The integration challenges of social regulatory barriers to GM crops. This so-called ideal regulatory framework must promote regulatory stability and integration, subject to several important parameters. First, the framework must balance the competing economic and social interests, calling simultaneously for technological progress and precaution. In this sense, the approach must achieve an acceptable political compromise.
Secondly, the regulatory framework must be precise enough to be operational – that is, in order to deal with regulatory externalities, eliminate instability and avoid trade tensions, the regulatory framework must have precise rules that clearly outline regulatory procedures. It should avoid vague or ambiguous regulatory principles, which lead to delay and indecisiveness.
Thirdly, the regulatory framework must be strategically targeted. The regulatory resources of governments are crucially limited and yet technological innovation is a dynamic phenomenon. In this sense, the regulatory framework must be a dynamic approach, focused on the application, management and distribution of GM technology and capable of keeping pace with technological innovation, rather than a complete command and control approach, which quickly becomes obsolete.
Fourthly, in respect of regulatory integration, the regulatory framework must avoid autarky. It must disentangle those regulatory aspects that can be coordinated with regulations in other jurisdictions from those regulatory aspects that, because of crucial domestic pressures, must remain under the complete control of the jurisdiction. Further, it must be considerate of relevant international obligations.
Given these important parameters, the ideal regulatory framework employs a risk-analysis framework to the regulation of GM crops. As identified in Part III, both the North American and the European regulatory approaches are within the risk-analysis framework, and yet they differ substantially on several important framework principles and specific principles for regulating advanced technologies such as GM crops.
Comparing the North American and the European regulatory approaches reveals the sources of regulatory regionalism. Essentially, while the North American regulations remain congruent with the scientific-rationality approach, the European regulations have departed from this trajectory and shifted-to a distinctly social-rationality approach to regulating GM crops, which tends to be more congruent with its regulatory tradition.
The transatlantic regulatory regionalism and social regulatory barriers facing GM crops are caused by structural differences in the regulatory approaches employed in North America and Europe. In order to promote stable regulatory integration, the ideal regulatory framework must overcome the significant structural regulatory differences in the risk-analysis approach employed in the two dominant jurisdictions.
Although both risk-analysis approaches have their strengths, neither approach is the most appropriate for addressing the issue of social regulatory barriers to GM crops. For instance, the North American approach, while supported by economic interests, is simply not socially responsive enough to address social interests and would be vulnerable to a dramatic public crisis over GM foods, as has occurred in the UK.
Yet the European Union (EU) approach, which has shifted to meet the demands of social interests, has failed to establish an approach supported by either economic or social interests. It does not have a solid enough foundation of risk assessment to be stable and predictable and is constantly reacting to perceived risk, regardless of the scientific justification for the public concern. Therefore, both approaches must be amended to more equitably address the legitimate economic and social interests in a stable, transparent and socially responsible manner.
The ideal regulatory framework aims to be socially responsive in the regulatory development process, but not to the detriment of regulatory framework stability and integration. The key to this is to employ the scientific-rationality approach to risk assessment, providing a solid foundation for risk, and yet to employ the social-rationality approach to risk management, providing a socially responsive framework to meet social interests.
Beck argues that despite the apparent mutual exclusivity of the scientific- and social-rationality paradigms, they can be integrated because they are mutually reinforcing – ‘scientific rationality without social rationality remains empty, but social rationality without scientific rationality remains blind’.
In short, the ideal regulatory framework essentially builds social credence into the scientific-rationality paradigm. This is accomplished by combining a scientific risk-assessment approach with a social risk-management approach and a transparent risk-communication strategy.
This ideal risk-analysis framework will be discussed below in its three constituent parts:
1. Risk Assessment,
2. Risk Management and
3. Risk Communication.
1. Risk Assessment:
The objective of risk-assessment procedures is to produce neutral and transparent risk information to inform the risk- management process. Risk assessment can enhance regulatory stability and regulatory integration by producing clear and precise procedures, establishing essential minimum requirements (EMRs) for safety applicable in all regulatory jurisdictions.
In order to integrate the scientific- and social-rationality paradigms in the risk-assessment procedures, the only principle of scientific rationality that must be abandoned is the idea that empirical questions are logically prior to normative questions. The reason for this is that a decision must be made as to the type of risk that the risk assessment will focus on. This is a normative question, which is in fact prior to the empirical question. But, once it is answered, empirical questions may be asked and assessed by recognized experts in the field, resulting in legitimate, credible, neutral and transparent risk information to assist in the risk-management procedure.
