standards became a more urgent priority (Hough, 1998; Braithwaite and Drahos, 2000). .... Committee on Trade and Environment (CTE) and assigned it a broad ...
Transboundary Risk Regulation
Globalisation and Transboundary Risk Regulation: Pesticides and Genetically Modified Crops
Joyce Tait and Ann Bruce
Abstract. Globalisation of food production systems and accompanying pressures for trade liberalisation are raising new issues for risk regulation and also placing greater demands on risk regulatory systems. Transboundary food-related risks are categorised here as ‘traded’ risks, subdivided into those which are product-based and those which are production system based. The international systems for regulating the risks of pesticide residues in food and of GM crops are summarised and examples are given of how the risks are monitored and evaluated. For GM crops and pesticides, although in different proportions, concerns focus on risks inherent in food products themselves and in the food production systems of which they form components. Different public motivations (self interest versus fundamental values) underlie the expressions of concern and different approaches are needed for resolution and public reassurance in each case. We propose an approach which assigns legitimate and clearly specified roles to the two approaches, product-based and production system based, which would elevate the debate about GM crops to a higher systemic level where it may have a greater chance of being resolved.
Transboundary Risk Regulation
Submitted to Health, Risk and Society
Transboundary Risk Regulation
Transboundary Risk Regulation The increasingly rapid pace of technological innovation and the increasing size and power of multinational companies are leading to globalisation of production and trading systems accompanied by pressures for further trade liberalisation in the ‘Millennium Round’ of negotiations under the World Trade Organisation (WTO). At the same time transboundary risks, those generated under one regulatory jurisdiction with significant actual or anticipated impacts in another jurisdiction, regionally or globally, are a source of concern for regulators, politicians and public. A diverse spectrum of issues can be included under the heading ‘transboundary risks’, prominent recent examples being the Chernobyl nuclear disaster, acid rain in Europe and North America, pollution of seas and of the River Rhine, the Colorado River and the Great Lakes, bovine spongiform encephalopathy (BSE), genetically modified (GM) crops, hormone-treated beef, and global climate change (Linnerooth-Bayer, 2000). As our ability to generate hazards which cross national boundaries has grown we have had to develop a range of international mechanisms to regulate them. The apparently impregnable power bases of the major players in the globalisation trajectory, multinational companies, international regulatory bodies and multinational governmental groupings, has resulted in a reduced sense of power and influence for individual citizens, raising questions about sovereignty, governance and accountability for risks generated. One outcome of these developments has been the increasingly important part played by public interest groups in risk related debates. Indeed, as the European public response to genetically modified (GM) crops has shown, public interest groups are using issues of risk management to attempt to influence the pace and trajectory of the globalisation process itself. Based on a new approach to categorising transboundary risks, this paper describes developments in transboundary regulation of the risks of pesticides and of GM crops, the sources of public concerns about such risks and the social processes which underlie public responses. Categorisation of transboundary risks Linnerooth-Bayer (2000) suggests that the concept of ‘consent’ or ‘voluntariness’ is important for comparing transboundary risk issues. She distinguishes between ‘involuntary’ risks that cannot be detained at borders and thus do not require any form of consent from the importing country (for example acid rain), and ‘voluntary’ risks which may require the consent of the importing authorities (for example GM crops). We have renamed these two categories ‘traded’ and ‘public’ risks and identified two sub-categories within each of these (see Table 1) (Tait and Bruce, 2000). [Table 1 near here] Traded risks Traded risks cross national boundaries as a result of commercial transactions, usually with the knowledge and consent of national authorities charged with risk regulation. National authorities can choose whether to prevent risk-bearing products from crossing their borders but such
Transboundary Risk Regulation national actions need to be backed up by internationally coordinated standards. Transboundary regulation in these cases is about controlling the mechanisms of trade, avoiding risks but also avoiding the use of national regulations to discriminate unfairly among suppliers. Within the traded risk category there are two major classes, product-based and production system based, which raise different issues and require different approaches to management. For traded product-based risks the product itself is considered potentially hazardous (food contaminated by pesticide residues or radioactivity, defective cars, international trade in waste products, GM food or seeds). National authorities can sample products and test for such hazards at the frontier and can restrict entry. For traded production system based risks the negative attribute is only symbolically attached to the traded product (e.g. the fishing method used for tuna; unsustainable logging methods for timber products; intensive farming methods for food products). In most cases there is no internationally accepted legal basis for national authorities to reject such products at customs control points. However, if the origin of the products is identified by labeling, environmental and other pressure groups can campaign against it and individual consumers can exercise their right ‘not to buy’. In this case, the risk itself does not cross national boundaries but public concerns do – people want to have an influence on what happens in other countries, often from an altruistic basis of concern for global or local environmental sustainability or for the health or well-being of workers in other countries. Public risks The term ‘public risks’ describes the obverse of the economist’s ‘public good’ – just as it is difficult to exclude individuals from using public goods, it is difficult to exclude members of the public from the effects of public risks. A hazardous entity in this category cannot be prevented from crossing national boundaries but once it has done so, national or regional measures can be taken to mitigate its effects (e.g. adding lime to lakes in the case of acid rain). The costs of such measures will fall on the public purse; the public and their governments, in the absence of an effective international regulatory system, have no choice on whether to accept the risk and/or the costs of mitigating it. Two distinct types of public risk are particularly relevant in a transboundary context: contained public risks which arise from point sources and only cross national boundaries to an unacceptable extent if there is an accidental release of polluting material; and pervasive public risks, usually chronic and insidious in their effects, often arising from diffuse sources. Food Production and ‘Traded’ Risks Until the 1950s food was generally consumed in the country of origin and indeed it was a preoccupation of many countries to become more self-sufficient in food products and less reliant on imports. Once international trade in food began to expand, international harmonisation of food standards became a more urgent priority (Hough, 1998; Braithwaite and Drahos, 2000). This paper focuses on traded risks, as defined above, which are often related to health concerns involving food, its wholesomeness and its methods of production, particularly pesticide residues in food and GM crops.
Transboundary Risk Regulation Both the development of GM crops by industry and their regulation by governments has involved close links with pesticides. Since the mid 1980s, GM crops have been seen by the agrochemical industry as providing a new wave of technological innovation to enable farming systems to become ever more productive, to provide food for an expanding world population and to enable the industry to remain as an innovationbased high value added sector (Fernandez, 1985). The precautionary regulatory system developed for GM crops in Europe also owed something to the early experience of pesticide regulation, particularly the delay in acknowledging the environmental risks posed by the organochlorine insecticides, and a desire to ensure that the new technology was regulated from the beginning in a more responsible manner. Despite such promises and good intentions, trade in GM seeds and crops has become one of the most contentious international risk issues; NGOs and some national governments (in response to public pressure) are calling for much more rigorous controls, a moratorium on GM crop developments or an outright ban. Because the development of the technology has been dominated by multinational companies, the innovation strategies chosen have been those that fit well with the existing interests of agrochemical companies, increasingly organised on a global basis (Chataway and Tait, 1993). The early products of GM technology were thus those that would support intensive farming systems. Although reduction in pesticide use is a potential health and environmental benefit from GM crops, multinational companies have only recently begun to emphasise this aspect of the new technology, at least partly because of the potential to undermine their existing pesticide product range (Tait and Chataway, 2000). These historic links have meant that industry familiarity with the product-based risk regulatory system for pesticides has conditioned to some extent the evolution of the regulatory system for GM crops. Also, from the public point of view, concerns about intensive farming systems which are supported by pesticides (production system based risks) have been transferred in magnified form to GM crops. Transboundary Regulation of Pesticide Residues in Food Impacts and monitoring of pesticide residues The term ‘pesticide’ covers herbicides, insecticides and fungicides. They come from a wide range of chemical groups with an equally wide range of acute and chronic impacts on people and the environment, of levels of toxicity and persistence, and of mobility in food chains. In international trade, apart from the small volume of organic food products, most crops intended for human or animal consumption will have been treated several times with pesticides of various types, with the potential to leave pesticide residues on the crop itself. In developing a pesticide, an acceptable daily intake (ADI) level will be established (the level at which the pesticide has no observed effect on animals in feeding trials, divided by a safety factor of 100); and maximum residue limits (MRLs) (the maximum