Decision-making on biotechnology: developing new principles for regulation

Journal of Environmental Assessment Policy and Management Vol. 1, No. 1 (March 1999) pp. 61-79 Imperial College Press

decision-making on biotechnology: developing new principles for regulation

by Julie Hill Biotechnology, specifically genetic modification, offers potential benefits to mankind, but also raises major social, environmental, health and ethical concerns. This paper deals with the agricultural applications of genetic technology, in particular, the potential environmental impacts of those applications. It considers the current underpinning principles of regulation in the United Kingdom (UK) and European Union (EU) and examines the problems for present decision-making processes, including disputes over risk assessment methodology, the handling of uncertainty, and lack of trust in official processes. The paper proposes a new set of underpinning principles for the decision-making process in the UK, and concludes that the UK should exercise leadership within the EU to ensure that these new principles are adopted across Europe.

Keywords: biotechnology, genetically modified organisms, environmental regulation, environmental decision-making, participation, risk assessment

introduction The term “biotechnology” covers any use of biological processes for human purposes.

Examples of “traditional” biotechnology are the use of yeast for brewing and baking; use of bacteria for medicines such as antibiotics; and the use of enzymes in washing power. However, it is the development of the so-called “modem biotechnology” that has excited controversy, specifically the development of techniques for genetic modification of plants, animals and micro-organisms. These techniques allow the transfer of genetic material from, in theory, any organism from any part of the natural world into any other organism. Thus human genes can be put into mice; jellyfish genes can be put into potatoes; and scorpion genes can be put into viruses.

Medicine and agriculture are the largest areas of application of genetic modification. In medicine, most of the work is with micro-organisms, altered to produce therapeutic drugs. In agriculture, most of the work has been to improve the ease of growing and the food quality of crops such as maize, oilseed rape sugar beet, potatoes and tomatoes, with staples such as wheat and rice, also in development. There are some transgenic animals, including sheep that produce human blood clotting factor and fish with growth hormone genes derived fro other fish species. Micro-organisms include viruses altered to make them better pest control agents, for instance, a caterpillar virus with genes that make it produce a scorpion toxin; and fungal micro-organisms altered so that they ac as factories for industrial enzymes.

'Julie Hill is the Programme Adviser to The Green Alliance, a UK-based environmental nongovernmental Organisation. She is also a member of the Advisory Committee on Releases to the Environment (ACRE), the statutory committee advising the UK Government on releases of Genetically Modified Organisms (GMOs).

This brief list of transgenics begins to illustrate the power and the potential reach of the technology. It is this power and potential that have given rise t vigorous political and public debate, particularly in Europe. Although in practice some plants, animals and micro-organisms have proved easier to transform t others, and there is as yet a relatively small group of transgenic organisms there is a perception that in the future all parts of the natural world will b amenable to man's intervention through genetic technology. This prospect raise considerable environmental, health, social and ethical concerns. concerns about the use of genetically modified organisms Environmental concerns include the possibility that altering the genes of crop plants might turn them into weeds capable of invading natural ecosystems, might enable them to cross-breed with wild species, and thus, spread the introduce genes into the environment with unpredictable consequences (RCEP, 1989; GA 1994). Crops engineered to have built-in pest-resistance, such as those with gene for bacteria-derived toxins might, it is feared, have a damaging effect on specie other than those targeted (English Nature, 1998). Less direct effects include how transgenic crops might alter patterns of chemicals use, enabling the us of more powerful weedkillers, which in turn would mean weed-free fields an less food for insects and birds (RSPB, 1997). Health concerns include whet genetically altered food could prove more likely to cause allergies, or whether introduced genes such as antibiotic resistance, which is often used in the course of the crop breeding process, might transfer to humans through the gut (Consumers Association, 1997). There are concerns about the safety of genetically modified drug products.

Social concerns include how transgenics will affect patterns of employment throughout the world, for instance, the technology produces convincing substitutes for valuable cash crops such as vanillin or cocoa, on which whole economies depend. The development in the US of a transgenic hormone to boost milk production raised fears that small dairy farmers would be put out of business. Ethical concerns include whether the transfer of genes from one organism to another affronts feelings about what is “natural” and also whether the benefits and risks of using genetically modified organisms (GMOS) are evenly distributed throughout society, both within individual countries and across the world (Grove-White et al., 1997). A dominant theme of the debates around GMOs has been the fact that the technology is concentrated in the hands of a small number of large multi-national companies, with inevitable questions raised as to whether the technology will be exploited primarily in the public or the private interest.

