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Statement by August
Schumacher, Jr.
Under Secretary for Farm and Foreign Agricultural Services
U.S. Department of Agriculture
Before the House Agriculture Committee
Subcommittee on Risk Management, Research and Specialty Crops
March 3, 1999
Mr. Chairman, members of the Subcommittee, it is a pleasure to appear before you with Jim Murphy from USTR to review issues involving products from agricultural biotechnology.
The Challenge–Feeding a Growing World
The world’s farmers and ranchers face two difficult challenges at the dawn of the 21st century: first, to grow more food at lower cost, higher quality, and greater variety than ever before; and second, to produce this abundance on a shrinking natural resource base amid growing concerns about the effect of agricultural practices on the environment.
Many countries, including the United States, are working vigorously to promote technological improvements to meet the need for food and fiber in the coming years. However, some have not matched their scientific advances with the necessary policy and regulatory adjustments. For instance, the U.S. Department of Agriculture is especially concerned about this problem in the European Union (EU).
As Secretary Glickman has said, we should consider these advances seriously and with an open mind. New products -- be they bio-engineered or not -- must meet the requirements of the law of the land and undergo rigorous testing and evaluation for safety. Our regulators do and must maintain an independent, arms-length relationship with the sponsors of these technologies. But as these products prove safe, we must use their immense potential to combat hunger and ensure a sustainable future.
The new techniques of biotechnology will be important to meet the world’s continuing need for increased and sustainable food production. However, we must put the use of these products in perspective. They are products with an array of tools that make up agricultural practices adapted to specific environments. This technology can lead to decreased dependence on chemical pesticides, increased yields, enhanced nutrient content, and reduced tillage and soil losses. Benefits include increasing biological protection against specific pests and diseases, thereby decreasing the need for synthetic chemical pesticides; augmenting plant tolerance to more environmentally safe herbicides; improving plant adaptability to harsh growing conditions, such as drought, salinity, and temperature extremes; and increasing yields to meet expanding world food needs.
Some people will always focus on the risks of new technologies. The concerns they raise are useful reminders that new technologies in food, medicine, transportation, communications, or anything else can pose risks. But we should remember that there are also risks in not taking advantage of the benefits that new technologies may offer.
No one dismisses legitimate concerns about safety, ethics, and values that biotechnology may raise. But neither should people be asked to go hungry for want of a higher yielding variety of corn, when all the evidence tells us it is as safe to produce and consume as any traditional hybrid.
Eighty percent of the additional wheat output in the developing world has come from genetically improved crops, while only 20 percent was the result of more land being planted. New corn varieties that resist both drought and acidic soil could feed an additional 50 million people per year and a biologically developed ‘super rice’ can yield as much as 100 million more tons of rice per year than is currently grown in Asia.
Genetic engineering and other agricultural biotechnology are among the most promising developments in modern science. By raising productivity and food production, agricultural biotechnology will reduce the need to cultivate new lands and could therefore help conserve biodiversity and protect fragile ecosystems.
We see in biotechnology and genetic engineering another set of tools through which agriculture can meet the demands of consumers for abundant, safe, nutritious, and affordable high-quality foods. Like any set of tools, we should use them wisely; that is one reason why we evaluate them before they are commercialized.
I would like to take a few moments to outline some of the challenges we are confronting around the world.
European Union
U.S. products from biotechnology face increasing barriers in the European Union (EU) market. Our problems are primarily two-fold: delays in product approval and burdensome labeling.
EU Approval Process: While in the United States, on average, a company can secure final regulatory approval for a product from biotechnology within 9 months of a company’s submission; the average EU approval takes 18 to 24 months.
The EU approval process has been problematic from the beginning. Political pressure to block products from biotechnology has increased in a number EU countries and member state objections to individual products have become the norm. As a result, this slow process has ground to a halt.
For example, even after EU scientific committee approval of products, member states like France have held up the approval of corn varieties for 6 months, effectively blocking the export of U.S. corn to the EU in 1998. As a result, U.S. corn growers lost $200 million in export sales in 1998, and face similar losses in 1999. In addition, with the exception of two carnation varieties, the EU has not approved any new products since August 1998.
