Biotechnology and the Environment: Navigating the Uneasy Tensions of WTO-Mandated Trade and Environmental Protection - Essay Example

?Biotechnology and the Environment: Navigating the Uneasy Tensions of WTO-Man d Trade and Environmental Protection The race is on to develop methods, to draw more income from the wildlands without killing them, and so to give the invisible hand of the free market a green thumb. E.O. Wilson (1992) Outline I. Introduction II. Creating a legal framework for biotechnology amidst a WTO-driven international trade regime: Tensions and uneasy concessions III. The Precautionary Principle and Science-Based Risk-Assessment: Tracing the Debates and Looking at the Jurisprudence IV. Liability and Redress: Uncertain Developments, New Ways Forward V. Conclusion Introduction There are very few areas where the tensions between trade and environmental protection are as clearly cut than in biotechnology. Because these tensions are set against the current backdrop of increasing liberalization and environmental degradation, the need to adequately address these tensions and strike a balance becomes urgent and compelling. Biotechnology is perceived by different people in different ways. For some, they are indications of science gone mad – the commodification of everything, of even the most basic and fundamental processes of nature. For others, it is a triumph of human innovation, an example of humankind’s superior knowledge over other organisms in the eco-system. The picture becomes even more complicated when the dispute in perspective is not North-South, but North-North, with Europe holding on to its “precautionary approach” in dealing with the issue of biotechnology and the United States maintaining that the European approach violates treade rules and that a science-based assessment approach remains more consistent with legal commitments to liberalization. The World Trade Organization has endeavoured to come up with a regulatory legal regime to govern trade in biotechnology to ensure that biosafety standards are in place and that biodiversity and ecology are not compromised. This paper will take on three parts. The first part will provide a historical overview of the legal framework regulating Biotechnology highlighted by the Cartagena Protocol on Biosafety which is the primary legal instrument, but which is only part of the bigger framework under the Convention on Biological Diversity. The contentious processes leading up to the general agreements will be traced. The second part will look at the legal debates and issues arising from biotechnology, in chief the conflict between the “precautionary principle” and the “science-based” principle, with the end in view of identifying the direction that biotechnology will be taking in the future. The third part will be a legal analysis on the notion of liability and redress, as framed by the recently concluded Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety. Creating a legal framework for biotechnology amidst a WTO-driven international trade regime: Tensions and uneasy concessions Biotechnology in its simplest and most straightforward definition is the modification of the genetic make-up of natural organisms to serve human use, consumption and exploitation. A popular example of biotechnology is the “golden rice” which involves genetic modification for the purported purpose of introducing more nutrients and vitamins, particularly Vitamin A. The genetic manipulation facilitates the production of carotenoids in the grain’s endosperm, thus giving it the yellow hue that gave rise to its name. (Paine, et. al., 2005: 482). Another example is the BT corn, which genetically modifies corn crops to protect it from predatory pests such as caterpillars. It is impossible to look at biotechnology without looking at the social backdrop on which it is foisted. According to Kloppenburg and Burrows (2001): In the United States, some 75 percent of all research and development is now undertaken by private industry. Worldwide, companies such as Monsanto, Novartis, DuPont, Aventis, AstraZeneca and Unilever have the almost exclusive capacity to develop and introduce biotechnologies. Given the increasing commodification of science and technology and the reality of where purchasing power lies, it is naive to expect a new tool such as biotechnology ever to fall outside corporate control. Much controversy has surrounded biotechnology and biotechnology crops from the start. Biotechnology giants like Monsanto have argued that biotechnology improves livelihoods for farmers. As explained in the BT corn example, for instance, farmers will no longer have to purchase pesticides and thus there will be a decrease in their production costs. They have also argued that biotechnology also means cheap food accessible to a great number of people and more nutritious as we ll. On a more lofty plane of analysis, proponents of biotechnology, laud it as a triumph of human innovation, an example of humankind’s superior knowledge over other organisms in the eco-system. Some even argue that “sustainable agriculture is possible only with biotechnology and imaginative chemistry.” (Schneiderman and Carpenter, 1990). But bio-technology does not want for critics. On the more practical level, these critics argue that it worsens the lot of farmers rather than improve it because it creates a pattern of corporate dependence. Taking the BT-corn example, after some time, pests would develop a tolerance to modified strain in the corn crop and farmers will have no choice but to purchase new pesticides from the corporations at prices that will exploit their lack of choices. Environmental advocates, on the other hand, warn of the hazards of biotechnology on biodiversity and other life-forms. For example, environmentalists assert that the corn that is keeping pests away is also killing the Monarch butterfly. In truth, these issues are peripheral to the central debate that