-Caveat Lector- Library: Environmental risk disharmonies of European biotechnology regulation Les Levidow, Susan Carr and David Wield Centre for Technology Strategy, Open University, Milton Keynes MK7 6AA, UK ABSTRACT Since the 1980s, there has been a public controversy over the risks of biotechnology. In response to this legitimacy problem, the European Community adopted uncertainty-based legislation; the Deliberate Release Directive 90/220 provided a common 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, member states have given different interpretations to key statutory terms, e.g. 'risk', 'adverse effects', and the 'step-by-step' principle. Moreover, each marketing application has led to disputes over which potential effects must be prevented, as well as over product labelling. Often at issue is the prospect that transgenic crops may adversely pre-empt or encourage changes in agrochemical usage. In that regard, risk assessment rests upon normative judgements about what modes of crop protection are acceptable or even desirable. Presumed benefits of products have no agreed criteria, yet may influence working definitions of environmental harm. In all these ways, safety decisions cannot avoid an implicit technology assessment on product design, and thus on the R&D trajectory of agricultural biotechnology. Such implicit judgements give rise to European disharmonies of environmental risk. Thus precautionary regulation bears the difficult burden of the legitimacy problems that it was designed to overcome. 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 biotechnologists' stated 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 agriculture 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 some critics, society is at risk from biotechnology, whose development marginalizes or even precludes beneficial alternatives. Each concept of 'risk' includes its own concept of benefit, with a particular account of nature and society. In these ways, the risk debate has served as an implicit technology assessment of a potential model for the future. 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 emphasised 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 that have generated selection pressure for 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 NGOs have understood such disagreements - perhaps all too well. In this context, safety regulation has had the implicit role of managing public debate. Regulators have sought ways to translate the risk debate into scientific terms, while separating risk assessment from any broader technology assessment. Let us examine the new legislative framework for doing so. Uncertainty-based regulation In response to the risk debate, the European Community enacted the Deliberate Release Directive 90/220. This legislation was precautionary, by virtue of preventing hazards not yet documented for GMOs (Tait and Levidow, 1992). It was based on a qualitative uncertainty about cause-effect models of harm, rather than upon 'risk' as a quantifiable harm. In its Preamble, the Directive cited the potential for organisms to cause 'irreversible' effects on the environment (EEC, 1990). It provided a framework for clarifying uncertainty about risk - or rather, about potential effects that might constitute or lead to environmental harm. As a policy document later explained the uncertainty, "there are concerns that this new technology might entail potential risks..." (CEC, 1993). As well as preventing environmental harm, the Directive was intended to "establish harmonized procedures and criteria", especially for market approval of products (EEC, 1990). It aimed to 'complete the internal market' by avoiding trade barriers; it modestly sought 'mutual recognition of data' among European countries, rather than uniform 'standards'. In practice, however, mutual recognition has proved difficult. The Directive left open the meaning of key terms such as 'risk', 'adverse effects', and the 'step-by-step' principle -- which have been interpreted differently by various national authorities. 'Risks': According to the Directive, for each proposed release, regulators must "evaluate the risks posed by the release". In practice, national regulators evaluate an uncertainty about risk and do so in diverse ways. France emphasises the 'risk' of genetic imprecision; French regulators seek to minimize environmental uncertainty, by requiring that GMOs be precisely constructed and characterized. The UK investigates 'perceived risks' or 'potential hazards', while attributing this uncertainty to the genetic novelty of a GMO. Denmark considers the ultimate effects of using a commercial product, even at the stage of the earliest small-scale trial releases. Thus member states emphasise different sources of environmental uncertainty. '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. The Directive did not specify what effects would be deemed harmful, nor the extent of causal chains to be included in the risk assessment. In discussing risks, an earlier report mentioned the scenario that a transgenic plant might intensify selection pressure for pesticide-resistant pests, by analogy to the 'pesticide treadmill' already documented for chemical-intensive agriculture (Mantegazzini, 1986). Member states have disagreed over whether a 'genetic treadmill' would count officially 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 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). Member states have disagreed over how safety could be tested safely, and therefore whether commercial use would be the final 'step' - or simply a larger experiment. EU-level disharmonies and ambiguities Given that European countries have interpreted key statutory terms in different ways, safety approvals for commercial products have encountered long delays. The EC Directive established a procedure whereby the applicant requests approval in one member state, which may then act as the lead country in proposing approval throughout the European Community (expanded to the European Union in 1995). This procedure was designed to accommodate any concerns within a Europe-wide decision. However, every marketing application has met objections from at least one country, often on grounds