permissible level of pesticide in a food) will be calculated by comparing the ADI with the likely daily level of consumption of a particular food product. The extent to which pesticide residues are a human health hazard is a hotly debated issue and there is little consensus on the health effects of traces of pesticides. Some scientists argue that it is inconsistent to be concerned about small amounts of chemical contamination when many foods contain much greater levels of natural toxins. Hough (1998) reports that Bruce Ames estimates the average American consumption of pesticides produced by plants as a natural defence mechanism to be 1.5 grammes per day, ten thousand times the daily consumption of synthetic pesticide. Others argue that we should reduce the overall pesticide burden by limiting human exposure to the externally applied chemicals over which we do have some control; or alternatively that ADI levels and MRLs are not necessarily safe for vulnerable groups such
Transboundary Risk Regulation as children, the elderly or malnourished people, who are more susceptible to toxic effects than the ‘average’ benchmark, usually a well-fed male. Taking a ‘traded risk, product-based’ perspective on pesticide residues, products can be sampled and tested at the point of entry to a country to make sure that they comply with MRLs for pesticides. International action in this area was stimulated by concerns that some countries might permit the use of pesticides which were banned in others because of risks to people or the environment or that standards of compliance with national regulatory measures might be more lax in some countries than others. Monitoring and testing schemes have only occasionally found MRLs exceeded but some regulatory officials are concerned about the levels of sampling and the comparability of data from different national laboratories. The Codex Alimentarius The Codex Alimentarius is the main system for international regulation of food standards, including the presence of pesticide residues in food. It was established in the 1960s as a collaboration between the Food and Agriculture Organisation (FAO) and the World Health Organisation (WHO) with the aims of protecting the health of consumers and ensuring fair practices in the food trade. The Codex contains more than 200 standards for individual foods or groups of foods and in 1998 membership of the Codex Commission comprised 163 countries, representing 97% of the world population (Understanding the Codex Alimentarius, www.fao.org/docrep/w9114e/). The Codex Commission works through a number of Codex Committees, including General Subject Committees (such as Food Labeling, Pesticide Residues) and Commodity Committees (such as Fish and Fishery Products). The Codex Committee on Pesticide Residues (CCPR) has an ad-hoc working group, the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). For the JMPR, the WHO carries out toxicological studies and the FAO considers farm system based issues such as patterns of pesticide use, the fate of residues and metabolism by animals and plants. Based on these data, MRLs are considered by the CCPR for individual pesticides in food and feed items, providing a threshold level above which a food or food product can legitimately be rejected as potentially hazardous to health. The Codex Commission usually reaches agreement by consensus , sometimes returning a draft to the Committee for further work and more rarely taking a vote (Randell, 2000). Acceptance of MRLs by governments is voluntary, on the basis of (i)
‘full acceptance’ where governments undertake that both imported and domestic foods will conform to specifications and that they will not legislate to hinder distribution of food conforming to this limit; or
(ii)
‘free distribution’ where governments commit only to not enacting legislation to hinder distribution of food conforming to the limit.
Codex standards have a strong influence on the development of national standards. However, the EU and the USA have generally adopted more stringent standards than the Codex and any attempt to impose Codex standards worldwide as a means to removing trade barriers, would result in a lowering of standards in these countries (Hough, 1998). The Codex sees itself as undertaking a strictly scientific activity. Those selected for membership of expert consultations must be pre-eminent
Transboundary Risk Regulation in their specialty; they are not appointed as government representatives or spokespeople for organisations. Even so, the Codex Committees have been criticised for being dominated by industry and insufficiently open about their proceedings (UK National Food Alliance (1992) quoted in Braithwaite and Drahos, 2000). However since 1999 representatives from a range of other bodies, including the United Nations organisations, intergovernmental organisations and NGOs have been able to attend Codex meetings as observers, but not to participate in the meetings. Also many sessions are open to the public. Membership of panels and the selection criteria used to identify experts will also be published (Randell, 2000). World Trade Organisation The WTO is primarily concerned to allow unrestricted international trade in goods and services and was not originally involved in risk regulation. However, it has been drawn increasingly into international risk debates as transboundary risk regulation has been challenged by governments and industry as a restriction of trade. A notable recent example has been the reluctance of the European Union to accept imports of hormonetreated beef from the USA. Risk issues