European Voice Conference Release No. 0108.99 Remarks As Prepared for Delivery by Deputy Secretary of Agriculture Rich Rominger European Voice Conference Brussels, Belgium March 18, 1999 "Thank you very much ... and my appreciation, on behalf of the United States, to The European Voice for sponsoring these proceedings, for giving us a forum to talk and debate and keep open the channels of understanding. While we may not have come with a consensus about new technologies, we have come with the understanding that this is the moment for economic and trading relations around the world and that the paths we take on biotechnology will influence those relations, maybe forever. "Those of us with responsibility for moving international agriculture toward that future would do well to pause and consider agriculture as one of our deepest ties. For me, as a California farmer and former head of Food and Agriculture for California a state recognized for its environmental leadership -- agriculture has always been a consuming interest. The family farm is a link to my heritage, to my great-grandparents who came from the Black Forest to settle in California. "From that rich soil and those foothills in California's great Central Valley, my sons ask the same questions being asked by all of us about agriculture and its responsibility to the future. Decisions they make ... decisions about pesticides, wildlife habitat, preserving wetlands, sustainable farming practices are made by farmers the world over every day, and are profoundly influenced by forums like this. Agriculture gives them the opportunity to help shape tomorrow's world, to produce enough for increasing populations and preserve the resource base on which to do it IF their governments promote an efficient global trade environment. "We are all here today with an appreciation for the way agriculture links us to the future, in ways more complex and profound than ever before. I doubt that there is one among us who is not struggling with the knowledge that the way we handle those connections and the choices we make will affect our farmers our economies and our ability to feed more people and feed them well. It's a great burden. "And we hope our approach is broad and wise enough to protect the resources of this planet we all call home so that it, in turn, can protect our children and their children. "In the United States, we have learned to listen to the wisdom of Native Americans. The Iroquois Indians teach that we're the keepers of seven generations. Our actions today affect seven generations. Our grandchildren's children what kind of world will they live in? "We are all asking the same questions. If we share a vision of a healthy, 21st century community of nations built on a foundation of free and fair trade, the issue is how to achieve it. It is the conviction of the United States that the answers lie in open markets ... in expanding commerce that closes the gaps between those who have and who have not ... and on the ability of governments to adapt their policies to strong demand growth and the changing dynamics of international trade. THE EU APPROVAL PROCESS " Adaptability and responsiveness stand behind the economic reform embodied by Agenda 2000. I want to note the leadership of Commissioner Franz Fischler and the EU's executive body in incorporating greater flexibility in the internal farm programs of the EU, an important step toward market orientation. This sense of flexibility, innovation and the need for regulatory balance must be brought to the controversial matter of agricultural biotechnology. "We are extremely concerned about the status of the EU approval process for biotech products. I will be candid. We have waited for the EU to exercise leadership and deal systematically with the issues and opportunities posed by modern biotechnology. We have witnessed two years of deliberations within the Community to achieve consensus on approval and labeling policies. "On the matter of the EU biotech approval process, to use an American phrase, we are bending over backwards to understand your situation. We understand that there is no Community-wide regulatory system that parallels the U.S. system. The BSE outbreak in Europe seriously undermined public confidence in scientific assurances and heightened anxieties about food safety. Anti-biotech groups are active and vocal in several countries. Austria and Luxembourg still maintain unilateral bans on biotech products that have been approved by the EU Commission. "In the U.S., it takes an average of nine months for a biotech product to pass through the regulatory process. In the EU, that time frame is 18-24 months for approval to be granted, and the process is not open, transparent, or predictable. As a result, European companies are discouraged from developing varieties helpful to European farmers and consumers miss out on the benefits of biotechnology. "While we welcome proposed changes that will lead to a more predictable system, the U.S. is concerned about some of the proposals for revising the EU approval process for biotech products. It's essential that revisions of Directive 90/220 work toward a safe, open and transparent system with sound science as its base. "For the U.S., in the short term, the EU's lengthy, complex process costs us money -- about $200 million last year in lost corn exports to Spain, Portugal and other EU members. And since several U.S. biotech corn varieties remain unapproved in the EU, it's entirely possible that we won't export any corn to the EU this year. BENEFITS OF BIOTECHNOLOGY IN THE LONG-TERM "But our deeper concern is for the long-term, and the critical need to establish a scientifically sound and open system. If there is any skepticism about that need, consider the numbers and the people behind those numbers ... 