Summary of Meeting Paper

The 1996 Annual Meeting of the Society for Risk Analysis-Europe

The Policy Process Towards Discursive Procedures on Assessing the Risks of Genetically Modified Organisms. René von Schomberg, Tilburg University, Postbox 90153, NL-5000 LE Tilburg, The Netherlands, email: R.vonSchomberg@kub.nl

1. Introduction

The issue of the deliberate release of genetically modified organisms (GMOs) into the environment was posed as a policy problem. This was perhaps unavoidable since one of the reasons why the contained use of GMOs was regulated was that an unintentional release should be prevented. It was perceived as a problem with manifold aspects which could only be dealt with by appealing to science, manageability and social conventions. This threefold appeal to fundamental institutions of society implied a threefold reduction of the problem. The policy process for the release of GMOs into the environment is the focus of this paper and it is argued that a discursive policy process is needed to achieve an integrative, non-reductionist approach to the problem. In the Netherlands, for example, this has been the approach to some extent. I will argue that only a discursive policy process can overcome the problems of decision making in the context of uncertainties and I will here draw upon the experience gained during an EU funded study.¹

2. The Appeal to Science

The authorative appeal to science underlies the assumption that we have confidence in the functioning of the scientific system, for example, that it can provide policy makers with reliable knowledge and adequate predictions which are needed for a manageable practice for which policy regulations must set the framework. In the case of the deliberate release of GMOs, the usual confidence in science is problematic for two reasons. First, we have to deal with a trans-scientific problem, that is a problem that can be stated in the language of science but cannot be solved within the language of science. Our current knowledge does not provide us with the means to predict the ecological long-term effects of releasing organisms into the environment. So it is beyond the competence of the scientific system to answer such a question, despite the fact that competence is normally the basis for an authoritative appeal. In fact, science would not pose such a question to itself since there is no method to make this question researchable. Reasoned statements on this subject matter cannot go beyond theoretical speculation. The reason for an appeal to science is solely policy motivated: we would like to have the answer to this question for achieving a manageable practice. So we have a good reason to be suspicious if scientists are nevertheless prepared to provide us with some kind of answer to this question. We can reconstruct two kinds of 'answers' science has given us so far. The first answer came from one branch of science, where most scientists were biotechnologists, molecular biologists or microbiologists. They answered the question by acknowledging the trans-scientific problem and stating that the development of a testprotocol for identifying the risks of individual organisms would be an unachievable task (Brill 1985).² However, at the same time they argued that this is irrelevant knowledge since we can rely on the experience with traditional plant breeding practices, which differs, on their account, insignificantly from the practice of genetic engineering -- only in so far that we now exactly know what kind of new genes we are introducing. Ecologists on the other hand down-played the trans-scientific issue, by saying that they could develop precisely the type of knowledge policy makers asked for by doing research on so called 'microcosms' (see also Krimsky in this volume) needed to make predictions possible in terms of quantitative risk assessment (Tiedje et al. 1989).³

From a policy perspective both answers are unsatisfactory because a biotechnologist cannot address the problems in terms of safety or in terms of risk. They just rhetorically state that it would be an 'acceptable risk' (by appealing to the fact that we already accepted the risks associated with conventional plant breeding). However this does not give us an informed opinion on how to regulate individual cases, nor did it address the issue of a precautionary approach. Ecologists, on the other hand, underestimate the difficulties of the trans-scientific issue: the promise of providing a quantitative risk assessment in the course of microcosm-based experiments, and without conducting field experiments, cannot be fulfilled m the foreseeable future. Only if one fully appreciates the trans-scientific issue, one sees the dilemma for policy: allowing major field experiments might involve unknown environmental impacts. To impose too many constraints on these experiments, however, would imply that we will never gain knowledge on the behaviour of GMOs. In the next section we will see that this dilemma bounces back on the regulatory system we have in place: what did we learn from the field experiments conducted during the last decade?

The appeal to science for policy has been made without reflecting sufficiently on the trans-scientific issue underlying a scientific controversy. Science reduced this issue by translating it into a question of relevancy to which both molecular biologists and ecologists came up with unsatisfactory answers. As a consequence, the contradiction that arises between policy and science has not been reflected either:⁴ Policy has to be engaged m science to look for answers concerning perceived risks but cannot make a legitimate appeal to a science which does not resolve the relevancy question.

3. Appealing to Manageability

Hans Bergmans, Secretary of the Commission on Genetic Modification (COGEM in the Netherlands, does not agree with the familiar argument that the field experiments with GMOs have demonstrated their safe environmental use.⁵ According to Bergmans, it has only shown that experiments have been planned carefully. The experiments did not have any environmental impact other than those expected (to our knowledge). Consequently, the field experiments did not teach us anything about the behaviour of GMOs. This conclusion changes the initially intended perspective on the 'step-by-step' procedure. Rüdelsheim, from the company Plant Genetic Systems (PGS), based in Belgium, also affirmed this change in perspective at a workshop held in May 1995:⁶

One could say so far, the 'step by step' procedure focused more on

In conclusion, I would argue that if we still think that it is necessary to gain knowledge on the behaviour of GMOs we have to do something other than reviewing applications within the current 'step-by-step' procedure since it cannot demonstrate the safe environmental use of GMOs.