were not a prominent part of trade negotiations during the 1980s or in negotiations of the Uruguay Round of General Agreement on Tariffs and Trade (GATT) which preceded the formation of the WTO. However, following the Uruguay Round, trade ministers adopted the Decision on Trade and Environment which anchored environment and sustainable development issues in WTO work. They set up the Committee on Trade and Environment (CTE) and assigned it a broad mandate, covering virtually all aspects of the trade and environment interface. The CTE is open to all Members of WTO. Since 1995, Codex standards have been used by the WTO as a reference for a series of agreements outlining what are regarded as legitimate restrictions on trade. The most relevant to risk issues is on the application of Sanitary and Phytosanitary (SPS) Measures which acknowledges governments’ rights to protect human, animal or plant life or health. However, the measures taken must be based on scientific principles and they can only be applied to the extent necessary for this purpose (Nordstrom and Vaughan, 1999). The SPS Agreement was a major step in the globalisation of food standards and set Codex standards as the benchmark against which national regulations are evaluated. If national standards are higher than those of the Codex, the additional safeguard must be based on scientific evidence and grounded in risk assessment (Vogel, 1995, p188). Governments also cannot discriminate by applying different requirements to different countries without scientific justification. One result of this linkage between WTO and Codex standards is that the previously scientific Codex process is becoming politicised (Braithwaite and Drahos, 2000, p. 403). Pesticide Residues as a Production System Based Traded Risk The emphasis on scientific principles and demonstrable hazard as a basis for decisions about the acceptability of pesticide residues in food can be found throughout the relevant official documents. However, concerns about pesticide residues in food crops are closely related in the public mind to concerns about pesticide use in intensive farming systems and the sustainability or otherwise of such systems. A significant sector of public opinion believes that the only truly sustainable farming systems are organic systems which do not make any use of chemical pesticides (Tait and Morris, 2000). Pesticides themselves are thus viewed as a production system-based risk and the presence of pesticide residues on crops is just one manifestation of this risk.
Transboundary Risk Regulation People who approach the issue of pesticide residues in food from this worldview may not be particularly concerned about the risks of the residues per se. Their concerns may be about the environmental risks of intensive farming systems of which pesticides are an integral part or the risks to farm workers who apply pesticides, often with inadequate protection, particularly in developing countries. Despite the more open approach to decision making adopted recently by regulatory bodies such as the WTO, formal risk regulation processes, national or transboundary, do not yet accommodate value based perspectives. This leads to what are often described as irrational public responses to risk issues when demands are made that appear to go far beyond what could be justified on a purely scientific basis. For traded, production system based risks the only option available to the public to exert an influence across national boundaries is through their purchasing power as consumers. This requires the adoption of agreed standards by producers who commit themselves to more publicly acceptable production methods and the identification of such produce by labeling. International and national standards of this type are in the process of being developed. Transboundary Regulation of GM crops and foods Health Related Risks of GM Crops Health-related concerns about GM food include (Organisation for Economic Co-operation and Development (OECD), 2000a): •
potential toxicity;
•
unexpected gene transfer of antibiotic resistance marker genes; and
•
food allergies caused by foreign proteins;
•
increased cancer risks;
•
potential damage to food quality and nutrition.
Hileman (2000) has also suggested that the unpredictable nature of genetic modification, including the number of inserts of the construct, their location and their stability may generate product related risks; the location of insertion may cause disruption of the function of another gene; and promoters such as the cauliflower mosaic virus promoter can affect the function of genes other than the one it is introduced to control. She quotes the example of a tobacco plant engineered to produce linolenic acid which also produced the toxic octadecatetraenoic acid. Antibiotic resistance marker genes are present in most GM crops as a by-product of the modification process and there is concern that the resistance gene can be transferred to gut micro-organisms in animals and humans, reducing the clinical effectiveness of antibiotic drugs. However, research in this area has shown that such risks are relatively insignificant compared to drug treatment itself (of both farm animals and humans) as a source of drug resistant strains of pathogens (König, 2000). It is difficult to remove these marker genes from a GM crop during the development process and industry strategies to avoid this cause of public concern have focused on finding alternatives. For example Novartis has developed a sugar-based marker gene system with first commercial release of crops expected in 2001-2 (Novartis, 2000).
