USDA AND BIOTECHNOLOGY What is biotechnology? Agricultural biotechnology is a collection of scientific techniques, including genetic engineering, that are used to create, improve, or modify plants, animals, and microorganisms. Using conventional techniques, such as selective breeding, scientists have been working to improve plants and animals for human benefit for hundreds of years. Modern techniques now enable scientists to move genes (and therefore desirable traits) in ways they could not before - and with greater ease and precision. How can biotechnology help farmers and consumers? Combating human diseases - The first biotechnology products were medicines designed to address human diseases. Insulin, used to treat diabetics, and blood clot-busting enzymes for heart attack victims are now produced easily and cheaply as a result of biotechnology. New research by USDA^s Agricultural Research Service (ARS) finds that transgenic animals may be a new source of valuable hormones and drugs to treat emphysema and infections in babies. Promoting human health - Researchers are creating ways to boost the nutritional value of foods using biotechnology. Combating animal diseases - Biotechnology helped produce a vaccine that protects animals in the wild against rabies and a vaccine for "shipping fever" of cattle, the biggest killer of beef cattle in feedlots. Fighting hunger by resisting plant diseases and increasing crop yields - Biotechnology can help farmers increase crop yields and feed even more people. For example, an ARS scientist used biotechnology to pinpoint a gene that could help wheat, a major food staple, grow on millions of acres worldwide that are now hostile to the crop. ARS scientists have also developed an experimental potato hybrid that contains genes to resist a new, more virulent strain of the so-called "late blight," the disease that caused the Irish potato famine in the 1840s. Helping the environment by reducing pesticide use - Biotechnology can help farmers reduce their reliance on insecticides and herbicides. For example, Bt cotton, a widely grown biotech crop, kills several important cotton pests. Which Federal agencies regulate agricultural biotechnology? The Federal government has a well-coordinated system to ensure that new agricultural biotechnology products are safe for the environment and to animal and human health. While these agencies act independently, they have a close working relationship. * USDA^s Animal and Plant Health Inspection Service (APHIS) is responsible for protecting American agriculture against pests and diseases. The agency regulates the field testing of genetically engineered plants and certain microorganisms. APHIS also approves and licenses veterinary biological substances, including animal vaccines, that may be the product of biotechnology. * USDA^s Food Safety and Inspection Service (FSIS) ensures the safety of meat and poultry consumed as food. * The Department of Health and Human Service^s Food and Drug Administration (FDA) governs the safety and labeling of drugs and the nation s food and feed supply, excluding meat and poultry. The Environmental Protection Agency (EPA) ensures the safety and safe use of pesticidal and herbicidal substances in the environment and for certain industrial uses of microbes in the environment. *The Department of Health and Human Service^s National Institutes of Health have developed guidelines for the laboratory use of genetically engineered organisms. While these guidelines are generally voluntary, they are mandatory for any research conducted under Federal grants and they are widely followed by academic and industrial scientists around the world. What is APHIS^s role in regulating biotechnology? APHIS is the government^s lead agency regulating the safe testing, under controlled circumstances, of biotechnology-derived, new plant varieties. A company, academic or research institution, non-profit organization or public sector scientist wishing to field test or move a biotechnology-derived plant must generally obtain APHIS approval before proceeding. If someone wants to test a biotechnology-derived plant, what do they do? Applicants ask APHIS for permission to allow field testing (environmental release). They provide information about the plant, including all new genes and gene products, their origin, the purpose of the test, how the test will be conducted, and specific precautions to be taken to prevent the escape of pollen, plants, or plant parts from the field test site. An APHIS scientific reviewer evaluates the possible environmental impacts of the proposed field test. The possible impact of new plant varieties on endangered or threatened species is considered. Non-target species, those not meant to be directly impacted by the new plant, are also taken into account. In an effort to streamline the permit process, most applicants can now use a simplified procedure in which they notify APHIS before they plan to move or field test a biotech crop. APHIS then has 30 days to review the notification prior to any testing. These field tests are still required to meet all the same safety standards as trials that are approved through the permit process. Are other precautions