Index

Biotechnology

Heike Baumüller

“Since Seattle, there has been little reference to biotechnology in WTO discussions, although it clearly underlies countries’ negotiating positions in related areas, such as the patentability of life forms, the relationship between the trade and environment regimes, eco-labelling and agriculture.”

Biotechnology continues to capture public attention worldwide. A wide range of interest groups are united in their opposition to it, expressing concerns over environmental risks, impacts on rural livelihoods, the economic dominance of multinational companies and ethical complications. On the other side are those who are equally convinced of the potential of biotechnology to contribute to food security and environmental protection as well as powerful business interests.

The need to address the potential environmental risks of biotechnology found international recognition in Agenda 21, adopted at the Rio Earth Summit in 1992, which includes an entire chapter on the environmentally sound management of biotechnology. Also negotiated in 1992, the Convention on Biological Diversity (CBD) explicitly refers to the need to “regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology” and calls for a protocol to regulate the “safe transfer, handling and use” of such organisms. In the context of the CBD, biotechnology is defined as “technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.” The Convention also recognizes the importance of facilitating access to and transfer of biotechnology, in particular for developing countries that provide the genetic resources.

The mandate to negotiate a protocol came in response to a number of environmental and health-related concerns over the use of biotechnology. Some fear that genes from herbicide tolerant varieties could “escape” by being transferred to another crop or wild relative, which in turn could become “superweeds” that are difficult to control. Moreover, plants engineered to produce a toxin might harm non-target species, such as making the plant “toxic” to wildlife that feed on the crop. Certain genetic use restriction technologies (GURTs)—also called “terminator technologies” by their critics—which allow seeds to be altered so that they do not germinate when replanted, have been particularly controversial. While agrobiotech businesses claim to promote GURTs as a way of addressing environmental concerns by preventing transgenic plants from spreading, opponents see the technology as an attempt to control the world’s seed supply and maximize profits by forcing farmers to purchase new seeds every year.

Regarding health risks, the use of antibiotic resistance marker genes has raised significant concerns. These genes are inserted in the modified organism to identify genetically transformed plants; i.e., only plants with the marker gene will grow on material that contains antibiotics. Some fear that these genes may be transferred into bacteria in the stomach, thereby making potentially harmful bacteria resistant to antibiotics. Other healthrelated concerns include increased allergenicity and toxicity of biotech food, unintended side effects resulting from the process of genetic modification itself and changes in nutritional value. Despite ongoing research in this area, significant uncertainties remain over the actual risks associated with biotech products.

These concerns and uncertainties, coupled with strong opposition to biotechnology in some countries, have given rise to a whole range of import regulations and measures targeted at biotech products. Several Southern African countries, for instance, banned imports of food aid found to contain genetically modified corn (although most of them subsequently allowed imports provided that the grain was milled prior to or upon arrival). The reaction in these countries was partly attributed to fears that farmers may cultivate the corn that could potentially affect exports of grain-fed beef to countries with strict import regulations, such as the European Union. Similarly, in 2000 the discovery of Starlink corn (a corn variety approved for feed use by U.S. authorities, but not for human consumption) in food grain exports led Japan to ban the import of U.S. corn for several months. Biotech-exporting countries, for their part, have criticized import regulations in some markets as unnecessarily restrictive, alleging significant losses in trade revenues, and as an obstacle to developing countries’ agricultural and economic development.

At the multilateral level, it was during the negotiations of the Cartagena Protocol on Biosafety that trade considerations came to the fore, turning the negotiating process into a delicate balancing act between trade interests, on the one hand, and environmental and health concerns on the other. Among the countries with significant biotech interests, the U.S.—joined in the “Miami Group” by Canada, Australia, Argentina, Chile and Uruguay—made every effort to contain the scope of the Protocol, in particular its application to trade in agricultural commodities, and to ensure that multilateral trade rules were not affected by the Protocol’s provisions. The Europeans and many developing countries, in contrast, pushed for a strong Protocol with a broad scope, emphasizing the importance of precautionary decision-making.