Transboundary Risk Regulation An example of potential food allergies caused by introduced genes is the transfer of a gene from Brazil nuts to soya bean to enhance its value as animal feed. Allergenicity testing demonstrated possible reactions to the soya product among people allergic to Brazil nuts and commercial development of the product was stopped (Taylor, 2000). Alternatively, as a positive contribution to food safety, GM technology can be used to remove known allergens from current conventional crops such as rice and peanuts (Bindslev-Jensen, 2000). In categorising the risks of pesticide residues, as noted above, the balance of emphasis was on the product-based perspective, the production system based perspective being present in the background. Despite the fact that the food-related hazards of GM crops are so far mainly hypothetical, that development of a product has been stopped if the potential to generate harmful effects has been demonstrated, and that there are no documented cases of harm arising from a GM crop, trade in GM products has become a highly contentious international risk issue. Research on public attitudes has shown that concerns are at least as much about the intensive farming systems of which GM crops are components as about product-based risks (Grove-White et al., 1997; Martin and Tait, 1993; Tait, in press). Much of the apparent public irrationality in debates about GM crops as a risk issue stems from the need to express public concern through the formal risk regulation process which, despite its more precautionary nature, is still reluctant to accept value-based arguments. Regulating GM Crops The EC Deliberate Release Directive 90/220 (EEC, 1990) was concerned to ensure uniform conditions throughout the EU for the development and regulation of biotechnology (Levidow et al., 1996; Bijman and Tait, 1998). However, political events since 1998 have prevented achievement of this aim (Levidow et al., 2000). The first binding international agreement addressing situations where GM crops cross national borders was provided by the United Nations Environment Programme (UNEP) based Cartagena Protocol on Biosafety to the Biodiversity Convention (Tait and Bruce, 2000), agreed in January 2000 when environment ministers and trade negotiators from 138 governments concluded five years of talks (Bridges, 2000a). The treaty was opened for signature in May 2000 and will enter into force once it has been ratified by 50 countries. The main issues for debate in the protracted negotiations were trade, the scope of the Protocol, the relevance of the precautionary principle, the relationship to other agreements and allocation of liability (Cosbey and Burgiel, 2000). Under the Protocol, governments will signal whether they are willing to accept imports of agricultural commodities that include living modified organisms ( LMOs)1, communicating their decision via an Internet-based Biosafety Clearing House. Shipments of commodities that may contain LMOs will be clearly labeled. Stricter procedures apply to LMOs that will be intentionally introduced into the environment, including the requirements to provide detailed information to the importing country in advance of the first shipment and for the importer to authorise the shipment. The aim is to ensure that recipient countries have both the opportunity and the capacity to assess potential risks involving GM organisms.
1
The distinction between all GMOs, including products derived from them, and LMOs, was an important point of debate in the negotiations. LMOs are presumed capable of replication and would include seeds (e.g. maize or soya) for planting as agricultural crops or for animal feed. Ground maize or soya including material from GMOs would not be classed as an LMO.
Transboundary Risk Regulation Concern has been expressed that concessions made in the CartagenaProtocol could compromise its objectives. The Miami group (Argentina, Australia, Canada, Chile, Uruguay and the US) was very forceful in seeking to water down labeling requirements and succeeded in that the Protocol applies only to LMOs so that no segregation is required for non-living GM organisms, to the disappointment of the Like-Minded Group of developing countries and environmental NGOs. The fudge over the relationship of the Protocol with WTO trade-related regulations was also of concern. The preamble states, ‘this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements’ and also ‘the above recital is not intended to subordinate this Protocol to other international agreements’. An EU official noted that the effect of the two sentences was to cancel each other out (Bridges, 2000b) and this is bound to be an important debating point as the implications of the Protocol are clarified. OECD Initiatives Although not itself a regulatory body, the OECD has a long history of co-ordinating and guiding regulatory approaches for a range of risk issues including both pesticides and biotechnology. In June 1999 the heads of state of the Group of Eight (G8) industrial countries took notice of public concern about the safety of GM crops and food and invited the OECD to undertake a study of the safety aspects of GM food and to report to the G8 summit meeting in Okinawa, Japan in July 2000. One outcome of this initiative was a major international meeting on ‘GM Food Safety: Facts, Uncertainties and Assessment’ held in Edinburgh from 28 February – 1 March 2000 (OECD, 2000b). The points identified by rapporteurs at this conference, on which they claimed there was agreement by the majority of participants, included the need for more openness and transparency in debates and in the policy process, and acknowledgement that there is potential benefit to be gained from GM technology. They also noted that many consumers eat GM foods with as yet no significant effects on health. There were, however, more opposing views than points of agreement expressed at the conference. They often related to the fact that some participants regard human health aspects of GM foods as inseparable from wider issues such as the impact on the environment, trade and economic factors and belief systems. There was also disagreement about the extent to which genetic modification constituted a fundamental change in the way new crops are produced, necessitating new ways of assessing food safety and whether individual countries should be allowed to develop GM technology for food production according to their own needs, or whether there should be a global moratorium on such developments. Other contentious issues included mandatory labeling of GM crops, the usefulness of feeding trials in animals for GM foods, the process of assessing consumer concerns and the need for further work on potential long term effects of GM food on human health, worker safety and the environment. Sir John Krebs, chairman of the meeting, recognised a need for continuing international dialogue on this issue, to inform rather than to make policy, and recommended the creation of an international consultative panel to address all sides of the GM debate. “It should take science as its starting point… plus the broader issues of economic development, trade and other concerns” and build on work already being done in other fora. (OECD, 2000b). A suggested model for this body is the Intergovernmental Panel on Climate Change, accepting the need in the case of GM crops to involve other stakeholders in addition to scientists.
