EU biotech crop regulations and environmental risk: a case of the emperor's new clothes? more

Opinion TRENDS in Biotechnology Vol.25 No.1 EU biotech crop regulations and environmental risk: a case of the emperor’s new clothes? Shane H. Morrisa 26 Woodford Way, Ottawa, Ontario, K2J4B9, Canada European Union Commissioner for the Environment Stavros Dimas recently hailed ‘upgraded’ non-genetically modified (GM) crops as an alternative to GM crops. A comparative analysis of the environmental risks associated with such non-GM herbicide-resistant crops and GM herbicide-resistant crops is presented here. The analysis highlights serious weaknesses in the European Union (EU) regulatory framework, and the contradictory policy of the EU Commission on the precautionary principle is also shown. The continued political stance of ignoring these regulatory and policy inconsistencies is examined and found to be flawed. It is postulated that, even in the face of these flaws and coupled with recent statements from the UK drawing attention to inconsistencies in the EU regulatory framework, the EU will continue to ignore the real and present environmental risks associated with upgraded non-GM crops for biopolitical reasons. Introduction In 1837, Hans Christian Andersen wrote a fairy tale entitled The Emperor’s New Clothes [1]: the story tells how an overwhelming majority willingly shared in a collective charade in the face of an obvious fabrication, lest anyone should think they were a fool. On 5th April 2006, in a move akin to the poorly advised emperor showing off his drafty new clothes, the EU Environment Commissioner, Stavros Dimas, at the Freedom of Choice conference on genetically modified organism (GMO) co-existence declared: ‘As an environment commissioner, I am keen to ensure that the environment is protected from potential risks arising from the cultivation of GMOs’ [2]. He further proclaimed, ‘we should not ignore the use of ‘‘upgraded’’ conventional varieties as an alternative to GM crops, particularly where similar characteristics can be introduced without genetic modification’. The heralding of these non-GM ‘upgraded’ varieties by Commissioner Dimas exposes the fact that the current EU regulatory framework poorly covers, in scant manner reminiscent of the emperor’s new clothes, possible environmental risks arising from the cultivation of non-GM upgraded crops. His statements Corresponding author: Morris, S.H. (shane.morris@rogers.com). Disclaimer: the opinions expressed herein are strictly those of the author who is a citizen of the European Union. Shane Morris contributed to this article in his personal capacity. The views expressed are his own and do not represent those of his employer, Agriculture and Agri-food Canada, or the Government of Canada. Available online 20 November 2006. a also suggest that, like our fabled emperor, he has been poorly advised on the facts. GMOs, as defined by the EU Directive 2001/18/EC [3], are organisms ‘in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination’. EU Directive 2001/18/EC only regulates the release of GMOs and requires an environmental risk assessment of potential immediate and/or delayed direct and indirect environmental impacts of the specific cultivation, management and harvesting techniques used for GM plants. The upgraded crops advocated by Commissioner Dimas are those created without the use of genetic modification as defined by Directive 2001/18/EC but do permit the use of induced mutagenesis or embryo rescue to facilitate intraspecific crossings that would not occur naturally. These upgraded crops are not regulated under EU law from the perspective of environmental risk. Up to now, many have been willing to ignore the obviously unequal risk assessment criteria that are currently applied to GM versus upgraded crops within the EU regulatory framework. However, with Commissioner Dimas intent on drawing attention to the matter, the polite position of ignoring the regulatory ‘elephant’ in the room is becoming increasingly difficult to maintain. Currently, several pertinent issues remain unexplained in official EU documentation and go unexamined in the published literature, namely: (i) Environmental risks associated with upgraded varieties can exist and are often similar (if not often identical) from an ecological impact perspective to GM crops. (ii) The EU regulatory framework under Directive 2001/ 18/EC currently fails to consider the potential environmental risks associated with upgraded, biotechnology-derived non-GM crop varieties and only considers products derived from the process of genetic modification [3]. (iii) The EU Commission expects EU citizens to accept that it assesses potential (and much debated) environmental risks regarding GMOs by way of the precautionary principle enshrined in Directive 2001/ 18/EC. On the contrary, it expects EU citizens to accept the fact that EU regulations offer no precautionary regulatory