Meanwhile, a parallel process was unfolding at the World Trade Organization (WTO), where several countries sought to place biotechnology on the agenda. As part of the preparatory process for the WTO Ministerial Conference in Seattle in December 1999, the U.S. called for “disciplines to ensure trade in agricultural biotechnology products is based on transparent, predictable and timely processes.” Discussions on trade in biotech products were also supported by Japan, while Canada proposed the establishment of a working group on biotechnology in the WTO. At Seattle, however, these proposals were vehemently rejected by the EU’s Environment Ministers in direct contradiction of their own trade spokespersons.

Following the failed attempt to bring biotechnology into the WTO, the Biosafety Protocol negotiations became the battleground for countries to iron out their differences, culminating in the adoption of the Protocol in 2001. The Protocol was greeted with varying degrees of enthusiasm, being hailed by some as a “victory” for the environment and consumers, while others regard it as a “biotrade” protocol that had sacrificed biosafety concerns to trade interests. The Protocol, which regulates the transfer, handling and use of living modified organisms (LMOs)—with the focus clearly on the transfer of such organisms—establishes a notification and approval process for the transboundary movement of LMOs. Although a number of issues remain to be resolved, the Protocol allows for the precautionary decision- making in cases of scientific uncertainty.

Since Seattle, there has been little reference to biotechnology in WTO discussions, although it clearly underlies countries’ negotiating positions in related areas, such as the patentability of life forms, the relationship between the trade and environment regimes, eco-labelling and agriculture. Instead, disagreements are being carried out in the WTO dispute settlement system, where the U.S., Canada and Argentina in May 2003 launched a case against the EU’s de facto moratorium on the approval of new biotech products in place since 1998, as well as a number of national bans imposed by EU member states. The three complainants argued that these measures are not scientifically justified or based on risk assessment. The EU denied the existence of any moratorium and defended the national measures as temporary, provisional and based on the precautionary principle. In its ruling, which the EU chose not to appeal, the WTO panel sided with the complainants on procedural grounds, but refrained from taking a stance on the safety of biotech products or the legality of stringent import regulations.

Another, often neglected forum for debate are the international standard-setting bodies, particularly the Codex Alimentarius Commission, the International Plant Protection Convention (IPPC) and the World Animal Health Organisation (OIE). These organizations were explicitly cited as international standard-setting bodies in the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and their standards are presumed to be consistent with the Agreement. This recognition has given the previously voluntary standards a quasi-legal status, thereby increasingly turning these organizations—and in particular the Codex Alimentarius Commission which deals with food safety standards— into political fora, where much of the trade and biotech debate has effectively moved.

Interests and Fault Lines

The production of biotech crops is dominated by a handful of countries. In 2006, just six countries accounted for 96 per cent of global crop area: the United States (54 per cent); Argentina (18 per cent); Brazil (11 per cent); Canada (six per cent); India (four per cent); and China (three per cent). Other minor biotech producers include (in order of hectarage) Paraguay, South Africa, Uruguay, the Philippines, Australia, Romania, Mexico, Spain, Colombia, France, Iran, Honduras, Czech Republic, Portugal, Germany and Slovakia. Herbicide-tolerant or insect-resistant soy, corn, cotton and canola are the main GM crops under cultivation.

Policy-makers in the U.S. generally regard modern biotechnology as just another form of genetic modification that has been practiced ever since farmers started to crossbreed plants. This attitude is clearly reflected in the regulatory framework, which does not establish specific legislation or institutions to deal with biotechnology, but rather splits the responsibility between the existing ones. Biotech products have been on the market in the U.S. since 1994 and the American public has by and large been supportive of—or at least not openly opposed to—genetically modified organisms (GMOs).

The European Union, in contrast, has established a distinct and thorough risk assessment and approval process for biotech products. The EU cites the Biosafety Protocol in support of its approach, which it sees as recognition by the international community that such products require their own authorization process. Its regulations also respond to widespread resistance to biotech crops and foods among European consumers, who are insisting on their “right to know” and “right to choose.” Among other factors, this skepticism can be traced to a general mistrust towards food safety authorities and governments’ ability to manage food crises, in particular following the handling of the spread of mad cow disease in the late 1990s.