Transboundary Risk Regulation Assessing the Health Risks of GM Crops Viewing GM crops and foods from a ‘traded, product based risks’ perspective, demands for more rigorous assessment of their risks to consumers have been growing, particularly since 1998. In dealing with this issue, the concept of ‘substantial equivalence’, adopted in the EU, Australia, Canada and the USA, has been the main guideline. Substantial equivalence is assessed by comparing a modified crop against the unmodified crop, on a case-by-case basis, assigning GM crops or related food products to one of three categories: •
substantially equivalent to a conventional counterpart;
•
substantially equivalent to a conventional counterpart except for a few clearly defined differences;
•
not substantially equivalent to a conventional counterpart, either because the differences cannot be defined or because there is no existing counterpart to compare it with.
If a crop or food is deemed to be substantially equivalent, it is considered to be as safe as the existing food product and therefore not in need of further testing. Any identified differences are subject to safety assessment including toxicological testing. The concept of substantial equivalence is unsatisfactory to many consumers and those who oppose GM technology, being viewed as a substitute for safety assessment, “… a commercial and political judgement masquerading as if it were scientific” and “… anti-scientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests.” (Millstone et al., 1999). Regulatory bodies on the other hand treat it as part of the assessment process, indicating whether any further other toxicological evaluation is necessary (OECD, 1993). Industry protagonists argue that it is inconsistent to demand special consideration of all GM food and ignore all the other new crop varieties coming on the market (Miller, 1999). The solution proposed to the problems listed by Millstone et al. is to conduct a range of toxicological tests and use the evidence generated to set acceptable daily intake (ADI) levels. However, moving to a toxicological basis for testing GM foods is not a straightforward matter (Tomlinson, 2000). Animal testing as traditionally used to assess the safety of pesticides or pharmaceuticals cannot be transferred simply to assessing food safety. Pesticides and pharmaceuticals are well characterised, pure chemicals, of no nutritional value, consumed as a very small proportion of the total diet. Foods, by contrast, are complex entities with a wide variation in chemical composition and nutritional value. They can only be fed at low multiples of the amounts that might be present in a natural diet and even this may cause dietary imbalance or other negative effects due to anti-nutritive factors present naturally in the food. This demonstrates the impossibility of devising, for example, an ADI level for a GM food. The difficulties of testing GM crops for toxic effects are further compounded when concern is for chronic, low dose toxicity, particularly at vulnerable stages of development (Howard, 2000). Labeling GM Crops and Food Products The issue of the labeling of GM crops and food products at point of sale to the consumer was important in the evolution of public concern about GM crops. Consumer organisations initially took a much more neutral stance on GM crops than environmental pressure groups. They could
Transboundary Risk Regulation envisage potential risks but they could also envisage consumer benefits. When GM crops began to be imported into Europe from the USA their views became highly influential in the debate about public acceptability of the new technology. Issues raised during this debate focused more on democratic freedom to avoid food derived from production systems of which consumers disapproved than on actual risks from consumption of GM food (Tait, 2000) (placing the issue in the ‘traded, production system-based’ category). For consumer organisations, the labeling of GM crops was crucial to public acceptance as consumers could only exercise their democratic right ‘not to buy’ if such products were labelled. Industry, on the other hand, particularly the US-based companies that were the first to develop GM crops for world markets, used the concept of substantial equivalence to argue strongly, at WTO level, against the need for labeling of GM crops. If such crops were substantially equivalent, the argument went, then there was no scientific basis to distinguish between a GM and a non-GM crop. From this perspective, any state or group of states which required identification and labeling of GM crops could thus be regarded as infringing WTO rules. Social Processes and their Influence on Risk Regulation This paper has introduced an approach to categorising transboundary risks in general and demonstrated its application in the contexts of food and health related risks involving pesticide residues and GM crops. All such categorisations reflect the purposes and perspectives of those who develop them. Our perspective derives from a systemic, interdisciplinary approach to policy analysis. Our purpose is to contribute to the understanding and improvement of regulatory processes – where complex regulatory problems exist, a systemic understanding of the underlying issues and their interactions can facilitate their resolution. For both GM crops and pesticides, although in different proportions, concerns focus on risks inherent in food products themselves and in the food production systems of which they form components. Different public motivations (self interest versus fundamental values) underlie the expressions of concern (Tait 2000) and different approaches are needed to resolution and public reassurance in each case. The issues highlighted in the analysis presented in this paper include: •
the need to devise approaches to risk regulation which do not discriminate unfairly among nations engaged in international trade in food products;
•
the need to preserve and in some cases reinforce the legitimate role of science in detecting, analysing and regulating potential risks in food products; and
•
the need to provide an approach to public involvement in risk regulation which is more open and allows constructive engagement in debate without paralysing decision making and without resulting in public disillusionment.
