BioSafety Journal Pontificia Universidad Católica de Valparaíso ISSN: 1366 0233 Vol. 3, Num. 1, 1997

European Biotechnology Regulation: contested boundaries of environmental risk

Les Levidow, Susan Carr and David Wield

Centre for Technology Strategy, Open University, Milton Keynes, MK7 6AA, UK
tel: +44 1908-653759, fax: +44 1908 652175,
email: L.Levidow@open.ac.uk

Received February 3rd, 1997
Accepted February 14th, 1997

Code Number: BY97001
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ABSTRACT

In response to the legitimacy problems of biotechnology, the European Community adopted the Deliberate Release Directive 90/220/EEC, as the statutory framework for regulating releases of genetically modified organisms (GMOs). The Directive aimed to 'establish harmonized procedures and criteria', especially for Europe-wide approval of commercial products. In practice, however, each marketing application has led to disputes among member states, e.g. regarding whether to consider secondary effects, how to define adverse effects, and whether to require product labelling.

Some member states exclude secondary effects, arguing that the Directive encompasses only product safety, i.e. direct ecological effects of the GMO or its inserted genes. Other member states emphasize the Directive's requirement that all appropriate measures be taken 'to avoid adverse effects on human health and the environment' - which may be interpreted to encompass agricultural practices in using the product. This issue has proven contentious because of the prospect that transgenic crops may ultimately pre-empt, encourage or force changes in crop-protection methods.

In excluding such considerations, some regulators have acknowledged that their decisions leave a 'regulatory gap' between environmental protection and agricultural policy. Yet the problem also lies within risk assessment, which rests upon judgements about what modes of crop protection are acceptable or even desirable. Safety decisions necessarily involve an implicit technology assessment on product design, with its contentious assumptions about natural resources and human practices. Moreover, these concerns have been displaced to the consumer stage, where the labelling issue compounds the dispute over the statutory relevance of pesticide implications. In sum, the contested boundaries of risk regulation arise from its origins in the legitimacy problems of biotechnology.

KEYWORDS: Environmental risk regulation, biotechnology, genetically modified organisms (GMOs), step-by-step procedure, regulatory harmonization, EC Deliberate Release Directive 90/220, European Union.

BIOTECHNOLOGICAL RISK AS A LEGITIMACY PROBLEM

Since the 1980s there has been a wide-ranging risk debate over biotechnology, in particular over genetically modified organisms (GMOs) which are designed for commercial use in the environment. Public concerns have included: ethical qualms about interfering with nature, environmental harm from the early trial releases, long-term effects on agriculture, and the commercial motives of the agrochemical companies involved. An underlying issue has been the avowed aim of industrializing agriculture, i.e., treating nature as a bioreactor whose industrial efficiency must be optimized.

For all those reasons, biotechnology has faced a legitimacy problem. According to biotechnologists, they merely correct genetic deficiencies, thus supplementing or improving natural processes; they promise environment-friendly products for benignly protecting crops, even for feeding the world. According to some critics, however, the most likely products will aggravate the familiar problems of intensive monoculture and technological dependency.

The wider public debate has featured incompatible concepts of risk. For proponents, society is at risk of failing to reap the cornucopian benefits of biotechnology. For critics, society is at risk from biotechnology, whose development precludes or marginalizes beneficial alternatives. These divergent concepts of risk each includes a divergent concept of benefit. In this way, the risk debate serves as an implicit technology assessment.

When scientists entered the public debate, they disagreed about what knowledge-base is necessary for assessing the environmental risks. Molecular biologists have portrayed GMOs as familiar products and thus as predictable, even as inherently safe. Ecologists have tended to regard the genetic novelty of GMOs as a source of environmental unpredictability; they have emphasized the need for careful safety testing and for better ecological knowledge. Some have warned that inserted genes might inadvertently confer a selective advantage, by analogy to the behaviour of some non-indigenous organisms entering a new environment. Along with environmentalists, some scientists have warned that GMO products could impose a genetic treadmill, by analogy to the chemical treadmill of pesticides which have generated resistant pests (Levidow and Tait, 1991).

