Before exploring the existing regulatory framework in the UK, it is necessary to examine international legal contexts. Such a process highlights the ways in which pro-GM countries have exerted political and economic pressure to create international GM laws that are sympathetic and subservient to industry and trade.
International regulations
A crucial and central principle of international environmental law is the duty of states not to cause environmental harm. In both Articles 21 of the 1972 Stockholm Declaration and Article 2 of the 1992 Rio Declaration this obli- gation was reaffirmed along with the notion of responsibility and account- ability for those states that cause damage or harm to the environment. As Hunter et al. (1998: 348) succinctly identify the ongoing deficiencies of obli- gation under international law by asking:‘what level of harm should trigger the obligation? To what standard of care should the State be held? What activities should be considered under the jurisdiction and control, of the State? What remedies should be available to States who suffer damage?’ The answers to these questions are complex and continue to provide challenges for parties to environment treaties. However, what is agreed upon is that the answers to the above questions are to be found in the negotiating processes of international protocols that aim to achieve maximum consensus and that are subsequently reflected in individual nation-state legislation.
One of the most significant recent developments in the international reg- ulation of GMOs has emerged with the signing of the Cartagena Protocol on
Biosafety. Like many international agreements the passing of the Cartagena Protocol on Biosafety was anything but smooth and straightforward. Indeed its negotiation and enactment were described by the Executive Director of the United Nations Environment Programme, Mr Klaus Topfer, as‘mission impossible’ (Topfer, 2004). As Nijar (2002: 263) identifies, every step of the way, ‘the biotechnology industry and its governmental protagonists in the negotiating process fought to prevent the protocol from coming into exis- tence’. Bail et al. (2002) provide a detailed insight into the often bitter debate that transpired between negotiating groups that were polarised by vested interests. For example, the self-titled ‘Miami Group’ (Argentina, Australia, Canada, Chile, Uruguay and the United States) represented (at times) a strong opposition to the Protocol for its potential deleterious effects on global trade. The ‘Like Minded Group’ (Ethiopia, Jamaica, Brazil, Phil- ippines, Seychelles, Iran and China) voiced the concerns of developing countries and urged that a protocol was necessary for the protection of bio- diversity from living modified organisms. The European Union comprised another key player in negotiations and supported the concerns raised by developing countries as well as emphasising the risks to the environment posed by genetically modified organisms. The fourth major contingent were the ‘Compromise Group’ (Switzerland, Norway, Japan and Mexico, later joined by Singapore and New Zealand) who adopted a middle-ground approach to the divided positions of the Miami and Like-Minded Groups.
The Protocol came into force on 11 September 2003, exactly 90 days after the 50th signatory had ratified it. As of December 2009, a total of 156 countries had signed the Protocol, notably none of the above mentioned Miami Group has yet to ratify the Protocol (see Convention on Biological Diversity, 2009). The Protocol provides a mandate for the safe transfer, handling and use of‘living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biologi- cal diversity, taking also into account risks to human health, and specifically focusing on transboundary movements’ (Article 1). Countries that plan to introduce living modified organisms into another country will be required to submit an application notifying exact details of content (Articles 7 and 8), and all products intended for food, or feed must be labelled (Article 18). The importation of all genetically modified organisms (GMOs) to nations that are party to the Protocol will require risk assessments and the express written approval of the receiving country (Articles 11, 15 and 16). No signatory to the Protocol can be forced to accept GMOs without their consent, thus pre- serving sovereign rights – an issue that is being contested by the United States in the WTO. Moreover illegal movement of GMOs, notably in con- travention of the Protocol (Article 25), provides for liability and redress that includes financial penalties (see Articles 27 and 28). This final point was a major sticking point in the negotiation process as pro-GM groups sought to eliminate liability from the agreement. However, ‘no liability, no protocol’
was a hardline position adopted by developing nations with the support of most other countries (Cook, 2002). In addition, the Protocol is consistent with the Convention on Biological Diversity and adopting the precautionary Principle 15 of the Rio Declaration which states‘that where there is threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat’.