that the product could adversely affect agrochemical usage, as a relevant 'secondary effect'. Defining 'adverse effects' The EU-level conflicts can be illustrated by two GMO products in particular. In one case, Plant Genetic Systems (PGS) requested market 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 future options for weed-control methods and for government policy (Levidow et al., 1996a,b). In another difficult case, Ciba-Geigy requested market approval for a maize plant that contains genes for both an insecticide (a Bacillus thuringiensis (Bt) toxin) and herbicide-tolerance. When France recommended market approval, other member states objected on various grounds, leading to a long dispute (FoEE, 1996, 1997; Johnson, 1996; UBA, 1997). There was concern that product usage could intensify selection pressure for insects resistant to the naturally occurring Bt toxin, thus eliminating a safe alternative to chemical pesticides. There were also concerns about the herbicide implications, as well as about the health effects of an antibiotic-resistance gene that was used to create the genetically modified plant. For both products, member states disagreed on the statutory relevance of so-called 'secondary effects', e.g. ultimate environmental effects of changes in agrochemical usage. Proponents of market approval argued that the Directive encompasses only 'product safety', i.e. the direct ecological effects of the GMO or its inserted genes. Other member states emphasised 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. Also in dispute were effects on agriculture itself. In the PGS case, UK regulators acknowledged some uncertainty about potential spread of the herbicide-tolerance gene to other oilseed rape and its weedy relatives, but they judged that this effect would not harm 'the agricultural environment' because other effective herbicides were available (ACRE, 1995: 7). In granting market approval, the European Commission acknowledged the weed-control issue by reiterating the UK's domestic rationale: namely, "that any spread of transfer of the herbicide-tolerance gene could be controlled by using existing management strategies" (EC, 1996). Beneath the official government stances, there lay some ambiguity in defining the effects relevant to Directive 90/220. '"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). In such ways, regulators cannot avoid judgements about strategic advantages or disadvantages of a product; presumed benefits may influence how regulators define harm. Thus an implicit technology assessment enters their safety judgement. Redefining 'steps' A similar ambiguity about environmental harm arose among French advisors and regulators. For herbicide-tolerant oilseed rape, the French advisory committee perceived "no uncertainties about an identified or potential risk". Rather, it emphasised "unknowns about socio-economic consequences", i.e. the prospect of generating herbicide-tolerant weeds. Given those unknowns, the committee recommended that market approval be granted only on a five-year basis, with mandatory monitoring of commercial usage (Kahn, 1996). If French advisors perceived no environmental risk at all, then how could they justify such stringent restrictions? 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). Implicitly, 'the environment' was defined more broadly for post-market monitoring than for the market approval itself. Thus environmental harm has been flexibly defined, depending upon the 'step' to be justified. There are other apparent inconsistencies in interpreting the 'step-by-step principle'. 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, after recommending market approval of the PGS crop, the UK funded large-scale monitoring (Levidow et al., 1996a: 151). For Ciba-Geigy's Bt maize, the French regulators did not require the company to monitor commercial use of the product. Nevertheless they implied that large-scale releases would be necessary to provide extra data for an adequate risk assessment; in effect, they redefined the original 'step-by-step principle'. In these circumstances, market approval would authorize a large-scale experiment, especially for the prospect that the product could intensify selection pressure for resistant insects. The Bt maize ultimately gained EU-wide market approval, despite objections from several member states. According to the official decision, the possible development of insect resistance 'cannot be considered an adverse environmental effect, as existing agricultural means of controlling such resistant species of insects will still be available' (EC, 1997). That is, it would be acceptable for farmers to lose the insecticidal effectiveness of naturally occurring Bt, on grounds similar to herbicide-tolerant weeds in the PGS case. In this case, moreover, the official rationale valued organic insecticides no more highly than genetically modified or even chemical ones. This normative judgement accepted the genetic-treadmill perspective that guides biotechnology R&D. Labelling Market approvals have also provoked disputes about what labelling (if any) to require. As the prevalent stance among member states, labelling can be required only 'in relation to the risk assessment' (DGXI, 1995). That is, labelling cannot be required if the product has been assessed as safe, regardless of how it is used. In contrast, some member states have argued that all genetically modified products should be labelled as such, regardless of their safety, in order to guarantee consumers' right to know. Such a requirement would accommodate NGOs, which had demanded that any novel food be labelled. For example, consumers want adequate information for exercising the right not to buy food that has been produced from crops modified to withstand herbicide treatments. By early 1997, some GMO products faced consumer boycotts and/or national bans. Soon the European Commission concluded that market approval of further products would be unlikely without a labelling requirement, so it proposed to amend the Deliberate Release Directive accordingly. This requirement was now deemed necessary to provide consumer choice, as well as to implement the precautionary principle - e.g. by helping to generate