taken if testing is approved? If testing is approved, APHIS personnel and state agriculture officials may inspect the field test site before, during, or after the test to ensure that is conducted and managed safely. What is necessary for commercial production of a biotech plant? Generally, before a genetically engineered crop can be produced on a wider scale and sold commercially, its creators must petition APHIS for a "determination of non-regulated status," which requires the submission of more information than a field test permit request. APHIS must be provided scientific details about the genetics of the plant, the nature and origin of the genetic material used, information about indirect effects on other plants, field test reports, and even information unfavorable to the petition. All petitions are published in the Federal Register and the public is given time to comment. APHIS grants the petition only if it determines that the plant poses no significant risk to other plants in the environment and is as safe to use as more traditional varieties. What does "determination of non-regulated status" mean? This is a determination by APHIS that the new plant should be treated like any other plant and, therefore, may be grown, tested, or used for traditional crop breeding without any additional APHIS action. Essentially, this determination permits the plant to be widely grown and commercialized. Does APHIS regulate other actions with biotechnology-derived plants? Authorizations are also required for the movement into the United States or between states of any genetically engineered organism that is a potential plant pest. And, some developers of the very few biotech plants that are not regulated by APHIS may seek a voluntary courtesy permit, which may make it easier to move or field test the plant. How widespread are biotech crops? With APHIS approval, over 5000 field trials have been safely conducted since 1987. About 40 new agricultural products have completed all the federal regulatory requirements (from all relevant agencies) and may be sold commercially. They range from longer-lasting tomatoes to pest-resistant corn. USDA^s Economic Research Service (ERS) recently released the first government data on acreage of biotechnology-derived crops. The ERS report - available on the web at www.econ.ag.gov/whatsnew/issues/biotech - indicates that biotech soybean, cotton, and corn acreages have increased dramatically since the introduction of these crops in the mid-1990^s. They accounted for 20-44 percent of acreage planted in 1998. What is the role of the EPA? EPA approves new herbicidal and pesticidal substances. EPA also issues permits for large scale testing of herbicides and biotechnology-derived plants containing new pesticidal substances. In deciding whether to register a new pesticide, EPA considers human safety, the fate of the substance in the environment, the safety for humans, its effectiveness on the target pest, and any effects on other, so-called "non-target" species. What is the role of the FDA? FDA ensures that foods derived from new plant varieties are safe to eat, holding them to the same high standard of safety as any more traditional food product. Are products derived from biotechnology required to be labeled? Legal authority for food labeling rests with the Food and Drug Administration. Foods derived from biotechnology currently must be labeled only if they differ significantly from their conventional counterparts - for example, if their nutritional content or potential to cause allergic reactions is altered. In an effort to provide consumers with more information, Secretary Glickman actively encourages voluntary labeling of biotechnology-derived products. What about the recent monarch butterfly study? The recent study indicating that monarch butterflies in laboratory conditions may be harmed by eating pollen from Bt corn plants is provocative, raising concerns that biotechnology-derived plants might harm animals or the environment. However, it is important to note that this was a preliminary report, based on laboratory results, not results in the field. Even the study^s authors have cautioned against over-interpreting the results or concluding that Bt corn may pose a serious threat to monarchs. Indeed, the Bt in those corn plants was chosen in order to protect against damage from insects closely related to the monarch butterfly. And, the pesticides used on traditional crops to kill insects are known to harm butterflies, as well. There are a number of reasons that the effect of Bt corn pollen on monarchs is likely small. Corn pollen is produced for only a short time during the growing season. Corn pollen is heavy and is not blown far from corn fields by the wind. Farmers control the monarch^s primary host plant, milkweed, in and around their fields, just as they control other weeds. Finally, it is not known whether monarch butterflies will choose to feed on milkweed plants with Bt pollen when given the opportunity to choose other plants in the field. Bt crops and the Bt pesticide were evaluated for environmental safety by the EPA and by APHIS. Research reviewed by those agencies has confirmed the safety of Bt against