While the U.S. and EU positions are comparatively clear-cut, any generalization for the rest of the world will necessarily be rather broad. This is partly due to the fact that biotechnology cannot be characterized as a typical North-South issue, but rather finds fervent opponents and supporters on both sides. Broadly speaking, countries with significant biotech interests, such as Argentina and Canada, have largely followed in the footsteps of the U.S., while many other countries have moved more cautiously, aiming to set up the necessary regulatory frameworks before embarking on the biotech path. Many in these countries have stressed the need to take into account the local environment and capacity constraints when assessing and managing the risks associated with biotechnology. They would also like to see local research and development capabilities strengthened to allow for the development of GMOs adapted to local needs. They also consider it important to ensure the ability of poor farmers to access and reuse seeds that are not protected by patents.

The Latin American region is marked by stark differences in their dealings with biotechnology, with Argentina and Brazil among the region’s leaders in terms of production, while others, in particular the Central American and Andean countries, continue to lag behind in setting up regulatory systems and developing their biotechnology research capacities. Brazil is a particularly interesting case. While some government officials and industry groups have pushed for the adoption of GMOs and the country counts among the research leaders in the developing world, civil society groups have waged a continued battled against the introduction of biotechnology. In the meantime, biotech seeds have been smuggled across the Argentinean border into the southern states, assuring Brazil a place among the top agrobiotech producers in the world.

Asia, and notably China, has been generally quicker to engage in the biotech business, opting in particular for medical and industrial applications. Several Asian countries, including China, Korea, Japan and Thailand, have set up stringent import regulations, with Japan and Korea emerging, like the EU, as markets particularly averse to GMOs. With regard to agricultural biotechnology, the region has focused much of its attention on GM cotton grown in China, India and Indonesia. Some countries are also considering the introduction of GM rice, raising serious concerns among environmental groups that the GM rice could contaminate traditional varieties, in particular given that China is a centre of origin for rice. Critics point to similar experiences in Mexico where traces of transgenic corn had been found in native landraces despite a ban on GM corn cultivation.

Most African nations, in contrast, have become pawns in the biotech game and remain far behind in this field. They often lack the scientific, financial and institutional capacities to conduct biotech research (with the notable exception of South Africa and more recently Kenya and Egypt). Opinions appear deeply polarized in some regions, while others show a cautious willingness to assess the merits and dangers of biotechnology. Biotech crops adapted to harsh conditions, such as drought tolerance, or with nutritional benefits, such as added vitamins or vaccines, have most to offer for the continent, provided that concerns over the ownership of seeds, the need to assess the risks within particular local conditions and the adaptation of biotechnology to local requirements are addressed.

Labelling

The U.S. regulatory system does not require labelling for biotech product, which is in line with its approach that GMO products are not distinct from conventional products per se. Other biotech producers, such as Canada and Argentina, have followed a similar approach, while South Africa and Australia only require labels for a restricted set of GMOs. The EU stands at the other end of the spectrum with a stringent labelling and traceability system that even covers products derived from GMOs, but where the GM content is no longer detectable (such as soy oil made from GM soy). The EU considers such a system essential to enable consumer choice, allow for withdrawal of a product should unforeseen risks occur, and monitor potential effects on human health and the environment. Labelling mechanisms are also becoming increasingly prevalent in some developing countries, such as Brazil, Mexico, China, Thailand and Korea.

Given these differences in approach, labelling of LMO commodity shipments emerged as one of the most contentious issues during the negotiations of the Biosafety Protocol and detailed documentation requirements were left to be developed after the Protocol’s adoption. African countries insist that the LMO content of a shipment, whether known or potentially present, should be clearly specified. The EU was pushing for requirements similar to its own regulations, including the use of “unique identification” to clearly identify each transgenic plant line and flexibility for countries to set thresholds for the accidental presence of LMOs. In contrast, the main LMO exporters, such as the U.S., Australia and Canada, would have liked to keep documentation requirements to a minimum so as not to hinder trade, and they do not support the inclusion of the unintentional presence of LMOs. The final agreement on labelling rules reached in March 2006 was only possible by leaving the most contentious points sufficiently ambiguous to accommodate the different positions.