Given the substantial overlap between public and scientific concerns about risk, biotechnology proponents foresaw political dangers from open debate. For example, some government regulators and advisors expressed concern that scientific disagreements 'could be amplified and misunderstood in public opinion' (OECD, 1989). Yet environmental Non Governmental Organisations (NGOs) have understood such disagreements, perhaps all too well. In this context, safety regulation has had the implicit role of managing public debate. Regulators seek means for credibly translating the risk debate into scientific terms, while separating risk assessment from technology assessment.

UNCERTAINTY-BASED REGULATION

In response to the risk debate, the European Community enacted the Deliberate Release Directive 90/220 (European Commission, 1990). This precautionary legislation aimed to prevent hazards not yet documented for GMOs (Tait and Levidow, 1992). It provided a framework for clarifying uncertainty about risk, i.e., about potential effects which may constitute or lead to environmental harm. As a policy document later explained, 'there are concerns that this new technology might entail potential risks...', which were not officially defined (European Commission 1993).

In Directive 90/220, the aim was to 'establish harmonized procedures and criteria', especially for marketing approval of products. It aimed to 'complete the internal market' by avoiding trade barriers; it sought 'mutual recognition of data' among European countries, rather than uniform 'standards'. For risk assessment, the Directive left open the meaning of key terms, which have since been interpreted differently by various national authorities. In particular:

Risks: According to the Directive, for each proposed release, regulators must 'evaluate the risks posed by the release'. In practice, national regulators conceptualize and manage an uncertainty about risk, in diverse ways. France emphasizes the 'risk' of genetic imprecision; it requires that GMOs be precisely constructed and characterized, as a means to minimize environmental uncertainty. The UK investigates 'perceived risks' or 'potential hazards'; it attributes this uncertainty to the genetic novelty of a GMO. Denmark considers the effects of using an eventual product, even at the stage of the earliest trial releases. Given that GMOs are perceived in such different ways, even by regulators, what would this mean for harmonizing evidence of safety?

Adverse effects: According to the Directive, member states must take all appropriate measures 'to avoid adverse effects to human health and the environment' from GMO releases. It did not specify the relevance of secondary effects, i.e. the extent of causal chains to be included in the risk assessment. For example, would a genetic treadmill count as an adverse effect?

Step-by-step principle: According to the Directive, when increasing scale or decreasing containment, a release may be approved only if the evaluation of earlier steps indicate that the next step can be taken.' In this way, the 1990 EC Directive codified an international agreement: that GMO releases should follow 'a logical, incremental, step-wise process, whereby safety and performance data are collected' (OECD, 1986). However, it was later acknowledged that this process had scientific limitations: 'In biosafety terms, it is clear that the amount of useful information gained from the releases to date has been limited. The releases have in effect been field containment rather than true releases' (OECD, 1993). How, then, could safety be tested safely? Would commercial use be the final 'step, or simply a larger experiment?

EU-LEVEL DISHARMONIES AND AMBIGUITIES

Member states of the European Union have given different answers to those questions, especially at the commercial stage. Every marketing application has met objections from at least one country, often on grounds that the product could affect agrochemical usage, as a relevant secondary effect. It is mainly the Scandinavian countries which have interpreted the Directive more broadly, thus better accommodating environmental concerns (Levidow et al., 1996a). The EU-level conflicts can be illustrated by two GMO products in particular.