EU Labeling Requirements: Implementation of the EU’s novel food legislation in 1998 is adding to the slowdown. This legislation contains labeling regulations that have added to the confusion. On September 3, 1998, the EU implemented mandatory labeling on foods containing genetically modified corn and soybeans. However, details still have not been provided to food processors as to how the regulation will be implemented: companies still do not know which products will be exempt, testing procedures for detecting products from biotechnology, or de minimus levels. Even companies that are trying to export products that are not genetically engineered are having problems. The EU has not established clear testing procedures that allow companies to demonstrate that their products are not bioengineered.
U.S. Actions: The United States has raised concerns about the EU’s labeling policy to the EU Commission and in the World Trade Organization’s Technical Barriers to Trade Committee. The United States has questioned the scientific basis of a number of these issues with the EU and finds many aspects of the labeling regulation ambiguous and impractical.
We continue to encourage the EU to evaluate genetically modified products using scientifically based analysis and to keep U.S. exporters informed of developments in the EU to help ensure that there is no disruption of trade.
In addition, we use every opportunity to educate EU officials and others about the U.S. regulatory process and product safety. Our agricultural counselors and attaches discuss these issues on a nearly daily basis with their counterparts, with regulators, the media, and consumer groups throughout Europe. USDA officials have met with EU member state regulators, given speeches at numerous European conferences, and even testified before the British House of Lords. We have invited groups of European decision makers, government officials, scientists, and journalists to come to the United States to meet with government officials, farmers who use the technology, company representatives who develop the products, and commodity buyers and sellers along the food handling process. In this way, Europeans can see for themselves how we regulate products from biotechnology, how broadly the technology has spread in the United States and why segregation of products from biotechnology from non-biotech products would be unnecessary, difficult, and expensive.
For the future, approval of products from biotechnology was one area identified under the Transatlantic Economic Partnership (TEP) process that could be improved through greater cooperation between EU and U.S. regulatory agencies. A TEP Biotech Working Group met for the first time on February 11 to begin discussing terms of reference for a pilot project that would lead to a comparison and, where possible, harmonization, of certain aspects of U.S. and EU member country regulatory review processes for transgenic plants.
Australia and New Zealand
Australia and New Zealand have been generally supportive of agricultural biotechnology and have regulatory frameworks that should facilitate evolution of the technology. However, Australian State Health Ministers recently asked the Australian/New Zealand Food Authority (ANZFA) to require labeling of all foods containing genetically modified material. New Zealand has historically shared the U.S. position that mandatory labeling for foods containing genetically modified materials should only be required when the food differs significantly from its traditional counterpart in its nutritional composition, use or handling. We will be working with our New Zealand counterparts to ensure that this change in policy does not adversely affect our exporters.
Asia
The Japanese government also has been supportive of biotechnology and has patterned its regulatory process after that of the United States. In fact, just last month, the Japanese Cabinet adopted an industrial revitalization plan that will encourage expansion in the fledgling Japanese biotechnology industry.
Until recently, Japan modeled its labeling policy for agricultural biotechnology products after that of the U.S. Food and Drug Administration. However, Japanese media and consumers are beginning to demand additional labeling. To date, the government has not made any decisions about requiring mandatory labeling. The Ministry of Agriculture, Fisheries and Food Committee charged with reviewing this issue has deferred a decision until June 1999. We will, of course, be monitoring this situation closely and our USDA staff in Japan will be working to address U.S. concerns with the Japanese proposal.
Other Asian countries are watching the actions of the United States, Europe, Japan, Australia and New Zealand while moving forward to establish their own regulatory frameworks. Singapore’s Ministry of National Development, for example, recently hosted a meeting for members of the Association of Southeast Asian Nations (ASEAN) to discuss risk assessment procedures and public awareness of agricultural products derived from biotechnology. The event was co-sponsored by the U.S. Department of Agriculture, the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency and the Canadian Food Inspection Agency.
Many Asian nations have active biotechnology research programs. For example, the Philippine Congress is seeking advice on how to market a broad range of products such as virus-resistant papaya and bananas, and coconuts with increased fatty acids.
