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This chapter discusses European Community legislation for traceability and labeling of genetically modified crops, food, and feed. After a brief discussion of EC law making and the role of the precautionary principle, the chapter discusses EC measures for authorization of bioengineered or genetically modified organisms (GMOs) and GM food and feed. It focuses on EC Regulations that require, and establish thresholds for, traceability and labeling of GMOS and their food and feed products. The chapter addresses the practical issue of coexistence of GM crops with conventional and organic crops, and it reviews EC policy documents and Member State measures to ensure coexistence.

Increased global cultivation of GM crops raises concerns about the coexistence of GM varieties with conventional and organic crops. In the European Union, where few GM crops are grown, GM content that exceeds strict regulatory thresholds triggers requirements for labelling and traceability. Successful coexistence measures can minimize GM presence and avoid those labelling and traceability requirements. Though the European Union does not impose standards for coexistence, a 2003 Commission Recommendation lays down guidelines for Member State strategies and best practices. Member States have enacted (or will enact) coexistence measures, including education, notification, and on-farm practices. Significant issues related to coexistence include limits on GM content in seeds, the effects of GMOs on organic production, the legality of GM-free areas in the European Union, and liability for damage caused by commingling of GM and other crops.

The European Union has now put in place an extensive regime for the regulation of GMOs and this chapter provides an overview of that regime. In particular, it maps out the legislation which governs: the contained use of GMOs, the deliberate release of GMOs into the environment and their placing on the market, GM food and feed, and traceability and labelling. At a broader level, it also assesses the extent to which these specific measures have been integrated into wider European Union policy on food law. It focuses their interaction with the Food Law Regulation, the role of the precautionary principle, and the provision of information for consumers and civil society.

Modern biotechnology has promised much for agriculture, and these promises are certainly attractive in the case of Africa. Importantly, a number of countries in the continent continue to grapple with food insecurity and starvation. But it remains controversial whether modern biotechnology, in its current state, can overcome these unique challenges. For reasons such as biosafety and fear of loss of export markets, Africa has remained largely ambivalent towards GM crops, and the regulatory regimes governing biosafety in several countries largely restrict their development. While recognizing some of the hurdles which modern biotechnology must clear before it can deliver its promises, this chapter argues that the continent stands to benefit from promoting the development and safe use of GM crops. It further argues that African countries should invest heavily in research and development, with a view to owning the technology and ensuring relevance to their circumstances. This should be the guiding objective of biosafety regulation in Africa.

There has been a high level of public engagement in the regulation of GMOs and this chapter seeks to explore this engagement, whether conducted through formal or informal channels. In the case of formal channels, it examines the opportunities for public participation under measures enacted at international, European Union, and national levels, addressing, inter alia, the detailed provisions of the Cartagena Protocol and Aarhus Convention. In the case of informal channels, attention is directed to consumer preferences and public protest, and a salient feature identified is the reluctance of United Kingdom juries to convict anti-GM activists, as compared with the willingness of (non-jury) courts in France to convict Faucheurs Volontaires.

This chapter focuses on the risks posed by genetically modified crops. It argues that many of the risks which are likely to materialize fall comfortably within traditional heads of damage such as personal injury or damage to property. There is also, however, a risk of environmental damage per se, which legal systems may find more problematic. In particular, the notion of damage to ‘biological diversity’ requires careful consideration, especially in light of the definition in the Biodiversity Convention. In the same context, while compensable damage should include the costs of preventive measures and reasonable measures of reinstatement, it should not be so limited, since it may well no longer be feasible to recall the GMO in question.

Genetically modified (GM) crops are now part of mainstream agriculture, and the trend towards increased use of GM organisms in plant and animal agriculture will undoubtedly continue. This chapter provides a brief outline of the technologies used to produce GM crop plants and livestock, the means whereby GM products can be detected as minor contaminants in food, and some of the difficulties and paradoxes that must be faced in attempts to label products derived from GM organisms.