As Graff (2002) points out, such precautionary principles in international environmental law are rare. Therefore the Cartagena Protocol (notably Articles 1, 10 and 11) encourage parties to incorporate precautionary mea- sures into their national framework. In doing so, it grants a right to take precaution based on national or internal risk assessments. A lack of scientific evidence confirming ‘potential adverse effects’ cannot be asserted to force any country to accept GMOs. The Cartagena Protocol permits all parties to self-determine their acceptance or rejection of GMOs based on their own mechanisms of risk assessment. This principal creates tensions with notions of free trade and international trade law. The US-led case in the WTO against the EU’s so-called moratorium on GM food has been premised on the assumption that anti-GMO stances based on unscientific and inconclusive evidence constitute illegal trade barriers (see Falkner, 2004).
The 2009 report of the compliance committee of the Cartagena Protocol of Biosafety identified that gathering national information from signatories has proven difficult. The Protocol requires signatories to meet certain ‘reporting’ requirements to ensure that the terms and conditions of the Pro- tocol are implemented. There is still much work to be done in this regard. As the Committee concluded, ‘lack of legal and administrative regulations for biosafety of having no or little activity related to biosafety could hold back some Parties from fulfilling their reporting obligations’ (Convention of Bio- safety, 2009b:4). In addition, the Compliance Committee received informa- tion from an NGO alleging that one country had violated the conditions of the Protocol. The Committee met in private to discuss the submission and debated whether or not it should even receive the report, let alone act on it. As such, the Compliance Committee’s role is more about gathering infor- mation and assisting nation-states to implement the Protocol rather than enforcing its contents.
The Cartagena Protocol has been strengthened with the ratification of the International Treaty on Plant Genetic Resources for Food and Agriculture that officially became law on 29 June 2004. This agreement has been reached in harmony with the Convention on Biological Diversity and has two dis- tinct objectives. The first is the ‘conservation and sustainable use of plant genetic resources for food and agriculture’ and the second is the ‘fair and equitable sharing of the benefits arising out of their use’ (Article 1). As a result, the treaty aims to address acts of bio-piracy and bio-prospecting. The commercial use of genetic resources must result in equitable sharing
(information-exchange, access to technology, capacity building andfinancial payments) to the country of genetic origin (Article 13). Moreover, the treaty identifies the important role of farmers and indigenous knowledge in the preservation of genetic resources and establishes a set of ‘farmers’ rights’ that includes the ‘right to equitably participate in sharing benefits arising from the utilisation of plant genetic resources for food and agriculture’ and ‘the right to participate in making decisions, at the national level, on matters related to the conservation and sustainable use of plant genetic resources’ (Article 9). This legal framework aims to safeguard against genetic exploi- tation, notably the plunder of developing countries by international corporations that remains widespread (see Simwanda and Mwila, 2004). European Union legislative framework
Both international and national regulation of GM food relies upon three key principles: the precautionary principle, the preventative principle and the polluter pay principle. The above principles have been acknowledged by European Community (EC) legislation and integrated into member state legal frameworks. Since the early 1990s EC law, notably in the form of the Contained Use Directive (92/219/EEC) and the Deliberative Release Direc- tive (90/220/EEC), has provided the regulatory leadership on the production, handling and release of GMOs (Walters, 2007).
In 2001, the Deliberative Release Directive was amended to include stric- ter controls over scientific consultations and compulsory monitoring of environmental impacts (Thornton and Beckwith, 2004). Moreover, EC law regulates the marketing of GMOs where all manufacturers and importers of GM food products must submit notifications with risk assessments to the receiving countries’ authorities and enter into a ‘consent agreement’ that stipulates the uses and prohibitions of the designated foodstuff. In addition, labelling and traceability laws have been passed by the EC that require all GM products and their derivatives to be labelled and for the origin of all stages of the product handling to be clearly traceable. That said, the GM Food and Feed Regulation (EC 1829/2003) requires food containing GMOs to be labelled; however, dairy and yoghurts produced with GM enzymes do not require labelling nor do meats and dairy products produced from ani- mals fed on GM grain (Food Standards Agency, 2006).