With respect to the type of risk targeted in risk assessment, the focus of risk assessment must be on asking empirical questions about hypothetical risks, not speculative risks. In other words, risk should be something that can be defined empirically and testable by empirical means, rather than based on unsubstantiated logical possibilities. Empirical questions have the important ability to clarify risk according to accepted analytical methods and causal-consequence mechanisms, while limiting the social and political influence over the risk-assessment procedure.
Is this approach acceptable? Indeed, even within the scientific community, there is considerable disagreement over empirical conclusions. Yet disputes among hypothetical risks can at least be assessed through further study and analysis.
In fact, it has been argued that this is the approach used in medical risk assessment and it enjoys widespread confidence from all stakeholders. Speculative risks based on logical possibilities cannot be ‘refuted’ by the scientific process and are the refuge of those uninterested in a genuine risk dialogue. In this sense, speculative risks are not an operational regulatory principle.
Focusing on hypothetical risks because they are subject to accepted analytical methods does not mean that new analytical methods cannot be developed, nor does it imply that ‘no evidence’ means ‘no risk’. It has been argued that the problem with current risk-analysis approaches to GM crops is the lack of a predictive ecology framework. Without such a framework, critics argue that they must bypass risk assessment based on hypothetical risks and rely instead on risk management that assumes speculative risks.
Yet this approach adds nothing to risk information and seems to undermine the development of an alternative analytical method, because of the lack of research and development. Indeed, it would be irresponsible to abandon biotechnology, because biotechnology and genetically modified organisms is an inevitable feature on the industrial landscape. Developments in biotechnology in general benefit specific applications; hence, technology will continue, even with a ban in one specific area, such as agricultural biotechnologies.
Also, due to the significant economic stakes of agricultural biotechnology, a regulatory ban in one jurisdiction will only lead to a redistribution of GM-crop development, not a halt. It is in the interest of the most advanced nations, with the most advanced scientific capacity and regulatory systems, to regulate the hypothetical risks of GM crops according to the best analytical methods at their disposal in order to set the global standards.
Further, when scientific risk assessments do not yield conclusive results, it is an imperative part of the scientific precautionary approach that no evidence from inconclusive results implies more investigation, and not a conclusion of any risk. Therefore, the development of new analytical methods, such as predictive ecology, must be a regulatory priority. The new methods may prove that past hypothetical risks were underestimated; however, they may equally prove that past hypothetical risks were overestimated, as they were at the initial Asilomar Conference in 1975.
With respect to the risk-assessment debate regarding the principle of substantial equivalence of some GM crops, there appears to be no scientific or moral reason to assert that production-improving and some output-improving GM crops are not substantially equivalent to non-GM varieties for regulatory purposes.
Instead, from a regulatory perspective, risk assessment should be focused on the hypothetical risks of the novel features of GM crops, not on the use of genetic modification per se. This is similar to long-standing regulatory control over exotic plants and pests regulated according to their novelty.
Hence, from a regulatory perspective, it is reasonable to conclude that GM and non-GM crops are substantially equivalent unless the GM crops are novel. This should not be interpreted, however, to mean that consumers do not have a right to know whether a crop is GM or conventional.
Of course, if consumers want to know, they must have access to this information. In this sense, substantial equivalence is only a useful principle for establishing the necessary level of regulatory oversight for risk assessment, but it cannot be a dominant principle for establishing risk-management responses. Instead, the consumers’ right to know must be an important principle in risk management.
Should risk assessment focus on other legitimate factors? In risk assessment, where the goal is to develop empirical questions to gain neutral, transparent and credible information about the hypothetical risks of GM crops, there is no role for the normative ‘other legitimate factors’, including food quality and socio-economic impacts.
That is, once the definition of risk is established, a science basis predicated on hypothetical risks and the best available analytical methods should be the only factors in risk assessment. Risk assessors should only be charged with ensuring that a food is safe, not assuaging consumer fears and proving social benefit.
With respect to the debate over the regulatory principle of burden of proof, a logical and legitimate compromise is to maintain the traditional burden of proof (minimize the risk that a technology is rejected when it is in fact safe) but regulate new technology more stringently. However, this is then a risk-management activity and will be discussed in greater detail below.