According to Bergmans, we should now plan experiments with an intended environmental effect in order to gain the necessary knowledge. Bergmans advocates that we should allow applications with GMOs with similarly manageable effects such as the accepted agronomic effects of conventional agriculture. These types of releases could yield information on the behaviour of GMOs. Stressing the fact that only an increased knowledge of basic natural processes can help risk analysis, he also claims that it would be useful to use GMOs in order to increase our knowledge of micro-organisms in the environment and suggests that genetic modification can be used for the 'tagging' of micro-organisms so that they can be followed in the environment.

The task for policy is to translate the precautionary assumptions of the legislation which is based on a 'case-by-case' and 'step-by-step' procedure into a manageable practice that acknowledges these assumptions and make a science-informed learning process possible. We have observed that Bergmans addressed the trans-scientific issue explicitly, but we must realize that he has not given us an answer to the sequential questions: What intended effects can be manageable, on the one hand, and provide us, on the other hand, with usable information on the behaviour of GMOs that would provide a basis for risk assessment? What intended effects will be acceptable effects?

These questions cannot be answered yet, since not only the appeal to science implies a reduction of the problem, the manageability criterion, imposed by regulatory policy on the practice of field experiments has produced another possibly reductionist position: manageability has been equated with planning safe experiments from which we cannot learn enough.

4. Reducing Acceptability to Social Conventions

Existing legislation does not provide regulators with normative standards to evaluate applications concerning the acceptability of their environmental impact. Without a normative standard, however, it is impossible to draw a valid conclusion on the acceptability of a product or a release. Therefore, regulators have to make normative assumptions which could render a certain conclusion acceptable. So far, the implicit strategy has been to make an appeal to a conventional norm, that is to say a standard which would be acceptable because one can be certain it is widely accepted and uncontroversial. What kind of standard would that be? The Dutch advisory committee made the following statements in the evaluation of the application of the company Plant Genetic Systems (cf. Levidow et al. in this volume) in June 1994:

outcrossing transgenic characteristics will not cause a persistently negative impact on the environment [and] outcrossing the gene and its property male sterility ... will not lead to a persistently unacceptable impact of these relatives on the composition of varieties in natural vegetation.

To draw a conclusion on the acceptability of an impact, one has to use phrases with normative implications like 'negative impact' or 'unacceptable impact'. In this case, the advisory committee assumed that a conventional standard, and therefore a non-controversial reference point, would be the 'natural situation' itself It is assumed that so long as any impact would be an impact which could be counter-balanced by nature, which would allow nature to return to its original situation, it would be an 'acceptable impact'. Generally, this conclusion, which at first glance seems quite uncontroversial, implies that any process or impact caused by releases or new agricultural practices would be acceptable if we found that such a process or impact would be an instance occurring in nature itself. Indeed, advisory committees came to the conclusion that herbicide-resistant genes, for instance, are widespread in the natural environment and that, therefore, a possible spread of these genes caused by man-made varieties would be an acceptable phenomenon, comparable with existing natural processes.

However, unproblematic this appeal to a conventional nor-in seems to be, it soon runs into difficulties when one tries to apply this normative reference point, in diverse cases over time. The assumption we make by its application is that we have a full understanding of natural processes. Now, in the case of the ecological impact of organisms introduced, we do not have such a body of knowledge. Our perception of nature changes over time and, for instance, up to some years ago we believed that a thing like 'gene flow' is not a natural phenomenon (and therefore unacceptable), but now we have found that it occurs in nature as well, which would turn it into an acceptable impact in case human practices would causeidentical phenomena. So, our further analyses turn our 'convention' into a transformable normative reference point, which depends on (and evolves synchronically with) the historical change in our perception of nature.

Do we want environmental policy to be dependent on such standards? Regulators are now forced to study nature if they are to apply this standard consistently. Indeed, this is current practice to some extent. The assumption has always been that such a study would probably yield information that would eliminate the concept of hypothetical risk. Secondly, the standard would raise controversy if we were to say that anything happening in nature would be acceptable for human practices. Now we know that quite some natural events are unacceptable, otherwise it would not be possible any more to talk about natural catastrophes, precisely the kind of events some ecologists think that might happen with an intensified, biotechnology-based agriculture. Here we face the classical naturalistic fallacy: we cannot derive valid normative conclusions from factual statements. Thirdly, although we came to the conclusion that we are dealing with a transformable norm, since it is dependent on our perception of nature, it was not the intention of regulators to create such a standard (although the standard is rather well received by industrialists, who prefer to speak about 'flexible' standards).

I will argue in this paper that it became unavoidable for policy makers to go beyond discussing safety issues without acknowledging that this is current policy. The unarticulated shift from risk-based regulation to uncertainty-based regulation needs a new justification since the vocabulary of a risk assessment model is inappropriate for current practice. Open discussion on transformable standards and the justification of an uncertainty-based regulatory system is hindered by the EC directive which restricts policy makers to the matter of scientific aspects of safety issues.

Table 1: Characteristics of regulatory systems

In the following I will discuss that implementing an uncertainty based regulation can only be achieved by acknowledging discursive procedures in the policy making context.

References:

Ad van Dommelen (ed.), Coping with Deliberate Release, The Limits of Risk Assessment, Tilburg: International Centre for Human and Public Affairs, 1996.

Les levidow et al., Regulating Agricultural Biotechnology in Europe, special issue Science and Public Policy, forthcoming June 1996.

René von Schomberg (ed.), Contested Technology. Ethics, Risk and Public Debate. Tilburg: International Centre for Human and Public Affairs, 1995.

1. This essay arises from the context of a study for the European Commission "GMO releases: Managing Uncertainties about biosafety," conducted by Les Levidow et al., Open University, UK. I also thank Dr. Peter Wheale for useful comments.