75 million more mouths to feed each year. Experts say the global demand for food will triple in the next 50 years. And much of that growth will take place in the poorest countries. "Add to that the fact that yields on the main grain crops chiefly wheat and rice -- may be leveling off. Scientists tell us that in the developing world, 80 percent of the recent growth in wheat production has come from increased yields... only 20 percent from more planted acreage. More than half the world's fertilizer use is in developing countries. India and China now irrigate half the grain they grow, but new irrigation projects face barriers of all kinds technical, environmental, financial. And land is finite, especially in Asia. "The fact is that we must feed another 1.5 billion people in the next two decades without any more land. New research techniques and products, like biotechnology, offer this promise. But technology is outpacing bureaucracy. Technology's ability to innovate and develop new products is outrunning the ability of government regulatory processes to assess these products and deal with the political pressures surrounding them. The result is a dazed and uninformed public. Not understanding the technology, and unable to look to their governments, consumers in too many countries are unable to sort good information from bad. "To the U.S., facts and numbers like these are a mandate, a global call for responsible stewardship. One of our greatest statesmen and humanitarians, the late Vice President Hubert Humphrey, said that, "The oppressed people of the world, the downtrodden and the helpless, do not aspire to a trip to the moon. They seek a safer and better journey through life." "That is something we have within our capacity to give. By bridging the gap between the staggering population numbers and the constraint of limited land and water resources, we have the potential to deliver the quantum leaps in yields that the next half-century demands ... the kind of progress that U.S. agricultural research made possible in the past half-century. "In 1942, someone brought a rotten cantaloupe into a USDA researcher in Illinois, who was an expert on the nutrition of molds. Today, his portrait hangs alongside Thomas Edison's and the Wright Brothers' in the Inventors Hall of Fame. The name Dr. Edward Moyer may not be as familiar as Alexander Fleming, who discovered penicillin. But it was Moyer who unlocked the mystery of how to mass produce it -- giving the world a miracle cure for common infections just in time to save many allied soldiers wounded on D-Day. " In 1945, a USDA agronomist who was part of General MacArthur's occupation force in Japan spotted a hearty, short strain of wheat that he did not recognize. He brought some seeds home, took them to a USDA lab inWashington state. They did some more work, then sent their research and the seeds along to CIMMYT, the international wheat research center in Mexico. The eventual result? Norin 10, the gene that launched the green revolution, enabling countries like India and Pakistan to increase their wheat harvests by 60%. At CIMMYT today, there's a shrine to Norin 10 with this inscription on the wall: a single gene has saved 100 million lives.' No hospital in the world can make that same claim. But now we must shed any notion that traditional research techniques will stand by us in the next half century. They won't their returns are diminishing. Here on this continent that gave us Dolly, the cloned sheep, we must remember that science must serve humanity, never the other way around. "As President Clinton has said, "If the last 50 years were the age of physics, the next 50 will be the age of biology ... where once nations measured their strength by the size of their armies and arsenals, in the world of the future knowledge will matter most." THE U.S. EXPERIENCE IN BIOTECH REGULATION "And I can tell you that knowledge brought directly to the people has been the starting point for all biotechnology in the U.S. "American consumers are as deeply concerned about the safety of their food as Europeans. So we made their needs, their demands, and their right to know central to the U.S. regulatory process. "More than a decade ago, when we began developing policy on agricultural biotechnology, we recognized that consumer confidence in the integrity of the regulatory system would be the final arbiter of public acceptance of biotech products. "Without qualification, that system has been grounded in the most demanding, scrupulous science. In 1986, we defined the regulatory path for testing and commercializing biotech products as they move from lab to field to marketplace. Decisions are based on rigor in analysis and sound scientific principles. Three federal agencies the Food and Drug Administration, U.S. Department of Agriculture, and the Environmental Protection Agency have authority over the use of biotech products in the United States. No product may be used without meeting strict government requirements. Our process is open and inclusive. We hold public meetings with scientific advisory panels. We post information on products under review on a web site to keep people fully informed. "Existing U.S. laws on environmental impact, pesticide and chemical use, and food safety provide the solid framework for testing biotech products .... assessing their safety for people and animals and the environment. "As a result, transparency, consistency, and independence mark the U.S. biotech regulatory system. And we have an educated public confident in its government, in its regulatory processes, and in the products of biotechnology because they've watched it happen and participated. "They understand that from the time Gregor Mendel started cross-pollinating peas in the 1800s, virtually