In response to some of these concerns, although not all, GMOs have become the subject of complex legislation, and convoluted sometimes conflicting, policy approaches in Europe. This paper deals with the agricultural applications of genetic technology, in particular, the potential environmental impacts of those applications, and examines the problems for the decision-making processes in the United Kingdom (UK) and in the European Union (EU) as they stand. It also proposes a new set of underpinning principles for the decision-making process in the UK.

the principles of existing European Regulation on GMOs There are two “horizontal” EU directives covering GMOS, meaning that they cover any application of the technology, no matter what the end products are. One covers the

use of GMOs in laboratories, factories and other contained facilities (90/219/EEC); the other covers the deliberate release of GMOs into the environment (90/220/EEC). The directives work on the following broad principles: health and safety based: The directives aim to prevent harm to humans or to the environment by requiring those wishing to work with GMOs to make risk assessments and to obtain consent to proceed on the basis of those risk assessments. They do not provide any mechanism for deliberating as to whether the technology is ethically acceptable or desirable. They do not provide for explicit assessment of benefits indeed, some commentators have argued that by constructing a mechanism to look at health and safety, the benefits are taken for granted (Green Alliance, 1998a). preventative: The directives require all applications to release GMOS, and many applications involving contained use, must have explicit consent. This provides a mechanism for ensuring that all applications of genetically modified (GM) technology are scrutinised, in case they have the potential to cause a problem, and in the hope of preventing any problems before they arise. This is not because it is assumed that all applications of the technology are dangerous (although critics of the regulatory system from the industry side argue that is the impression that has been given) but because it is feared a small minority will be, and in order to be sure of catching these, everything must be scrutinised. science-based: The final consents are granted by politicians, but in most countries in Europe they are acting on the advice of scientifically qualified "experts" who are capable of interpreting and judging the risk assessments put forward by applicants. In the UK at least, the advice of the scientific expert committees has never been rejected by the political authority. precautionary: This element is contested. The system is often presented as precautionary, although sometimes politicians use the term "precautionary" as another way of saying "preventative", i.e. it aims to identify problems before they happen.

However, there is another important sense of precaution, which is the action taken in the face of scientific evidence, in particular, how much evidence is needed to justify a course of action. This is an important aspect of regulation and policy on GMOs because of the large areas of scientific uncertainty in many of the risk assessments, particularly those that deal with long-term environmental impact (Hill, 1995). Given these areas of uncertainty, critics of the regulatory system argue that the precautionary principle dictates a halt, i.e. not going ahead with releases to the environment (Parr, 1997). Others argue that this cannot be the proper interpretation of the precautionary principle because it results in inertia, and will not lead to any expansion of our knowledge.

problems for the decision-making process lack of experience of the risks The regulatory system in Europe is based on the ability to obtain and scrutinise “risk assessments� for each release made. In the UK, the directives are implemented by Part VI of the Environmental Protection Act 1990 and the Genetically Modified Organisms (Deliberate Release) Regulations 1992, amended by the Genetically Modified Organisms (Deliberate Release) Regulations 1995. The heart of this system is the

requirement for anyone proposing to release a genetically modified organism, whether for experimental or marketing purposes, to submit a risk assessment and a dossier of supporting data. The detailed requirements for this are set out in guidance to the regulations (DOE/ACRE, 1993, 1995), drawing on the data requirements in the European Directive.

However, predictions about risk must be made without any experience of problems caused by GMOS, for the very reason that the system was designed as preventative and was put in place before any evidence of problems could arise. This means that risk assessment must rely on what is known about the organism that is being manipulated, what is known about the genes that have been inserted, and what is known about the environment into which the GMO is to be released. These three basic areas of knowledge are then bridged by assumptions about how they will interact.

For instance, for an oilseed rape plant that has been altered with genes for herbicide tolerance taken from a bacterium, which was the first application for a consent to release a GMO on a commercial scale in Europe, the assessment was based on the following rationale: that “a lot is known about oilseed rape and although it comes up on roadsides, it is not an invasive plant of natural areas; we know what these genes are designed to do and do not see any reason why they should alter the rape in such a way that would make it more invasive, nor do we see how those introduced genes could affect the environment in any other way; we know that in this environment, rape has very few wild relatives with which it could hybridise and pass on genes, but even if the genes did spread they would not be expected to confer any competitive advantage, so according to the laws of natural selection, they will not persist in wild populations of plants”. This is the kind of analysis (paraphrased) provided by the company submitting applications for release, and was endorsed by the majority of scientific experts on the UK's scientific committee, the Advisory Committee on Releases to the Environment (ACRE) (PGS, 1994; ACRE, 1995).