Within the framework imposed at European Union level, Member States have taken advantage of the considerable discretion which they are accorded when implementing coexistence measures at national level. This divergence is examined by reference to four Member States: France, Italy, Spain, and the United Kingdom. While there may be important similarities in approach (for example, in all four Member States the choice has been taken to regulate by legislative means), there are also notable differences. In France, the emphasis is on freedom of cropping, with the result that actions seeking to impose GM-free zones, whether initiated by organic producers or local authorities, have met with little success. In Italy, until recently, there has been a legislative impasse by reason of a battle for competence between the state and the regions. In Spain, a draft Royal Decree has been promulgated, but it remains to be implemented, and several of its measures have already proved controversial. In the United Kingdom, the devolved administrations of Scotland and Wales have shown marked hostility to GMOs, while, more generally, the slow pace of legislative progress may be attributed to the absence of immediate intent to proceed to commercialization of GM crops.

Why has the problem of tobacco energized NGOs and policy entrepreneurs in the USA but much less in the EU? Why has transgenic food provoked similar kinds of collective responses in the EU, but much less in the USA? First, the USA and EU-15 possess different ‘cultural markers’ in that they express different values/collective preferences. Second, institutional arrangements vary and steer even similar preferences and values to produce different political results.

This chapter considers the concept of risk as it applies to the regulation of GMOs. In so doing, it examines the oftentimes problematic, yet still dominant, hybrid scientific and political character of risk regulation in the arena of agricultural biotechnology and its legal ramifications. The dominance of technocracy and difficulties of constructing viable inter-disciplinary dialogue are also discussed. Further, the chapter considers the problems experienced in attempting to invoke greater public participation as a regulatory response to engaging with and determining acceptable levels of risk, something that is increasingly viewed as a contested concept. A central point of discussion is the role of law in dealing with the disputes that inevitably arise in so controversial a field.

Cost-benefit analysis (CBA) is an attempt to estimate a monetary value for environmental or public health degradation. In a regulatory context, it should be seen as a complementary tool to risk assessment for the purposes of public decision-making. CBA should, therefore, be particularly relevant in the governance of modern biotechnology. GMOs, however, provide a ‘textbook case’ of the complexity which results from any attempt to conduct CBA in relation to innovation, this being a function of their novelty, the ethical concerns which they raise, their economic importance, the danger of potentially irreversible effects on biodiversity, the absence of scientific unanimity in risk assessment, and consumer fear. This chapter underlines the importance of CBA in the regulation of GMOs and highlights the specific difficulties with which such analysis is confronted. It argues that these difficulties should not be considered as a reason to dispense with economic evaluation.

This chapter assesses the role for environmental liability in the context of the GMOs, with emphasis on the provisions of the Community Environmental Liability Directive. It commences with discussion of the role of liability regimes more generally (adopting Coasean analysis) and compares and contrasts the Environmental Liability Directive with the Lugano Convention. The application of the Environmental Liability Directive is then considered in detail, with particular attention devoted to: the definition of environmental damage, the basis of liability (whether strict or grounded upon fault), the use of the administrative liability model, and risk allocation and insurance. The chapter concludes that the Community regime has serious limitations. Not least, its territorial application is largely restricted to the Natura 2000 network of protected wildlife sites, where GM crop cultivation is in practice unlikely to occur.

Canada approved GM canola for unconfined release in 1995, but it did so without open and informed debate about the problems of coexistence of GM and non-GM agriculture, and without a regulatory structure to adequate addressing them. They are, therefore, being dealt with by the courts. This chapter first discusses what this entails for affected farmers in the well-known cases of Monsanto v Schmeiser and Hoffman v Monsanto. It then explores the possibility of bringing an action against the government for negligence in regulating and controlling GM technology, particularly in failing to provide adequately for the coexistence of GM and non-GM agriculture. Several class actions relating to BSE currently before the Canadian courts are presented as examples.

This chapter begins by providing an outline of the process of integration which is currently being undertaken by the members of MERCOSUR, with specific reference to the legal order which governs such integration. As a further preliminary matter, it considers the extent to which the members of MERCOSUR have embraced the GM revolution, with Argentina being revealed as the most enthusiastic. The various national regimes regulating GMOs are then discussed in detail, identifying common characteristics and differences. In all cases national regimes are found to be based upon pre-existing rules governing seeds and crops, although specific regimes are also being developed. However, only in Brazil has a major statute been enacted for the purposes of governing GMOs. More generally, the chapter looks to whether there is a realistic possibility of enacting a harmonized regime for GMOs across all the members of MERCOSUR and, in this context, it identifies recent initiatives.