oversight for a comparable environmental risk, simply because the risk is associated www.sciencedirect.com 0167-7799/$ – see front matter ß 2006 Elsevier Ltd. All rights reserved. doi:10.1016/j.tibtech.2006.11.004 Opinion TRENDS in Biotechnology Vol.25 No.1 3 with another technology platform eliciting the same phenotypic (trait) outcome. One example of currently available upgraded non-GM varieties with similar characteristics to GM crops are the herbicide-resistant (HR) CLEARFIELDTM crops developed by BASF. The Weed Science Society of America (WSSA; http://www.weedscience.org/paper/definitions.htm) defines herbicide resistance as ‘the inherited ability of a plant to survive and reproduce following exposure to a dose of herbicide normally lethal to the wild type’. The CLEARFIELDTM trait (http://www.agriculturalproducts.basf. com/p02/AP-Internet/en_GB/portal/show-content/content/ Products_Folder / Clearfield_Production_System) enables these upgraded crops to survive a broad-spectrum herbicide normally lethal to the crop. This trait is heritable and potentially transmissible through pollen to adjacent crops of the same species and progenitor in addition to weedy relatives. This suite of HR crop varieties have been developed using mutagenesis and/or traditional breeding methods and contains no introduced genetic material; as a result, they are not considered to be a GMO by the EU and thus are not covered by Directive 2001/18/EC. In Europe, these HR crops include rice, maize, oilseed rape and sunflowers, with wheat possibly soon to follow. BASF has even instituted a Grower Stewardship Plan, to help mitigate the environmental risks that they feel could exist. Tan et al. state that: Management of herbicide-resistant weeds and gene flow from crops to weeds are issues that must be considered with the development of any herbicideresistant crop. Thus, extensive stewardship programs have been developed to address these issues for CLEARFIELDTM crop [4]. It is interesting to note that four of the five authors of this publication are BASF scientists. Currently, BASF has the largest portfolio of non-GM herbicide-resistant (HR) traits in the world (http://www. agriculturalproducts . basf.com /p02/AP-Internet/en_GB/ function/conversions:/publish/upload/CLEARFIELDBrochure.pdf) and they believe that the potential sales value of the CLEARFIELDTM concept is in excess of s300 million (http://www.corporate.basf.com/en/investor/news/ praesentationen/-evasset.htm?aid=84&MTITEL=Goldman +Sachs+Sixth+Annual+AgChemical+/+AgBiotechnology+ Conference:+Handouts+Herr+Hans-Walther+Reiners& suffix=.pdf). In 2002, it was estimated that CLEARFIELDTM maize was planted on 4.9 million hectares (15% of total maize planting hectares) in the USA. In Canada, it was estimated that $20% of canola planted in 2000 and 2001 was non-GM HR CLEARFIELDTM canola [4]. Environmental Risk A simple, albeit technocratic, definition of risk is ‘the probability that an outcome will occur times the consequence, or level of impact, should that outcome occur’ [5]. Consequently, there are three basic questions of risk assessment [6]: what can go wrong (i.e. environmental concerns or harm)? how probable is it that harm will occur? and what are the consequences of that harm happening? Some of the environmental concerns raised by European commentators regarding GM HR crops include, www.sciencedirect.com  the appearance of superweeds as a result of gene flow [7];  the fertilization of the sympatric compatible wild relatives [8];  spatial and temporal dispersal of seeds: oilseed rape might lead to feral oilseed rape populations outside the cropped areas and oilseed rape volunteers in subsequent crops in the rotation [8];  effects on wildlife biodiversity [9]; and  potential irreversibility of any negative impact [10]. Such environmental risks have been summarized well in several other publications [6,11–13]. These risks and the quantitative potential for their mode of occurrence, incidence and impact remain debated [14] and are beyond the scope of this article. Such concerns are a result of the welldocumented scientific opinion concerning possible risks arising from gene flow to wild relatives [15–20], although a considerable number of studies have focused only on GM crops when examining environmental gene flow concerns ˆ ´ [21–25]. In fact, a recent article by Brule-Bable et al. [26], outlining some of the possible gene flow-related environment risks concerning HR GM wheat transgene movement (e.g. it could alter farming practices. . .or irreversibly alter the ecosystem), contains substantial sections that can equally be applied to non-GM HR upgraded wheat. This and other articles discuss at length the various risks associated with GM HR crop gene flow but never refers to non-GM upgraded HR crops and their gene flow risks. Nevertheless, the authors clearly state that ‘genes such as herbicide-resistance that confer a fitness advantage to the recipient