underpins the biotechnology discourse: balancing the WTO principles on liberalization and the environmental concerns of biotechnology. To quote Herdegen (2010): Biotechnology on the international level, is covered by the said Multilateral Environmental Agreements (MEAs), which build their judicial content upon a precautionary approach. On the other hand, WTO trade law is deemed to focus on the abolition of trade barriers and the combating of protectionism and unjustified discrimination. Therefore there is a potential for conflict between trade law and MEAs, especially in the field of biotechnology. It is this conflict that has made the crafting of an international legal framework for biotechnology so fraught with tensions, and the road to Cartagena so bumpy. The proposal for the international regulation of biotechnology was spawned by a 1986 incident, wherein the United States tested a genetically-modified rabies vaccine in Argentina, without having informed, much less obtained consent, from the Argentine government. This raised fears that with without an international legal framework for biotechnology, developed countries would use developing countries as laboratories, thus putting citizens of the latter at great risk. (Gupta, 2000: 24). There was a pre-existing Convention on Biological Diversity that could be used to serve as a framework for the creation of a convention particularly and specifically addressing biotechnology concerns and issues. Article 8 of the CBD called on Parties to “establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biodiversity, taking also into account the risks to human health.” On the basis of Article 8, the parties to the Convention decided to form a working group to hammer out a protocol acceptable by all. Delegates from 170 nations locked heads in Cartagena to work through the contentious issues being raised and the various points of divergence between nations and stakeholders. In a press release by the United Nations Environment Program (UNEP) in 1999, Klaus Toepfer, executive director of the program, was quoted as saying: “we need a widely accepted protocol that protects the environment, strengthens the capacity of developing countries to ensure biosafety, complements existing national regulations, and promotes public confidence in biotechnology and all the benefits it can offer.” This, however, proved to be easier said than done. Countries from Europe and from the developing world found themselves forming an alliance to push for the precautionary principle, whilst top agricultural exporters such as the United States, Canada and Argentina raised objections that the principle, especially if codified in a Convention, was not in consonance with trade rules under the WTO. The trade agreements which would be affected by the precautionary principle are the Agreement on Application of Sanitary and Phyto-Sanitary Measures (SPS), Agreement on Technical Barriers to Trade (TBT agreement) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). In the end, however, the an agreement had been brokered and was named the Cartagena Protocol, a supplement to the Convention on Biological Diversity. According to Article 4 of the Protocol, it shall “apply to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biodiversity..” To allay fears that the Protocol would result in unwarranted trade restrictions and be an used an excuse for protectionism, the preamble states that parties “recognise that trade and environment agreements should be mutually supportive”, “emphasise that the Protocol is not interpreted as implying a change in the rights and obligations under any existing agreements”, but also that the parties “understand that the above recital is not intended to subordinate this protocol to other international agreements.” The proponents still claimed victory however, because of the express adoption of the precautionary principle that was first crystallized in the Rio Declaration. Specifically, the adoption of the precautionary principle is reposed in Article 10.6 of the protocol, to wit – Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism in question as referred to in paragraph 3 above, in order to avoid or minimize such potential adverse effects. Aside from the establishment of the precautionary principle as the cornerstone for the international legal regime concerning biotechnology, an essential feature of the Cartagena Protocol is the Advance Informed Agreement procedure for the transboundary movement of LMOs that are to be intentionally introduced into the environment of a country different from the country of origin and are deemed to have “adverse effects on the conservation and sustainable use of biological diversity.” The protocol states that for there to be compliance to the AIA procedure, the exporter country must have notified the importer country, the importer country must have acknowledged receipt of the notification, the decision procedure is done, and there must be ample opportunity to review the decision. There is a different procedure with respect to LMOs that are intended for direct use as food or feed, or for processing. In that case, a country has the right to make a decision based on its own domestic legal framework, provided that the domestic framework is consistent with the principles of the Cartagena Protocol (Article 11.4), a copy of such decision is reposed in the Biosafety Clearing House (Article 11.1), and a copy of natonal laws, policies and regulations applicable to the import of LMO’s to be used food or feed or processing. (Article 11.5). An important provision in the Protocol, which perhaps is becoming even more important in recent times in light of the many accidents taking place, is the provision on unintended transfers of LMOs. The Protocol reads as follows: In order to minimize any significant adverse effects on the conservation and sustainable use of biodiversity, taking also into account risks to human