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Making Good on Biotechnology's Global Potential By Under Secretary of State Alan Larson We are all indebted to Nobel Laureate Norman Borlaug for a lifetime dedicated to agricultural research. We also thank you, Dr. Borlaug, for conceiving of the World Food Prize as a way to honor outstanding scientists like Dr. Vasal and Dr. Villegas. Their hard work and ingenuity in developing quality protein maize (qpm) and making the technology available in developing country markets is a concrete demonstration of how we can make technology work for the good of humankind. We need more such examples. Despite magnificent advances in agricultural productivity during the last quarter century, some 800 million people are still undernourished. Over 200 million of them are children. In fifty years, the worldÕs population could grow to 10.7 billion. For a population this large to be adequately fed, the world will need to double food production. In the past, experimenters and scientists helped the world avert a Malthusian disaster by improving the genetic characteristics of crops through crossbreeding. Dr. Borlaug and others now conclude that the world has reached the stage where conventional cross-breeding will not be enough. Modern biotechnology will be needed to improve crops sufficiently to meet future food requirements. Biotechnology provides unique opportunities to increase the quantity, quality and reliability of food supply. These gains can be achieved with potentially less need for pesticides and herbicides, less demand on scarce water supplies and less pressure to use ecologically sensitive land. Biotechnology holds particular promise for developing countries and for poverty alleviation. Despite considerable progress during the past quarter century, many countries, especially in Africa, have been unable to achieve sustained gains in agricultural productivity. Increasing farm productivity will raise the incomes of the rural poor and free up workers to support growth in the manufacturing and service sectors. Raising agricultural productivity will be critical in any effective strategy for achieving sustainable growth and poverty alleviation in Africa, and to continued progress in the rest of the developing world. Notwithstanding its great potential for good, agricultural biotechnology faces formidable challenges and an uncertain future. These challenges are not primarily scientific or technological; rather, they are essentially political. Overcoming these challenges will require cross-fertilization, not just of seeds but of minds. I am excited about this conference precisely because it is bringing together the sort of diverse expertise that can help public policy find a way forward. Let me highlight the public policy challenges that must be addressed if agricultural biotechnology is to achieve its full potential. • First, here in the United States we must ensure
that our food safety system continues to be the worldÕs best. Fair and Transparent Regulatory Processes The United States benefits from a science-based, professional and independent process for ensuring food safety. This system not only has protected and reassured consumers at home, it helped make the U.S. a key contributor to global food supplies by maintaining the confidence of consumers and regulators abroad. Such trust is a precious asset that we intend to preserve. During the last year a number of scientific reports and conferences reaffirmed that the biotech foods now on the market are safe. I was particularly impressed by the study by scientists from the Third World Academy and six national academies of science: the U.S., U.K., Mexico, China, India and Brazil. These consensus findings reaffirm the basic integrity of the United States approach to food safety. We cannot, however, rest on our laurels. As technology advances, we will need continually to monitor food safety and refine regulatory processes. We also must rigorously investigate any lapses in compliance with food safety regulations, including the apparent presence in taco shells of biotech corn not yet approved for human consumption. We must also do so transparently. At the same time, we need to establish workable distribution systems and timely, science-based approval processes that facilitate compliance and help us understand any relevant risks. We should all be careful not to create undue regulatory burdens or liabilities where relevant risks cannot be found or are truly minimal. But where we have effective rules to address food safety risks, we must vigorously enforce them, while being honest about any lapses and potential consequences. Some consumers may decide to avoid biotech products, despite their safety. If such a market develops, industry will want to serve it. The federal government stands ready to facilitate industry efforts to develop truthful and non-misleading voluntary labels. We also welcome industry initiatives to provide information about the characteristics of the food products, for example, through toll-free hot lines and internet-based information sites. Our goal is to maintain consumer confidence worldwide that American food products set the standard for safety and quality. Let me be clear, if we find any U.S. food product unsafe for general consumption, we do not and will not allow it to be sold, period. To meet consumer expectations, industry probably will need to make more progress on the segregation of different crop varieties. Being an