a number of non-target animal species and its safety for food and feed use. However, USDA and EPA scientists have had discussions with the study^s researchers to learn more about ongoing experiments. And USDA scientists in Iowa are currently conducting follow-up studies. We are also working to identify follow-up information and research that would be useful to refine our understanding of how monarchs and corn pollen interact in the field. USDA is committed to further research on the potential impacts of new technologies in agriculture. Why has biotechnology become a trade issue? Some people may not feel comfortable with new technology. They may worry about environmental, social and economic consequences - real or simply feared. Particularly in Europe, these consumer concerns have led to a resistance toward biotechnology-derived plants and food, though not medicine. European consumer concerns may also be bolstered by a historic distrust in their governments^ ability to ensure the safety of the food supply after the "mad cow" scare and more recent dioxin contamination. Consequently, European governments have been slow to permit the importation of biotechnology-derived products, even if they have been proven safe to human and animal health and the environment. This has created friction with the United States and other trading partners, who believe sound science should be the basis of regulatory systems. The failure of other countries to develop consistent and science-based regulatory processes governing biotechnology has the potential to constrain scientific innovation and disrupt trade. USDA recognizes and appreciates differences in the political, social, and cultural situations in countries around the world. However, regulatory processes must be predictable and transparent if they are to be understood and trusted by industry and the public. Therefore, in the context of upcoming World Trade Organization negotiations, USDA would like to work with other nations to ensure that sound science is the cornerstone of any approval process. We also want to facilitate mutual understanding and harmonization of evaluation of risk for the products of biotechnology. What is USDA doing to promote public dialogue on the complex issues related to agricultural biotechnology? Agriculture Secretary Dan Glickman will soon appoint an Advisory Committee to provide him with advice on a broad range of policy issues relating to agriculture and biotechnology. This Committee will also help facilitate a public dialogue on biotechnology, ensuring the inclusion of diverse voices and ideas. The Secretary has also encouraged industry and consumer groups to seek more opportunities to engage in an open dialogue and exchange of ideas. What new policies did Secretary Glickman announce in his speech on biotechnology to the National Press Club in July? In the speech, available on the web at http://www.usda.gov/news/releases/1999/07/0285, Secretary Glickman announced several new measures: * Plan to establish regional pest management centers. USDA will establish 8 to 12 centers across the country to address regional pest management needs. Regions may be based on shared geography, ecology, weather, crops, pest problems, and related agricultural concerns. The centers will help evaluate biotech products over a long period of time, develop and share expertise, and provide information of an ongoing basis to growers, consumers, researchers, and regulators. USDA believes there is sufficient existing funding to begin developing the centers this year. However, it is likely that additional funding will be sought in FY 2001 to continue the effort. * An independent scientific review of USDA^s biotechnology regulatory system. On September 29, 1999, Secretary Glickman announced that USDA reached an agreement with the National Academy of Sciences (NAS) to undertake an independent, on-going, scientific review of USDA^s regulatory process for biotechnology-derived plants. NAS will establish a standing Committee of about 15 members to review various aspects of the USDA^s biotechnology regulatory process. In its first year, the committee will examine the environmental impacts associated with commercialization of biotechnology-derived plants and provide guidance on how best to assess and mitigate those risks. The Committee will also serve to rapidly address emerging scientific issues. * Requested reporting of adverse or unexpected environmental or agricultural effects of the biotechnology-derived plants. Such reporting will be requested in future guidelines and regulatory decisions even after a product has been deregulated. * Ensuring arm^s length regulation of biotechnology. The Secretary has ordered a review to ensure that USDA trade support and biotechnology regulation activities are kept separate from each other. --------------- The United States Department of Agriculture (USDA) is one of three Federal Agencies, along with the Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA), primarily responsible for regulating biotechnology in the United States. Products are regulated according to their intended use, with some products being regulated under more than one agency.

Uploaded: 2/21/2004