health, each Party, under whose jurisdiction the release of the living modified organism referred to in paragraph 1above, occurs, shall immediately consult the affected or potentially affected states to enable them to determine appropriate responses and initiate necessary action, including emergency measures. (Article 17). A promising development too is the operationalization of the public participation provision of the Protocol, under the ambit of the GMO Working Group of the Aarhus Convention. Critics have pointed out that the overly-technical nature of the Cartagena Protocol and the biotechnology framework, systematically ignoring conversations on the socio-economic dimensions of genetic engineering and biotechnology and the realities of the North-South dichotomy. The Cartagena protocol mitigates the environmental and biodiversity risk of LMOs but focuses only on the transboundary movement of these genetically-modified organisms, without looking at how countries in the developed and developing world are differently impacted in terms of environmental consequences by biotechnology. The insertion of “good governance” provisions seek to amend that by operationalizing the right to transparency and ensuring that the public and other stakeholders (i.e., non-government organizations) be given the right to be consulted and give comments that would be considered and factored in during the technical decision-making processes. Herdegen calls the development an important one in that it ensures “a minimal standardized approach to how public participation and access to information should be organized at the international level and the role of the public in making decisions on GMO’s.”(2010). This is truly a crucial development in that the general public are the one most affected by a deteriorating environment and are the most vulnerable to the health risks that these LMOs carry. Moreover, the technical expertise of non-government organizations, particularly those involved in policy research, provide invaluable tools, particularly considering that the policy area of biotechnology is still constantly evolving and thus requiring continuous study. Moreover, the involvement of NGOs can serve to balance out what many times can be called the corporate overreach of pharmaceutical companies and other biotechnology groups who often have moral suasion and leverage over their governments. The Precautionary Principle and Science-Based Risk-Assessment: Tracing the Debates and Looking at the Jurisprudence Environmentalists all over the world lauded the inclusion of the Precautionary Principle in the Cartagena Protocol in 2000: its inclusion, after all, was something that organisations such as Greenpeace had intensely lobbied for, along with governments from the European Union. While inroads were made in legislation, however, the decisions taken by the WTO with respect to disputes on the restrictions of genetically modified foods and meat with artificial hormones reveals a score card that favours science-based risk assessment over the precautionary principle – a trend that triggers alarm bells for experts that argue that the absence of evidence indicating the risks of biotechnology does not necessarily mean that these biotech commodities are safe, but that there has been no adequate testing for these hazards. (Doyle, 1995.) We discuss two particular decisions in WTO jurisprudence that bear upon this conflict: the beef hormone controversy, which began before the Cartagena Protocol, and the biotechnology crops, which was decided under the international law regime of the Cartagena Protocol. Beef hormone controversy Amidst growing consumer scare in Europe on the use of growth hormones in meat production and most importantly, the mad cow disease crisis, governments in the European Union were under pressure from their citizens to ban the import of meat that contained artificial hormones. Meat producers and cattle ranchers in the United States and Canada were angered at the ban, calling it a violation of WTO rules. They filed suit against the EU in the WTO Dispute Settlement Body, which in 1997 ruled against the EU. The EU filed an appeal. Central to the dispute was a provision under the Agreement on the Application of Sanitary and Phyto-Sanitary Measures that allowed Parties to restrict trade of certain commodities on the basis of health and safety reasons, for as long as this was supported by scientific analysis and evidence. The US and Canada asserted that the hormones in beef had been tested and deemed safe in Northern America for 50 years, and all of the hormones used were legal and licensed for use in the territories of the states bringing suit. In contrast the EU maintained – premising its argument on the precautionary principle – that there was no way to determine with certainty that the use of hormones in meat production would have no adverse effects. At the heart of its contention is that when science is inconclusive, it is better safe than sorry and governments have the right to take precautions it deems necessary to protect the welfare of its citizens. Ruling against the EU, the WTO Appellate Body affirmed the original findings in a decision made in 1998. Section 208 of the report read as follows: [W]e find that the European Communities did not actually proceed to an assessment, within the meaning of Articles 5.1 and 5.2, of the risks arising from the failure of observance of good veterinary practice combined with problems of control of the use of hormones for growth promotion purposes. The absence of such risk assessment, when considered in conjunction with the conclusion actually reached by most, if not all, of the scientific studies relating to the other aspects of risk noted earlier, leads us to the conclusion that no risk assessment that reasonably supports or warrants the import prohibition embodied in the EC Directives was furnished to the Panel. We affirm, therefore, the ultimate