Iowan with a lifelong interest in agriculture, I have some idea of how difficult it will be to prevent incidental co-mingling in bulk shipments. Procedures related to biotech need to be tightened and improved based on realistic tolerances and trustworthy testing procedures. Market demands, science and risk assessment and food security should be part of that equation. Fostering Science-based Regulatory Systems Abroad Encouraging the adoption of transparent, science-based food safety regulatory regimes worldwide is a key policy challenge. In developing countries there is a need to build capacity to implement science-based food safety systems. We are trying to help through engagement by the U.S. Agency for International Development, the U.S. Department of Agriculture and the Food and Drug Administration. This is a particular struggle in Europe, however. At first, the politicization of food safety regulation made EU governments too slow to take action to protect the public. As a result, government mishandled public health issues related to dioxin-contaminated feed and "mad cow" disease. Many Europeans lost confidence in their governmentsÕ approach to food safety. Now there is a backlash in Europe, and it threatens to spill over. Food regulation there is more politicized than ever, but now it is marked by undue and unscientific fears of new technology and a paralysis in science-based food safety approvals and regulation. Despite early positive efforts by some European authorities, political parties and governments now invoke the so-called "precautionary principle" to justify decisions that have no scientific foundation. European Union member states have imposed a de facto moratorium on imports of biotech corn varieties Ð- many grown right here in the Mid-west -- already approved as safe by European scientific authorities. Italy recently banned four types of biotech corn already approved for EU consumers. EU science bodies have stated that ItalyÕs move was based on no credible scientific evidence of any human health risk, and yet ItalyÕs law still stands. Meanwhile, EU politicians are producing a blizzard of new regulations on biotech that have little or no basis in science. These regulations raise food supply costs with little apparent benefit to food safety. They are arising so fast that we literally cannot keep track of them, and there is little advance discussion. At the same time, there has been little progress on EU President ProdiÕs sensible idea to establish a Europe-wide food safety regulatory body modeled in large measure after the U.S. FDA. Clearly, we will all need to work hard to avoid new food regulations that restrict consumer choices and raise costs, that are not grounded in scientific risk assessment, and that almost certainly violate WTO rules. WTO rules, after all, are fully consistent with Ð- and certainly allow Ð food safety protection. They also protect us all from ad hoc and unwarranted trade barriers, which history has proven can cause real harm to peoplesÕ prosperity and aspirations. WTO members have all agreed to abide by these rules, and developing countries are already struggling to do so. Many governments are considering imposing highly restrictive biotech regulations. Japan, Australia and New Zealand all plan mandatory biotech food labeling systems, though some consideration is now being given to impacts on food supply costs. Yet, others are poised to join. Korea may soon impose mandatory labeling on both processed and bulk biotech food products. Saudi Arabia has rescinded a ban on biotech products, but will require importers to stipulate in writing that they know of the potential dangers of biotech foods, despite the scientific consensus that there are none. This will clearly limit biotech shipments to Saudi Arabia, perhaps sharply. Singapore is seeking government certification of all biotech food shipments, again, despite their presumed safety. Now we are hearing that European governments will seek to regulate and restrict even biotech feed grain by, among other things, imposing onerous traceability conditions where no known health risk of any kind has been found. Many countries currently favor extremely low tolerances for the presence of biotech, though credible tests at such levels are not now possible. We are working with all of these governments to ensure that their decisions take into account the science on biotech food safety, impacts on food costs and security, and the full range of biotech regulatory options. The next year could be a crucial one for biotechnology in international fora. The science-based Codex Alimentarius Commission on food safety will address such important issues as labeling and the appropriate use of regulatory precaution in cases where the science on both risks and benefits is not conclusive. Codex is a critical technical forum that brings together regulators and scientists from around the world to help guide approaches to food safety regulation and trade. Deliberations within Codex are becoming more politicized. We need the help of independent scientists to ensure that this organization of over 150 member countries and many NGOs continues its work to protect consumers based on science and analysis, not politics. Assessing New Agricultural Technology and the Environment As we all look for a way forward on biotechnology and other new agricultural technologies, it will be extremely important to look hard at the risks they may pose to the environment. The consensus amongst