It can be seen from this kind of argument that risk assessments are based more on “deductive reasoning” than on direct observation. This means that in order for others, particularly those outside the regulatory system, to agree with the risk assessments and the regulatory judgements made on them, they have to agree with the assumptions and the deductions made. This is not always the case. In the example above, just about all the assumptions in the risk assessments were challenged by environmental groups.

Critics pointed to a lack of scientific data, for instance, on the possible degree of hybridisation and the persistence of introduced genes, which made certain assumptions unsafe, and therefore, a false basis from which to reason (GeneWatch, 1998).

These disagreements raise important issues about the handling of a scientific uncertainty and the meaning of precaution in this context. Given that the making of a final decision on whether or not to go ahead with a release involves a leap of logic rather than a set of observations, how much uncertainty can the system bear? Does it accept the uncertainties, make the leap, hope that the assumptions are correct, and institute monitoring to see if the assumptions are home out in the field? Or does it wait for more empirical data to diminish the uncertainties? The environmental groups invariably say that in the interests of precaution, it should be the latter. Scientists and the biotechnology industry tend to argue that this is a recipe for inertia and it is not an acceptable way to regulate.

there is no consensus about what kind of harm the system is trying to prevent Problems of uncertainty and precaution are complicated by a lack of any very definite sense of what kind of harm the regulatory system is trying to prevent. The European Directive does not define the types of environmental damage that might result from releasing GMOs and neither does the UK’s Envirom-nental Protection Act 1990, which enacts the European Directive. The guidance to the UK’s regulations begins to differentiate “low, medium and severe harm” and suggests how changes to populations and species might be classified into one of these categories. However, this guidance has not been widely debated and has certainly not received wide assent (DOE, 1993).

The view from outside the system, that it has not made up its mind on what to try to prevent, was reinforced by what appeared to be a major shift in the attitudes of scientific advisers and regulators in the case of the oilseed rape described above. Before the application to release the rape on a commercial scale, most applications for experimental trials sought to limit the spread of genes (gene flow) by various means, including preventing the crop from flowering and removing wild relatives in the vicinity. This had three important consequences: it gave the impression that gene flow was a bad thing per se; it also gave the impression that the system was behaving in a highly precautionary manner; and it meant that there was no useful empirical data about gene flow obtained from field trials. So when the first application to release the rape on a commercial scale came forward, and the scientific advisers saw no problem with the fact that there would be some gene flow, many commentators felt that the view on harm had changed, and that the precautionary nature of the system had been undermined (Hill, 1995; FOE, 1997; GeneWatch, 1998). to assess the effects of GMOs on agricultural practice One of the main criticisms of the European regulatory system has been that it does not deal adequately with “indirect” effects. “Direct” effects are thought of as the effects of the introduced genes on the behaviour of the crop, or the consequences of the spread of introduced genes in the environment. Indirect effects are the ways in which the use of GMOs might affect agriculture more broadly, and thus, affect the impact of agriculture on the environment. This includes changes to patterns of chemical use important because many of the first wave of GM crops are designed to be used as a package with chemicals - and changes to agricultural practices, such as where particular crops are grown (English Nature, 1998; RSPB, 1997; GA, 1994). Most member states of the EU have in the past argued against incorporating such indirect considerations into risk assessments, partly because such issues are often considered to be the business of agricultural authorities rather than the environment, which is where the GMO policy tends to reside, and partly for reasons of administrative complexity. However, this situation is changing, as more and more countries, including the UK, accept the need to factor in the less direct effects. The difficulty is how to assess them, in particular, how to analyse the contribution of GMOs to what are likely to be general trends in agriculture, such as intensive use of chemicals.

BSE and other food scares have led to a climate of distrust in the Government In the UK, in particular, the BSE (bovine spongiform encephalopathy – “mad cow” disease) debacle has eroded faith in the Government’s ability to protect consumer