conclusions of the Panel that the EC import prohibition is not based on a risk assessment within the meaning of Articles 5.1 and 5.2 of the SPS Agreement and is, therefore, inconsistent with the requirements of Article 5.1. Moreover, the WTO Appellate also noted the argument of the US and Canada that the EU had been inconsistent in the trade restrictions it has set, with other items and products being allowed into its territories even if it posed similar risks. An important contribution of the WTO Appellate body was a clarification of what it meant by “risk assessment”. Article 5.2 underlines the factors that are important for a valid risk assessment, to wit: “”Members shall take into account available scientific evidence, relevant processes and production methods; relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of pest- or disease-free areas; relevant ecological and environmental conditions…”. To this the Appellate body held that the list of factors is not exhaustive and says that the risk is not only scientific risk, but “the actual potential for adverse effects on human health in the real world where people live and work and die.” For many experts, the decision was remarkable, clear-cut, precedent-setting and a guide post of what to expect of future decisions of the World Trade Organization. For Josling, Roberts and Hashan the WTO Panel had managed to strke a balance between protecting free trade as embodied in the WTO framework from protectionism , and the right of countries to look out for the health and welfare of its citizens. In their words, “the EU also found some comfort in the result: the ruling affirmed its right to establish a level of consumer protection that is higher than the level set by international health standards, provided it is backed by an objective risk assessment.” (1999). Bio-tech crops In 2006, another WTO dispute was resolved in favour of biotechnology. In the case, the United States brought suit on the national bans issued by the governments of Austria, France, Germany, Greece, Italy and Luxembourg on biotechnology crops. The third parties were Argentina, Australia, Brazil, Canada, Chile, China, Chinese Taipei, Colombia, El Salvador, Honduras, Mexico, New Zealand, Norway, Paraguay, Peru, Thailand and Uruguay. The framework of arguments of both sides was essentially similar to the arguments that each had raised during the beef hormone controversy, with the US, et. al. – enjoying support from biotechnology companies such as Monsanto, DuPont and Dow – alleging that the European countries were engaging in unlawful trade restrictions by banning biotechnology crops without the backing of sufficient scientific evidence. Specifically, the US was alleging that the measures were inconsistent with the EC obligations under the SPS Agreement (Article 2, 5, 7 and 8, and Annexes B and C), GATT 1994 (Articles I, III, X and XI), the Agriculture Agreement (Article IV) and the Technical Barriers to Trade Agreement (Articles 2 and 5). (WTO, 2006) On the other hand, the European countries assert the precautionary principle. The WTO Panel that the European Committees had established a “de facto moratorium” on agricultural biotech products, finding to the effect that – a general de facto moratorium on approvals of biotech products was in effect on the date of panel establishment, i.e., August 2003. It was general in that it applied to all applications for approval pending in August 2003 under the relevant EC legislation, and de facto because it had not been formally adopted. Approvals were prevented through actions/omissions by a group of five EC member States and/or the European Commission. The 2006 decision was met with great support by the biotechnology firms and biotech exporting countries. It made clear that the WTO was not going to side the precautionary principle if such had the end result of erecting barriers where WTO trade rules say there should be none. Scholars like Adler would have most likely found the decision to be a step in the right decision, as his problem with the precautionary principle was that it was not responsive to the threats of biodiversity conservation, because in his words “it could actually increase risks to biodiversity by making it more difficult for farmers to feed a growing global population without clearing more species habitat”. (Adler: 2002). But while the decision has been lauded in many scientific and agri-business circles, it has also undergone heavy criticism not only from environmentalists, Europeans and ardent supporters of the precautionary principle, but also legal thinkers like Zurek (2010) who argued that the WTO’s market-centric perspective and free trade bias have made it disregard other cultural values and norms, from a legal perspective, other treaties that are equally binding, such as the Convention on Biological Diversity. Perhaps a more serious implication of the decision is from Henckel (2006) who argued that “new evidence showing a greater degree of uncertainty regarding risk than that which was previously understood could never trigger a provisional measure.” This means that if a product had been given prior approval as a tradeable commodity, subsequent research findings demonstrating its health and environmental risks will not have any effect whatsoever. Not only does this reduce the autonomy of states, it also gives rise to serious problems, considering the nature of biotechnology, wherein the effects may not be manifest now but can be felt far into the future. In sum, it can be said that the issues on trade and the environment remain contentious. There will always be arguments for either side and interests in both sides. It is incumbent upon law to craft a policy framework that will balance these competing paradigms and come up with a long-term and sustainable strategy to ensure that trade rules and environmental protection are given equal consideration. Liability and Redress: New