Our analysis opens up one possible approach to meeting the above set of needs by allocating legitimate and clearly specified roles to both product-based and production system based approaches. This would be a major change from the current situation where production system based concerns are more usually side-lined or ignored and are rarely recognised in formal risk regulatory procedures.
Transboundary Risk Regulation In the context of GM crop development, risk regulation on the basis of the process, rather than the product, is regarded by some as illegitimate, irrational and anti-scientific. This attitude was at the root of earlier disputes over the risk regulation of GM developments between the USA and Europe (Tait and Levidow, 1992) and the tension, still unresolved, underlies current disputes over hormone treated beef and GM crops. The approach proposed involves two strands, of equal validity but based on different sets of criteria, and with different modes of operation. 1. Product-based risks should be identified and characterised by processes of scientific investigation. Products should be tested according to internationally agreed criteria and should not be discriminated against in international trade if they conform to such criteria. In the context of GM crops, the concept of substantial equivalence may need to be refined or replaced but changes should be made only on the basis of new scientific information. This system would continue to operate at international and national government levels. All products in international trade would conform with product-based risk regulatory standards and there would be no need to emphasise this fact by labeling. 2. Production system based concerns should be dealt with by labeling products according to their source, the validity of the label being backed up by internationally recognised standards. There would be no international restriction of trade on this basis but individual consumers would have the opportunity to exercise their preferences at the point of sale. Such systems would not necessarily involve governments at national or international levels; they could be supported by commercial trading systems, ensuring traceability of products in the food chain. We do not claim that this simple mechanism can remove all conflict and debate from what are highly contentious issues. Before it can begin to operate, a decision has to be taken on whether to regard an issue as product based or production system based and this in itself can be contentious. However, it does elevate the debate to a more productive level where it may have a greater chance of being resolved and removes inappropriate debate from lower levels of decision making where it generates confusion rather than enlightenment. At present the structure of the debate is amorphous and therefore unproductive.
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Transboundary Risk Regulation LEVIDOW , L., CARR, S. AND W IELD, D. (2000) Genetically modified crops in the European Union: regulatory conflicts as precautionary opportunities. Journal of Risk Research, 3(3), 189-208. LINNEROOTH-BAYER, J., (2000) Introduction, in J. LINNEROOTH-BAYER, R. LOEFSTEDT AND G. SJOESTEDT (Eds.) Transboundary Risk Management in Europe (London, Earthscan. MARTIN, S. AND TAIT, J. (1993) Biotechnology: Cognitive Structures of Public Groups, pp 55. (Report to the Department of Trade and Industry, Laboratory of the Government Chemist, June 1992). Published by Centre for Technology Strategy, Open University, Walton Hall, Milton Keynes MK7 6AA. MILLSTONE E; BRUNNER E; MAYER S (1999). Beyond substantial equivalence. Nature, 401, 525-526. NORDSTROM, H. AND VAUGHAN, S, (1999) Trade and Environment, WTO Special Studies 4 NOVARTIS (2000) Positech™ breakthrough offers alternative to antibiotic resistance marker genes for genetically enhanced crops. Basel, 5/23/00 www.seeds.novartis.com/news/news_article.asp OECD (1993) Safety evaluation of foods derived through modern biotechnology: concepts and principles (Paris, OECD). OECD (2000a) Summary of Input from Conference Webpage Consultation. GM Food Safety: Facts, Uncertainties and Assessment. OECD Edinburgh Conference on the Scientific and Health Aspects of Genetically Modified Foods, 28 February – 1 March 2000 OECD (2000b) GM Food Safety: Facts, Uncertainties, and Assessment. Chairman’s Report and Rapporteurs’ Summary; C(2000)86/ADD3. www.oecd.org/subject/biotech/edinburgh.htm RANDELL, A. (2000) The Work of the Codex Alimentarius Commission. Paper presented at GM Food Safety: Facts, Uncertainties and Assessment. OECD Edinburgh Conference on the Scientific and Health Aspects of Genetically Modified Foods, 28 February – 1 March 2000; www.oecd.org/subject/biotech/edinburgh.htm TAIT, J. (in press) More Faust than Frankenstein: the European Debate about Risk Regulation for Genetically Modified Food. Journal of Risk Research. TAIT, J. AND MORRIS, D (2000) Sustainable Development of Agricultural Systems: Competing Objectives and Critical Limits. Futures, 32, 247260. TAIT, J. AND BRUCE, A. (2000) Global Change and Transboundary Risks Paper prepared for Society of Risk Analysis Symposium on Risk and Governance, Virginia, USA, June 2000. TAIT, J. AND CHATAWAY, J. (2000) Technological foresight and environmental precaution: genetically modified crops, in M.P. COTTAM, D.W. HARVEY, R.P.PAPE AND J. TAIT (Eds.) Foresight and Precaution, Proceedings of ESREL 2000, SARS and SRA-Europe Annual Conference, Edinburgh, Scotland, 15-17 May, 2000, Vol 2. Rotterdam: Balkema, pp 829-838.
Transboundary Risk Regulation TAIT, J. AND LEVIDOW , L. (1992) Proactive and Reactive Approaches to Risk Regulation: the Case of Biotechnology, Futures, April, 1992, pp 219-231. TAYLOR, S. (2000) Allergenicity. Paper for a Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology. Geneva, 29 May – 2 June, 2000. TOMLINSON, N. (2000) The Concept of Substantial Equivalence, its Historical Development and Current Use. Paper for a Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology. Geneva, 29 May – 2 June 2000. VOGEL, D. (1995) Trading Up: Consumer and Environmental Regulation in a Global Economy (Cambridge, Mass., Harvard University Press)
Transboundary Risk Regulation
Table 1 Categorising trans-boundary risks Traded risks Product based
Public risks
Production system based
Contained
Pervasive
Risk characteristics and examples
The product per se may be risky, e.g. pesticide residues or fungal carcinogens in food imports, defective imported cars; international trade in waste products, GM seeds and crop commodities
Risk is ‘symbolically’ attached to products which are traded across boundaries, e.g. fishing method for tuna, intensive farming methods for food products, ‘unsustainable’ timber exploitation
Risk is, in principle, contained and only materializes in the case of an accident; therefore mainly point sources, e.g. nuclear power accidents (Chernobyl)
Chronic, often insidious risks, from diffuse sources e.g. acid rain, ozone depletion, greenhouse gases and global climate change
Regulation and control
Sampling and testing of products for conformance with internationally agreed standards; prior informed consent
Labeling and consumer choice or voluntary accreditation schemes. Needs industry collaboration.
Potentially affected countries are reliant on another jurisdiction’s regulatory system and vigilance, international liability mainly lacking, only legal rights through courts in country of origin
Usually through international agreements requiring quotas or bans; or by allocating the equivalent of internationally effective ‘property rights’
Source of pressure for regulation or management of risks
Mainly industry and regulators, but public and environmental groups become involved if perceived lack of control
Mainly public interest groups, NGOs
National governments may perceive a threat to their economy or environment; also involved in clean-up in event of an accident. Strong interest of environmental groups and often the public.
Mainly governments and NGOs; scientific community often very active in identifying risks
Approach to risk regulation
Accepted risk assessment procedures available; varying degrees of uncertainty; benefits straightforward to identify. Precautionary principle is not usually relevant.
Difficult to assess intangibles; often strongly value based assessment of risks. Precautionary principle may be relevant or may be used to justify intervention
Complications in assessing low probability events; access to information in foreign countries limited. Precautionary principle may be relevant but not usually applied
Sources of pollution and damage difficult to identify; difficult to determine cause-effect relationships. Precautionary principle relevant to major impacts with high levels of uncertainty and irreversibility.