population may have considerable impacts on population structure and dynamics’ [26]. Even with numerous gene flow studies focusing intensely on GM crops, no scientific evidence indicates that the process of genetic modification, per se, causes potential environmental risks. Rather, it is the new phenotypic trait, such as herbicide resistance, bestowed upon the crop that carries the primary environmental risk. In missing this fact, it would seem that the EU Commission, similar to those advisors sent to check the emperor’s new clothes during weaving, have chosen to ignore the obvious risks associated with upgraded non-GM HR crops that are clear and present but remain unregulated. The reasons behind such an oversight is a matter of speculation, but it is plainly evident that by using the relevant potential direct and indirect impacts of GM crops on the environment, outlined in Dale et al. [9] (as applicable to herbicide resistant crops), a comparative risk assessment table (Table 1) comparing both GM HR and non-GM HR varieties can be produced. From an environmental concern perspective, Table 1 demonstrates that there is little or no difference between GM-derived and non-GM HR crops. For equivalent traits, the technology type chosen to obtain the expression of herbicide resistance does not have a direct bearing on the potential environmental risks. It is not suggested that the lack of risk differential should cause HR GM crops to forego EU regulatory oversight; however, it does suggest that, from a policy perspective, the EU should explain why non-GM upgraded HR crops are not being subjected to some form of environmental risk assessment in accordance 4 Opinion TRENDS in Biotechnology Vol.25 No.1 Table 1. Potential impacts of GM herbicide-resistant crops versus non-GM herbicide-resistant crops on the environment Impact type Risk Class Examples GM herbicide resistant (regulated in the EU) Risk possible Upgraded non-GM herbicide resistant (not regulated in the EU) Risk possible Direct Impact Change in persistence or invasiveness of the crop Direct impact Indirect impact Gene flow by pollination to weeds and feral plants Reduced efficacy of weed control Indirect impact Indirect impact Effect on wildlife biodiversity Effect on soil and water Persistence in agricultural habitat Invasiveness in natural habitats Transfer of herbicide resistance to weeds Development of weeds resistant to herbicides by evolution and selection from within the weed gene pool Effects of broadspectrum herbicides Change in herbicide use Change in soil cultivation patterns Risk possible Risk possible Risk possible Risk possible Risk possible Risk possible Risk possible Risk possible with the precautionary principle and current EU policy, considering they have the same phenotypic traits as their GM counterparts. The current disparity in environmental risk assessment also leaves the EU open to the reverse question: if non-GM HR crops obtained through mutagenesis are currently cultivated without restriction, why is there an environmental need to regulate equivalent HR GM crops? Voicing Reason Following this logic, a UK GM regulatory body – the Advisory Committee on Releases to the Environment (ACRE) sub-group – released a draft consultation report on 17th March 2006 (three weeks before Commissioner Dimas made his comments) entitled Managing the Footprint of Agriculture: Towards a Comparative Assessment of Risks and Benefits for Novel Agricultural Systems [27]. This report states that: In recent years, it has become apparent that there are inconsistencies in the [EU] regulatory assessment of the environmental impact of GM crops in comparison with other agricultural crops and practices. The report additionally criticizes EU regulation by stating: This inconsistency is further illustrated by GM herbicide tolerant [sic] crops that require an extensive environmental risk assessment before approval for cultivation and marketing while herbicide tolerant [sic] crops produced by non-GM breeding methods can be grown without an equivalent assessment. The scientific basis of this criticism is the fact that the farm-scale evaluations of herbicide-resistant crops in the UK showed that the impact of GM crops on the environment could be comparable with that of non-GM crops expressing the same HR trait if the management regime is the same [28]. With the risk to the environment so clearly similar that national regulatory bodies within the EU have highlighted this similarity, it is difficult to understand on a scientific and risk assessment basis why non-GM upgraded www.sciencedirect.com HR crops have not had the same levels of regulatory precaution or risk assessment applied to them by the EU. Despite the evidence, it is clear that the EU prefers to focus its attention only on crops derived from genetic modification. A recent 2006 EU commission policy document entitled EU Policy on Biotechnology [29], forwarded by Commissioner Dimas, states