developments, uncertain ways forward One of the most recent, if not the most recent, significant developments in the international policy regime governing biotechnology and the environment is the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (hereinafter NKLSP), adopted on October 16, 2010. The legal mandate for the Supplementary Protocol is reposed in Article 27 of the Cartagena Protocol, which reads: The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms, analysing and taking due account of the ongoing processes in international law on these matters, and shall endeavour to complete this process within four years. While the NKLSP is a significant step forward in the direction of seeking accountability for damages wrought by biotechnology and its transnational movement, it is immediately discernible that the Supplementary Protocol is still saddled by a number of limitations. A lot of these limitations have to do with the inherent nature of biotechnology that make it difficult to ascertain with any veracity the extent of damage that it has caused, if indeed the causation can be proven in the first place. According to Kmeri-Mbote, “In international law, liability is normally associated with the obligation to provide for compensation for damage caused to persons, property and the environment. Rules of state liability at international law for the fundamental basis for liability and redress in international law. (2004)” And yet, a perusal of the NKLSP reveals that non-mandatory terms were used with regard to the authority of States to impose penalties and assign liability on entities under their jurisdiction for damages caused to other states. (Tsioumani, 2010). Also, biotechnology often involves private operators, exporters and businesses like Monsanto are the ones that engage in the transport of biotechnology, not countries like the United States, Argentina and Canada. According to Duall, (2004), “A regime that does not attribute private conduct to the State would significantly reduce the effectiveness of a liability regime and ignores the existence of obligations on States to regulate and control the conduct of private persons within its jurisdiction or control.” Whilst the NKLSP does mandate states to regulate the conduct of private entities under their jurisdiction, there are no consequences for the states for if these provisions are ignored. Secondly, the NKLSP defines damage as: an adverse effect on the conservation and sustainable use of biological diversity, taking also into account risks to human health, that … is measurable or otherwise observable taking into account, wherever available, scientifically-established baselines recognized by a competent authority that takes into account any other human induced variation and natural variation; and … is significant. (Article 2.2B, NKSP) The main problem with this definition, as also articulated by Tsioumani (ibid). is that it leaves much discretion in the domestic laws of the country that has jurisdiction to prosecute the damage. As we have seen with great clarity in the jurisprudence discussed earlier, the United States and Canada have vastly different notions of damage and risk than the European communities. But another problem may be equally important and compelling: as stated by Duall (2004) once LMOs and GMOs are released into the atmosphere it is exceedingly difficult to reverse the damage that is wrought and the common notion of restitution and redress – that is, to endeavour to bring things to their previous condition – might be difficult, if not impossible. To quote Kloppenburg and Burrows again, (2001): Given biotechnology’s power to create wholly new organisms that could not be produced without the intervention of a scientist, and a corporately funded one at that, it represents a qualitatively new threat to the environment from the possible escape and proliferation of recombinant organisms, from unintended gene transfers, or simply from mutation or interaction which no one foresaw or intended. A last point is that it is quite difficult to measure damage if the damage takes place or is discernible far into the future, which is what can happen where biotechnology is concerned. Given that the propensity of the courts is to look for hard scientific evidence, that evidence may be lost and causation no longer traceable. Conclusion This paper has far from covered the depth and breadth of the nexus between the environment and trade where biotechnology is concerned. What it does demonstrate is that the relationship is a complex one – fraught with tensions and imbalances. There are no easy answers, and there are no fast solutions. Ths is made even more complicated by the fact that the environment is undergoing rapid deterioration. While the law is replete with invocations to protect and preserve our diminishing biodiversity, it is impossible to vew the law as a neutral bedrock, without taking into account the political economy that underpins it. For as long as corporate agriculture maintains its influence on the states that are the primary players, and these states maintain their influence over bodies like the World Trade Organization, no significant divergence from the jurisprudence on the beef hormones and the biotech crops can be expected in the near future. While there are laudable inroads and progressions in international law, it appears that the current policy regime still very much favors market imperatives over environmental considerations. References Adler, J. (2000). “The Cartagena Protocol and Biodiversity: Biosafe or Bio-sorry?” Georgetown International Environmental Law Review. Vol. 12. [Electronic] Available at http://www.cbd.int/doc/articles/2002-/a-00189.pdf Doyle, J. (1995). “Effects of genetically engineered microorganisms on microbial population and processes in natural habitats”. Advances in Applied Microbiology. Vol. 40. p. 237. Duall, E. 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