Participation in the risk-assessment procedures must be reserved for experts only, and the real issue is finding independent and credible scientific experts to perform the hypothetical risk assessment – a process requiring considerable consensus building. The experts must be as independent of industry as possible and can include known supporters and critics. This ensures wide participation among the experts and ensures that broad concerns will remain on the agenda.
Yet, at the same time, the involvement of scientific experts decreases the variance in normative preferences. Decision-making by the participants must be judicial and rules- based, not consensus-based, in order to ensure timeliness in risk assessments in a field characterized by rapid technological innovation. Finally, the deliberations and decisions of participants must be fully transparent to all interested stakeholders.
The ideal risk-assessment procedures are more congruent with the North American approach than with the European approach and are generally supported by the Organization for Economic Cooperation and Development (OECD), the World Health Organization (WHO) and the Food and Agriculture Organization (FAO).
In this sense, the European approach must shift towards a rules-based and science-based risk-assessment procedure for GM crops, adopting the scientific interpretation of the precautionary principle and limiting the risk assessment to short- and long-term human and environmental safety, not to other legitimate factors. It must also adopt a product- or application-based focus.
In addition, it must increase the transparency of the assessment procedures and resist the temptation to overturn assessment decisions that are incompatible with political decisions. Making these amendments solves the European problems of instability and inoperability.
Although largely congruent with the North American approach, the ideal risk-assessment procedures do require the North American approach to include greater participation in the procedures. Experts from a broader range of interests and yet familiar with the specified frame of reference and the analytical methods, would participate and wield policy power, not just the GM-crop developers and government regulators.
The ideal scientific risk-assessment procedures benefit both regulatory stability and integration. Stability is increased, because the language of risk, safety and precaution is harmonized, eliminating confusion and ambiguity associated with divergent risk assessments and effectively levelling the playing-field for all stakeholders. Technological precaution is explicitly built into the assessment procedures, through risk-averse assumptions and likelihood functions, allowing credence goods to shift to experience and search goods in a controlled manner.
Non-market regulatory objectives, such as human and environmental safety, would be dealt with by specifying the frame of reference at the outset, establishing regulatory floors based on shared EMRs. Participation would be greatly increased by making critics a part of the scientific risk-assessment procedure, rather than excluded actors claiming unsubstantiated risks from outside the regulatory development process.
The prospects for regulatory integration are also increased, because of the harmonized risk-assessment procedures. This limits the problem that could arise because there is no supranational institution to decide on EMRs. It also limits the degree of possible normative disagreement, because scientific disagreements can be dealt with subject to accepted rules of scientific debate.
Essentially, the ideal risk-assessment procedures establish regulatory principles that are operational in an international integration framework, because the conditions for risk information are precise and stable.
The likelihood that both the North American and the European regulatory approaches can and would adopt the ideal scientific risk-assessment procedures is good, despite the necessary modifications.
The analysis of the economic and social interests has revealed that, in most instances, opposition to GM crops is not actually opposition to the technology per se. Instead, it is opposition to the application of the technology.
The ideal scientific risk assessment focuses on the risks of these application issues, rather than obfuscating the debates by widely condemning the technology of genetic modification. Further, in both regions, there is a desire to avoid the ‘my scientist vs. your scientist’ debates which occurred in the World Trade Organization (WTO) beef-hormones dispute.
More recently, this debate occurred in the autumn of 1999, when British beef approved as safe in Britain and by the EU Food Safety Committee was not approved as safe by French authorities and France refused to lift its ban on British beef.
Both sides repeatedly claimed that they had science on their side. Adopting the ideal scientific risk-assessment procedures would prevent or drastically limit regulatory barriers being justified according to controversial debates over science.
2. Risk Management:
While it is necessary to centralize and harmonize the scientific risk-assessment procedures, the objective of risk management must be to build social credence into the scientific regulatory approach. Although the goal of the risk-management process is risk reduction and prevention, it is undeniably an inherently political exercise of balancing the rights and interests of both supporters and critics.
In this sense, it is incorrect to characterize risk management as just a process of creating economic instruments to correct market failures, where the only indicators of regulatory effectiveness are economic measures of market efficiency. In other words, once based on a common framework of risk information, risk-management decisions must retain the freedom to be socially responsive.