that the EU legal framework ‘is possibly the strictest GMO legislation in the world’. This might be true but it ignores the often equal agri-environmental risks raised by so-called upgraded crops; by focusing purely on the process of genetic modification as a regulatory trigger, the EU does a side step around the potential impacts of upgraded crops on the environment. It seems EU Environment Commissioner Dimas is content simply to limit his focus on only one form of biotechnology (i.e. GMOs) because, in his opinion, ‘GMO products raise a whole new series of possible risks to the environment, notably potential long-term effects that could impact on biodiversity’ [2]. However, in light of the often comparable risks associated with upgraded crops (e.g. the case of HR crops), such a stance can hardly be said to be based on sound science, good risk assessment practice or a responsible application of the precautionary principle. In fact, this position is arguably contradictory to the 2002 EU Commission strategy, which developed ‘a plan to transform policy into action to exploit the development of biotechnologies in a responsible manner’ [30]. EU precautionary equality? The primary regulatory instrument in the EU for the protection of the environment from GM crops is Directive 2001/18/EC, which has the precautionary principle as its basis: ‘In accordance with the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment. . .’ [3]. One could ask, is there not a case for the equal application of the precautionary principle to non-GM Opinion TRENDS in Biotechnology Vol.25 No.1 5 upgraded HR crops? The EU Commission issued a policy ´ communique in 2000 outlining ‘the Commission’s approach to using the precautionary principle’ and to ‘establish Commission guidelines for applying it’ [31]. The guidelines clearly state that the precautionary principle should be applied in a proportional, non-discriminatory and consistent manner, with an examination of the benefits and costs of action (or lack of action) and with an examination of scientific developments. The principle of non-discrimination means that comparable situations should not be treated differently and importantly: Measures taken under the precautionary principle should be designed to achieve an equivalent level of protection without invoking the geographical origin or the nature of the production process to apply different treatments in an arbitrary manner. ´ Furthermore, the communique states that ‘measures should be consistent with measures already adopted in similar circumstances or using similar approaches’. Arguably, the promotion by Commissioner Dimas of upgraded crops, created by a different production process (e.g. nonGM HR crops) than regulated GM crops, could be considered contrary to the guidelines of the EU commission on applying the precautionary principle in a consistent and non-discriminatory manner. In the ACRE [27] report, the Canadian regulatory approach was referenced as an example of a model worth considering, ‘which would avoid or minimize some of the anomalies of the current [EU] system’. In Canada, the need for an environmental safety assessment exists, regardless of whether the introduction of a ‘novel’ trait(s) (e.g. herbicide resistance) is achieved through mutagenesis and selective breeding (e.g. upgraded crops) or through genetic engineering [32]. To date, from the 70 novel plants that the Canadian Food Inspection Agency (CFIA) approved after carrying out environmental risk assessments for, 13 are considered non-GM (upgraded) crops, 12 of which are herbicide resistant (HR) (http://active.inspection.gc.ca/ eng/plaveg/bio/pntvcne.asp). Under the current European regulatory framework, these same non-GM product types fall outside the scope of Directive 2001/18/EC and hence are not subject to an environmental risk assessment in the EU. Within social science literature, it has been established that risk assessment depends on political, social and regulatory contexts [33]. Political culture is intimately linked to the ways in which nations choose to govern the uncertainties that necessarily accompany technological innovation [34]. It is clear that scientific cultures are, at one and the same time, political cultures [35]. It is these cultural contexts in different political cultures that explain why judgements about the same hazard, based on the same scientific knowledge and evidence, do not always lead to the estimates of possible harms in different national regulatory systems [33]. In short, regulatory systems are characterized by a particular ‘culture of rationality’ [36]. This might be the conclusion when comparing different national regulatory systems with each other [35]. However, the suggestion that the field of environmental regulation (e.g. concepts of risk and safety, www.sciencedirect.com and methods of compiling and validating data) reflects deep-seated social assumptions that rob them of universal