meaningful risk-assessment data during 'post-release observation' of GMOs, such as post-market monitoring (European Commission, press statement, 02.04.97). In that way, a safety rationale was found in order to justify the labelling requirements that had been previously rejected. Thus labelling disputes have rekindled issues that originally arose in the environmental risk assessment, e.g. as regards defining 'adverse effects' and 'steps'. When EU-level decisions on market approval excluded 'secondary effects' and/or accepted the prospect of resistant pests, these environmental concerns were not resolved but rather displaced to the consumer stage. Regulatory gap or implicit technology assessment? Some regulators have acknowledged a 'regulatory gap', given that potential effects on/of chemical usage lie beyond the administrative boundaries of both GMO and agrochemical regulation. To call this a 'regulatory gap', however, wrongly implies that the problem lies beyond risk assessment. On the contrary, the problem lies within risk assessment (Levidow et al., 1996a). When regulators approve a GMO product as safe, regardless of how it is used, this judgement involves two conflicting assumptions. On the one hand, it assumes that existing modes of crop protection are acceptable, or even desirable. On the other hand, it attributes any undesirable effects to those agricultural practices, rather than to the product as such. This distinction ignores or even denies the in-built link between the use and design of a product. By delinking the product use and design, market approvals limit official responsibility for potential effects of commercial agriculture. For genetically modified products, 'risk assessment' conceptually narrows the range of potential effects that must be prevented, and whose implausibility must be demonstrated. The more narrow account takes for granted, for example, a genetic-pesticide treadmill of technological dependency. In criticizing proposed products, some member states counterpose criteria of sustainable development, seeking to overcome such dependency. When regulators define the relevant 'adverse effects' and appropriate 'steps', their judgements involve an implicit technology assessment on the biotechnological R&D trajectory. Some also conceptualize risk and harm according to presumed advantages or disadvantages of the product. Such normative judgements were not specified by the Directive but remain unavoidable when implementing it. Consequently, the EC framework has had disharmonious interpretations - which 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 and scientific concerns. On the other hand, the broader the official remit, the less readily the procedure can justify market approval, especially as a final 'step'. Ultimate environmental effects of product usage are difficult to test in advance, yet post-market monitoring implies that commercial use is a larger-scale 'experiment'. Conclusion Although the European Union has a common legislative framework for harmonizing biosafety criteria, it faces regulatory disharmonies over key statutory terms, e.g. 'risk', 'adverse effects', and the 'step-by-step' principle. Safety regulation faces the awkward task of 'completing the internal market', amidst diverse models for such a market. EU member states promote different criteria for accepting biotechnology products as normal commodities. Each marketing application has led to disputes over which potential effects must be prevented, as well as over product labelling. Often at issue is the prospect that transgenic crops may adversely pre-empt or encourage changes in agrochemical usage, while perpetuating a technological dependency. Some crops carry an in-built 'genetic treadmill', posing problems for farmers and environmental protection. At the same time, this scenario offers biotechnologists the opportunity of devising new products to solve the problems created by previous ones. For all those reasons, 'risk assessment' rests upon normative judgements about what modes of crop protection are acceptable or even desirable. Presumed benefits are also evaluated in diverse ways and may even influence the regulatory definition of environmental harm. Safety decisions cannot avoid an implicit technology assessment on product design, and thus on the R&D trajectory of agricultural biotechnology. Such implicit judgements give rise to European disharmonies of environmental risk. Thus precautionary regulation bears the difficult burden of the legitimacy problems that it was designed to overcome, and may even perpetuate those problems. Acknowledgements This essay 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 the UK's Economic and Social Research Council during 1995-96. References ACRE (1995) ACRE: Annual Report No. 2: 1994/95. CEC (1993) Towards Sustainable Development, 5th Environmental Action Programme; also in Official Journal of the European Communities, C 138, 17 May: 5-98. CEC (1994) Biotechnology and the White Paper on Growth, Competitiveness and Employment - preparing the next stage, EBIS Newsletter 4 (2), 2-5. CEC (1996) Report on the Review of Directive 90/220/EEC in the Context of the Commission's Communication on 'Biotechnology and the White Paper' [CEC, 1994]. Brussels: Commission of the European Communities. 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OECD (1993) Safety Considerations for Biotechnology Scale-Up of Crop Plants. Paris: OECD. OECD (1995) Commercialisation of Agricultural Products Derived Through Modern Biotechnology: Survey Results. Paris: OECD, Environment Monograph No. 99. Tait, J. ; Levidow, L. (1992) Proactive and reactive approaches to regulation: the case of biotechnology. Futures 24, 219-231. UBA (1997) Technical Aspects of Potential Health and Environmental Risks Caused by Ciba-Geigy's Genetically Modified Maize, Vienna: Umweltbundesamt, typescript, 17 January. Library: Environmental risk disharmonies of European biotechnology regulation http://binas.unido.org/binas/Library/cabi/levidow.html DECLARATION & DISCLAIMER ========== CTRL is a discussion and informational exchange list. Proselyzting propagandic screeds are not allowed. Substance�not soapboxing! 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