Korea’s National Institute of Agricultural Science and Technology has developed transgenic rice that is resistant to bacterial leaf blight and is working to isolate genes associated with carotenoid biosynthesis in hot peppers.
USDA Efforts
In addition to the actions I described earlier, USDA has undertaken regular efforts to share information, conduct bilateral talks, and sponsor international symposia and workshops to facilitate international understanding of our regulatory process, the factors we take into account in conducting safety assessments, and our labeling policy. Although the roles of our regulatory and trade agencies are very distinct, we collaborate in the education of our trading partners on our regulatory process.
In Latin America, we have been working especially closely with Argentina and Chile. Argentina, like the United States, is intent on ensuring that agricultural trade rules do not unnecessarily impede the development and commercialization of agricultural biotechnology. In 1998, Argentina planted over 3 million acres with Round-up Ready soybeans and approved four BT corn varieties for planting.
In 1998, the United States launched binational consultative committees with Argentina and Chile. USDA participation in these commissions ensures that agricultural issues such as biotechnology are highlighted in discussions with these key trading partners.
The Organization for Economic Cooperation and Development (OECD) is a valuable international forum for building consensus on methodology for environmental and food safety review of genetically engineered products. Scientifically based regulatory approaches for transgenic crop plants have been developed for testing, and now for commercialization and international trade. A significant result of work in OECD has been the adoption of principles and approaches for environmental review of transgenic plants by other nations that are compatible with U.S. principles and assessment approaches. In addition, the OECD-sponsored BioTrack OnLine on the World Wide Web has made available information about field tests and commercial products and regulatory developments of OECD member countries concerning biotechnology, as well as documents produced by OECD. These documents are used by regulators, applicants, and in public education.
In West Asia and North Africa, biotechnology research and biosafety policies are just beginning to take shape. To aid in the education process, the United States and Egypt just last month co-sponsored a workshop in Cairo to inform key officials, researchers, producers, consumers, and local media about biotechnology and biosafety issues. As an outcome of this meeting, officials now have the foundation upon which to establish regional cooperation in addressing biosafety protocol issues and biotechnology research and development.
The United States is a key proponent of a biotech initiative under the Asian Pacific Economic Cooperation (APEC) forum. The United States has sponsored educational workshops aimed at harmonizing regulatory approaches to biotech products among APEC members. The establishment of the U.S.- Indonesia Food and Agricultural Forum insured continued dialog among senior public and private sector officials of both countries on issues related to food safety, genetically engineered products and trade. We see this as a model to engage the leadership of other countries in a continuing discussion of these important issues.
Biosafety Protocol
The latest round of negotiations of a Biosafety Protocol under the Convention on Biological Diversity took place just two weeks ago in Colombia. The goal of this protocol is to protect biodiversity, but it will also lay out requirements for the export and import of living biotechnology products. We have been working with other nations to ensure that the final protocol protects biodiversity, while at the same time does not erect any unnecessary barriers to trade. As a result of the efforts of the United States, Argentina, Australia, Canada, Chile, and Uruguay, the final protocol decisions will delayed at least one year, which we hope will allow increased understanding of these products and how they can be most effectively handled in international trade.
New Round of Multilateral Trade Negotiations
Along with our goals of eliminating export subsidies, reforming state trading enterprises, cutting tariffs, and tightening rules on domestic subsidies, we also have identified as a major objective during the next WTO round of negotiations the clarification of rules on technical barriers that unjustifiably restrict trade. The upcoming negotiations need to ensure that countries neither hinder nor prohibit imports of new products unless there are legitimate scientific concerns. Too often these actions are merely a guise to protect domestic agriculture from import competition and fail to adhere to the WTO principle that such measures be grounded in sound science. We will work through the WTO to encourage the adoption of international standards that facilitate trade while giving full protection to consumers’ health and safety. Consumers have the right to insist on such safeguards, and farmers, whether European or American, have the right to a level playing field.
Mr. Chairman, as you can see, we have a full plate of issues dealing with trade in products from biotechnology. I would be happy to answer any questions.
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