In one case, Plant Genetic Systems (PGS) requested marketing approval for a herbicide-tolerant oilseed rape. When the UK recommended approval, some member states objected that the herbicide-tolerance gene could spread and generate herbicide- tolerant weeds, thus potentially restricting options for weed- control methods and for government policy (Levidow et al., 1996b). In another difficult case, Ciba-Geigy requested marketing approval for a maize plant which contained genes for both an insecticide (a Bacillus thuringiensis toxin, Bt) and herbicide-tolerance. When France recommended marketing approval, some member states objected that product usage could intensify selection pressure for insects resistant to the naturally occurring toxin, thus eliminating a safe alternative to chemical pesticides. (See Note 1)

In both cases, member states disagreed on the statutory relevance of so-called 'secondary effects', e.g. ultimate environmental effects of changes in agrochemical usage. Proponents of marketing approval argued that the Directive encompasses only product safety, i.e. the direct ecological effects of the GMO or its inserted genes. Others emphasized the Directive's requirement that all appropriate measures be taken 'to avoid adverse effects on human health and the environment', which they interpreted to encompass agricultural practices in using the product.

Beneath the official government stances, there lay some ambiguity in defining the effects relevant to Directive 90/220. In the PGS case, UK regulators judged that spread of the herbicide-tolerance gene could not cause harm to agriculture, because other effective herbicides were available (ACRE, 1995). 'A weed is not a problem if you can control it', according to a member of the UK advisory committee. However, he also acknowledged, 'There is a grey area between safety and agricultural strategy... We think about this grey area all the time, so as to get a clearer definition of environmental harm' (interview, June 1995).

Thus perceived advantages or disadvantages of a product may influence how regulators define harm; an implicit technology assessment enters the safety judgement. Although regulators consider potential benefits, the UK does not do so officially, while other member states emphasize quite different types of effects (OECD, 1995, Levidow et al., 1996a). They have little agreement over what 'harm' or 'benefit' to consider, much less over a 'risk-benefit analysis'. Thus safety regulation involves ambiguous, diverse assumptions about agricultural effects.

A similar ambiguity operated in France. For herbicide- tolerant oilseed rape, the French advisory committee perceived 'no uncertainties about an identified or potential risk'. Rather, it emphasized 'unknowns about socio-economic consequences', i.e. the prospect of generating herbicide- tolerant weeds. Given those unknowns, the committee recommended that marketing approval be granted only on a five- year basis, with mandatory monitoring of commercial usage. How could this legal restriction be justified, if there is no environmental risk? According to the chairman of the French advisory committee, 'The term "environment" should be understood in a broad sense: herbicide-resistant weeds can be an environmental problem for the relevant agrosystem...' (email interview, April 1996). Thus environmental harm has been flexibly defined, depending upon the step to be justified.

Indeed, the step-by-step principle has had inconsistent interpretations. According to a UK regulator, 'If the hazard assessment says that the product is safe..., then there is little point in monitoring' (interview, April 1995). Nevertheless the UK funded large-scale monitoring of the PGS crop - after recommending market approval (Levidow et al., 1996a: 151).

For the Bt maize, France proposed to require no monitoring but suggested that large-scale releases would be necessary to provide extra data for an adequate risk assessment. In effect, the original 'step-by-step principle' was redefined, or even reversed. In effect, marketing approval would now authorize a large-scale experiment. When the Bt maize ultimately gained EU-wide marketing approval, the official decision judged that it would be acceptable for insect resistance to render naturally occurring Bt useless, on grounds similar to the PGS case: namely, that farmers could still use other pest-control agents, i.e. chemical insecticides 'A potential development of insect resistance to the Bt-toxin cannot be considered an adverse environmental effect, as existing agricultural means of controlling such resistant species of insects will still be available' (18.12.96 statement, European Commission).

Marketing approvals also involve disputes over what labelling (if any) to require. Some member states argue that labelling may be required only in relation to the risk assessment, which supposedly shows that the products would be safe, regardless of how they are used. Other member states ask that products be labelled as genetically modified, regardless of their safety. Similarly, NGOs had demanded that any novel food be labelled, in order to ensure an informed choice for consumers, e.g. the right not to buy food which had been produced via crops specially modified to withstand herbicide treatments. When environmental safety approval of crops had excluded 'econdary effects'and accepted a genetic treadmill, these environmental concerns were not resolved but rather displaced to the consumer stage. Thus the labelling issue compounds the dispute over the statutory relevance of herbicide implications.