Individual member states of the EC are not required or expected to transpose or replicate regulations into national legal frameworks – such regulations, once they come into force, immediately constitute law within member states. On the one hand, directives are not binding but are designed to‘promote harmonization’, a common spirit or purpose regarding specific environmental issues that should be integrated into national law. Most European countries have adopted various forms of biosafety legislation that include regulatory mechanisms for genetically modified foods.
That said, it is clear that trade remains central to the actions of the EC and to member states. The European Court of Justice ruling in the case of Procureur du Roi v Dassonville highlights the importance of promoting trade and sets standards for trade restriction. The widely quoted Dassonville formula serves to preserve and stress that community beneficial trade is the cornerstone of the EU. This formula identifies:
[a]ll rules enacted by Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade are to be considered as measures having an effect equivalent to quantitative restrictions.
(Case 8/74 Procureur du Roi v Dassonville [1974] ECR 837) Should EC member states wish to introduce environmental measures then such national laws must reflect the priorities of trade. Therefore, coexistence between free trade and environmentalism is a complex issue. The EU was premised on an economic foundation. Its development has been underpinned by economic imperatives that are frequently at odds with environmental protection. The challenges that face the EC are to integrate environmental concerns into a model that has continually prioritised trade and economic prosperity for five decades. Harmonising environmental legislation across culturally and economically diverse nations within an historical context that prioritises trade and economic stability is a demanding and challenging enterprise. The integration of EC environmental law currently remains insufficient and in many instances inadequate.
Yet the tensions of environmental protection within trade law are not an EU specific problem but a global one where the priorities of the free market are emphasised. It is true that at an international level, trade agreements continue to insert clauses that acknowledge the need to protect the environ- ment in what is commonly referred to as‘greening the GATT’. While parties to environmental agreements may seek trade restrictions where the trade is deemed to harm human, animal or plant health or threatens the existence of a natural resource,‘there is no internationally agreed set of principles to deal with the potential difficulties caused by the overlap between the GATT rules and the trade provisions of environmental provisions’ (Thornton and Beck- worth, 2004: 40). Indeed, the imperatives of trade law have always usurped the contents of environmental agreements. For example the widely cited Tuna Dolphin case brought by the European Union against the United States in 1994 demonstrates this point. The United States placed a ban on all imported tuna known to be caught with nets detrimental to dolphins and other marine life. The WTO ruled that even though the method of fishing was a breach of international environmental law, the US embargo was in violation of the GATT and was, therefore, illegal. Interestingly the WTO stated that if exporting countries agreed with the US imposed trade
sanctions then the embargo would have been lawful. Similar cases have been heard by WTO (see Shaffer, 1998 and the Shrimp Turtle case) where trade restrictions imposed by one country on another for environmental reasons have been found to be unlawful under trade law.
For the EU, its GMO regulations emphasise‘expert-led’ risk assessments for the authorisation of licenses. Holder and Lee (2007: 209) argue that existing EU GM food laws provide central guidance for member states with, as yet, unknown results. They conclude:‘agricultural biotechnology has been an extraordinarily fraught issue for the EU, and there are as yet no guarantees as to the stability of the regulatory regime’.
UK GM food law
Thornton and Beckwith (2004: 422) describe Britain’s regulatory regime for GMOs ‘as the tightest in the world’. This comment has merit when com- pared to the United States where public opinion supporting labeling GM food, and National Academy of Science concerns for human health and environ- mental safety, have been sidelined in favour of a biotech industry led reg- ulatory system based on voluntary partnership and not monitoring and enforcement (Montague, 2000). Regulations in the UK have also been sub- jected to numerous stinging criticisms. As the opening quotation to this book identified, industry controls the regulatory regime in Britain and biotech lobby groups have been widely reported to influence the corridors of White- hall (Monbiot, 2000; Rees, 2006). For example, British law does not require products with GM ingredients below 0.9 per cent for approved GM varieties and 0.5 per cent for unapproved GM to be labeled. As a result, there are numerous varieties of food in UK supermarkets that will be unlabelled as derivates of GM products or considered‘GM free’, an issue that has drawn widespread criticism (Soil Association, 2007; Smith, 2004).