An important feature of the risk-management stage is that endogenous or internal pressures lock risk management at the national level. Essentially, the economic and social stakes are too high to give up authority over risk management. Therefore, it is impractical to expect an international regulatory approach to emerge in the short or even medium term. Instead, risk management remains the domain of regulatory jurisdictions and cannot be effectively centralized or harmonized at the multilateral level.
Within this context, the ideal risk-management process aims to ensure that regulatory development, while being socially responsive, is simultaneously considerate of both the scientific risk-assessment procedures and the obligations to other countries under various international agreements.
Under the ideal risk-management process, science matters and the risk-management deliberations must be based on a common foundation of risk information, provided by the risk-assessment procedure. With respect to the regulatory debate associated with risk tolerance, risk management must accept that zero tolerance is not a realistic goal. Instead, the focus must be on the relative risk of the GM-crop application, subject to some tolerated level of risk, permitting the technological progress necessary to increase risk information.
Without this basis, risk management is arbitrary and vulnerable both to regulatory capture and to criticisms that it is scientifically unjustifiable. One solution is to introduce a ‘technology penalty’ at the risk-management stage, designed to build consumer confidence in the regulatory control over new technologies. In fact, it has been argued that greater scrutiny of GM crops has already been established in this way, without having to reverse the burden of proof.
Ager and Fincham and Ravetz both argue that GMOs have faced greater regulatory scrutiny in the UK, despite the fact that there is no empirical evidence to justify this. In this case, risk-management regulations are primarily for confidence building to address the credence factors and not for enhancing safety.
Yet, given the discussion on the UK, it is clear that the technology penalty must also be accompanied by a more concerted effort by proponents to address the information gap created by the commercialization of their own applications. In essence, the burden of proof remains the traditional principle, but the new technology must meet more stringent conditions on product or application performance and on dealing with credence factors.
Therefore, unlike risk assessment, science cannot be the final arbiter of risk management; it can only inform the regulatory development process. With respect to the risk-management debate over the use of science or other legitimate factors, the ideal risk management must consider the social dimensions of GM crops and involve the participation of all stakeholders from either end of the support-opposition spectrum. In this sense, risk management cannot be independent or normative-free, because it cannot be disentangled from the interests and concerns of both supporters and critics.
Crucially, this requires compromise and concession on the part of both supporters and critics and the realization that the goal of risk management is not to build normative consensus; rather, it is only to strike an acceptable balance.
On the one hand, private firms must endeavour to assess GM crops to the highest level of consumer and environmental protection available. They must also respect the social dimensions and credence nature of GM crops by meeting the consumers’ right to know, even in the absence of safety issues.
The failure to preserve consumer choice among GM and non-GM crops has had disastrous consequences in Europe, despite the absence of safety issues or justifications. In addition, product-liability laws should be included in regulatory approaches, to make sure that the risk to human and environmental safety becomes internalized by the firm as commercial risk, which the firm then minimizes. Indeed, it has been argued that, with product-liability laws, ‘regulators may have significantly more freedom in coercing the market toward efficient outcomes’.
On the other hand, critics cannot expect regulatory approaches to fully reflect their belief systems and must be prepared to compromise without illegal action. They must participate in and respect the risk information provided in the risk-assessment procedure, and some level of risk tolerance must be accepted in risk management, as there is no such thing as zero risk. They must be prepared to engage in cooperative, non-antagonistic actions during the risk-management process.
The ideal risk-management process also requires governments to abandon the inward focus common for food-safety and environmental-protection regulation. Instead, governments must give equal consideration to the impact of their risk-management decisions upon other countries as well, according to their obligations under various international agreements.
There is no such thing as ‘autarky’ and, as regulations have an impact on market access, risk-management policies must consider those impacts. Governments must resist domestic pressures to impose regulatory barriers that are unjustified according either to the scientific risk assessment or to acceptable measures agreed to in, for example, trade agreements.
To achieve this, mutual recognition must be built into the domestic risk-management process. The reason for this is because domestic regulations represent a political balance and, once a balance is achieved, it is crucial for political stability that the regulatory framework prevents foreign GM crops from circumventing the domestic requirements, thus creating concerns that destabilize the balance. If governments cannot resist establishing unjustified regulatory barriers, then they must be prepared to acknowledge that the barriers are driven by unjustified factors in violation of international obligations.