interests, including environmental interests. It has also put the spotlight on the way in which scientific advice is given to government, in particular on the independence and integrity of those advisers, on the adequacy of the information on which they base their advice, and on the way in which their advice is used. For GMOS, and for food policy in general, these questions have led to calls for much greater transparency of the scientific advisory system, to attacks on some members of advisory committees for having “links to the industry�, and to very detailed examinations of committee advice by pressure groups. as part of the EU system, member states' sovereignty is limited Part of the rationale for a Europe-wide system of regulation on GMOS, alongside the physical fact that living organisms do not necessarily respect political borders, is one of ensuring that individual countries’ regulations do not present barriers to trade. This means an elaborate system for securing an agreement among all 15 countries that a GMO product can have a consent to be commercialised, and an even more elaborate system for arbitrating disputes if they do not agree the first time round. Because of the range of concerns brought to the considerations of the environmental impacts of GMOS, as outlined above, very few marketing consents have gone through the system without any dispute. The European Commission, left with the difficult job of coming up with possible compromise positions, has resorted to taking advice from another layer of scientific committees, constituted under the Consumer Affairs Directorate (DGXXIV) of the Commission. On occasion this advice, which has been used by the Commission as the basis for a final decision to determine for or against the marketing consent, has been at odds with the scientific advice given by committees in the individual member states. This has led to the impression that national sovereignty is being eroded and national concerns are being over-ridden. the industry developing the technology is not trusted Considerable knowledge and resources are needed to take a transgenic product from experimental stage, through a series of trials and on to marketing approval. This means that the technology has tended to concentrate into the hands of less than a dozen multinational companies, many of them chemical companies, because of the potential for chemical/GMO seed packages. These companies need to be sure of being able to recoup their large investments in the technology, and some have gained a reputation for aggressive marketing of GM products, and appear to ignore the concerns of consumers. The US company Monsanto, for instance, has been heavily criticised for trying to introduce BST, a genetically modified product designed to boost milk, into Europe against a background of strong animal welfare and economic concerns.

Monsanto was also the producer of the first GM food to be imported into Europe - soya beans engineered to be herbicide resistant. Monsanto appeared to be resistant to any suggestions that the product should be segregated from the non-GM version, and that the foods made from it should be labelled, which has also attracted strong criticism from the environmental and consumer groups.

The aggressive stance adopted by Monsanto is widely thought to have coloured perceptions of the rest of the industry. This situation puts additional pressure on regulators to be seen to be intervening in the activities of companies in the public interest.

adapting the decision-making processes Given these problems for the regulatory process as it stands, there have been moves, particularly in the UK, to consider whether the underpinning principles of regulation and control are correct, and if not, how to adapt them. The following section debates the possibilities for a new set of underpinning principles. regulation and policy could be “ethically-based” This idea has been put forward by English Nature (1998), one of the UK Government's official advisers on nature conservation. The suggestion is that regulation would work within an ethical “code of conduct” which would set the boundaries for GMO development. The agreement of such a code across society would help to answer some of the difficulties about trust in the Government and trust in the industry developing the technology.

This could mean the Government making a statement about the kind of GM development that should be considered unacceptable on ethical grounds. The parallels for this kind of government intervention in science are mainly in medicine -for instance, the development of UK guidelines and then legislation to limit research on human embryos produced as a result of in vitro fertilisation. There are no precedents for intervention in agricultural developments. Although there have been vigorous debates about the cloning of animals (which is a kind of genetic manipulation), no rules have been set other than the banning of cloning of humans. The debate has not yet extended to rules about plants.

One of the difficulties of ruling developments as acceptable or unacceptable on ethical grounds is deciding exactly what “ethical grounds” are. If they are principled objections to particular types of manipulation, i.e. objections to the process taking place, regardless of the consequences, it is fair to ask whose principles are being reflected. Should they be the principles arrived at by a body of the “great and good”, in other words, a learned committee, on behalf of the rest of the population? Or should they reflect the majority view of the population? If so, how do policy makers find out what the majority of the population feel, particularly when many people have limited knowledge of the implications of genetic technology?

If the ethical grounds for rejection of certain applications of the technology are more to do with outcomes than principles, then understanding the outcomes takes us back to all the problems of the risk assessment and prediction outlined above. Ethical grounds could be the existence of a certain level of uncertainty in the risk assessment process in other words, unless our knowledge is sound in key areas, it would be unethical to go ahead. This interpretation is one likely to be favoured by environmental groups.

The aspiration of setting an ethical framework for regulation would be to reflect society’s broad interests in the technology, in a way which might not be captured by purely safety-based regulation. As such, an ethical framework could cover the principles of the way in which GMOs are managed, as well as attempting to define the acceptable and unacceptable. It could require, for instance, that the provision of choice is a key condition for bringing GM products to the market, and thus, GM crops must be segregated from non-GM crops and GM food labelled as such. It could require that GM crops should lead to an improvement in the impact of agriculture on wildlife,

rather than assume that the effects of GM should be no worse than the effects of socalled “conventional agricultural practice�, which is the current inbuilt assumption of risk assessments. Such a requirement would necessitate a detailed examination of the impacts of the GM crops and of their non-GM counterparts, which is the kind of examination and comparison many environmental groups have called for. An ethical framework could require that the use of GM technology is justified, over the use of alternative methods, if available. This approaches the realms of cost-benefit analysis, which is discussed further below. policy on GMOs could be risk-benefit or cost-benefit-based One of the frequent complaints about the current regulatory system in Europe and in the UK is that it is entirely focused on risk, and that there is no mechanism for considering the benefits of the technology. This complaint comes both from the biotechnology industry and from nongovernmental groups (NGOS) - the former doubtless thinking that with formal consideration, the benefits would be seen to outweigh the risks, and many of the latter doubtless thinking the opposite, although there are some NGOs that are prepared to accept those biotechnology products with demonstrable benefits (de Vriend, 1997).

