Trade Regulators Struggle with Biotechnology Issues

 
The development of a genetically modified variety of rice that naturally produces beta carotene is the latest example of the potential applications of biotechnology to combat hunger and malnutrition in the developing world. Yet, few topics produce such passionate debate as genetic engineering. One scientist's pest-resistant corn is another person's "Frankenfood." Advances in biotechnology, especially in the creation of genetically modified organisms (GMOs), have run ahead of the ability of policy makers, bureaucrats and even scientists to regulate, control and implement them. There is general agreement on the need to ensure the safety of biotechnology products through effective risk assessment, management and communication. However, private scientists and public authorities take different approaches toward these measures in public policy and decision making.

Some countries (the US, Japan and Canada, among them), bureaucrats and scientists argue that "sound science" should be used as a basis for restricting trade in products that pose a threat to the environment and human health. Others call instead for "precautionary measures" to restrict the trade in GMOs in the absence of full scientific certainty of their safety. In 1992, the United Nations Conference on Environment and Development (UNCED) adopted Principle 15, which states that "where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation."

Critics, including the US, consider Principle 15 to be too restrictive. The "precautionary principle" has met resistance in international trade among those who believe that counties can use it as a protectionist measure. In response to these concerns, other serious efforts have been made to set standards and rules in international trade. The World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS), for example, sets out some basic rules for standard-setting for food safety, animal and plant health. The Agreement on Technical Barriers to Trade (TBT) deals with standards for other items, including vehicles and equipment, as well as labeling requirements. Both agreements recognize that governments have the sovereign right to set standards as high as they deem necessary. Their central objective is to prevent protectionism in the form of standards that favor domestic producers or discriminate against foreign goods and services.

One problem with applying the precautionary principle to GMOs is the lack of universal agreement on what the principle means or how it should be applied. Speaking at an international conference on Biotechnology in the Global Economy: Science and the Precautionary Principle at Harvard University in September 2000, Jeffrey Sachs pointed out that "biotechnology is still in its infancy; it will continue to grow, especially since poor countries will need agro-biotechnology to feed growing populations." The precautionary principle is essentially a risk assessment tool, Sachs argued. He proposed labeling to keep consumers informed and suggested the need for "delivery assessment to look at biotechnology's net effects; risk evasion frameworks to evaluate whether the loss of a technological application is more painful than its gains; investing in a better understanding of biotechnology; decentralized decision-making; and using independent scientists and peer reviews to evaluate risks."

At the same conference, John Holdren of Harvard University noted that the precautionary principle "offers little guidance on the kinds of measures to be taken and the specific costs and risks involved; constitutes a 'prescription for paralysis'; and places health and environmental values over economic ones." Other speakers recommended that biotechnology work toward precise applications adapted to the local needs of farmers and the environment and that attempt to mimic biodiversity's natural processes.

The conference underlined the divisions between environmentalists, agricultural researchers, bureaucrats, scientists and politicians. The rapid dissemination of scientific advances and the potential profit to be made by private companies, combined with ever more open markets, means that globalization has become the context for this debate. Some observers complain that it has become a political struggle between an industry that underestimates risks and NGOs that exaggerate them.

Trade organizations, international financial institutions and food research groups have addressed the complex issue of how to handle trade, safety and intellectual property rights involving genetically modified organisms. The WTO's SPS and TBT agreements support international standards as a means to prevent unnecessary obstacles to trade. These standards are generally based on best practice in developed countries, but they leave individual governments free to set higher standards.

International concern for protection of the environment led to the negotiation of the Convention on Biodiversity (CBD) and the Cartagena Biosafety Protocol. Developing countries that lack scientific, institutional and legal infrastructure are counting on the protocol to protect them against the potentially adverse effects of genetically altered organisms developed elsewhere. The protocol's entry into force would generate guidelines for applying the precautionary principle. Common and normative standards would help developing countries make sense of the principle and effect its implementation. The US is not a party to the protocol (it considers it to be too vague and restrictive), and not enough countries have ratified it so far to allow it to enter into force.

In the meantime, a number of international organizations and agreements coordinate and pursue food research using biotechnology. Among the most important are the Consultative Group on International Agricultural Research (CGIAR) and the International Service for National Agricultural Research (ISNAR). CGIAR's mission is to contribute to food security and poverty eradication in developing countries through research, partnership, capacity building and policy support, promoting sustainable agricultural development based on the environmentally sound management of natural resources. ISNAR, a member of CGIAR, formed the Intermediary Biotechnology Service (IBS) to act as an independent advisory group on matters of agricultural biotechnology research and policy. Over the past seven years it has built partnerships with advanced research programs in more than 25 developing countries. By providing information and building skills in biotechnology management, ISNAR's partnerships help developing countries judge how far the biosafety protocol will be effective in bridging gaps in their own national biosafety policies.

The WTO agreement on intellectual property, known as TRIPS, is essential to growth and trade in biotechnology, especially in the area of GMOs. Companies carrying out expensive and long-term research need assurances regarding the protection of their investment and its possible profitability. TRIPS seeks to ensure that patent holders receive 20 years protection for their invention but leaves it to individual governments to decide whether some kinds of inventions (for instance, medical treatment methods) should be patentable. Plant variety rights are similar to patents. They grant the breeder exclusive rights to produce and commercialize a new variety for at least 15 years. Codex Alimentarius, a joint body of two specialized UN agencies (WHO and FAO), also establishes food reference standards. It also requires SPS measures to be based on an appropriate assessment of risks, taking into account available scientific evidence and such relevant factors as inspection and testing methods, and potential damage from the spread of a pest or disease.

The US and the European Union established a consultative forum on biotechnology issues, but the Europeans have taken a cautious approach and no change in EU policy for trade in biotechnology products is likely for many years. The US, China and India have been leaders in biotechnology research and trade, and it is sure to become an important issue in Florida, given the involvement of the state's universities in biotechnology research and the extensive trade between it and Latin America. In Latin America itself, Argentina is open to research and trade in GMOs and other biotechnology advances in food production, while Brazil has taken a typically more cautious and bureaucratic approach.

Observations
Biotechnology is already an international issue. Joint research efforts and trade involve GM products, and biotechnology is a concern in the negotiation of international agreements. Domestic actions taken in one country will have implications for others; in the end, countries and associations that seek to stop or slow biotechnology advances are likely to be on the losing end. Even if only a few countries were to pursue the use of GMOs, others would not be able to resist the pressure eventually to acquire those same benefits for themselves. The challenge should be to accept biotechnology while insisting on consideration of environmental impacts, risk assessment, rules-based systems for trade, development of sound science-based regulatory processes, and food safety, as well as political, ethical and technical concerns.

US Department of State www.state.gov,www.aphis.usda.gov,www.ita.usdoc.gov,www.ustr.gov www.wto.org,www.epa.gov
Report of the International Conference on Biotechnology in the Global Economy: Science and the Precautionary Principle, 22-23 September 2000, Cambridge, Mass.