A REGULATORY GAP - OR IMPLICIT TECHNOLOGY ASSESSMENT?

Some regulators have acknowledged a gap between GMO and agrochemical regulation, given that potential effects on chemical usage lie beyond those administrative boundaries. To call this a regulatory gap, however, wrongly implies that the problem lies beyond risk assessment. On the contrary, the problem also lies inside risk assessment (Levidow et al., 1996a).

When regulators claim that a GMO product is safe, regardless of how it is used, they try to have it both ways. On the one hand, they assume that particular modes of crop protection are acceptable, or even desirable. On the other hand, they attribute any undesirable effects to those agricultural practices, rather than to the product as such. This distinction ignores (or denies) the in-built link between the use and design of a product. On this basis, their safety claim serves to limit official responsibility for potential effects in commercial agriculture.

In such ways, risk assessment conceptually narrows the range of potential effects which must be prevented, and whose implausibility must be demonstrated. When regulators define the relevant adverse effects and appropriate steps, their judgements involve an implicit technology assessment. They link risk with presumed advantages or disadvantages of the product, according to their assumptions about agriculture and society. Such normative judgements were not specified by the Directive but remain essential for implementing it.

Consequently, the regulatory procedure has had contested boundaries: of risk, adverse effects, steps, and product labelling. These also pose dilemmas. The more narrowly the procedure defines the statutory remit, the more readily it can accept the applicant's proposal, yet the less readily it can accommodate public concerns. On the other hand, the broader the remit, the less readily the procedure can justify marketing approval, especially as a final step. Ultimate environmental effects of product usage are difficult to test, yet post-marketing monitoring implies that commercial use is a larger-scale experiment.

In sum, as biotechnology further industrializes agriculture, its R&D devises chemical-like, genetic-level methods of environmental control. Safety regulation faces the awkward task of 'completing the internal market' for products which pre-empt agricultural options, e.g. by accepting an in-built genetic treadmill. Indeed, such products impose a model of the market itself, by offering benefits which mainly lie in mitigating problems caused by previous products. Safety decisions necessarily involve an implicit technology assessment on the product design, with its contentious assumptions about natural resources and human practices. Thus the contested boundaries of 'risk' regulation arise from the legitimacy problem of biotechnology, as an implicit model of the socio-natural order.

NOTE 1. Some member states also objected on grounds of food risks, in particular from antibiotic-resistance markers, which lie beyond the scope of this brief article. For the PGS crop, the UK proposed that the product approval cover only environmental aspects, while banning food uses until the appropriate approval could be obtained; however, the EU had no credible way to prevent such uses, nor to prevent spread of the kanamycin-resistance marker to other food crops, as some member states argued (Levidow et al., 1996b). For the Ciba-Geigy maize, most member states eventually objected that the ampicillin-resistance marker could transfer to pathogenic gut bacteria, thus undermining the therapeutic utility of that antibiotic (e.g. as reported by Johnson, 1996; FoEE, 1996, 1997).

ACKNOWLEDGEMENTS

This paper arises from two studies: GMO Releases: Managing Uncertainties about Biosafety, funded by the European Commission's DGXII/E-1 during 1994-95; and From Precautionary to Risk-Based Regulation: the Case of GMO Releases, funded by Britain's Economic and Social Research Council during 1995-96.

REFERENCES

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FoEE (1996, 1997) Mailout 2(8), 3(1). Brussels: Friends of the Earth Europe

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Levidow, L., Carr, S., von Schomberg, R., Wield, D., 1996b. Bounding the risk assessment of a herbicide-tolerant crop, in Ad van Dommelen, ed., Coping with Deliberate Release: The Limits of Risk Assessment, pp.81-102, Tilburg: International Centre for Human and Public Affairs, ICHPA, 25 Pastoor Smitsstraat, NL-5014 RH Tilburg, Netherlands, (e-mail R.von Schomberg@kub.nl).

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Tait, J. and Levidow, L. 1992. Proactive and reactive approaches to regulation: the case of biotechnology, Futures 24 (3): 219-31.

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