validity [35] clearly does not adequately explain the blatant contradictions that exist within the EU when applying the precautionary principle in both its environmental risk mitigation policy and regulatory framework. In measuring policy success or failure, one implicitly adopts contingent, locally specific standards of reliability and validity [35]. However, what makes the EU case of GM HR crop versus non-GM HR crops interesting is that it is the intraspecific standards of reliability and validity of the EU itself that are seen to fail as a result of their own locally produced risk assessment inconsistencies. Thus, instead of reflecting a culture of rationality by way of a consistent regulatory system based on its own social assumptions, the EU currently reflects what can only be described as a culture of irrationality. Conclusion In light of the fact the EU Commission is now promoting the development of upgraded crops as an ‘alternative to GM crops’ [2], even when similar environmental risks exist, and considering the regulatory framework does not provide a risk assessment for upgraded crops, it might be time for the EU to re-examine the framing [37] and application of its risk assessment criteria currently employed to protect the environment of Europe. In not doing so, two clear questions arise: (i) does the EU Commission not concede there are potential risks to the environment from upgraded crop lines and that a gap exists in the EU regulatory framework? Or, alternatively, (ii) is there a biopolitical [38] attempt to ignore the potential environmental risks and not subject these upgraded products to a risk assessment, contrary to the precautionary principle and, arguably, unfairly applying environmental regulation solely to the phenotypically identical GM crops? The European citizenry deserves clear answers from the EU Commission to these questions. In the meantime, one can only speculate that EU Commissioner Dimas has been convinced by disinformation (in a similar way to our beloved emperor) that the EU has covered the environmental risks pertaining to modern crop biotechnology. The often-hazardous road walked by the EU Commission between science and politics certainly seems to be narrowing as time goes on. For example, considering GM HR crops are covered by EU regulations and upgraded HR crops are not, it is currently plausible to suggest that non-GM HR upgraded crops could be more likely to cause ecological harm because they remain unregulated and unsupervised within the EU. It is clear that the EU cannot sustain its inconsistent process-based regulatory position and it must decide to either: (i) regulate non-GM so-called upgraded crops (e.g. HR) from an environmental risk perspective in a similar fashion to GM crops; or (ii) remove environmental regulations from GM crops that have equal environmental risks to unregulated non-GM crops (e.g. HR). 6 Opinion TRENDS in Biotechnology Vol.25 No.1 It is scientifically inaccurate and politically unjust for the EU Commission to frame upgraded HR crops as something different to GM HR crops in terms of environmental risk; as a result, there is an environmental need to reframe EU risk assessment, whereby it would regulate novel phenotypic traits rather than the new technologies used to produce new traits. However, considering that risk can also be defined as Risk = Hazard  Outrage [39], the fact that the EU public have not developed a sense of outrage toward upgraded HR crops suggests that the political road for the EU Commission might remain comfortably wide for sometime. Even if the road was to become politically difficult and the regulatory charade exposed, it is the opinion of this EU citizen that the EU Commission, for biopolitical reasons that are not based on cultural contexts, would still continue to ignore the ‘inconsistencies’ [27] in the European regulatory framework, just like our powerful, but naked, emperor: ‘But he hasn’t got anything on!’ the whole town cried out at last. The Emperor shivered, for he suspected they were right. ‘But,’ he thought, ‘this procession has got to go on’ [1]. Acknowledgements The author would like to thank deeply Vardit Ravitsky, Annie Murray, Linda Hall, Jonathan Gressel, Nicole Luce-Rizzo and Charles Spillane for their time, effort and insightful comments on various drafts. Thanks and appreciation is also extended to the anonymous reviewers for their constructive comments on the manuscript. References 1 Anderson, H. (1949) The Emperor’s New Clothes, North-South Books 2 Dimas, S. Co-existence of genetically modified, conventional and organic crops: freedom of choice. Speech presented at Conference on GMO Co-existence, Vienna, April 2006 (http://europa.eu/rapid/ pressReleasesAction.do?reference=SPEECH/06/224&format= HTML&aged=1&language=EN&guiLanguage=en) 3 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/ 220/EEC – Commission Declaration. 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