Much has been written on the legal implications of the international regulation of GMOs. This chapter does not reproduce this discussion, but rather considers how general rules of international law, together with more general trends in related legal and policy fields, are likely to prove increasingly apposite in the ongoing debate over how to manage and govern GM activity. In particular, it considers two specific issues: first, the role of treaty interpretation in promoting synergies and reconciling apparently conflicting primary rules; and, secondly, the utility of the concept of sustainable development in determining a balanced framework for the inclusion of socio-economic considerations within GM decision-making processes, as permitted under the Cartagena Protocol. The chapter concludes that an approach which concentrates solely on the regulatory detail will invariably ignore the importance of general international law in regulating such an issue.

Biological materials such as infectious agents, recombinant DNA molecules, and genetically modified organisms can cause serious health risks if they are not contained properly. Therefore, the federal government has established a series of rules, regulations, and best practices for proper containment of hazardous materials. Federal guidelines classify the health hazard of biological agents and their containment facilities based on the different levels of risk associated with their use in research. To ensure compliance, the federal government requires the appointment of an institutional biosafety committee and a biological safety officer to review all recombinant DNA research, including agricultural research using genetically modified organisms. Select agents are any biological organisms or toxins that potentially pose a severe threat to human, animal, or plant, health. Any institution that uses select agents must register with the federal government, and the researchers must undergo a federal security risk assessment. The federal government has also established licensing procedures for radioactive material that regulate exposure limits and permissible possession amounts. The broad license requires the appointment of a radiation safety committee and a radiation safety officer to monitor institutional regulatory compliance. Likewise, all hazardous waste must be handled according to rigid federal and state regulations.

In this chapter, Aarti Gupta analyses the extent to which information disclosure facilitates safe global trade and use of genetically modified organisms (GMOs), as mandated within the Cartagena Protocol on Biosafety negotiated under the Convention on Biological Diversity. The chapter analyses whether the scope and practices of disclosure relating to GMOs in agricultural trade further a right to know and choose of importing (developing) countries, in permitting or restricting such trade.Through analysing the limited disclosure obligations imposed on GMO exporting (industrialized) countries by the protocol, the chapter argues that disclosure follows rather than shapes market developments, since no existing practices have to change. Furthermore, a complex detection and testing infrastructure is required to put the limited disclosed information to use. As such, themarket-facilitating norm of caveat emptor(let the buyer beware) prevails in practice. Transparency thus fails to empower the poorest countries most reliant on globally induced disclosure in this case.

This chapter reviews the development of both EU and US regulatory policies and practices regarding agricultural biotechnology since 2000, in light of bilateral and international pressures. The first section examines the remarkable root-and-branch reform of the EU's regulatory framework. The second section examines the domestic debate over the adequacy and possible reform of the US regulatory framework for GM foods and crops, and the resulting incremental changes to the behaviour of market actors as well as US national regulators. The story of US and EU regulation of GMOs since 2000 has primarily been one of continuity, with the US retaining its preference for a relatively lax, technocratic, and product-oriented regulation, while the EU has retained the essential features of its more precautionary and process-oriented regulatory system involving individual approval decisions by politicians.

This introductory chapter begins with a description of persistent regulatory differences between the United States and the European Union with regards to the regulation of genetically modified organisms (GMOs). It then sets out the purpose of the book, which is to investigate the challenges — the obstacles to reconciling regulatory differences through international cooperation, and what happens when cooperation fails — through the prism of the US-European dispute over the regulation of agricultural biotechnology or GMOs. The book addresses the dynamic and reciprocal interactions of domestic law and politics, transgovernmental and transnational networks, international regimes, and global markets, through a theoretically grounded and empirically comprehensive analysis of the governance of GM foods and crops. An overview of the subsequent chapters is presented.