A risk/benefit debate would help to clarify what kinds of impacts should be considered harmful, since it would be impossible to weigh up risks and benefits without being clear about what kinds of risks and benefits were being taken into the equation. It would also force the development of techniques for assessing the impact of GMOs on agriculture, both positive and negative, since no risk/ benefit calculation could ignore this area of potential impacts.

The problems of making an assessment of benefits are similar to those of making an assessment of the risks - the primary one being availability of information. Some of the posited benefits are ones that could only be tested once the crop is grown on a commercial scale, for instance, the extent to which the use of chemicals is obviated or reduced. The reality of chemical use might be hard to assess in advance of a commercial consent being granted, so it is questionable whether this kind of consideration could be part of the granting of commercial consent. Also, judgements about benefits are likely to be even more value-laden than judgements about risks something that counts as a benefit to a farmer may be a definite disbenefit to a conservationist. That raises the question of who decides what is to be considered a benefit.

If it were possible to construct a process for assessing benefits that commanded widespread assent, it might be possible to present policy makers with an account of benefits set alongside the account of risks. The question would then be how to weigh one against the other and who would be responsible for doing this. The benefits and risks are likely to be of very different orders - someone would be presented with the task of deciding whether an indeterminable risk of spread of introduced genes into wild relatives of oilseed rape does or does not outweigh the benefit of farmers being able to grow the crop more easily, or rape oil producers being able to process the oil more easily. One solution to this would be to confine weighing up (or trading-off, because this is what it would amount to) of risks and benefits to risks and benefits of the same broad kind, i.e. environmental, economic and social. Even then, there would be value judgements to be exercised by someone, and that someone, whether an expert committee or a politician, would have a considerable responsibility. The result of such

a trading-off might be pressure to accept a higher degree of risk than has previously been allowed in return for certain benefits. In societal terms, this might seem logical and proper, but would attract criticism from environmental groups who tend to argue that there should be no enhanced risk to the environment from GMOS. The other danger of risk-benefit analysis is that it might be translated into cost-benefit analysis, in the way traditionally used by the UK and other governments. Although it is always possible to express both “costs” and “benefits” qualitatively, there is a strong tendency to want to turn them into monetary units. This may be valid for some aspects of costs -for instance, if one of the risks of using GM crops is damage to hedgerows from the particular chemical designed to be used in conjunction with that crop, it may be possible to make a monetary estimate of the costs of reinstating that hedge (although, conservationists would argue that an ancient hedge and its associated wildlife would be irreplaceable). However, it would be very difficult to attach a monetary value to the risk of gene flow, and entirely spurious to attempt to use contingent valuation techniques, one of the most criticised tools of cost-benefit analysis, to find a proxy value for the possible environmental damage. Using contingent valuation might involve asking people how much they would be prepared to pay to avoid gene flow a question unlikely to yield a meaningful result.

So the call to incorporate consideration of benefits into the regulatory and policy system for GMOs raises considerable methodological and political problems, and needs to be carefully debated. decision-making could be more “participative” NGOs frequently call for greater participation in decision-making processes, in all areas of environmental policy, and GMO policy has been no exception. In the UK, the main theme has been the need to broaden the range of advice given to the Government away from purely scientific advice to incorporate the views of a wider range of people (Macrory, 1997). The implication is that the scientific advisory system tends to narrow down the questions asked about the GMOs so that they are more easily amenable to scientific evidence; it tends to compartmentalise and ignore linkages between issues, for instance, the strong links between the GMO and pesticides policies; and it plays down the significance of uncertainty and the role of value judgements in coming to final decisions. The call for greater participation seems to be based on the idea that these problems could be lessened by diluting, or at least augmenting, the views of experts with views from people who are less expert but more aware of the broad implications of the technology. However, deciding what amounts to “participation” is not straightforward.