scientists is that any potential risks associated with biotech are manageable. But there is more that remains to be understood than there is with respect to food safety. At the same time, we all recognize the substantial environmental impacts of current agricultural practices. Yet, often we fail to consider the effects of new practices relative to that baseline. There is very good scientific work on the potential of biotechnology to help protect the environment. Even some existing varieties require less pesticide applications and involve lower losses from disease, storage, and deterioration. Tthat means we need fewer resources to deliver a given amount of food, and in turn that means less environmental impact. Biotechnology is not the only new approach with potential environmental benefits, but it is a promising tool that deserves to be tried, better understood, and considered as part of our effort to feed an expanding population sustainably. The United States took an active part in helping to establish the Biosafety Protocol, which aims to help protect global biodiversity. Our support for protecting and preserving plant genetic resources is longstanding and includes substantial work with developing countries. We are therefore proud of our cooperation to shape a workable Biosafety Protocol, and continue to work to ensure effective, science-based approaches that support beneficial trade. Currently, the ProtocolÕs implementing body is working on capacity building and information sharing, with a strong focus on the internet-based Biosafety Clearing House. Well-implemented, the Biosafety Clearing House mechanism will help disseminate widely the available information on the environmental aspects of approved biotechnology products. Interestingly, some have suggested that the biotechnologyÕs very potential creates strong incentives to protect and preserve genetic diversity. Biotechnology is one of the clearest examples we have of the possibility that even unremarkable species may embody genetic characteristics with incredibly beneficial applications. We need to work together to understand the environmental aspects of biotechnology, including its potential benefits, in the context of existing practices and environmental stresses, and weigh carefully the potential costs of foregoing its careful development. Better Communication on Risk Assessment and Risk Management It is essential that scientists and businesses work with government to communicate more effectively on the important issues of risk assessment and risk management. These are integral parts of how policymakers and regulators work to protect public health and safety while ensuring the tremendous benefits of having a wide range of choices and innovations available to consumers. The United States has over a century of experience with regulatory precaution, and yet we are renowned for an economy that provides abundant innovation and choice for our own consumers, and consumers worldwide. Unfortunately, too much recent rhetoric seems designed not to illuminate but to obscure the real issues surrounding regulatory precaution. I am especially concerned about the effort, led by Europe, to enshrine in international law an intentionally ambiguous and elastic doctrine called "the precautionary principle." Any sensible person would agree that a sound regulation system should incorporate precaution. When scientific evidence is incomplete or contradictory, U.S. regulators seek to resolve the uncertainties. In the meantime, they take measures to protect consumers until additional pertinent information is available and more complete risk assessments are performed. Our approach to risk management involves balancing the potential advantages and disadvantages of alternative courses of action. Our objective is to promote public welfare, not to minimize risk, as some critics seem to prefer. In contrast, some advocates of the precautionary principle focus only on minimizing the risks of new technologies, and not at all on the benefits. They are also highly selective in their focus; French groups that are alarmed about biotechnology may be unconcerned about nuclear power, unpasteurized cheese or even smoking, activities for which science has identified clear risks. The call for absolute scientific certainty can be a cover for unscientific decision-making; when the preconceived goal is to impose a ban or restriction, no evidence of potential harm is too threadbare and no risk too hypothetical to offer a justification. In private, some senior European officials often admit that certain of these decisions were taken on the basis of political expediency, not principle. If we try to imagine governments making real efforts to minimize all risks to their citizens, the incredible limitations that would be required on individualsÕ activities and choices, and the near complete lack of reliance on their judgment, become apparent. When it comes to regulation, as in life, there really is no riskless course of action and certainly no way to establish with scientific certainty that risk is absent. We will all benefit if we can develop a new vocabulary for talking about the decisions regulators make as they seek to assess and manage risks. Ensuring Stability in Agricultural Trade A well-functioning international trade regime is of fundamental importance to all countries. Agricultural trade is particularly important: it contributes to food security by allowing market forces to draw food production into the locations