Hence, although governments can opt out of their obligations, they cannot do so without cost – in this case, paying compensation to affected foreign firms in a manner that they have already agreed to under international agreements. In this sense, national governments are free to choose whatever risk-management regulatory response they wish, but they are not free to use controversial scientific justifications.
Additionally, the intergovernmental discussions on mutual recognition must abandon traditional trade-diplomacy features, such as limited participation and un-transparent, closed-door discussions. Instead, discussions of mutual recognition must occur with both an open dialogue and wider participation.
The key result of the open, transparent, mutual-recognition strategy is that, while national governments are free to pursue those regulatory responses that are domestically necessary, they must accept the regulatory responses of other governments as equivalent to their own. Of course, this further supports the centralization of scientific risk-assessment procedures, so that a domestic government can ensure that the safety assessments are domestically acceptable.
The ideal risk-management process is more congruent with the European regulatory-accountability approach, where regulatory development responds to the social dimensions, not just to market failures. In order to achieve the ideal risk-management process, the European approach must fully commit to scientific risk-assessment procedures as an important foundation for risk management, and it must be prepared to support a level of tolerable risk, even in the face of public pressure. Further, social risk-management decisions taken in absence of a scientific justification must be considered in the context of international rights and obligations, where contravention, although permissible, is not without cost.
Meanwhile, the North American regulatory approach must accept the legitimacy of other factors in risk management, beyond scientific factors. In other words, it must accept a social risk- management process. This includes provisions to address the credence nature of GM crops by permitting regulations predicated on the consumers’ right to know, even in the absence of safety concerns. For instance, this means that non-product-related production and processing method (PPM)-based labelling rules must be developed and accepted and not challenged under narrow international trade law, which fails to adequately account for a social approach to risk management.
Essentially, in dealing with regulatory barriers to trade, the ideal risk-management approach is crucially focused on building social credence into the scientific-rationality approach. It accepts the fact that regulations are political and that political factor differ between countries and regions, making it impossible to establish international risk-management responses. Divergence in regulatory approach will occur, but this divergence will be minimized by basing risk management on centralized scientific risk-assessment procedures. Further, the proactive regulatory-coordination strategy of mutual recognition prevents the tensions and disputes that arise under regulatory competition.
The ideal risk-management approach can increase regulatory stability by ensuring that it is based on a foundation of credible, harmonized scientific risk-assessment procedures. It preserves sovereignty or autonomy over regulatory responses, meeting crucial subsidiarity pressures. It acknowledges the critical role of political and social factors in regulatory development and it supports the legitimacy of these other factors beyond the limited market-failure and scientific factors.
The ideal risk-management approach also enhances regulatory integration through regulatory coordination by promoting cooperative, proactive efforts to develop mutual recognition agreements, avoiding the forced convergence of regulatory competition.
Mutual recognition avoids both the difficulties of harmonizing risk management across countries and regions with divergent economic, social and political factors and the potential democratic deficit created when international institutions wield regulatory authority in the absence of clear accountability provisions.
It promotes greater commercial certainty through stable market-access rules, creating economies of scale and reducing transaction costs. Although this strategy cannot prevent regulatory barriers, it can discipline their use in a framework more capable of meeting the concerns that make disciplining regulatory barriers under a regulatory competition framework at the WTO unacceptable.
Finally, the ideal risk-management process can prevent the perception of a competitive deregulation or regulatory race to the bottom, because it explicitly provides for the inclusion of legitimate, non-market objectives in domestic regulatory responses.
3. Risk Communication:
The biggest failure in the risk-analysis framework in both North America and Europe has been a lack of transparency – the failure to provide adequate and accurate risk communication. GM crops exhibit credence factors that are poorly understood by consumers because of a significant information gap. Both supporters and critics have failed to provide accurate information, and instead have manipulated information to meet their own interests.
Consider, for instance, supporters and their global-welfare promises and critics and their sensational dread predictions based on emotive, speculative risks. Governments, pulled in opposite directions to meet the interests of both supporters and critics, have understandably chosen to quietly deal with GM crops in an attempt to keep them out of the political agenda. Together, the polarity of views and the un-transparent government approach represent a completely unacceptable strategy of risk communication.