One interpretation of “participative”, and one that is relatively easy to implement, is “consultative”. There are two fronts on which a government could undertake consultation: the broad thrust of a GMO policy; and day-by-day decisions as to whether to let specific experiments or marketing consents go ahead. On a day-to-day basis, the UK Government publishes information about applications to make a GMO release, and says that it allows time for comments before the application goes any further. In practice, there is often little time to receive comments between the publication of the application and a meeting of the scientific advisory committee (ACRE), which is one of the places where comments can be considered. Comments are few. First, potential commentators have to notice that an application has come forward that interests them; the easiest way is by checking the internet index, which is not

accessible to everyone. Then they have to request details of the application from the government department, which can take time. Then they have to digest it and comment on it. Some might argue that the fact that very few people trouble themselves to go through this process, and those that do tend to be the staff of pressure groups rather than members of the public, indicates acceptance of the technology, or at least of the way the regulatory system is handling it. This cannot be assumed.

Another tacit means of consultation is the presence on the ACRE of a member drawn from an environmental pressure group (myself). Although, technically I do not represent Green Alliance, and am not expected to be directly mandated to express particular views by a constituency of other environmental groups, it is assumed that part of the role is to communicate with, and to reflect the views of, environmentalists other than myself. Although my presence on that committee, as a non-scientifically trained expert but as someone with NGO sensibilities, does amount to some broadening of participation, it is on a small scale.

It would be possible to improve consultation on individual applications by actively sending them out for comment, or by holding meetings on applications that raise new issues, so-called “first of a kind” consents. However, calls for participation in decisionmaking seem aimed more at the general direction of the technology rather than at the specifics of individual applications - questions such as “is it needed?”, “is it justified?”, and “is it ethical?” cannot be answered only by reference to particular proposed releases, but need to be debated in relation to the aspirations of the technology.

In the UK, consultation on the broad thrust of policy has been sporadic. There were consultation exercises on the framing of the UK law and the underpinning regulations in advance of, and during, their progress through Parliament in the early 1990s. There was a "consensus conference" on plant biotechnology in 1994 organised by one of the government-funded research councils (BBSRC, 1994), but since the exercise was not directly commissioned by the government, and had no obvious regulatory role, it did not appear to have much purchase on policy. Escalating complaints from a number of influential organisations that the government had no strategic policy on GMOs led to a “National Biotechnology Conference” in 1997, attended mainly by representatives of interest groups. The conference took place in the dying days of the Conservative administration, but after eighteen months in power, the Labour administration had yet to make a response. The Department of the Environment holds regular “contact group meetings” with a range of interest groups, including environmental NGOs and industry interests, but these tend to be more for exchange of information than explicit consultations on the direction of policy.

Denmark and Norway are two countries which have put in place mechanisms to ensure a broader consultation at a national level.

In Denmark, the need for a broad consideration of biotechnology and other technologies was recognised in 1995 when the Danish Parliament voted to establish the Danish Board of Technology. The Board of Technology aims to “further the technology debate, assess technological impacts and options and advise the Danish Parliament and the Government” (DBT, 1998). Its mission is to “promote the technology debate and public enlightenment concerning the potential of, and consequences of, technology”. It employs a variety of methods including consensus conferences, scenario workshops and a US technique called “future search”. The Board makes a distinction between “stakeholders”, which are people belonging to various

interest groups, including NGOS; and “citizens”, i.e. “non- Stakeholders”. Consensus conferences are used to access the views of citizens a body of people felt to be broadly, if not statistically, representative of the Danish people who are asked to receive information about, and deliberate on, a question over several days. A forthcoming consensus conference will consider what should be the Danish policy on GM food.

Scenario workshops are used to explore the views of stakeholders from a range of interest groups, to see how far they agree on policy options within their own group, and then whether they can agree across the groups. Future Search is a technique used to find consensus on policy options amongst groups that so far have not been able to agree on anything, by first getting the participants to agree that something must be done, then examining who has been responsible for killing initiatives in the past, and then exploring a wide range of options for the future to find some that all can endorse.

This is a technique that may in the future be used on the issue of GM food.

These techniques result in recommendations that the Board feeds to the Government and the Parliament. On the GMO policy, it is augmenting the advice from the Department of the Environment, which undertakes the scientific risk assessment of individual applications for releases. According to the Director of the Board, the influence exerted by the Board ranges from a direct translation of recommendations into the law (infrequent, but has happened) to a reinforcement of the policy prescriptions put forward by others. It is hard to evaluate the total effect that this has had on the Danish policy on GMOS, but one commentator has conjectured that, perhaps as a consequence of the Board’s activities, “Danish regulators have remained under pressure to consider broad implications of GMO products for agricultural strategy” (Levidow, 1998), a consideration that has only very recently had any credibility in UK policy discussions.