that have a comparative advantage and by ensuring that consumers have access to the best products, the best prices, and the widest choices. A well-functioning agricultural trade system requires confidence between producers and consumers and rules that are respected. The United States has worked hard to build that confidence and respect those rules. We have sought to demonstrate our reliability as an exporter not only by maintaining high quality standards but also by assuring importers that they can count on us for supply. As a matter of longstanding policy, we are committed to avoid using export restrictions to deal with high agricultural prices or short food supplies at home. Last year the Administration went one step further and removed food and medicine from the scope of our economic sanctions, even in the case of states we judge to be sponsors of terrorism. Food importing nations have obligations as well. One of these obligations is to respect trade agreements and to refrain from restricting food imports in a manner inconsistent with the provisions of the WTOÕs provisions on sanitary and phytosanitary standards. Since 1998, however, U.S. corn exporters have lost some $200 million in sales annually because the EU has not permitted the import of varieties of biotech corn that already have been approved as safe by the EU. New measures under consideration by the EU would seem to put at risk other substantial export markets, including corn gluten. Recognizing the sensitivity of European opinion, we have taken a constructive approach worked out by President Clinton and EU President Prodi. A group of senior officials from both sides is meeting regularly in an effort to work out practical arrangements to restart corn exports and to address wider market access issues. At the same time, we have established a Consultative Forum composed of eminent persons from both sides of the Atlantic to address the areas of concern that now confront agricultural biotechnology. Dr. Borlaug is one of the 10 American participants in the Consultative Forum and I am looking forward to hosting a lunch for the entire group tomorrow in Washington on the occasion of their second meeting. It is important that this collaborative effort bear fruit. The United States already is concerned about EuropeÕs refusal to date to comply with WTO rulings that have found EU programs on beef and bananas to be inconsistent with the WTO. Agricultural trade tensions are likely to rise as we continue negotiations under the built-in agenda of the Uruguay Round and once we launch a new round of multilateral trade negotiations, especially if low commodity prices persist. The United States, supported by other farm exporters and by many developing countries, will seek to eliminate agricultural export subsidies and dramatically reduce trade-distorting domestic subsidies, and protective tariffs and quotas. These are precisely the policies that Europe has used to protect its farmers from competition. Unless we can re-establish a predictable rules-based trading regime for agricultural, including for biotech products, we run the risk of proliferating trade disputes. It would be difficult to confine such disputes to agriculture. I am hopeful that there is good will in many quarters in Europe to work through these problems, but time is of the essence. The December 18 US-EU Summit will be an important milestone at which we need to show real progress on biotechnology. Helping Developing Countries Benefit from Agricultural Biotechnology Part of the resistance to biotech crops arises from a distrust of large corporations and a resistance to globalization. Some feel that biotechnology is suspect because it has been developed largely by the private sector and has found its first uses in developed countries. Most developing countries do not see it this way. The report I cited earlier by seven academies of science, including five from developing countries, drew attention to the important role of biotechnology in giving developing countries tools for feeding their people. In a recent opinion piece in the Washington Post, Nigerian Minister of Agriculture Adamu criticized anti-biotech groups in developed countries, saying, "We do not want to be denied this technology because of the misguided notion that we donÕt understand the dangers or future consequences. We will proceed carefully and thoughtfully, but we want to have the opportunity to save the lives of millions of people and change the course of history in many nations." The international community must make sure that enlightened leaders like the Nigerian Minister get the help they need to secure the benefits of biotechnology for their countries. The Green Revolution succeeded precisely because the international community helped such countries as Mexico, India and China to make the new varieties and techniques work for them. Good efforts are underway. USDA and USAID have programs to promote cooperative research and technology development, and to help educate developing country officials on biotechnology. USDAÕs Agricultural Research Service shares biotechnology germplasm with developing countries. USAID spends over $7 million a year, often in cooperation with U.S. universities, on supporting biotechnology development and technology tranfer, primarily in Africa. USAID also is providing help on regulating biotech appropriately, based on science. The Consultative Group on International Agricultural Research is doing valuable work on adapting