The ideal risk-communication strategy is a complete commitment, by all stakeholders, to the two-way flow of transparent information between scientific risk-assessment procedures and the risk-management process. The risk information produced in the scientific risk-assessment procedures must be available to all interested stakeholders, including interested parties in other countries. To make this possible, GM-crop developer must abandon both their global-welfare promises and their overused claims of ‘proprietary information’.
Consumers have a right to know, and a lack of transparency is easily construed to imply that there is something to hide. Providing the results of in-house human- and environmental-risk assessments does not reveal crucial proprietary knowledge, but it does significantly limit the vulnerability of firms to spurious, sensational criticisms.
Further, the results of the scientific risk-assessment procedures, as well as the deliberations, must be completely available to all stakeholders in the risk-management process. In turn, however, the social dimensions of the risk- management process must also flow back into the scientific risk- assessment procedures – in terms of the scientific precautionary principle, for instance.
The goals of the ideal risk-communication strategy are to reduce the information gap caused by the credence nature of GM crops and to increase public confidence in the regulatory approach. To achieve this, the North American approach must accept that the risk communication of GM crops must meet the consumers’ right to know about the non-safety aspects.
The European approach must increase its transparency to eliminate the unacceptable regulatory hold-up without explanation. Both approaches must better acknowledge the unavoidable regulatory externalities or global aspects of GM crops.
By addressing the credence nature of GM crops, the polarity is minimized, resulting in informed consumerism based more appropriately on the actual benefits and risks, and fully in support of consumer choice.
Given the enormous economic, human-health and environmental benefits, it is difficult to believe that consumers, truly informed, would reject GM crops. Instead, they would understand that it is the application that matters and that applications are best controlled through a risk-analysis framework.
In short, the ideal risk-communication strategy enhances stability and integration by enhancing transparency and public confidence.
Implications of Regulatory Framework of GM Crops:
The ideal regulatory framework essentially builds social credence into the scientific-rationality approach, resulting in a stable framework that is congruent with deeper social integration according to a regulatory-coordination strategy.
Social credence is built in by ensuring consumer information, trust and choice. This approach meets the prerequisites of balancing the competing interests within an operational, dynamic, rules-based approach, capable of managing the applications of advanced technologies.
There are significant implications of this ideal regulatory framework for governments, the GM-crop industry, international organizations and non-governmental actors, which will be discussed below in this order:
1. Implications for Governments:
Within the transatlantic regulatory regions, governments must reconcile the divergence in their regulatory frameworks. With respect to risk-assessment procedures, the EU approach must become more like the North American approach, while, for the risk-management process, the North American approach must become more like the EU approach, with greater stakeholder participation. For risk communication, both the North American and EU approaches must endeavour to be more transparent and accessible.
In dealing with the problem of regulatory integration, governments must engage in proactive regulatory coordination, not regulatory competition. In this sense, the North American approach must become more like the EU and could learn a great deal from the European experience with integrating economies. Also, recognizing the severe weaknesses in dealing with regulatory integration, governments must refuse to take disputes over social regulatory barriers to the WTO.
The ideal regulatory framework allows countries to pursue their own social regulatory approaches unilaterally and they may even ban GM crops, if they wish, according to the scientific interpretation of the precautionary principle. However, it prevents them from misusing ‘science’ in order to support domestic political concerns and holds them accountable for obligations that they have already agreed to under international treaties.
2. Implications for the GM-Crop Industry:
The GM-crop development industry in both North America and Europe must accept that regulations are not instruments used only to correct market failures and that consumers are not just economic agents. Instead, regulations play a legitimate, crucial role in meeting broader social concerns and they must not be viewed only as economic costs. The industry must take a proactive role in addressing the information gap associated with their products, through accurate and transparent risk communication.
The consumer does have a right to know whether or not products are derived from GM crops. In meeting this right, industry must endeavour to identity-preserve, regardless of the incremental costs. As segregation is necessary for both output-trait GM varieties and bioengineered products, this simply speeds up the introduction of effective segregation procedures.
Industry must also accept that science cannot be the final arbiter and, instead, there must be scope for the use of the scientific interpretation of the precautionary principle in regulatory approaches. The scientific precautionary principle is a legitimate regulatory objective and it may be used to restrict or ban particular GM-crop varieties.
Finally, industry must accept that the comprehensive range of concerns associated with GM crops requires an international regulatory integration approach that is broader in remit than the traditional trade approach. In this sense, industry must accept that the WTO cannot be the dominant international institution and they must be prepared to avoid using the WTO to adjudicate on the appropriateness of domestic risk-management regulations.