Academic commentators have also criticised the UK GM food regulatory regimes for focusing too much on the ‘means’ or techniques of genetic modification and not on the ‘ends’ or outcomes; that regulatory authorities and government advisory bodies are too closely aligned with the bio- technology industry; that clear guidelines do not exist stipulating distances between GM and non-GM crops; that precaution is half hearted and regulation fragmented (Hughes et al., 2002).
Under the Blair years, Britain was clearly pro-GM. The UK opposed both France and Greece’s efforts to introduce an EU GM moratorium during 1999 and was actively against the labelling of food products with GM deri- vative (Monbiot, 2000). Former Environment Minister Michael Meacher was increasingly attacked by biotech representatives for his resistance and caution to GM crops (Colin and Elliot, 2003).
Senior scientific figures with the New Labour Government have continually promoted GM food. For example, the Chief Scientific Officer in Scotland,
Professor Anne Glover, who is a strong advocate of GM food, has been referred to as a ‘business-savvy genetic engineer’. She angered envi- ronmentalists with her reported suggestion that GM food is better for the environment and an answer to world poverty and hunger (Edwards, 2006). Within government there have been documents critical of the existing reg- ulatory regimes for GMOs. Take for example, the 2003 cost-benefit analyses conducted by the Cabinet Office’s Strategy Unit. This report emphasised the eminence of economics in UK environmental policies, and suggested that present and future regulatory regimes would tend to adapt to a range of unexpected events brought about by international markers and innova- tions in science (Cabinet Office, 2003). This thoughtful report was forwarded to Defra for dissemination and rollout – yet it has barely seen the light of day and the challenges it alludes to for future agricultural and environmental impacts and regulations are virtually ignored. Instead, we have the softer and ‘do-able’ sections ‘cherry-picked’ and utilised by government for contemporary practice.
In setting out its regulatory stall, Defra has been openly critical of the EU ban on GM foods and has emphasised that a ‘one size fits all’ approach is unsatisfactory. In its place Defra has proposed a regulatory approach that treats GM crops as separate and distinct issues; concluding ‘The results of the Farm-Scale Evaluations demonstrate very clearly that each crop is different, and must be considered on its own merits (Defra, 2004:13).
The European Union Directives noted above have been integrated into UK law in the form of the Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2002, and the Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2005. There are several bodies associated with regulations of GMOs in Britain including Defra, FSA, Heath and Safety Executive, Environment Agency, Scottish Environment Protection Agency as well as local authorities.
Health and safety executive
The three main bodies are Defra (for the deliberate release and marketing of GMOs), FSA (GM food safety) and HSC (GMO contained use). Defra (2009d) summarises the regulation of GMOs in Britain as follows:
The legislation adopts a step-by-step approach to the assessment of GMOs. This means that initial developments are carried out in con- tainment and only released into the environment if they are assessed to be sufficiently safe. The initial releases outside containment are small, and carefully controlled and precautionary measures can be applied to prevent or minimise the spread of genetically modified DNA. The scale of the releases is increased gradually and tested at each level. The tests at each stage indicate whether the next step can be taken.
All GMOs are first kept in a contained environment. The Health Safety Executive defines contained use as:
… where control measures are used to limit contact between GMOs and humans and the environment so as to provide a high level of safety. In practice, this involves work in laboratories, animal houses, plant growth facilities (including growth rooms in buildings and suitable glasshouses) and large-scale production facilities on industrial sites.
(HSE, 2009) The majority of genes that are manipulated in the UK are‘crippled’ whilst in the laboratory to prevent their growth outside the contained environment. However, as the HSC notes‘only a small number of activities involve GMOs that are not disabled and still capable of growth outside of the laboratory’