biotechnology for developing countries, supported by participants such as the Rockefeller Foundation. There are many other groups and institutions involved in adapting biotechnology and other new approaches for use in developing countries. I am concerned, however, that compared to the task before us, this international effort is under-funded and not receiving adequate priority. I hope we can all cooperate further to enhance agricultural productivity in developing countries, including through biotechnology. Public-private partnerships must be part of the answer. One encouraging example is the cooperation of Monsanto, USAID and the Government of Kenya to develop a disease-resistant sweet potato. This will likely be among the first genetically-engineered crops tested in sub-Saharan Africa. Not for profit organizations have a vital role; the Rockefeller Foundation has been instrumental in the development of "golden rice," a crop that combats vitamin A deficiency and could save hundreds of millions of children from blindness and other serious health problems related to the deficiency. Developing and Disseminating Useful Knowledge Privately funded research and development is a powerful force for innovation. In the last two decades, capital markets have deepened and improved their capacity to support innovation. For these markets to work well, there must be a sound framework of intellectual property rights protection to ensure an economic return for those research and development expenditures that generate useful innovations. These considerations may help explain why some of the first commercially available biotech products were produced by American farmers, particularly the corn and soybean farmers of the Midwest. Farmers here are used to innovation and attentive to the cost-savings these crops offer by reducing the need for herbicides and pesticides, for example. We will need to think hard about whether this private sector model will work everywhere. To be sure, as an economist, I believe the laws of economics operate in all countries. If there are gains to be had from developing a rice variety tolerant of brackish water, I see no a priori reason why economic incentives should not play a role in stimulating the innovation. At the same time, we need to be aware that in many developing countries, markets work imperfectly. Prices or information may be controlled, credit markets may be weak or non-existent and land tenure may be insecure. Potential investors may fear that intellectual property rights may not be protected or they may simply find that the costs of developing adequate information about fragmented developing country markets are too high. In short, for some businesses it may be more attractive to concentrate on products produced by developed country farmers. I am inclined, therefore, to believe that there will also be an important responsibility for the public sector and the not-for-profit private sector. Public support for basic scientific knowledge is a well-established role. There may also be a case for using public funds to support research targeted on specific needs of developing countries and for developing local R and D capacity in these countries. Conclusion: Making Good on BiotechnologyÕs Global Potential The State Department was recently named the Harry S. Truman Building. We are proud to be bearing the name of the President who presided over a remarkable period of American foreign policy: the conclusion of World War II, the formation of NATO, the launch of the Marshall Plan and the recognition of the state of Israel, to name just a few. At a recent ceremony at the State Department, the historian Michael Beschloss commented on how fortuitous it was that the man from Missouri, Harry Truman, had replaced Henry Wallace as Franklin RooseveltÕs Vice Presidential running mate in the 1944 election. Wallace, Beschloss argued, would have been unprepared by background and temperament for the consequential decisions our Nation faced between 1945 and 1952. I will leave it to John Culver, author of a fascinating biography of Wallace, to tell you in his presentation tomorrow whether he agrees with that contention. My point simply is to stress that in addressing our foreign policy challenges of today, we need to bring forward skills and characteristics representing the best of both Truman and Wallace. During the last week, the President and the Secretary of State have devoted their energies to consolidating a victory for democracy in the Balkans and preserving the hope of peace in the Middle East: these are tasks reminiscent of the traditional foreign policy challenges Harry Truman faced so squarely. At the same time, Secretary Albright has consistently emphasized the prominence in our foreign policy of economic and agricultural issues such as biotechnology. While they sometimes are less newsworthy than the crisis of the day, how they are managed can have far-reaching consequences. This is why, after a meeting with Iowa farmers last year, the Secretary of State asked me to establish an Advisory Group on the international aspects of biotechnology to actively seek ideas and support. And that is why, in crafting a successful American foreign policy for this century, we should seek inspiration from the vision of Henry Wallace and the courage of Harry Truman Thank you. I am sure your deliberations will bring us closer to ensuring that biotechnology makes good on its global potential. |
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