Therefore, industry must engage fully in a regulatory coordination strategy, though, for instance, simultaneous approval applications in North America and the EU, in order to highlight the common, shared objectives rather than the differences.
3. Implications for International Institutions:
International organizations must facilitate regulatory coordination where possible and, where not possible, must be prepared to stay out of the way. The key lesson is that, when the fundamental regulatory framework is unstable and divergent in North America and the EU there is very little hope that an international regulatory framework will be imposed top-down.
The implication of this is that international organizations, such as the OECD, Codex, WHO and FAO, should continue to assist the risk-assessment procedures for the safety of GM crops, and yet they should avoid involving themselves in the risk-management process, for fear of tarnishing their independence and credibility.
Similarly, the WTO should be kept out of social regulatory integration when what is at issue is the development of fundamental regulatory principles. It cannot credibly rule on which regulatory framework ought to be used, because it is fundamentally built on the economic perspective and yet social regulations are most often driven from the social perspective. This is not to say that the WTO is not a valuable institution.
Indeed, it should continue to focus on trade liberalization through the administration and enforcement of rules and, in areas of little controversy, it can play a role in brokering international rules. But it should not be charged with establishing the fundamental regulatory framework and adjudicating whether or not social regulations are compatible with trade objectives. Such a role only serves to seriously undermine support and confidence in an otherwise very valuable institution.
Of course, this raises an important question about what to do with the Agreement on Sanitary and Phytosanitary Standards (SPS Agreement) – a trade agreement right in the middle of the controversy between trade objectives and social regulations.
Clearly, the SPS Agreement should not be renounced, but careful guidelines on its applicability must be established. Essentially, it is vital to determine whether or not the regulatory barrier under investigation has created trade tensions because of disagreements over framework principles or specific principles.
If, for instance, there is widespread international agreement on framework principles, then the trade dispute over specific regulatory interpretations can be reasonably brought to the WTO’s dispute-settlement mechanism. If, on the other hand, the dispute arises because two jurisdictions disagree on a fundamental framework principle, then it is obvious that the WTO cannot credibly deal with this dispute.
4. Implications for International Non-Governmental Organizations:
The international non-governmental organizations (INGOs) that compose the social interests must accept that regulatory development is a political exercise requiring compromise and concession. While the ideal risk-analysis framework amends the regulatory approaches to more effectively deal with their concerns, at the same time, INGOs must be prepared to participate in the entire regulatory development process, even if their belief systems are not met in their entirety.
For instance, criticisms of the risk-assessment procedures can only be considered valid if the organizations are involved in the procedures, rather than raising sensational speculative risks from the sidelines. They must be fully engaged in the risk-management process and accept that their interests are not the only ones that regulations must consider.
Finally, and perhaps most crucially, they must also commit to an accurate and transparent risk-communication strategy, with the objective of increasing informed consumerism. They wield enormous power in capturing media attention on emotive issues and this power must be wielded responsibly. In fact, their greatest contribution would be as an active participant in the regulatory development process, engaged in finding common ground among the stakeholders.
Future Suggestions for Meeting the Social Regulatory Barriers to the Trade of GM Crops:
There should be no doubts about the difficulty of meeting the challenge of social regulatory barriers to the trade of GM crops. Dealing with these barriers requires drastic structural changes to the traditional trade-diplomacy framework, as well as crucial compromise and concession from all involved stakeholders – both supporters and critics. This is not an issue of extremes. Instead, all stakeholders must endeavour to find the elusive common ground of a more reasoned and rational approach. Only then can the benefits of trade liberalization and socially acceptable regulatory oversight be simultaneously achieved.
Once the transatlantic rules for establishing a regulatory approach capable of balancing technological progress with precaution are developed, the approach must be taken to the international level to begin the process of multi-lateralization.
Admittedly, this next step is also fraught with enormous challenge, because it must reconcile the often competing interests of developed and developing countries – the so-called North-South divide. In this sense, transatlantic regulatory coordination is time-sensitive, as perhaps more pressing or urgent North-South issues will continue to be insufficiently addressed until the pillars of the international economic order reconcile their transatlantic differences.
Finally, only when a multilateral regulatory framework is established can the WTO then play its role as the principal trade liberator, clear of the controversies associated with social regulatory integration.