Labelling of biotech foods also continues to bog down discussions at the Codex Committee on Food Labelling, which has been working on a related standard since 1993. Given the quasi-legal status of the Codex standards, countries’ positions have reflected their domestic labelling practices in an effort to obtain international backing and a stronger defense for their national labelling regulations should they ever become subject to a WTO challenge. This is clearly reflected in the two labelling options that have crystallized in the debate. Under the first, which is supported by the U.S. and Canada, labelling would only be required where the biotech product differs significantly from its conventional counterpart with regard to composition, nutritional value or intended use. The emphasis here is clearly on food safety. Under the second option, which is favoured by the EU, Switzerland, India, Norway, Brazil and others, all genetically modified foods would be labelled to provide consumers with the freedom to choose.

Precaution

The role of a precautionary approach in biotech trade and decision-making remains hotly debated. Many consider the Biosafety Protocol’s references to the precautionary approach in the preamble and the flexibility for countries to reject LMO imports where they lack scientific certainty as the first operationalization of the precautionary principle in international law. In WTO law, more limited space for precautionary decision-making is provided in Article 5.7 of the SPS Agreement, which allows countries to take provisional SPS measures in cases where scientific information is insufficient, provided that these measures are reviewed within “a reasonable period of time” and Members continue to “seek additional information.” The Codex principles for risk analysis of biotech foods include elements of precaution, requiring authorities to take into account uncertainties identified in safety assessment and allowing them to implement appropriate risk management measures. At the Codex Committee on General Principles, however, differences over the inclusion of references to precaution in the risk analysis principles have stalled talks for the past few years.

At the international level, the U.S. has strongly resisted references to the precautionary principle—stressing the need for science-based, case-by-case decision-making—and disputes that the Biosafety Protocol enables countries to invoke the principle. The EU, in contrast, has introduced the precautionary principle as the basis of policy with its inclusion in the 1993 Maastricht Treaty and is a strong defender of the principle as a basis of international law. Developing countries appear to be ambivalent in their support for either position. Many of them strongly advocated mention of the precautionary approach in the Biosafety Protocol negotiations while taking a non-committal stance (in the case of many African countries) or opposing such references (in the case of some Latin American and South-East Asian countries) in the Codex Alimentarius Commission.

Trends and Future Directions

Given continued scientific uncertainties, high economic stakes, deep-seated divisions and ongoing trade liberalization that will bring the various perspectives into ever closer contact, the biotechnology debate is likely to remain controversial for some time. Developing countries are often stuck in the middle of these debates, facing the challenge of assessing their interests and evaluating them against associated risks and opportunities. Strengthening scientific, regulatory and institutional capacities—including to better understand countries’ regulatory flexibility to take measures that respond to their selfdefined goals in light of multilateral trade interests and obligations—combined with inclusive policy-making processes and priority- setting, will be fundamental perquisites to allow for informed decision-making on their biotech future.

The agreement on documentation requirements has given the Biosafety Protocol renewed political credibility and parties can now turn to the task of implementing the treaty’s provisions, although a number of trade-related issues, including compliance measures and liability, remain to be hammered out. The labelling debate can also be expected to start afresh in 2012 when the documentation decision is again up for review. The main challenge now will be to get the key biotech exporting countries on board. While the U.S. cannot be expected to join the Protocol in the near future, efforts will need to focus on involving some of the other biotech exporters, such as Canada, Australia and Argentina, who will have to weigh the competitive advantages and disadvantages of joining the pact.

Moreover, there is a need for greater recognition of the growing role of the international standard-setting bodies in light of their relevance to the WTO system, notably the Codex Alimentarius Commission where negotiations on an international standard for domestic biotech labelling continue. To date, participation of developing countries in the standard-setting process remains limited, owing in part to the complexity of the discussions and the lack of capacities and resources to engage in the negotiations. This has led to the adoption of standards that reflect the domestic standards of industrialized countries, with insufficient regard for the capacities of developing countries to implement these standards and for the products and issues of interest to them. Thus, capacity building and technical assistance efforts should focus on improving effective participation of developing countries to ensure that agreed standards take into account their interests and constraints.