all food has been improved genetically by plant breeders. "They understand the exciting environmental benefits that biotech products have to offer. They increase crop yields, cutting back on the land needed to grow food. Insect-resistant plants mean fewer pesticides. They offer biological protection against specific pests and diseases, meaning less dependence on synthetic chemical pesticides and a boost in plant tolerance for environmentally safer herbicides. As biotechnology improves plant adaptability to harsh growing conditions -- such as drought, salinity, and temperature extremes -- it holds out the promise of increasing production to meet the growing number of mouths to feed. "The American people understand these things, and they welcome advancement ... like last month's announcement coming out of the University of Newcastle in England and Dartmouth College in the U.S. By isolating a gene controlling the iron in plants, researchers may have taken that critical first step toward solving one of the world's most serious nutritional problems iron deficiency. The World Health Organization estimates that 3.7 billion people worldwide suffer from iron deficiency a problem so grave it's called "the hidden hunger." This is just a start toward helping farmers grow iron-rich plants, but it's one more example of the extraordinary research taking place in laboratories around the world. "The American people welcome this kind of advance. They accept biotechnology because unbiased, scientific information has addressed their legitimate questions. To gauge public acceptance, just look at the numbers. Until a few years ago, not a single genetically-engineered crop was planted for commercial use. By 1998, in the U.S., about 40 percent of the soybeans planted, a quarter of the corn crop and a third of the cotton crop, were products of biotechnology. In the U.S., more than 30 transgenic crops have been approved. "But don't confuse acceptance with complacence. Americans are as skeptical about change and as demanding about safety as Europeans. But once satisfied that the science is sound, they recognize that not moving to the next plateau of human achievement is a step backward. They recognize that focusing only on risk and not on benefits, with the urgency of 21st century needs pressing upon us, is the riskiest business of all. "About moving forward, a salute to the leadership of Belgium. The Belgian biotech industry of over 50 companies invests more than 8.5 billion francs each year in research and development. BIOSAFETY PROTOCOL "One of the thorniest issues in the biotech debate is the impact of living modified organisms on biodiversity. Since the Swedish botanist Linnaeus published his system for classifying living things in the mid-1700s, taxonomists have identified between 1.5 million and 1.75 million species ... with many more yet to be named and described. "On behalf of that biodiversity, more than 130 nations were represented last month at negotiations on a Biosafety Protocol in Cartagena, Columbia. Their goal was to finalize a protocol to the Convention on Biological Diversity. After 10 days of discussion on extremely complex matters, delegates failed to reach consensus on key issues and the negotiations were suspended. "We feel the discussions served a purpose by clarifying major points and narrowing differences. Our goal is a protocol that will protect biological diversity and the environment without encumbering the trade of biotech products with unnecessary restrictions, and we feel this is still possible. We should focus on those biotech products posing the greatest risk to biological diversity We must help developing countries make informed decisions, and encourage nations to keep an open dialogue on introducing living modified organisms into the environment. And we must achieve a protocol that fosters continued, vital research in biotechnology. . "We have so much yet to learn about the earth's fragile web. As the National Geographic pointed out last month, "Life, we now know, flourishes from the canopies of the tropical forests to the deserts of Australia to the hot volcanic cracks in the bottom of the seas. This great diversity sustains human life, maintaining the most fundamental resources air and water. It also gives the opportunity to make wonderful, life-changing discoveries. For instance ... a microbe harvested from Yellowstone's hot springs has provided the perfect enzyme for mass-producing DNA, leading to today's boom in genetic research. A wild species of maize promises to reinvigorate corn crops. The natural world thus stretches before scientists like the uncharted seas of old, and researchers puzzle over what they know and don't know like sailors stepping ashore on a new land." CONCLUSION "What we do know is that millions already benefit from genetically modified products. As we move into the next century, we must push forward the frontiers of science and knowledge for medicines and vaccines, an abundant food supply, an environmentally friendly agriculture. The ability of the world's producers to feed growing populations hinges on the ability of governments to foster an efficient global trade environment. As we go into this year's WTO talks, with the goal of a free and fair world trading system, we owe this to agriculture. And as traditional trade barriers begin to fall, we owe it to consumers to see that food safety does not become the next trade battleground. Science is doing its job. Producers are doing theirs. It is time now for governments to do their part for a sustainable future. A balanced regulatory environment calls for science-based resolutions to biotech differences, educated consumers, and the embrace of what has been proven as progress and the next step in human achievement. Thank you".