many population groups, are also poorly understood.

  These public health concepts are also often disputed by those from other disciplines so it seems unlikely that important new public health concerns will have much impact in Codex let alone in the WTO. Therefore how GMOs will be handled given the startlingly different attitudes in Europe and the US to the risk/benefit ratios of new GMOs is very uncertain.

4. THE ABILITY OF THE CURRENT SYSTEM TO RESPOND TO RAPID SCIENTIFIC DEVELOPMENTS

  The very few GMOs currently cleared in the UK have not presented any major problems in relation to public health during their evaluation. Thus neither of us is concerned with the current GM foods available for sale within the UK. However, given the extremely large number of GMOs currently under trial, we consider that there is a need to develop new screening strategies which take account of current scientific knowledge and the need, clearly expressed within Europe, to have greater assurances on the safety of GMOs.

  The system does not at present respond well to rapid scientific developments for the following reasons:—

(a)  Most companies understandably and properly have followed guidelines for submitting data on safety. These guidelines, however, were established many years ago. Since almost all scrutinised data on a GMO are company derived, they inevitably conform with these older guidelines. Only when objections come from a country's expert evaluation will further work be undertaken.

(b)  The types of safety evaluation are, as expected, those traditionally used in toxicological analyses.

(c)  The response to novel developments is usually to base the assessment on screening methods which have evolved after decades of experience with hundreds of environmental contaminants/pesticides etc. An assessment is then made of whether a chemical compound is "substantially equivalent". If so, then it is expected to behave similarly to older compounds.

  We believe that both on a UK and EU basis there is a need to upgrade and extend the safety evaluation processes so that clear guidelines can be generated based on modern scientific analyses and understanding. This therefore requires a new proactive role in developing more extensive and sophisticated guidelines which should be regularly updated.

5. THE VALUE OF AN OVERARCHING BODY FOR GMOS

  We understand that the health issues relating to GMOs will be dealt with by the new Food Standards Agency (FSA) if, as seems likely, it is established during this Parliamentary session. In the original proposal for establishing the FSA it was assumed that when there were issues relating to other problems, eg environmental concerns, there would be a need for a conjoint group to link the two areas of concern. Such a mechanism still seems to be appropriate.

6. THE GOVERNMENT AS AN "INTELLIGENT CUSTOMER" FOR ADVICE RECEIVED

  The role of scientists within the senior Civil Service has been much debated for several decades. With the recent cuts in senior Civil Service posts, the support structures for departmental senior scientists seem to have been markedly reduced. Nevertheless, the welcome new emphasis on the industrial significance of scientific innovation, the Foresight exercises and the prominent roles of the Chief Scientists and Director of Research Councils are evidence of the Government's ability to act as an "intelligent customer". The recognition of the need for sophisticated scientific interpretation for policy making when coping with the BSE crises has amplified the importance of high quality science at a senior level. Whether the UK has the "capacity" to cope with the welter of new scientific issues might need, however, spearate analysis.

7. CONCLUSIONS RELATING TO THE COMMITTEE'S SPECIFIC QUESTIONS

  The UK has an exceptionally good reputation for the quality and range of scientific advise available to it for policy-making purposes. The effectiveness of the advice depends, however, on maintaining very high quality senior Civil Servants with scientific expertise. Given the very substantial increase in the number of GM crops for scrutiny in the next five to 10 years, the UK needs to be sure that it can cope with the demand for rapid assessments. We consider, as set out in more detail below, that there is a need to develop more effective guidelines for the scrutiny of GM crops. We assume that the Food Standards Agency will be proactive in enhancing the quality of scientific data required and in ensuring that Non Governmental Organisations and other public interest groups recognise and contribute to the assurance of safety. The development of more effective guidelines should also take advantage of the continuing Royal Society scrutinty of these issues and regular updating of the guidelines will be required.

  The complexity of UK/EU and World Trade Organisation relationships needs to be recognised. It is suggested that a proactive UK role in developing better guidelines which go well beyond current US FDA requirements could contribute to improving the interaction of UK and EU scientific analyses. Trade disputes might well arise and the UK would then need to have in place a substantial body of scientific research and opinion to provide to the Codex Alimentarius Commission which is not currently tuned to exert its designated role in global arbitration on these complex scientific issues.

8. A MORE DETAILED SCIENTIFIC ANALYSIS OF GM ISSUES

  Dr Chesson's experience of scrutinising GMOs on a European basis has led to a more detailed analysis of the issues and the development of proposals as set out below.

  In the EU the assessment of risk to humans, animals and the environment centres on Directive 90/220/ECC and any hazard following "accidental" consumption or exposure. In addition, the requirements of the Novel Foods and Novel Food Ingredients Regulation (EC 258/97) must be satisfied before a GM crop (or any product derived from it) can be used for food purposes. In the UK, Ministers are advised on these issues by the Advisory Committee on Releases to the Environment (ACRE) and the Advisory Committee Novel Foods and Processes (ACNFP). In the future, the feed use of GM crops may be separated from the present system and dealt with by new regulations and/or advisory bodies in both the UK and EU.

  The current principal issues considered by advisory bodies in relation to the release of GMOs are:

—  the potential for transfer of the introduced gene(s) to other species;

—  the safety of the introduced gene product(s) and

—  the question of "substantial equivalence".

  The third issue is a commonly applied concept used to suggest that inadvertent changes, ie other than those deliberately introduced by recombinant technology, can be expected to be of no significance in the transformed plant. This approach has proved adequate for the few crops than have been formally assessed for safety to date at a National or European level, but it is based only on the experience gained from the consideration of a handful of structural and regulatory genes (Table 1).