In Norway, the Gene Technology Act 1993 requires that alongside a scientific assessment of risks to the environment and to the health, there is an assessment of the social benefit of the application, the contribution of the product to sustainable development, and a judgement as to whether the application is ethical and justifiable.

All these factors should be brought together when a decision is made. In theory, these requirements apply to experimental releases as well as to applications for marketing consents, although it is difficult to see how such an assessment can be made of a smallscale trial. The regulatory authorities acknowledge that the main basis of decisions is the scientific risk assessment, and that assessing the other aspects has presented a major challenge.

Norway’s Biotechnology Advisory Board, a body independent of government which has members drawn from science, ethics, organisations for the handicapped, consumer groups, labour groups, industry, and environment groups, has struggled with a methodology for doing this for some time, and held an international conference in 1995 to debate the issues and make contact with expertise outside Norway (NBAB, 1995). The board is currently working up a more detailed guidance for the government on how to assess these various considerations, so it is too early to assess the value of this inclusive and participative approach.

It is clear that the initiatives in Denmark and Norway have provided the governments of these countries with good intelligence about societal views on biotechnology, something which has so far been lacking in the UK. However, they are still taking place at a slight distance from the centre of decision-making. One of the questions raised by the kind of consultative and advisory processes employed in these countries is how far these can be extended to mean a more direct participation in the regulatory system.

The UK Government is beginning to consider the creation of a “stakeholder body” to help assess the “wider” impacts of GMOS. The Government so far has not proposed a detailed model for this body, but the Green Alliance has put forward some of the options in a discussion document (GA, 1998b). Such a body might be composed of representatives from the NGOS, industry, scientific institutions and government departments, amongst others. It could have a remit to review the scientific advice put forward by the specialist advisory committees, both in terms of scrutinising the risk assessment methodologies employed, and also highlighting areas that it felt had received insufficient attention, such as uncertainty in the scientific data. It could also, if mandated to do so, undertake assessments of the benefits of the technology, or of particular applications of the technology, to sit alongside the assessment of risks. It could introduce ethical considerations. Most important, it could sit within the Government department with primary responsibility for environmental policy on GMOS, acting alongside the scientific committees, and reporting directly to the Minister. It could have powers to obtain information from any relevant individual or government department, and the Government could have a duty to take its advice into account when making a decision. These powers and the duty of the Government could give the UK stakeholder body a purchase on Government unparalleled in Europe.

The idea of a stakeholder body addresses the problems of trust in the Government and trust in the activities of the companies developing the technology by providing a forum in which judgements about the value of the technology are explicit. At present, critics of the regulatory system argue that such judgements are not absent from scientific assessments; they are buried within them. Safety regulation starts from the assumption that the technology is acceptable and justifiable, so long as it is safe, and this, it is contended by critics, colours scientific risk assessment to be more accepting of scientific uncertainties than it should be. Giving a stakeholder body a role in overseeing risk assessment methodology and practice should help to clarify the boundaries between scientific knowledge and value judgement.

The UK proposal at present is only to consider “wider” impacts in relation to impacts on the environment, the chief of which is likely to be a consideration of how the GMOs might change agricultural practice, and how that might in turn affect biological diversity in the UK. There are no plans to have “stakeholders” consider the role of GM technology in food and to look at broader questions of how far the technology is considered acceptable or justifiable in itself. However, the proposal to have a body that would sit alongside the existing scientific committee is an acknowledgement that protecting the environment needs different kinds of information and deliberation than have so far been available, and that this needs to be sited close to the heart of the decision-making process to be both effective and credible. the system could be more transparent The UK advisory system has moved a long way towards greater transparency in the last two years. The 1990 Environmental Protection Act ensured some release of information by requiring that the applications for releases were placed on a public register (a physical storage of dossiers at a number of locations, available for the public to inspect). However, all the proceedings and outputs of the advisory committee meetings were confidential. Now, the advice of the committee on each application is placed on the register with the application, and reports (not a full minute since remarks

are not attributed to individuals) are made available. An index of the register entries and the reports of meetings are available on the Internet (DETR, 1998).

However, the UK’s move towards greater openness has so far stopped short of holding advisory committee meetings in public. This is the ultimate form of transparency, and is probably one of the most effective ways of clarifying the extent of the rigour of scientific deliberations, the role of government officials in guiding those deliberations, and the relationship of the final advice given to the range of views expressed - all of these are elements in building public confidence in the relationship between science and government. In particular, meetings in public would address fears that scientists are reflecting industry viewpoints, fears sparked by the fact that there are few scientific experts who have not acted as industry consultants at one time or another. It is important that they are able to demonstrate that such work does not compromise their independence in an advisory committee context.

There is a danger in moving towards meetings in public of committee members becoming over-conscious of their audience and over-careful of what they say. There is also a danger that government officials and committee members will, in any event, find ways of having difficult discussions and reaching decisions away from the public arena.

However, it seems likely that the benefits of holding meetings in public would outweigh either or both of these risks.

conclusions If the UK Government were to embrace these additional underpinning principles for the GMO regulation and policy, it would go a long way towards addressing the current problems for the regulatory regime, as set out earlier in the paper. Failure to address these problems will mean continuing paralysing disputes between European countries about the interpretation of risks and uncertainties; continued opposition to GMO releases and GMO food products from a range of groups, not just environmental and consumer NGOS, but increasingly those close to the heart of the establishment (Hill, 1998); continued uncertainty for the biotechnology industry and the food and farming industries; and the possibility of increased public disquiet about the technology leading to a rejection of a specific, or even, all applications.

However, the UK could not realistically operate these new principles in isolation from the rest of the EU, since they may result in the rejection of particular applications to release GMOS. Unless the rest of the EU shares the principles that have led to such a rejection, the UK would be open to legal challenge under the existing Directives. It is clear that the UK, and other countries wishing to expand the basis of decision-making on GMOS, have to win political change at the European level.

There is a good reason to be optimistic that the UK Government will exercise a leadership role in Europe. In December 1998, the Government announced a review of the framework for overseeing developments in biotechnology (Cabinet Office, 1998), stating that: “This review will address any gaps or unnecessary overlaps in our current framework and will also consider other important questions such as whether our systems could be simplified and made more transparent, and the ways in which we consider ethical and stakeholder interests�. Such a review provides a major opportunity for the UK policy to respond to the widespread concerns about biotechnology and to reconstruct the ailing UK and European regulatory systems.

references Advisory Committee on Releases to the Environment (ACRE, 1995) Annual Report No. 2. Department of the Environment, London, UK Biological and Biotechnological Sciences Research Council (BBSRC, 1994) Final report of the UK National Consensus Conference on plant biotechnology. BBSRC, Swindon, UK Cabinet Office (1998) 17 December 1998 News Release CAB273/98 Consumers' Association (1997) Gene Cuisine -A Consumer Agenda for Genetically Modified Foods. Consumers' Association, London Danish Board of Technology (DBT, 1998) Website: http://wwwtekno.dk Department of the Environment (DOE) and the Advisory Committee on Releases to the Environment (ACRE) (1993) The Regulation and Control of the Deliberate Release of Genetically Modified Organisms (GMOs). DOE/ACRE Guidance Note No. 1 Department of the Environment (DOE) and the Advisory Committee on Releases to the Environment (ACRE) (1995) Guidance to the Genetically Modified Organisms (Deliberate Release) Regulations 1995. DOE/ACRE Guidance Note No.7 Department of the Environment, Transport and the Regions (1998) Website of Register of Releases: http://wwwenvironment.detrgov.uk/acre/index.htm English Nature (1998) Position Statement on Genetically Modified Organisms Friends of the Earth (1997) Genetically Engineered Oilseed Rape: Briefing Paper GeneWatch (1998) Genetically Engineered Oilseed Rape: Agricultural Saviour or New Form of Pollution.

GeneWatch, Buxton, Derbyshire Green Alliance (1994) Why are Environmental Organisations Concerned About Release of Genetically Modified Organisms into the Environment? Green Alliance, London Green Alliance (1998a) Filling the Gaps: Improving the Advisory System for Genetically Modified Organisms. Proceedings of a meeting held on 16 June 1998 at the Institute of Legal Studies, London Green Alliance (1998b) Improving the Advisory System for Genetically Modified Organisms: Discussion Document on a Proposed Stakeholder Body. Green Alliance, London Grove-White, R., Macnaghten, P., Mayer, S. & Wynne, B. (1997) Uncertain World: Genetically Modified Organisms, Food and Public Attitudes in Britain. University of Lancaster, UK Hill, J. (1995) In Interpreting the Precautionary Principle, eds. T. O'Riordan & J. Cameron Earthscan Press Hill, J. (1998) Public concerns over the use of transgenic plants in the production of crops from pests and diseases and government responses in British Crop Protection Council Symposium Proceedings, No.71. In Biotechnology in Crop Protection: Facts and Fallacies.

Brighton

Levidow, L. (1998) Democratising technology - Or technologizing democracy?

Regulating agricultural biotechnology in Europe. Technology in Society, Vol. 20, 211-226 Macrory, R. (1997) Report of the Rapporteur. UK National Biotechnology Conference, March 1997, London